1 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES 2 SECRETARYS ADVISORY COMMITTEE ON HUMAN RESEARCH PROTECTION 3 MEETING 4 TUESDAY JULY 27, 2004 5 6 The Advisory Committee met in the Franklin Room in the Sheraton Four Points Hotel, 1201 K Street, N.W., 7 Washington, D.C., at 8:30 a.m., Ernest Prentice, Ph.D., Chairman, presiding. 8 9 PRESENT ERNEST D. PRENTICE, Ph.D. Chair 10 BERNARD A SCHWETZ, D.V.M, Ph.D. Acting Executive Secretary CATHERINE SLATINSHEK, M.A. Executive Director 11 THOMAS L. ADAMS, CAE Member MARK BARNES, J.D., L.L.M. Member 12 CELIA B. FISHER, Ph.D. Member E. NIGEL HARRIS, M. Phil., M.D., D.M. Member 13 NANCY L. JONES, Ph.D. Member FELIX A. KHIN-MUANG-GYI, Pharm. D. Member 14 SUSAN KORNETSKY, M.P.H. Member MARY L. POLAN, M.D., Ph.D., M.P.H. Member 15 SUSAN L. WEINER, Ph.D. Member 16 Ex Officio Members HOWARD L. BRADLEY Social Security Administration 17 FRANCIS X. BRICKFIELD Central Intelligence Agency FRANCIS D. CHESLEY, M.D. Agency for 18 Healthcare Research and Quality ROGER CORTESI U.S. Environmental Protection Agency 19 PATTY DECOT U.S. Department of Defense HELEN DERAMOND U.S. Department of Education 20 SUZANNE GAYNOR U.S. Department of Housing and Urban Development 21 DAVID LePAY, M.D., Ph.D. Food and Drug Administration 22 AMY P. PATTERSON National Institutes of Health NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 2 1 DAVID SHORE National Institutes of Health 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 3 1 I-N-D-E-X 2 Page 3 Additional Business 3 Ernest Prentice, Ph.D., Chairman, SACHRP 4 Social and Behavioral Research Issues Panelists 7 5 Michael Fendrick, Ph.D. 9 6 Institute of Juvenile Research University of Illinois at Chicago 7 Karen Hegtvedt, Ph.D. 22 8 Department of Sociology Emory University 9 Joan Sieber, Ph.D. 42 10 Professor of Psychology, Emerita California State University, Hayward 11 Philip Rubin, Ph.D. 55 12 Haskins Laboratories 13 HIPAA Presentation on Issues Mark Barnes, LLD 111 14 Subpart B Overview 15 Ernest Prentice, Ph.D. 170 Nancy Jones, Ph.D. 172 16 Mary Lake Polan, MD., Ph.D., M.P.H. 175 17 18 Discussion of Issues 19 Ernest Prentice, Ph.D. 196 20 21 Public Comment 245 22 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 4 1 P-R-O-C-E-E-D-I-N-G-S 2 8:35 a.m. 3 DR. PRENTICE: On the record. Good morning, 4 everybody. Lets get started if we may. Welcome to the second 5 day of the Secretarys Advisory Committee on Human Research 6 Protection meeting. We had a productive day yesterday and I 7 look forward to the same today. 8 This is what were going to be doing. Well take 9 some additional business between now and 8:45 a.m. The were 10 going to move into the Social Behavioral Research Panel. We 11 have four speakers who have graciously agreed to come and 12 speak to us today. Ill introduce them as we convene that 13 panel. We will then have a break. 14 Well move into the HIPAA presentation once again 15 and Mark Barnes and Susan Kornetsky will present the revised 16 recommendations that we considered yesterday. Well move into 17 lunch and then were going to have a Subpart B Overview which I 18 will present. I have two colleagues which will assist me 19 particularly in terms of clarifications, Nancy and Mary Lake 20 Polan. 21 Then between 2:00 p.m. and 3:00 p.m., we will 22 have discussion of various issues, future activities of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 5 1 SACHRP. Well have another public comment period and then 2 hopefully, were going to be able to adjourn by no later than 3 4:00 p.m. I recognize that some of you have airplanes to 4 catch. 5 The next SACHRP meeting will be on October 4 and 6 October 5, 2004. Were currently trying to establish our 7 meetings for 2005. So you are all invited to attend that 8 meeting. 9 Now in terms of additional business, we have two 10 items. One is the approval of the minutes from the last 11 meeting, March meeting. I assume that youve all read them. 12 May I have a motion? 13 MR. BARNES: So moved. 14 DR. PRENTICE: Second? 15 DR. WEINER: Second. 16 DR. PRENTICE: Any discussion? All those in 17 favor? 18 (Chorus of ayes.) 19 DR. PRENTICE: Any opposed? 20 (No response.) 21 DR. PRENTICE: Any abstentions? 22 (No response.) NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 6 1 DR. PRENTICE: Motion carries. Thank you. Now 2 I have a task that in some respects gives me pleasure and 3 other respects does not because unfortunately, were going to 4 be losing one of our members and I regret that. On the other 5 hand, Im enviously because of where he is going. Nigel, would 6 you please come up here? 7 Nigel Harris, as you know, is a member of SACHRP 8 and Nigel is going to be the Vice Chancellor at the University 9 of West Indies. You all know where that is. And I dont know 10 if you know what a vice chancellor of that particular 11 university is, but its basically the equivalent of being a 12 president of a university in the U.S. So we regret that youre 13 going there, but we understand perhaps why. Wed like to ask 14 you to invite us to have our next SACHRP at the University of 15 West Indies. 16 Now I have a letter here from Secretary 17 Thompson. If I may, Id like to read it to you. Dear Dr. 18 Harris: I would like to thank you for serving as a member of 19 the Secretarys Advisory Committee on Human Research 20 Protection. You have provided a valuable service to the 21 Department during your tenure as a member of the Committee. 22 The advice and counsel you provided have been a significant NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 7 1 contribution to enhancing the focus of the Department to 2 better address the concerns and issues impacting the 3 protection of human subjects in research. Your dedication and 4 loyalty to working on matters impacting this important area of 5 public health are greatly appreciated. 6 Good luck in your future endeavors. Although 7 you have accepted another position that will prevent you from 8 continuing as a member of SACHRP, it is hoped that we may be 9 able to call upon you for further assistance and advice if the 10 need arises. Signed, Tommy Thompson, Secretary of HHS. Thank 11 you for your services, Nigel. And from the Secretary of HHS, 12 there is a token of his and our appreciation. Perhaps you 13 would like to open the wrapping. 14 DR. HARRIS: Im not very good at this. Thank 15 you. The U.S. Department of Health and Human Services, my 16 name, presented in appreciation of the service you provided as 17 a member of the Secretarys Advisory Committee on Human 18 Research Protection, January and it gives the date. 19 Just to say a quick word. Thank you so much. I 20 think this has been a very, very useful experience and 21 certainly, I have always valued the opportunity to give some 22 little contribution and to meet such great people such as you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 8 1 are. I really do hope that you take us up in coming to 2 Jamaica. 3 DR. PRENTICE: Okay. Before we begin, I would 4 encourage people to please turn off their cell phones if they 5 could. Next, were going to move into the Social and 6 Behavioral Research Issues Panel. As you all know, there has 7 been concern expressed by a number of investigators who are 8 engaged in social and behavioral research that sometimes the 9 Common Rule is misinterpreted, applied in unreasonable ways 10 that could be perhaps construed as inhibitory towards the 11 conduct of important research. 12 Weve had requests from a number of individuals 13 as well as organizations to actually convene a panel to 14 discuss this particular issue. So with the assistance of 15 Celia Fisher, we have organized such as panel and invited 16 presenters to come and talk to us about what some of the 17 issues are. We have four presenters. Ill introduce each of 18 them individually as they come up and I would engage each 19 presenter to confirm their comments, their presentations, no 20 more than 20 minutes please. Also hold all questions until 21 the end and then we will address the panel at that particular 22 time. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 9 1 You also have the detailed biographical sketches 2 of each speaker. So in the interest of time, Im not going to 3 go through obviously the entire bio. I will simply tell you 4 who they are and allow you to read for yourself their 5 accomplishments in their fields. 6 The first speaker is Dr. Michael Fendrich who is 7 an Associate Professor of Psychology in the Department of 8 Psychiatry, Institute for Juvenile Research at the University 9 of Illinois in Chicago. Dr. Fendrich, would you please come 10 up? By the way, you may stand anywhere you wish, either at 11 the computer or at the table or whatever is your preference. 12 DR. FENDRICH: I am going to speak to you this 13 morning without getting in the way of my slides both based on 14 my experience as an IRB (Institutional Review Board) Chair in 15 a Behavioral Science IRB as well as an active researcher who 16 has done survey research as well as a citizen who experiences 17 everyday life and notices what I encounter in everyday life. 18 So let me get underway on the first slide. 19 This is actually related to my everyday life 20 experience. Im even on my way here I think I surveyed that I 21 liked the quality of the food at a specific restaurant that I 22 visited. The average person is literally bombarded with NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 10 1 surveys every day. You get them everywhere, on-line when you 2 visit various venues, shopping malls. 3 We know as part of our everyday life experience 4 that we dont have to participate in these surveys. Most of 5 them are pretty harmless. Most of them we sometimes ignore 6 these surveys. Sometimes we dont ignore them. Sometimes we 7 cant ignore them because what we can do may or may not be 8 contingent on whether we ignore those surveys. 9 And some surveys are actually sensitive. We 10 talk in behavioral sciences about sensitive questions. If you 11 look at the next slide, its an example of a survey with what 12 we might consider to be sensitive questions. Ill just walk 13 through these questions. This is from a widely-used survey. 14 This isnt the first question on the survey, but 15 Ive abstracted several questions from the survey. Usually you 16 lead up to these kind of questions. The first question is In 17 the past 12 months have you had sexual contact with anyone who 18 has HIV/AIDS or has had a positive test for HIV/AIDS virus? 19 Have you had sexual contact with a prostitute or anyone else 20 who takes money or drugs or other payment for sex? Have you 21 been in juvenile detention, lock-up, jail or prison for more 22 than 72 hours? NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 11 1 And then on this same survey for males, From 2 1997 to the present, have you had sexual contact with another 3 male even once? Then the surveys asks other questions on 4 this. Have you ever had positive tests for HIV/AIDS virus? 5 Have you used needles to take drugs, steroids or anything not 6 prescribed by your doctor? 7 Now I ask questions like this in my research, 8 but this is one particular study. Its not mine. Or its one 9 particular survey. The next slide, Ill tell you what this is 10 from. These questions were abstracted actually from FDA 11 website. It was excerpted from standard long form blood 12 donation screening questionnaire which actually many of these 13 questions have been in use for quite some time, but they are 14 proposing this as a standard questionnaire for blood banks. 15 So as I said, since 1980s, many of these questions have been 16 widely used. 17 Actually go back to the last slide. Im sorry. 