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Secretary's Advisory Committee on Human Research ProtectionsMeetingMarch 29-30, 2004Alexandria, VASummary Minutes TUESDAY, MARCH 30 Welcome and Opening Remarks Ernest Prentice, Ph.D. Dr. Prentice welcomed participants to the second day of the March, 2004 SACRHP meeting and commended the Committee for working so efficiently.
Litigation in Clinical Research: Problems and Solutions (E. Haavi Morreim, Ph.D., Professor of Bioethics, University of Tennessee)) Dr. Morreim discussed developments in case law and legislation as they relate to current clinical research issues, especially the challenges faced by IRBs. Litigation Trends Dr. Morreim explained that it is difficult to gather accurate trend information because many cases are settled out of court. She referred SACHRP members to her previously sent article for additional information. (Morreim, E.H.; Medical research litigation and malpractice tort doctrine: courts on a learning curve, Houston Journal of Health Law and Policy 2003; 4(1): 1-92.) Potential Sequelae Dr. Morreim observed that IRBs are very concerned about whether their decisions could result in litigation. She identified nine potential sequelae in this litigious atmosphere:
Insurance Challenges and Potential Responses In the current environment, entities involved in research efforts have difficulties obtaining adequate insurance. Only two insurers remain in the market and the policies they offer often have serious gaps in research coverage. Current challenges include increasing:
Other problems included the following:
A better economy will help resolve many of these problems. Other solutions involve:
Educate insurers about various research players’ diverse roles and varying risk levels involved in conducting studies Negotiate reduced rates
Group purchasing consortia Special riders to cover research Group self-insurance (although there are significant obstacles to this) Settling without Going to Litigation Settling without litigating often is very appealing to research institutions because they avoid the related costs and uncertainties as well as possible bad publicity and requirements to release sensitive information. In addition, some insurance policies mandate settlement with or without the consent of the insured. However, in the absence of judicial evaluation, plaintiffs may make significant claims about various parties’ responsibilities that may linger as “quasi-standards.” Alternatives to Settling or Litigation: Arbitration IRBs have not been able to rebut many unrealistic claims regarding their “responsibilities” because of institutional pressure to go to settlement. However, arbitration may provide an alternative to settlement or litigation that would enable IRBs to rebut these claims. The Federal government has evinced increasing interest in arbitration, and the States are following suit. Arbitration is simpler and quicker than going to court and involves relaxed rules of discovery and fewer administrative expenses. In addition, arbitration can provide limited compensation and can be conclusive if specified as binding. The drawbacks of arbitration fall mainly and the plaintiff and include limited: discovery, judicial review, procedural protections, and time to file. Recent decisions demonstrate that judges’ are moving to consider arbitration as:
In crafting arbitration agreements, research institutions must take special precautions to ensure that the results are enforceable. In the research context, these precautions include:
In addition, arbitration procedures must be within the research subject’s reasonable expectations and participation must be fully voluntary (i.e., not a prerequisite for entering the study). Alternatives to Settling or Litigation: Federal Immunity for IRBs. Providing IRBs with the qualified (presumed, but not automatically assumed) immunity could protect the Boards from unrealistic lawsuits, although legislation probably would be required before this remedy could be made readily available. Qualified immunity could:
Dr. Morreim discussed three models of qualified immunity that could be adapted for IRBs. They are, respectively, based on:
HCQIA. This law was enacted to protect peer review in health care institutions. It stipulates that reviewers will not be liable in damages if a “professional review action” meets certain standards of due process and fairness,. (This immunity applies to money damages, not lawsuits.) Decisions are made by judges, not juries, and the burden of proof falls on the plaintiffs. In making judgments, the standard applied is reasonableness, not good faith. Case law has upheld HCQIA. Dr. Morreim offered a draft version of HCQIA adapted for use by IRBs. For purposes of the protections set forth in this law, she proposed that an IRB action must be taken:
FTCA. This Act waives sovereign (absolute) immunity and allows the Federal government, rather than its employees, to respond to tort suits in certain situations. Judges, not juries, decide these cases and no punitive damages may be awarded. Under this Act, IRBs would have greater freedom to carry out their mission, their insurance costs would decrease, and members’ personal liability would be eliminated. In her rationale for including IRBs under the Act, Dr. Morreim noted that:
In addition, the Act already has been used to protect migrant health centers from the costs of comprehensive malpractice insurance. § 1983/Bivens. These decisions protect Constitutional rights yet also protect public officials from suits based on errors in judgment. Federal employees have qualified immunity and the plaintiff must demonstrate that the government representative: (1) violated a Constitutional right that was clearly established and (2) that “a reasonable person would have known that this conduct violated a Constitutional right.” Judges, not juries, decide these cases and no punitive damages may be awarded. Dr. Morreim presented her tentative conclusions about the implications of these decisions for IRBs. She noted that IRBs:
Recommendations Dr. Morreim recommended that IRBs take action to obtain qualified immunity via legislation. She identified six key features to be included in the immunity bill: Reasonableness of conduct secures immunity Judges, not juries, determine immunity The burden of evidence is placed on the plaintiff Immunity covers-- Monetary damages (minimal requirement) Suits (ideal) No punitive damages may be assigned If the defendant prevails, the plaintiff pays all litigation costs In addition, Dr. Morreim made the following overall administrative recommendations:
Discussion of Dr. Morreim’s Presentation Dr. Prentice thanked Dr. Morreim for her concision and clarity and for presenting SACRP with new approaches to a serious problem. He added information about a recent case that could set a “quasi-standard.” In the case of Richard Cuss v. Sherman Hospital, the Illinois appellate court ruled that the IRB had to be certain that participants signed and used the correct consent forms. Ultimately, the case was settled out of court. Dr. Prentice asked two questions:
Dr. Morreim explained that many court suits are denied or involve long amounts of time and sizeable awards to attorneys. It is not clear how long plaintiffs must wait to collect funds from judgments or how much money they receive. The advantages of arbitration are that plaintiffs are more likely to collect these smaller claims and to do so more rapidly. Nonetheless, because of the negatives associated with arbitration, Dr. Morreim recommended moving to this approach only if qualified immunity cannot be achieved. She added that, in her reading of the law, there are various ways to write IRB protections into arbitration contracts. Drs. Prentice and Morreim agreed that plaintiffs would be less likely to include IRBs in any kind of suit if an arbitration contract were in place. Dr. Hauser asked Dr. Morreim to recommend mechanisms for tracking litigation. Dr. Morreim suggested creating a central, informal registry of information about IRBs and others involved in public complaints concerning research. She was not familiar with specific mechanisms for putting registries in place. Dr. Hauser also asked how immunity would be extended to IRBs and what the Boards would need to do to qualify for immunity. Dr. Morreim responded that extending immunity via the HCQIA or FTCA model would require Congressional legislation. To qualify for immunity, the IRBs would have to comply with criteria specified in the legislation. (Those included in the HCQIA were more general than those specified by the FTCA.) Moving forward under the § 1983/Bivens model would require judicial decisions, ideally on the Supreme Court level. Mr. Barnes observed that DHHS could capture much of the litigation data using the National Practitioner Data Bank (NPDB) created by the HCQIA. HHS has the authority to expand NPDB so that research-related settlements and judgments are recorded. Dr. Morreim observed that the expanded databank would need to track filings as well as outcomes. Although not his viewpoint, Mr. Barnes reported that plaintiffs’ attorney Allan Millstein considers IRBs lazy and negligent. Mr. Millstein views the tort system as a good way to punish IRBs and ultimately reform their behavior. Dr. Morreim replied that the tort system does not work the way it should. The immunity system she propounds is a better remedy for addressing IRB problems. Nonetheless, some of the suits against IRBs have been useful wake-up calls to the field. Dr. Khin-Maung-Gyi asked whether requiring subjects to review arbitration materials as well as other required documents could be viewed as placing too heavy a burden on participants. Dr. Morreim agreed that this requirement could be considered a negative aspect of arbitration. However, having an arbitration process in place probably would result in IRB performance that was more flexible and perhaps more beneficial to subjects. In addition, as she mentioned earlier, arbitration benefits subjects in other ways. Dr. Fisher made several comments. She suggested that collecting data would be difficult because institutions are reluctant to make this information public, and she raised concerns about:
In addition, Dr. Fisher asked:
Dr. Morreim’s responses included the following points:
Before the session concluded, the following additional points were made:
SACHRP members thanked Dr. Morreim for her presentation. Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Panel The Privacy Rule and Research (Susan McAndrew, Senior Policy Specialist/HIPAA, Office for Civil Rights, Office the Secretary, DHHS) Ms. McAndrew provided an overview of the Privacy Rule in her PowerPoint presentation, The Privacy Rule and Research. The Rule was issued by HHS to meet HIPAA implementation requirements. Staff at the Office for Civil Rights (OCR) provide technical assistance regarding the Rule and investigate complaints. The Rule provides two types of protection:
The research provisions of the Rule enable CEs to use and disclose protected health information (PHI) with individual authorization or, under limited circumstances, without individual authorization. The Rule’s authority extends beyond those agencies regulated under the Common Rule or by the FDA; it applies to: (1) any research that includes treatment of research participants (e.g., clinical trials) and (2) records research using existing PHI (e.g., databases and repositories). However, the Rule does not override the Common Rule or FDA’s human subject protection regulations. Common Rule v. Privacy Rule. The Privacy Rule authorization process has been streamlined, and researchers should be able to mesh both sets of requirements into a single document when they judge this to be appropriate. As part of the streamlined process, Privacy Rule research authorizations:
Use and Disclosure of PHI for Research without Individual Authorization. OCR has developed four options to govern use and disclosure without individual authorization.
The use or disclosure of PHI involves no more than a minimal risk to the privacy of individuals. The research could not practicably be conducted without the alteration or waiver. The research could not practicably be conducted without access to and use of the PHI.
Accounting for Research Disclosures. Upon request, the CE must provide the individual with an accounting for research disclosures made without his or her authorization (except for research conducted under Option Four). In 2002, this requirement was relaxed for CEs conducting a great deal of research or large research studies (50 or more records). CE and Researcher Relationship. The researcher and the CE are two separate legal bodies. The Privacy Rule can apply to the entire entity or a hybrid status may be developed in which the treatment and research components are separated and the latter becomes a third entity. Resources and Future Plans. Ms. McAndrew directed SACHRP to the OCR and NIH Websites, respectively, for additional information: She also noted that OCR is working with NIH on issues related to international research and is tackling the recommendations developed by the National Committee on Vital and Health Statistics (NCVHS) at their November meeting, focusing particularly on clarifying Privacy Rule provisions for stand-alone authorization and patient recruitment. Association of American Medical Colleges (AAMC) Project to Document the Effects of HIPAA on Research (Susan Ehringhaus, J.D., AAMC Associate General Counsel) Susan Ehringhaus discussed the purposes, conduct, and results of the AAMC project. The 2003 AAMC HIPAA Survey was undertaken to document the effects of HIPAA on biomedical and health sciences research and to probe broadly defined HIPAA-related costs. A database of case reports was created to identify instances of research being delayed, hindered, abandoned, or foregone due to HIPAA as well as research that benefited as a result of the Act. Survey steering committee members were drawn from a range of professional health and medical associations. AAMC member institutions, working through designated representatives, collaborated in the project. The following AAMC principles guided the conduct of the survey:
The majority of survey respondents were investigators (62%), followed by study coordinators/managers (18%) and research administrators (9%). Other respondents targeted by the survey were: IRB personnel, officials concerned with privacy regulations, and medical school deans. The survey found that:
The types of effects of HIPAA on research include the following:
Ms. Ehringhaus cautioned SACHRP that the interpretation of the responses is limited by the relatively small size of the data set. It also is limited because the questions were asked in the earliest phase of HIPAA compliance and the initial interpretations of the regulations tended to be very conservative. Nonetheless, AAMC’s findings confirmed the results of the National Cancer Advisory Board (NCAB) survey of National Cancer Institute (NCI) Cancer Centers, Cooperative Groups, and Specialized Programs of Research Excellence (SPOREs). Based on both surveys, AAMC developed the following recommendations to improve HIPAA implementation: Eliminate the accounting of disclosures for research (consistent with NCAB results). For studies involving fewer than 50 subjects, the accounting of disclosures represent a large regulatory burden and ultimately will reduce the research base for epidemiological and health services studies. Research involving 50 or more subjects is generally carried out at major research entities conducting multiple protocols. The accounting for disclosures requirement puts an unreasonable burden on these institutions for assisting individuals in retrieving information and is a negative incentive for institutions to participate in research involving many subjects.