18 I skipped right ahead. The first question I wanted to ask is 19 Are surveys, interviews, research studies using such questions 20 more than minimal risk? This is sort of the regulatory issue 21 simply because they include such questions. I skipped that 22 slide. Lets go to the next one that I was just talking about. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 12 1 Ill tell you some more. Sorry to jump around 2 here. So blood banks have been screening for these risk 3 behaviors since the 1980s. I was trying to get an estimate as 4 to how many people have been exposed to questions like this. 5 What we do know is that eight million different people a year 6 estimated donate blood and may have to go through these kinds 7 of screening questionnaires just to donate blood. 8 Basically, millions of people have answered 9 questions like these. How many million? I was trying to get 10 a good estimate. Maybe up to 40 million, I dont know. Its a 11 ballpark, but its hard to get that estimate. But millions of 12 people have answered questions like this. I know I have when 13 trying to give blood right after 9/11 and this was the first 14 thing I was encountering and it was right around the time a 15 survey of mine was going through IRB review. 16 Okay. Definition of minimal risk on the next 17 slide. So in the definition from the 45 CFR 46, probability 18 and magnitude of harm or discomfort anticipated in the 19 research are not greater in and of themselves than those 20 ordinarily encountered in daily life or during the performance 21 of routine physical or psychological examinations or tests. 22 So we go back to this questionnaire that millions of people NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 13 1 are exposed to or answer in the process of giving blood if we 2 go to the next slide. 3 So by definition, simple expose to these kinds 4 of sensitive questions cannot be more than minimal risk since 5 for millions of people, millions of Americans, they are 6 ordinarily encountered during the process of giving blood. 7 These questions are part of a routine screening test. You 8 could go over other scenarios where people are encountering 9 questions and information and bombarded with these kinds of 10 sensitive behaviors, but this is one which is very commonly 11 encountered and experienced. Next slide. 12 So we are asked for suggested guidance. I would 13 say as part of an IRB both as somebody who submits proposals 14 and protocols and as somebody who reviews proposals and 15 protocols I think we have to be clear that the sensitivity of 16 the question should never be the sole basis for IRB 17 determination of risk level in a research study. Thats the 18 first point I want to leave you with. 19 We go to part two of this. So were talking 20 about informed consent here and the regulations describe eight 21 basic elements of informed consent. Some of these elements 22 are completely irrelevant to behavioral research or lets say NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 14 1 to observational, cross-sectional, behavioral survey research 2 like this element that Ive illustrated here, disclosure of 3 appropriate alternative procedures or courses of treatment, if 4 any, that might be advantageous to the subject. Thats one of 5 the elements that should be in an informed consent process. 6 Its irrelevant to most behavioral survey research. Next 7 slide. 8 But I would argue that not only are the elements 9 unnecessarily but some of the elements are counterproductive. 10 That is they undermine the research without protecting the 11 subjects. Lets go to the next slide. 12 Again, this is from 45 CFR 46.116. It says, The 13 following information shall be provided to each subject and 14 the item two is a description of any reasonable foreseeable 15 risk or discomforts to the subject. Item number five, A 16 statement describing the extent, if any, to which 17 confidentiality of records identifying the subject will be 18 maintained. So a parenthetical note on second point, even the 19 wording of that and for behavioral researchers, its a very 20 medical wording on Item number five. Were talking about 21 records, confidentiality of records, and survey researchers 22 those arent records. They are surveys. Next slide please. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 15 1 This is really small, but this is based on 2 experience reviewing what IRBs have required and requested. 3 Statements regarding confidentiality along with hypothetical 4 scenarios in which confidentiality will be breached. So these 5 are typical template statements, statements that appear that 6 IRBs often request that appear in consent documents. 7 All information we kept confidential unless we 8 noticed child abuse. In that circumstance, well have to 9 report you to the authorities since we are required by law to 10 do so. Now this type of clause, at least at one institution, 11 has become very common in consent documents for observational 12 research with mother/child diets. Its almost becoming 13 normative. Its not in the template. 14 But boards may ask, For parents and children, 15 are interactions being observed in some way? Well, we have to 16 tell them this. Okay, this is a very low probably scenario 17 and there are many other low probability scenarios. By the 18 way if were going to think about dangerous scenarios that need 19 to be put in as exceptions to confidentiality, we could 20 probably insist that they be put in as well. 21 But this one seems to have taken hold and I 22 would say if its extremely rare, why do we mention this? The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 16 1 statement itself may be threatening. Now should we be 2 concerned about the fact that a statement in a consent 3 document should be threatening? Well, I actually dont know. 4 There isnt a lot of research on peoples reactions to these 5 kinds of statements, to this specific statement, I should say. 6 Lets go to the next slide. 7 Another type of thing that we insist often in 8 IRBs that researchers do is that they speculate on the kinds 9 of things, kinds of reactions to be specific, that the 10 exposure to these kinds of questions may cause. So for 11 example, typical statements are Participation in this project 12 may cause you anxiety or discomfort, emotional discomfort. If 13 you need help as a result, we will provide you with access to 14 counseling. Thats always important. 15 You may feel uneasy or threatened by questions 16 that we ask. You may be embarrassed, uneasy or uncomfortable 17 about all or some of the questions we ask. These are warning 18 labels. We are insisting that people put these kinds of 19 warning labels on many surveys. Next slide please. 20 As a survey researcher, Im interested in finding 21 out how threatening are people finding these kinds of 22 questions and basically question threat clearly varies by NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 17 1 study population, person, location, mode of administration, 2 date of interview, etc. I have some data from my own research 3 on this because we ask people about their use of drugs and 4 other sensitive questions. 5 At the end of the survey, we ask these people 6 who have completed this survey through self-administrations, 7 private, the drug questions are administered privately and 8 then after the survey, the interviewer asks the respondent How 9 threatening did you consider the drug related in the survey to 10 be where one is not at all threatening and seven is very 11 threatening since the recent study we did and basically the 12 overwhelming majority felt that this was not at all 13 threatening. Now if you can believe what people say, but 14 thats basically just on empirical data alone. People didnt 15 find these somewhat sensitive questions very threatening at 16 all. 17 In general what I found from my research is that 18 reactions of extreme discomfort or embarrassment, the things 19 that we were warning people that they may experience, really 20 have very little empirical basis. They are extremely rare. 21 Next slide please. 22 I want to just give you the context that were NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 18 1 working in. Now we told - The first slide I told you were 2 literally bombarded with surveys every day. And most people 3 as a matter of course ignore surveys. But when were in the 4 business of research in behavioral sciences, in universities, 5 there are these parameters that were facing that really 6 undermine the validity of our work. First of all, most of the 7 surveys have no individual benefit. We may compensate people 8 for participating, but benefit is to society. There is no 9 individual benefit. 10 Now the other parameter is the declining rate of 11 survey participation which is an issue thats been widely 12 discussed in the survey field. Theres been a lot written 13 about it, but thats what we face in research. If you look at 14 this whole risk/benefit issue, the lower the response rate the 15 lower social benefit of the survey the lower the validity. We 16 want to generalize our research findings to the population. 17 Its hard to do that when participation is low. 18 I think the final point is - There are some 19 general considerations. I think we skipped ahead is what 20 happened. Theres one point I want to leave. Frontloading 21 with warnings about rare events and inclusion of vetting 22 unnecessary elements including documentation or signature may NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 19 1 discourage participation in the survey. So we are faced with 2 a situation where there is a lot of this front-loading 3 occurring, but were in an environment where participation is 4 an issue to begin with. 5 Now I want to go to the NRC report. It should 6 be the next slide. Yes. The National Research Council report 7 was published in 2003. They found that in a review of IRB 8 websites at 47 major research institutions that 28 percent do 9 not indicate that statements about irrelevant elements of 10 informed consent can be omitted from the consent document and 11 nine percent required that statements about all of the basic 12 elements be included in the consent document. 13 Exceptions in some institutions, in many 14 institutions, are rare. Waivers which are perfectly allowed 15 by the 45 CFR 46, they are not occurring and they are 16 exceptional, but these exceptions are often routinely as a 17 matter of course being disallowed. 18 So as a suggested OHRP guidance no. 2, this is 19 guidance. We asked for suggested guidance and as an IRB 20 member, I see these things as being necessary. Its a 21 personal, not an institutional, opinion, but IRBs should be 22 told. They should be reminded that minimal risk social NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 20 1 behavioral research is often most appropriate to waive certain 2 elements. I should say certain elements of informed consent. 3 What elements? Those are unnecessary specific 4 statements relevant to clinical research settings should be 5 omitted wherever possible so that the irrelevant statements 6 that I spoke about before. I think IRBs need to be reminded 7 that these waivers of certain elements should be occurring. 8 And then in the absence of relevant, empirical 9 evidence, specific statements about question risk and reaction 10 should generally be omitted from consent documents. In other 11 words, we have to talk here about the issue of warning labels 12 and IRBs, I think, may need to be reminded that sometimes 13 these warning labels that we have become part of our template 14 of informed consent may need to be omitted. 15 Then the other thing, this is out of the NRC 16 report and were talking about templates. As many institutions 17 are moving in that direction for a number of reasons including 18 the computerization of the application process, templates are 19 becoming more normative, but we need some examples and 20 templates of appropriate informed consent for this type of 21 research that follows best practice and these kinds of 22 templates and these kinds of standard ways of handling ways NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 21 1 minimal risk behavioral research that is survey research need 2 to be widely disseminated. Thats all I have to say. 3 DR. PRENTICE: Thank you, Michael. The next 4 speaker is Dr. Karen Hegtvedt. Dr. Hegtvedt is from Emory 5 University where she is an Associate Professor of Sociology. 6 DR. HEGTVEDT: First of all, I would like SACHRP 7 for inviting us to come and talk to you about behavioral 8 science issues. I want to give a word on my background too. 9 Im trained as an experimental social psychologist. Im in a 10 Sociology Department, but what Im going to talk about a whole 11 lot today is qualitative methodology. So Im not really 12 speaking out of my self interests and I study issues of 13 justice and legitimacy which I think are increasingly relevant 14 for IRBs operate and how investigators come to comply. But Im 15 not going to give the theoretical speech that Im saving for an 16 October meeting. Ive been on the IRB, chairing the IRB for 17 the last four years and participating in various committees 18 and workshops as my second job in addition to doing teaching 19 and researching, the normal routines that college professors 20 do. 21 What Im going to start with today are two 22 examples of looking at how in general terms the regulations NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 22 1 can be seen as reasonably invoked or unreasonably invoked. 2 The first is a study that was reviewed during, what I refer to 3 as, the dark age of our committee. It was a study by a 4 historian and he was going to Brazil. He was studying ethnic 5 groups in Brazil, specifically the Japanese. He just wanted 6 to have some brief conversations with people also using the 7 archives. 8 Well, we put him through the wringer because he 9 didnt want to get written documentation of consent and we were 10 incensed by this. How could he not do that? So we sent the 11 proposal to full blown IRB and ultimately we waived written 12 documentation of consent, but he had to go through a lot of 13 fiery hoops to get his approval. I have since apologized to 14 that investigator. 15 But then this May, I reviewed another study and 16 one would argue that this woman from Public Health who was 17 studying Yardonga (PH) which is distress and she said she 18 wanted to study it in rural Mongolia, did beautiful consent 19 forms, maybe not written at the eighth grade level. They were 20 very formal. All the details, all the elements of consent 21 were there and she wanted their signatures on a piece of 22 paper. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 23 1 I paused when I saw this because I realized this 2 is a post-Soviet era country. This is a rural population. 3 Whats the literacy rate here? So what I did was I called one 4 of my colleagues in history who studies this area and he said, 5 Oh my God, dont let her do that. So I wrote a letter that 6 said gently, You need to change this. This is not going to 7 fly in this situation for the following reasons. I gave her 8 suggestions on how she might more suitably seek consent and 9 indeed when she got in the country, she realized oh, yeah, 10 those documents werent going to fly. So during what I refer 11 to as our period of enlightenment, we recognized the 12 flexibility inherent in the regulations. 13 Here are a couple of lessons here that if we 14 take the regulations literally and apply them as the letter of 15 the law, we may discourage PIs (primary investigators) as in 16 the first case. Although I apologized to this historian, he 17 still grimaces every time he hears those letters IRB. And in 18 addition, as would be in the second case, having people in 19 that particular context sign a written document which who 20 knows whether or not they understood it they actually 21 increased the harms to the subjects. 22 In contrast, regulatory flexibility encourages NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 24 1 PIs. They know they are going to be able to get through the 2 IRB. They know that were going to look at the larger picture 3 of things and ultimately it should reduce risk of harms 4 because we are invoking a consent process that is suitable for 5 the nature of the research. Those are just two stories that I 6 have to tell to open with. 7 What I want to do now is shift to give you an 8 overview of the presentation because Im going to address in 9 part methodologies used in social and behavioral research, 10 some of which you are familiar with and some of which you may 11 not be. But then Im going to go into more detail about 12 qualitative research. Both the studies that I mentioned 13 earlier were qualitative projects. And in doing so, Ill shift 14 into issues and potential guidance on things that our IRB 15 repeatedly faces. 16 So in reviewing social and behavioral research 17 methodology, the first thing you recognize is there is a 18 diversity of methods although the methods are often 19 complimentary. And the reviews that we should be doing need 20 to be sensitive and appreciate the characteristics and the 21 differences across the different types of methodologies. Most 22 of the studies we review involve minimal risk. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 25 1 I understand yesterday that you had a great 2 presentation on minimal risk. So Im not going to say anything 3 more there except for reading the slide. Then Im also going 4 to alert you to the National Research Council which Michael 5 has also brought up and I know Phil will bring it up and I 6 think Joan brings it up, their recommendations on the review 7 of minimal risk studies. 8 There are generally two categories of research 9 that social and behavioral scientists follow. The first is 10 one that Im trained in. Im a quantitative researchers. In 11 quantitative methodologies, usually the goal is to create or 12 test causal models and hypotheses. We do so and then we go 13 out and we collect data in systematic ways and we test our 14 hypotheses using statistical analyses. So surveys like 15 Michaels already talked about fall into the quantitative 16 category, census information, experiments and so forth. Those 17 would be quantitative methodologies. 18 On the other hand, we have qualitative 19 methodologies and the goal here is to illuminate the 20 complexity of the social world. It relies on depth and 21 richness of experience. Theres lots of examples here, 22 observation research. There might be somebody hidden in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 26 1 crowd thats observing whats going on today and were going to 2 find a study about how this committee operates. Im kidding. 3 Interviews, both structured interviews and 4 unstructured interviews. All histories which Ill argue later 5 is just a form of interviewing. And focus groups, when you 6 bring people together and youre basically interviewing them in 7 a group. The overall goal of both of these types of research 8 is to extend our knowledge. They just go about it in 9 different ways and focus on different types of problems. 10 In particular cases, people may use both 11 quantitative analysis as well as compliment it by qualitative 12 analysis. An example here is one of our students who is 13 studying gender, race and mental health and the role of work 14 histories in that. She has a large dataset that shes using, 15 but she is also going out and interviewing people who fit 16 certain categories to get at the richness of their experience. 17 So focusing now on qualitative methodology, this 18 is sometimes known as field research, ethnographies. The key 19 elements are observation, both participant and nonparticipant, 20 as well as interviewing. Basically what field researchers do 21 is they spend time in a social setting. Sometimes they are 22 social situations too. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 27 1 An example of this studying kinship networks in 2 Pula and you go and you live in a village on this island for a 3 period of six months, a year. Youre emerging yourself in the 4 situation. You may want to compliment your observations and 5 your talking to people with document analysis, interpretation 6 of artifacts, visual depictions. Thats a big thing and its 7 going to one of my issues later as well as incorporating the 8 researchers own reflections. 9 Okay. Qualitative settings in the IRB. The 10 first question we ask when anything comes across our desk is 11 Is this research? And we look to that generalized ability 12 clause in regulations and a lot of qualitative research might 13 fall short of that criteria of generalizability if you 14 interpret generalizability only as hypotheses testing. That 15 is not what qualitative research is designed to do and 16 qualitative researchers both in anthropology and sociology 17 educated me on qualitative research and I must acknowledge 18 them. Theyve said, Thats not our purpose. When we often go 19 into a situation, we want to build from the bottom up. So 20 they may be developing theories that way. 21 They also do want to reveal patterns. They want 22 to look at maybe how kinship networks in this village might NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 28 1 differ from this village. And they also clearly want to 2 extend existing literatures so they want their work to be able 3 to generalize within the body of literature that stimulated 4 their work. Yes, they do generalize, but not in a narrow 5 sense. A second point, do they involve human subjects? Oh, 6 most definitely. 7 So what do we do when we review qualitative 8 research? We want to be mindful that, it is like Joan is 9 going to tell you again, its two people talking to each other. 10 Its a researcher talking to a respondent of some sort. What 11 we need to do, however, is to educate investigators on how to 12 present their study. We need, as the IRB, to understand their 13 purpose because understanding their purpose allows us to 14 assess the benefits of the study and the benefits as Michaels 15 already pointed out in lots of social and behavioral research 16 are social benefits. They are not benefits to the individual 17 per se. 18 They need to describe for you the context of the 19 study so we can understand this ability of their data 20 collection methods and their ways of preventing harm to their 21 participants. So we want to make sure when we look at the 22 data collection that it is going to produce the benefits that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 29 1 they say, its going to produce and its going to minimize risks 2 and harms. The way that they can minimize the risks and harms 3 is to make sure that what they present and what we review and 4 what we ask in terms of the consent process is appropriate 5 given the studys purpose, given the cultural context in which 6 it is appearing. So theres that sort of general overview on 7 qualitative methodology. 8 Now there are some specific issues that arise 9 and while Im saying they pertain to qualitative, they also may 10 pertain a little bit to quantitative too, but Im going to 11 focus more on the qualitative issues. The first issue that 12 sometimes arises has to do with observation. Where is the 13 observation taking place? Is it in a public space or a 14 private space? This is an important question to address 15 because if its in a public space, the study can fall under the 16 exempt category. If its in a private space, it may go to 17 expedited or full board review. 18 There are a lot of issues that come up. What 19 constitutes a public place these days? With all those 20 Internet chatrooms out there, are they public or are they 21 private? What happens when you have a public issue such as 22 justification of a low income black community, but its being NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 30 1 discussed in somebodys home? So you have a public issue being 2 discussed in a private location. Does that make it then a 3 private issue? 4 Do the people who are being observed realize 5 that they are being observed? Is their privacy in any way 6 being violated? Does it depend on the sensitivity of the 7 research topic? Going into chatrooms that are talking about 8 the care and feeding of their parents is different than going 9 into chatrooms talking about surviving breast cancer or coping 10 with sexual dysfunction. Do the people there know that they 11 are being observed, if you will, even though you could argue 12 theyre in a chatroom. Chatrooms are public, but are they 13 really public if its something very personal? It goes back to 14 that private and public issue. 15 A little guidance here. For each of these 16 issues, Ill offer some guidance. First, theres an important 17 need to define and delineate the openness of observation. Is 18 it public? When is it public? We need to attempt to gauge 19 whether or not the people themselves see this as a public 20 arena especially in those chatrooms? Do they see it as public 21 or do they see it as public or do they see it private? 22 Investigators and respondents sometimes have different NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 31 1 perceptions on this. I think that was illustrated by Michaels 2 noting that people skip the income questions, but answer the 3 drug use questions which I would have thought would have been 4 the reverse. 5 And we need to determine where and when an 6 investigator should reveal himself or herself as a researcher. 7 Recently, a student was going off to Tibet and she didnt want 8 to tell anybody there because she was studying religious 9 practices that she was a researcher because she was afraid if 10 she did that they wouldnt answer her question. We told her 11 she had to, but we gave her ways to do so so as to encourage 12 their participation instead of avoiding it. 13 The second issue, and Im shuddering up here a 14 little bit, is oral histories, clearly a big issue. Lots of 15 discussion last fall about this. I skipped a page here. Lots 16 of exchanges between the Oral History Association, the 17 American Historical Association and OHRP. 18 The key thing here, and I glean much of this 19 from communications I had seen from OHRP to various 20 individuals as well as some guidance from an NFS officer and 21 so froth, is all oral histories are not equal. Sometimes 22 there are no intent to draw conclusions plus they dont meet NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 32 1 any criteria for generalizability. 2 But other times, the intention is to create an 3 archive for research purposes or create patterns. Two 4 examples, one of our students was going to go and interview 5 the former owner of a Frank Lloyd Wright house in Alabama. I 6 dont know if you knew there was a Frank Lloyd Wright house in 7 Alabama. I didnt know that. She really wanted to get this 8 womans reflections. That I think fit well in an oral history 9 category. 10 Another was a student in history who was going 11 to go interview 40 people about their participation and their 12 experiences during the cultural revolution in China. She 13 wanted to compare how those of more of an intellectual class 14 compared to working class experienced that revolution. 15 Patterns. Patterns. Generalizability. So not all projects 16 are created equally. 17 Some concerns are that there is a confounding 18 between a method and a purpose and they are separate things. 19 Oral histories are very much like in-depth interviewing and 20 they do involve human subjects and OHA, Oral History 21 Association, has these very extensive guidelines that make the 22 IRB regulations look like childs play, but theres no one to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 33 1 decide whether or not a project does fit the criteria for a 2 solution. So some guidance here. 3 Oral history should be reviewed by third 4 parties, not necessarily IRB. But the key thing here is 5 uphold ethical standards. I think the Oral History 6 Association given their guidelines would agree with that. But 7 what we need to do is develop criteria, criteria for oral 8 historians to present it to the IRB as well as criteria for 9 determining when something should be excluded. 10 And we need to stress that IRBs have a lot of 11 flexibility so historians may say, Dont want to go to the IRB 12 because they will beat me up. We wont do that, but well teach 13 you how to approach us and to develop your proposals so we 14 understand. Again, its minimal risk. Refer to the NRC 15 recommendations. 16 A third issue is international context and local 17 review. This is relevant to the minimal risk studies because 18 most of these studies that we see in social behavioral 19 sciences are minimal risk. Were not going out and doing 20 medical experiments on people from developing countries. 21 Sometimes theres a confounding though between getting a local 22 review, that is to say, like an IRB in Zambia to review the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 34 1 protocol versus getting a local contact, somebody at a 2 university who is knowledgeable about the context or getting 3 an expert on campus or in a neighboring campus to talk about 4 the context. 5 Theres also concern that knowing about the 6 context gets confounded with requirement for local review. We 7 may not need to have a local review. IRBs need - Well, thats 8 guidance. And then of course, there are concerns about time 9 delays. Oh my God, I have to find an IRB in a foreign 10 country. Ill never get my research done. I hear stories of 11 people taking two years to get through various IRBs when they 12 are doing research aboard. 13 So I think one of the important things that IRBs 14 can do for minimal risk studies is rely on local expertise 15 either on the committee or within the university so that we 16 learn about the cultural context. Also IRBs also need to ask 17 themselves the question, Is lack of awareness about the 18 context going to increase risk in the study or increase the 19 harms to the participants? We need to consider that question 20 to determine whether or not we need to then have local contact 21 or local review. 22 A fourth issue has to do with photos and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 35 1 videotaping. Everybody has a digital camera today. Everybody 2 wants to use their digital camera, even the sophomores taking 3 their first anthropology class and they can be published. If 4 its digital, you can put it out on the web. We have one 5 researcher who likes to videotape American families eating 6 dinner and then put it on the website. 7 The issues here are consent to taking the images 8 as well as consent to the use of images which raises issues of 9 both privacy and confidentiality, privacy in terms of the 10 individual control over what happens initially and 11 confidentiality in terms of who else gets access to it. Joan 12 will talk about more of those concepts. Then we need special 13 considerations of video and photo documentation in an 14 international context. Again, knowing the local culture. 15 Some guidance here. I think its imperative that 16 when a researcher wants to take photos they get consent, maybe 17 oral consent, but they get consent to do that. Then we need 18 to create criteria for when it is necessary to obtain consent 19 for the use of those images. They may need to specify the 20 type of use. They may need to specify how they will be 21 released, whether or not other researchers will use them and 22 so forth. Then the issue of whether or not the identity of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 36 1 the individuals needs to be masked. Some individuals want to 2 be known for what theyve done. 3 The last issue is, and this is really at the 4 crux, I think, of the review of social and behavioral research 5 to make it workable, the use of waivers. They are specified 6 many times in the Federal regulations. I gave you some 7 examples and there are different types of waivers, waivers of 8 elements of consent, waivers of written documentation of 9 consent. You know all this so I dont need to go through it. 10 Waivers of parental consent. 11 And the concerns about waivers generally focus 12 on their under use. Why are IRBs not using waivers more? 13 Because sometimes, as Michaels already pointed out, you put 14 all those elements in consent and its really overkill for 15 minimal risk studies. Sometimes theres an inappropriate focus 16 on the individual when it really should be on the group. 17 Think of an anthropologist going to study 18 village economies in Fiji and its not the individual who he 19 needs consent from. Its the village tribal leader because you 20 dont want to usurp that authority because that would be 21 culturally inappropriate and so forth. It would create more 22 harm than good going forth. Waivers also of written NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 37 1 documentation of consent can help avoid breaches of 2 confidentiality, ways to minimize harm to subjects as would 3 have been the example for the second study I talked about, the 4 study in Mongolia. 5 Guidance on waivers. I think its really 6 important that we as IRBs learn, I think my IRB has, but other 7 IRBs need to learn the implication for the exempt status, when 8 you have an exempt study and not all elements of consent need 9 to be there. Secondly, the need to recognize different forms 10 of consent, forms both for the individual as well as for a 11 group. And then to use that regulatory flexibility to create 12 consent procedures appropriate to the purpose and context of 13 the study. Again, the NRC report has some recommendations on 14 this. 15 So in conclusion, I want to say a couple of 16 things. One is not on the slide, but the first is. I think 17 IRBs need when they review social and behavioral research to 18 pay careful consideration to the purpose of the study, the 19 context of the study, the nature of the study of the subject 20 in order to determine the most appropriate way to protect the 21 participants in that study as outlined by the regulations. 22 To do so, the IRB and investigators need to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 38 1 increase their familiarity with the flexibility inherent in 2 the regulations. We need to teach our investigators how they 3 can write a proposal to us that outlines the benefits, that 4 outlines the procedures, that requests the waivers. So the 5 IRB sees those as reasonable requests. Yes, of course. Why 6 not do it this way? 7 Secondly, I think we need to offer models of 8 IRBs that ensure the protections sensitive to research purpose 9 and context and a couple ways to do this is make sure the 10 relationships, Im a sociologist, I have to say something like 11 this, between members of the IRB themselves as well as the IRB 12 staff as well as their relationships with investigators are 13 characterized by mutual respect and trust. 14 We also need institutional resources and 15 legitimacy. I had to get that legitimacy in there. But the 16 key here is model the flexibility, find ways to model the 17 flexibility in published guidance and governments responses to 18 queries. Thank you. 19 DR. PRENTICE: Thank you, Karen. Our next 20 speaker is Dr. Joan Sieber. Joan is a psychologist, Professor 21 Emeritus, at California State University in Hayward, 22 California. Joan. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 39 1 DR. SIEBER: I want to thank SACHRP for inviting 2 all of us to testify. The issues that were going to discuss 3 here, ones that Ive thought about for many, many years. Ive 4 served on six IRBs and chaired four of them and Ive helped a 5 number of basically social and behavioral organizations to 6 develop standards. So the issues that I want to address today 7 are ones that - Theres a clicker. Oh, youre the clicker. Im 8 sorry to be so slow to understand the technology here. 9 I think that Michael and Karen have very well 10 set the framework for me. Im going to introduce two case 11 studies to show you how fundamentally different social and 12 behavioral research is from biomedical research. Indeed most 13 social and behavioral research is about two people talking. 14 The kinds of risks are primarily minimal risks, but there 15 really is another dimension that Michael and Karen have hinted 16 at pretty clearly and I want to underline. That is cultural 17 differences in issues of privacy and confidentiality. 18 Now typically fortunately, the regulations offer 19 a lot of flexibility. So how do you use that flexibility? 20 Well, what you need to use is good scientific background, good 21 scientific principles and a lot of mature moral judgment and 22 ethical sensitivity and you figure out whats the right way. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 40 1 What is the morally and scientifically right way to do the 2 research. 3 Then you look to the regs and you ask yourself, 4 What elements of flexibility need to be invoked so that I can 5 do this research in a moral and sound way and produce the 6 kinds of results that I need to produce? Of course, the regs 7 were written primarily with biomedical research in mind and an 8 ultra-timid IRB will want to say, Well, the way you do 9 research correctly is you go to this first rule and you follow 10 that. Thats the kind of issue that I want to address with a 11 couple of examples. 12 The major risks as I said are invasion of 13 privacy and breach of confidentiality. Let me define those a 14 little bit more because I want to illustrate that the terms 15 are not interchangeable and they dont mean what they are 16 sometimes taken to mean. Privacy refers to persons and to 17 the persons interest in controlling the access of others to 18 themselves. 19 Im always reminded of the story of the 20 criminologist who wanted to study an old, old thief who is now 21 toothless and 85 and said, Of course, I will protect your 22 privacy so that no one will know who you are. He said, The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 41 1 hell with that. I want my grandchildren to be proud of me. 2 Now that has no practical value for this group I dont think, 3 but it does illustrate that privacy is an issue that is 4 extremely variable in different cultures. 5 In Sri Lanka, for example, if you tried to 6 discuss a persons health issues in private, they would become 7 very uncomfortable because in Sri Lanka, health is always 8 discussed in a more public venue. Its just totally the 9 opposite of our situation. 10 Confidentiality refers to data and to agreements 11 about how data are to be handled, who will have access to the 12 data and I think that the criminologist example illustrates 13 that that guy didnt like the kind of promise that the 14 researcher was making. Confidentiality now is assured by a 15 very wide variety of quite sophisticated approaches and its 16 important that IRBs or their consultants understand the range 17 of possibilities. Well get to that again a little bit later. 18 Now is respecting privacy and confidentiality 19 always this easy? Ive sort of suggested that you just use 20 common sense. Well, not always and I think as we all will hit 21 upon very hard the National Research Council strongly urged 22 that where there is uncertainty that we not act on hunch and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 42 1 anecdote, but that we acquire and use some empirical data to 2 illustrate what the problems really are. I will talk a little 3 bit more about that presently. 4 I want now to give some examples. Im going to 5 give two examples of research. A 30 year longitudinal study 6 of family life styles will examine the effects of family life 7 style on the development of children. Young families having 8 at least one child will be recruited from various ethnic and 9 socio-economic strata. Family members will be interviewed 10 about their beliefs and goals and activities and they will be 11 observed and videotaped in the family context twice a year. 12 This is a 30 year study. This is a very costly 13 study. Its complicated. It promises to really provide 14 extremely important insight into family development and child 15 development and the retention of subjects remember is very 16 important here. If most of the subjects drop out, the study 17 isnt. It doesnt exist. 18 Now what are the ethical and sensible ways to 19 approach this? Well being the sensible researcher, you 20 realize that the family will want to have a lot of informal 21 conversation with you before they undertake to participate. 22 They will want to know what its for and how this will NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 43 1 contribute useful knowledge. What can they expect to happen 2 in each session and can they redact any of their data? Can 3 they have some of the videotape erased if they think, Well 4 gee, Im uncomfortable about that. 5 Now they will probably want to know something 6 about whether they can determine when the researchers visits 7 occur and what will happen if they decide to move away or 8 decide that they dont want to participate. They will probably 9 really appreciate having a little bit of informal discussion 10 about these issues each time the researcher comes along. 11 Now I talked about the importance of doing some 12 empirical research on what the issues really are. It would be 13 a real good idea for the researcher to do some focus groups of 14 some of the kinds of families to find out in a more 15 conversational way where they can remind each other what 16 their questions might be, the way they can learn about the 17 study and say what their concerns might be. 18 However, suppose that their IRB is very risk 19 adverse. It may feel that the informed consent is a consent 20 form that is signed. As my colleague, Murray Wax, who has 21 worked with Native Americans for many years as a cultural 22 anthropologist has crypted, every time a Native American signs NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 44 1 a legal looking form they lose another black hill. 2 Thats basically how many people from traditional 3 cultures feel. I dont understand this. I dont know why I 4 have to sign this thing. Look, Id love to participate in your 5 study, but Im not going to sign this thing. It is actually a 6 detriment to the individual, to science and so forth to thrust 7 a legal looking form that obviously protects someone other 8 than the subject. Of course, thats precisely what it does. 9 The other thing the IRB is likely to do is to 10 say, Well as soon as you have extracted some numbers from the 11 videotapes, you must destroy them. Now never mind the fact 12 that funding agencies increasingly want valuable and costly 13 data of this kind to be documented, archived and shared and 14 confidentiality can be protected through very sophisticated 15 methods of restricted data or restricted access. 16 But again, because many IRBs and many 17 researchers dont know those methods, there is the notion that 18 you protect confidentiality by destroying very valuable data. 19 NIH, by the way, has on their website a tremendous amount of 20 information on methods of preserving confidentiality of shared 21 data and the American Statistical Association has about 20 22 times more and the Census Bureau has lots of information. So NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 45 1 its really no secret that you can preserve the confidentiality 2 of shared data. 3 All of this concern has to do with you have to 4 follow the regs, but what do the regs really say. The regs 5 permit waiver of signed consent although many IRBs refuse to 6 use this procedure. This means that the research is very 7 limited in the cultures and individuals who can be studied. 8 If you want to make generalizations about society, you cant. 9 Secondly, the regulations do not require destruction of data. 10 They require appropriate protection of confidentiality for 11 which there are multitudes of methods. 12 Let me go on to the next example. Well, lets 13 see. Suppose that the IRB were also to invoke subparts B and 14 C. Up until two years ago, subpart B applied only to 15 research that was specifically directed at studying pregnancy 16 or development of the fetus. More recently, it was broadened. 17 This would mean that anyone who became pregnant in the course 18 of the 30 years of family study would have to be dropped from 19 the research because the research is not designed 20 specifically to benefit the pregnant woman or the fetus. 21 If subpart C were required, anyone who went to 22 jail even for a day would have to be dropped unless the IRB NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 46 1 had a special prisoners advocate already on board. Typically 2 such a member has not role on most IRBs and their membership 3 couldnt be maintained. So then no family that currently 4 included a pregnant or jailed member could be recruited into 5 the study. 6 Only members whose children were born before the 7 study and in which no one went to jail could participate. So 8 you would only be studying one child families. The merger 9 results would be pretty useless. So you cannot therefore 10 study two critically important family events which is the 11 birth of another child or the incarceration of a member. The 12 cost of applying subparts B and C to such a study would be 13 just phenomenal. It would simply destroy the study. 14 Id like to move then to the next example. High 15 school kids who are caught smoking have an opportunity to 16 participate in smoking cessation research. There are a whole 17 series of such studies that have been done. Most want to 18 participate, but because their parents dont know they smoke 19 they will participate only the parents dont have to be told. 20 Now the regulations permit waiver of permission 21 of parents if there is minimal risk. Now lets think about 22 this. The only risk is that the kid is going to get quite a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 47 1 spanking or quite a brow-beating from a very angry parent. 2 The benefit of participating in the study is 3 lifetime improvement of health. So the risk/benefit ratio is 4 a pretty big number in favor of the benefit and the way the 5 risk can be eliminated is by waiving parental permission. 6 Empirical research has been done to try to work with IRBs on 7 these issues. Only about 30 percent of students would 8 participate if their parents had to be told. 9 In surveying IRBs, 13 percent of IRBs never 10 waive parental permission. Never. They feel they are taking 11 a great moral high road and you can see how Procrustean that 12 is. Fifty-seven percent would waive parental permission, not 13 for this study, only for older children, for normal school 14 intervention which doesnt require parental permission anyhow 15 and for nonsensitive research. They would not waive parental 16 permission for a study such as this. 17 Okay. Lets see. Suppose that they applied 18 subparts B and C. Suppose that one of the girls in the study 19 became pregnant. Should she not participate in smoking 20 cessation? Suppose one of the kids got into a scrap with the 21 law and spent a night in the slammer. Should they be dropped 22 from the study? Again, it makes no sense. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 48 1 So what am I proposing here and what the 2 National Academy propose in their study of issues of 3 protecting human subjects? I propose that we work to craft 4 very flexible solutions that impose a minimal regulatory 5 structure. How do you do that? I think its important to 6 recognize the regulations do not tell us how to do that, what 7 steps are involved. 8 They are very simple. We first used common 9 sense and good science. What are the problems of protecting 10 human subjects and of respecting them, of respecting 11 individual and cultural differences in this context? Then as 12 good scientists, we craft effective solutions and we might 13 have to do some pilot research and some methodological 14 research to do that. And finally, we go back to the Federal 15 regs and say, Well, now how can we do this within the 16 flexibility thats allowed? 17 Okay. Thats basically what I have to say. I 18 guess Ive just said use common sense, but I hope that along 19 the way I illustrated that the social and behavioral research 20 is fundamentally different in most cases from biomedical 21 research. Thank you. 22 DR. PRENTICE: Thank you very much, Joan. Our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 49 1 next speaker is Dr. Philip Rubin who is the Chief Executive 2 Office, Vice President and a Senior Scientist at Haskins 3 Laboratories in New Haven, Connecticut. Dr. Rubin also was an 4 ex officio member of both SACHRP and NHRPAC (National Human 5 Research Protections Advisory Committee) when he was 6 representing NFS. Dr. Rubin, thank you for coming. 7 MR. BARNES: Can I say something while hes 8 getting ready? 9 DR. PRENTICE: Sure. 10 MR. BARNES: What better vindication could we 11 have for yesterdays report about the subsequently incarcerated 12 in subpart C than that presentation. Oh ye of little doubt. 13 DR. RUBIN: Good morning. Id like to first of 14 all thank SACHRP for providing the time and the opportunity 15 for this session and Celia Fisher for helping to organize it. 16 Thank you very much. Im going to provide essentially a 17 summary statement and its going to be a little bit repetitive. 18 Research, first of all, in behavioral and social 19 sciences if youre not that familiar with it is extremely 20 broad. It covers psychology, linguistics, economics, 21 sociology, political science, geography and regional science, 22 on and on and on. So this is a very broad area. However, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 50 1 time and resources of SACHRP are limited. Similarly, staffing 2 and funding are limited at OHRP. 3 In the past, considerable work has been done and 4 continues to be done by a variety of groups and experts. 5 Youve heard about some of them. I apologize in advance for 6 acronyms, but Ill do some of them. But, for example, youve 7 heard about National Academys NRC. Thats National Research 8 Council report. The predecessor to this group, NHRPAC. 9 Another group that you havent heard about but Ill be talking 10 about in a little detail later that came out of NHRPAC called 11 the Social Behavioral Sciences Working Group, SBSWG. An 12 interagency group, HSRS, Human Subjects Research Subcommittee. 13 Professional societies including Federation, APA APS, every 14 acronym you can think of. AERA. The American Sociological 15 Association, on and on. 16 What this says to me from my background which is 17 fairly diverse is that this group, this particular group, has 18 a unique and special opportunity at this particular time in 19 the history of this very exciting, important and problematic 20 enterprise to leverage whats gone on before and to take 21 advantage of that. 22 Youre really extremely well positioned to take NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 51 1 advantage of the work thats gone on before and we saw that 2 yesterday in certainly the morning session building upon 3 things that have happened in the past, selecting those things 4 that are important, but doing something that other groups 5 havent been able to do as effectively, moving things ahead as 6 recommendations to Secretary which is the charge and to OHRP. 7 So I think this is a very unique time. 8 Let me give some examples of the things that 9 went on before. In a minute, Im going to do that. You could 10 as all the previous speakers have suggested act on some of the 11 recommendations of the NRC report protecting participants and 12 facilitating social and behavioral sciences research. You 13 could build on work done by the social and behavioral sciences 14 working group that came out of NHRPAC. Again, Im going to go 15 into more detail with specific examples and take advantage of 16 the professional societies. 17 Again, the role of this group, I would think, 18 would be in terms of coordination, recommendations and 19 guidance. You could also coordinate with the HSRS which I 20 know in part and in main, Bern Schwetz takes that lead role, 21 but this group has a unique opportunity to do that. 22 All the previous speakers have talked about the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 52 1 NRC report. This is the NRC report. Its pretty good. Like 2 all these things, they get dated, but there are some really 3 unique opportunities to build on it. 4 Im going to summarize what the report says. 5 Here are the five categories of areas they talked about. This 6 is not all they talked about. Enhancing informed consent, 7 youve already heard about that today. Enhancing 8 confidentiality protections, youve already heard about that 9 today. Effective review of minimal risk research, you heard 10 about that both yesterday and today. Information gathering, 11 you heard about that more today. 12 A number of the previous speakers have talked 13 about research. Thats particularly problematic and a flat 14 funding environment. I was also at the NFS, but I think its 15 extremely important to guide the work by actual research. 16 Finally, some systemic level issues. 17 Im not going to be able to have the time to 18 touch on all of these. Ill give some specific examples. Now 19 Im just quoting from the NRC report. Again this is available 20 on the National Research Council website for free, but you 21 have to print it one page at a time or you can buy it. 22 Let me give you some very specific examples and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 53 1 Im just going to read whats here. You can carry this off with 2 you at the back. Enhancing informed consent. Recommendation 3 4.2. OHRP should develop detailed guidance for IRBs and 4 researchers on appropriate consent procedures for different 5 types of populations including language, minorities and such 6 vulnerable groups as undocumented immigrants, studies in 7 social, behavioral and economic sciences research. You just 8 heard about that from Joan. 9 The next. Recommendation 6.2. Effective review 10 of minimum risk research. IRBs should use efficient 11 procedures to review minor changes to minimum risk research 12 protocols that arise during the period of authorization. When 13 appropriate IRBs should approve protocols that allow 14 researchers flexibility in making specific designed decisions 15 during the course of their research without the need to seek 16 further review. This is an important issue out in the field. 17 An example would be one of two forms of a question, both being 18 minimal risk, to be decided on the basis of a pretest. 19 One more small set of examples and then I will 20 move on. Needed information. This is 6.5. Federal Research 21 funding agencies. Examples would be the National Science 22 Foundation, National Institute of Health, Department of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 54 1 Education, so on and so forth, Department of Justice. Federal 2 research funding agencies including the NFS and the NIH should 3 fund in-depth studies to better understand the operations and 4 effects of the IRB system and to develop useful indicators of 5 IRB performance. Behind that in part is the notion that it 6 really is important if were talking about some of these 7 things, informed consent, these different issues, what really 8 goes on. What would really change? Is there any systematic 9 research about things? 10 And finally, System level. 7.1. To improve IRB 11 research communication and facilitate the review process, IRBs 12 should clearly distinguish and justify changes to research 13 designs that are acquired for human participant protection 14 from suggested changes that are advisory and secondly, develop 15 ways to work cooperatively with investigators such as 16 providing opportunities for face to face meetings to discuss 17 significant changes in research protocols. 18 Again what this is about is taking a system that 19 many of us who have been involved with this both at funding 20 agencies, in HSRS, on the this committee and its predecessor, 21 we want to make sure that process does not become adversarial. 22 That rather its a process of cooperation in which IRBs, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 55 1 institutions, researchers and funding agencies are working 2 together with a goal of protecting participants in research 3 and in fostering good research. 4 Im going to move on to another topic. Theres 5 another group and I noticed in the room today that we have at 6 least three members of that group. For those who are 7 unfamiliar with it, again it has a long acronym, but Im going 8 to just use that. Im going to say it again. Its up on the 9 slide. Social/Behavioral Sciences Working Group, SBSWG which 10 came out of NHRPAC. 11 So the history of this group is it was a working 12 group just like your subpart working groups and it was a 13 working group on social/behavioral sciences. The head of that 14 group, Felice Levin, is here. Joan Sieber is on that group. 15 Celia, I think is on the group and Karen, Im not sure, is on 16 the group and is here. Im behind the post. So we have a 17 number of the people here. 18 One thing that Im going to advocate is you 19 either might want to think about working cooperatively with 20 this group, and I know that goes unsaid. Im not saying that 21 youre not, but also build on some recommendations. Heres some 22 examples of things that they have either worked on or are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 56 1 working on because again I dont think that you have the time 2 considering that you volunteer your time to do everything. 3 Work has gone on before. Its clear that you know very well 4 how to build on prior work and examples of things that if 5 youre not familiar that theyve done are things like the status 6 of third parties, public used datafiles, confidentiality and 7 research data protections, the issue of risk and harm, exempt 8 and expedited and research involving children. Im going to 9 give some examples of some of their recommendations, just in 10 one area, to show you. Some of you are very familiar with the 11 stuff theyve done in other areas and then thats pretty much 12 the end of my talk. 13 Examples in expedited review, here are some 14 recommendations from Social and Behavioral Sciences Working 15 Group. I think Im going to talk about five recommendations. 16 These are just examples. Im not saying that you should be 17 making these. Im illustrating the kinds of things they do. 18 All I did was pick and choose some things that might be of 19 interest. 20 Who should decide who will review what? 21 Institutional policy should be designed to ensure that sound 22 decisions about the need for IRB review are made promptly. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 57 1 Again weve heard too often about things that stretch on. If 2 they need to stretch on, fine. But when they dont, they 3 shouldnt. 4 And now were talking institutions. Its nice to 5 hear in the guidance also not just for OHRP but for 6 institutions and researchers. Institutions should designate 7 appropriate numbers of knowledgeable and disinterested 8 representatives to make decisions regarding the applicability 9 of the Common Rule and other relevant policies to propose 10 projects. 11 Who should review exempt or other research 12 activities? Research institutions should distribute the 13 review workload so that timely, informed and appropriate 14 reviews take place. Review mechanics should be established so 15 that appropriate IRB or non-IRB reviewers or review committees 16 are set up to accommodate the review and oversight of research 17 and research related activities involving humans. 18 What criteria should be applied to activities 19 that are not covered or exempt? Oversight mechanisms for 20 reviewing exempt or non-covered research activities involving 21 human subjects should establish clear, public criteria for the 22 review of proposed activities. These criteria should be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 58 1 appropriate to the nature of the activity and the ethical 2 standards of the relevant research community regarding 3 research training and related activities. 4 And finally, what is eligible for expedited 5 review? Institutions should develop guidance for researchers 6 about project eligibility for expedited review. Guidance 7 should explain how the IRB interprets the regulatory 8 definition of minimal risk, and Im delighted what I heard 9 yesterday, to propose research projects and how to determine 10 whether projects fall within the list of categories for 11 expedited review. So here is a case where progress is being 12 made and guidance could be delivered. 13 How can expedited review live up to its name? 14 Institutions should develop guidance to improve researchers 15 understanding of the information needed to accomplish 16 expedited review of eligible research projects. Institutions 17 should develop a system for prompt, efficient and thorough 18 expedited reviews. 19 I keep saying institutions here. I selected 20 those all intentionally because actually institutions, and Im 21 senior person at a small institution and a very junior person 22 at a large institution, always are sensitive to guidance NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 59 1 depending upon who that guidance comes from. If it come from 2 OHRP, NIH, SACHRP, theyll pay attention to that. So again, 3 though were talking about the institutions developing this, 4 they cant do it absence a context or a best practices. 5 In conclusion, and again youve heard this 6 before, although Im going to repeat this, we need to craft 7 flexible solutions that impose minimal regulatory burden. 8 Wherever possible, those engaged in the process should go 9 beyond the regulatory approach to find other ways of promoting 10 ethical behavior. Although the outcome of the regulations, 11 the protection of human research participants, should be 12 uniform, the procedures used to obtain that outcome should be 13 flexible to ensure appropriate expertise in each case. We 14 should always remember that the protection of the participants 15 in research should be our primary priority. 16 Okay. My conclusions on the final overhead. 17 Ive already talked about them. This process is about getting 18 everybody involved. All the stakeholders need to be engaged 19 and active. The enterprise includes research participants, 20 researchers, public and private institutions, funders, 21 governmental agencies, policy makers, professional societies, 22 advisory groups, the public, others. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 60 1 What Im trying to advocate is that we build on 2 the work thats already been done and draw on the expertise for 3 all of those who are interested in improving the system. 4 Again, Im going to make just a specific recommendation. I 5 think in the case of social and behavioral sciences it would 6 nice to have a SACHRP working group or in lieu of that for 7 SACHRP to work either with existing groups like the SBSWG with 8 professional societies, but to build on stuff thats been done 9 to save yourself time and to move ahead on work thats already 10 either has been completed or is in progress. 11 It can often be frustrating when reports like 12 this report that has been talked about just come out and sit 13 on the shelf. Theres an opportunity now not to implement the 14 whole thing, but to prioritize and select and then to use the 15 expertise of the community. There are people out here who 16 have done a lot of work and you have the ability to pick and 17 choose what the issues are and maybe how you want to either 18 create or use an effective group to move other things along. 19 Thank you. 20 DR. PRENTICE: Thank you, Philip. Will the 21 presenters please come up to the table. Okay. I would like 22 to thank all four of you for your excellent presentations and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 61 1 all of you were on time. Were on a tight schedule so we also 2 appreciate that very much. 3 I would also like to recognize the fact that you 4 were nominated by your organizations that you belong to, the 5 American Psychological Association, the Federation 6 Precognitive and Behavioral Sciences and the American 7 Sociological Association. So that a compliment to all of you. 8 So we want to recognize you for that. 9 Im sure that SACHRP members have a number of 10 questions for you. As the Chairmans prerogative, I always 11 get to ask the first question. Let me premise my question by 12 indicating that earlier this year I was invited by a 13 university that shall remain unknown, unnamed, who had a 14 revolution on-going among their behavioral/social science 15 faculty and they were very upset with the IRB system in place 16 at the university. 17 They alleged that the IRB was applying a 18 biomedical model to behavioral/social science research in 19 unreasonable ways and certainly some of your examples were 20 reflected by the examples that I encountered at this 21 particular institution. I spent an entire day there and quite 22 frankly, I found that the faculty were right on. They were NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 62 1 quire correct in their concerns about the way the IRBs was 2 working. My recommendations were based upon their concerns 3 and hopefully the situation has changed. 4 But that leads me to my question. Thats one 5 university. How prevalent is this problem across the United 6 States at universities? Do we really have a problem in terms 7 of (1) subpart A itself, the regulations; (2) how its being 8 interpreted, and (3) the extent to which this problem has 9 really tended to inhibit the conduct of important 10 behavioral/social science research? I throw this question 11 open to obviously all of you, not just one single individual. 12 DR. SIEBER: I dont know the answer to the 13 question, but as I see politicians do, Im going to answer a 14 different question. That is extremely difficult to study 15 because apart from palace revolutions, you find many 16 researchers who finally are able to persuade an IRB. I mean, 17 for example, I wanted to do a survey of scientists. I was 18 going to mail a survey to them and they wanted me to mail a 19 consent form first to be signed and sent back and then I could 20 mail the scientists the survey. 21 Its pretty silly and given my background, I 22 ranted and raved and finally prevailed. But I think that one NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 63 1 of the difficulties is self-censorship here. If you know that 2 a situation is pretty hopeless instead of doing the important 3 research that you would like to do if you want to publish 4 rather than perish, you do something trivial that you know 5 will get through the IRB. And I see that as the worst risk of 6 all. 7 DR. RUBIN: Not being a politician, Ill try to 8 answer the question, though I think Joan did a beautiful job 9 on that. This is not a criticism of Joan. Its a very 10 important and difficult question to answer and Ill try to do 11 it from the perspective of when I was in charge of funding 12 behavioral and cognitive science at the NSF which is a small 13 funding agency so only a very narrow window, what I would say 14 is a couple things. One is that during the time that I was 15 there from 1999 to 2003, we saw a sharp increase in incidents 16 like this. I cant talk as you couldnt. I cant talk about the 17 institutions but we saw a sharp increase and then things 18 started to change a little bit. 19 We dont have quantitative data. Thats one of 20 the recommendations here. Thats one of the things that was 21 encouraged and I can tell you that at least one professional 22 society is attempting to gather that using a survey, of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 64 1 course. Its difficult. The thing that we would encourage 2 when going around is at institutions, at most institutions, 3 you have to recognize that the faculty at most can be the 4 largest stakeholder and that we try to encourage them to get 5 engaged at their institution and turn what we call the 6 nightmare IRB into a very productive IRB and again, I dont 7 want to name names, but that has been done at several 8 institutions and they do that by becoming engaged in the 9 process and getting the appropriate expertise because often 10 thats what its about. This is about communication and 11 misunderstanding. 12 Often -- you know, when you say a nightmare IRB, 13 in a way thats unfair. Its an IRB thats coming from their 14 world experience. They know -- they view things in a certain 15 perspective. Even the predecessors to this committee, NHRPAC, 16 I remember the earliest meetings when some people heard about 17 social and behavioral research that dealt with risky 18 behaviors, like, Oh, its unethical to even do that research. 19 Quite the opposite. Its one of the most ethical things in the 20 world to do that kind of research and of extreme national 21 importance. So the issue then becomes one of getting at 22 those institutions and each institution, getting those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 65 1 stakeholders at those institutions across administration down 2 to a faculty and potential participants engaged in it as a 3 process. That has to be done through education. The only 4 group -- well, a couple of groups Ive seen doing that include 5 OHRP in its education meetings, PRIM&R at its recent meeting 6 with social and behavioral, the American Sociological 7 Association and then AERA which has outreach meetings at 8 professional societies that do that. So its a difficult 9 problem, so thats why its an extremely long-winded answer. 10 DR. FENDRICH: Im going to give my answer to 11 this. First of all, since I was the first speaker, I just 12 wanted to -- I didnt thank SACHRP for inviting me specifically 13 Celia Fisher for putting this together. This is a very -- I 14 appreciate your inviting me. The second point I wanted to 15 make is as a survey researcher, and a member of the task force 16 on research regulation, American Psychological Association. I 17 mean, we realize -- the answer to your question, just to echo 18 what Phil Rubin just said, is there is no good data on this, 19 on -- so and one of the things that were trying to do at APA 20 in this task force, is structure a survey so we can get some 21 good data. And it would also be nice to look at whether over 22 a period of time, if there is policy whether or not those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 66 1 kinds of things change and improve. So this is my response. 2 DR. PRENTICE: Susan? 3 MS. KORNETSKY: Sort of to follow up on that, I 4 have one question for all of you and then one specifically for 5 Michael. You know, over the past 20 years at least when I 6 have been involved with IRBs, a lot of universities now are 7 forming behavioral and social science IRBs and Im wondering, I 8 know you have no data, and I hope that if you do, you know, 9 research on this, whether that really has made a difference. 10 You know, my own -- you know, as many 11 institutions we were criticized at a hospital even our 12 behavioral and social scientists and several times now when we 13 have tried to put more of our behavioral and social 14 scientists, they, in turn, ended up being more brutal on the 15 research than before and Im not making that as a 16 generalization but I see Phil sort of shaking his head, so 17 maybe other people have experienced that. So Id just like 18 your input about whether this has helped. 19 And then Michael, the other thing that I would 20 just ask you to answer is, you had something up there on a 21 slide about a declining response rate to social service 22 research and surveys and Im just interested in your NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 67 1 perspective. I didnt know whether you were tying that to the 2 other point about front loading with warnings about rare 3 events or risks and sort of where that statement came from and 4 your thoughts about it. So those are the two issues. 5 DR. FENDRICH: Ill respond to -- actually, Ill 6 respond to both of them. The first question was about how to 7 structure IRBs in terms of whether or not -- if I can 8 understand the question, there should be separately 9 constituted boards that evaluate just behavioral research 10 versus -- 11 MS. KORNETSKY: Well, many places have gone to 12 that and Im just trying to figure, is that making a difference 13 because my own sort of little limited experience was, Im not 14 sure, you know. 15 DR. FENDRICH: I mean, if you go back to the 16 regulations, the IRBs shall -- the requirement is that there 17 should be sufficient expertise to review each protocol and 18 thats actually the key issue here. Is there sufficient 19 expertise brought to bear in that institutional arrangement 20 for redoing the protocols? And I think when -- in a medical 21 center, I mean, the danger is that there isnt sufficient 22 expertise if you have hybrid sorts of boards. And NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 68 1 antidotally, again, there is on data on this as far as I know. 2 Maybe the other panelists can speak to that. Antidotally, I 3 dont know whether theres an improvement if theyre separate 4 boards or not. 5 And so just to answer, I mean, my own experience 6 is I think its a positive factor in a medical center to have 7 -- you know, you can get into different refinements, because 8 then you could say, Well, theres clinical behavioral research 9 and theres observational behavioral research and you get to 10 mix those. I think the key question comes down to expertise 11 and in a case by case basis, I think the people -- that 12 researchers run into problems when there isnt sufficient 13 expertise. The problem is under the sort of institutional 14 structures we have, its very threatening for an investigator 15 to question the level of expertise or question the sufficiency 16 of expertise on a particular board. Im not sure how to 17 address that problem in a broader basis. 18 The specific question that you had to me 19 regarding the declining response rate, Im not going to -- I 20 mean, this is just a general framework, I think, that were 21 working under in survey research that viewing the context -- I 22 mean, I dont think its at all -- theres no doubt that its all NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 69 1 related to institutional review board processes but the 2 general context is that as we put more warning labels on our 3 university based research, the issue is warning labels, how is 4 that -- you know, where we already are in an environment where 5 its difficult to get people to fill out surveys, if were going 6 to threaten them with -- put threats about child abuse 7 notification, even though its a valid think to consider, is we 8 need to carefully consider those warning labels and the 9 context. 10 So and will it even -- the final point is as the 11 response rate diminishes, the risk benefit ratio is effected 12 adversely and then the whole -- as Joan was talking about, the 13 whole value of our research enterprise is questionable. So 14 thats it. 15 DR. HEGTVEDT: As the Chair of the Social 16 Behavioral Humanist IRB at Emory, which is one of five 17 committees, the other four are all medical, the switch to 18 allowing behavioral research dealing with health issues to be 19 reviewed by my committee was welcomed by people in public 20 health and nursing. One of the key investigators in public 21 health kept having her study of crack cocaine addicts denied 22 because it was a qualitative research. She went and hung out NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 70 1 in certain parts of Atlanta and she talked to these people and 2 they could see no benefit in that. That goes back to the 3 point that was made earlier about a lot of social and 4 behavioral research has a social benefit. 5 Back to the point that Phil just made a minute 6 ago, these are the kinds of questions we should ask because 7 they do have long-term potential for developing social 8 programs, and so forth. So where it has hindered is sometimes 9 we get studies by medical people that dont involve any 10 invasive procedures, devices or anything like that, but theyre 11 not trained in social research and then we raise questions for 12 them, like issues of social stigma and psychological harms 13 that they hadnt considered. 14 And so then it appears as if theyre getting a 15 tougher review but really it goes back, again, to the 16 expertise. We have a greater understanding of those issues on 17 our committee than they do on the medical committees. Thats 18 only one example. I dont think that there are any systematic 19 data looking at that transition. 20 DR. PRENTICE: Nigel? 21 DR. HARRIS: Thank you. I enjoyed the 22 presentations. It seems to me that because Im trying to think NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 71 1 of the role of SACHRP in terms of where these presentations 2 are and to some degree, a lot of what some of the concerns, 3 you know, are really based on lack of education, lack of 4 guidance to the IRB rather than, in fact, any regulatory 5 problem, per se, or any regulatory issues. There are a few 6 and the examples were given, of course, somebody becoming a 7 prisoner, somebody becoming pregnant and indeed, one may take 8 note of that. 9 And so one comment is the comment to make is 10 that really as one moves forward here trying to determine what 11 it is that SACHRP will need to do out of all of this, some of 12 it really is to encourage greater education, greater guidance, 13 having social behavior research experts or people who have 14 knowledge of this and IRBs and so on. And I dont know, you 15 know, the degree to which other than we can encourage that 16 this committee can help. So thats the general comment I had 17 to make is that a lot of this sounds to me like it requires 18 greater education, greater guidance but Im not sure that 19 theres a need for much regulatory change. 20 DR. RUBIN: Well, I couldnt agree more in terms 21 of the need for education, guidance and care about regulatory 22 changes. Also regulatory change even if its something that is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 72 1 important and there are some areas that were pointed out, is 2 difficult and moves very, very slowly in time, but where I 3 would slightly disagree with you, I do think that SACHRP has 4 more of a role than just mentioning that in the fact that, 5 again, the predecessor committee, NHRPAC, had been very 6 active, the most active working group in social and behavioral 7 working group. There doesnt exist one here. A lot of work 8 has been done. Im not saying you need to create one. You 9 have enough on your plate. Im not saying you shouldnt create 10 one. That could also be a good idea. 11 But what Im suggesting is there are a list of 12 things, again, you dealt with one of them which was minimal 13 risk but there are other broader issues. There are issues 14 that were raised by all the speakers on specific things having 15 to do with privacy and confidentiality and social behavioral 16 research, ethnographic, informed consent as a process. A lot 17 of work has gone on in this and so what Im asking you to do is 18 to consider how as a group you can leverage your position to 19 either endorse that guidance because it needs more than a 20 general statement that education or guidance are important, 21 specific recommendations for guidance on specific things. So 22 Im saying build on the NRC report, build on the work that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 73 1 SBSWG did, pick and choose those things that you think are 2 well positioned and if you dont think theyre there, think 3 about either using some external group, does SBSWB still 4 exist, or creating a small working group to just think about 5 giving the stamp of approval of this group to certain things 6 that youre comfortable with. 7 DR. PRENTICE: Mary. 8 DR. POLAN: Thank you. Thank you all very much 9 for coming. Speaking as someone who comes from a medical 10 school with a science background who didnt know that word 11 ethnography until several years ago in the School of Public 12 Health when somebody said that word and I raised my hand and 13 said, What is that, I see this as -- actually, I think it was 14 Dr. Hegtvedt who talked about objective quantified research 15 versus non-quantifiable research. Thats a concept that most 16 physicians dont understand, dont think about because if you 17 cant quantify it, its not research. It has no validity and so 18 if you bring any kind of epidemiologic public health 19 population study that has anything to do with opinion rather 20 than quantifiable data to an IRB, often nobody understands 21 what youre talking about and they dismiss it because they dont 22 believe its valid research. This goes back to really what NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701www.nealrgross.com 74 1 Nigel said; is there some way that SACHRP could help educate 2 medically oriented IRBs? I mean, if you have the resources to 3 set up a separate IRB, thats terrific but not everybody does. 4 5