Additional information about the survey can be found on the AAMC Website, http://services.aamc.org/easurvey/survey/login.cfm. The Website provides information on the results categorized by research function affected, nature of the problem, attempted resolution, and role of the respondent. The HIPAA Privacy Rule and Research: Recommendations of NCVHS (Mark A. Rothstein, J.D., Chair, NCVHS Subcommittee on Privacy and Confidentiality) Mark Rothstein discussed the NCVHS recommendations and the resulting letter to Secretary Thompson--Recommendation on the Effect of the Privacy Rule, March 4, 2004. NCVHS is a statutory Federal advisory committee providing guidance to Congress and the DHHS Secretary. The Committee comprises workgroups and subcommittees on specific topics. On November 19-20, 2003, the Privacy and Confidentiality Subcommittee held hearings to gather expert testimony on the impact of the HIPAA Privacy Rule on research. Five conclusions were developed:
Inconsistencies between the Privacy Rule and the Common Rule. Mr. Rothstein noted that the inconsistencies result in gaps in protection, create burdens on researchers, and contribute to confusion about research procedures. Specific problems that have arisen include the following: Under the “preparatory to research” provision, researchers and their business associates may contact patients and ask them to authorize the use of their PHI without prior submission to an IRB for approval or waiver. This violates the IRB’s primary directive: to review research before recruitment starts. The Privacy Rule permits the use of a combined informed consent/authorization document, but many institutions prefer to use separate forms. Because the Privacy Rule does not require IRB approval of stand-alone authorizations, some IRBs believe they are prevented from reviewing these documents. Under the Common Rule, IRBs may allow research subjects to provide informed consent for future, unspecified research. However, under the Privacy Rule, authorization generally must be protocol-specific and, therefore, a waiver or alteration from an IRB or Privacy Board would be needed before PHI could be disclosed from a repository. This creates unnecessary burdens on researchers. Other Areas of Concern Noted by NCVHS. Mr. Rothstein noted that additional issues were identified at the November hearings. Members expressed concerns about:
Recommendations to the DHHS Secretary. On March 5, 2004, NCVHS sent a letter to Secretary Thompson recommending that HHS clarify the intent and provisions of the Privacy Rule and make further efforts to harmonize the Privacy and Common Rules. Presentation to SACHRP (Joanne E. Pollack, J.D., Vice President and General Counsel at Johns Hopkins Health System, Inc.) Joanne Pollak discussed the practical impact of the Privacy Rule on an academic research institution, focusing on: (1) medical archives in CEs, (2) future unspecified research, and (3) the harmonization of HIPAA and Common Rule authorizations. Medical Archives. These are documents held by a medical institution; they include the records of patients and physicians, some of which may be very old. Under the Privacy Rule, two critical issues have arisen: access and publication.
To resolve these problems, Ms. Pollak suggested: (1) developing designated data sets to which HIPAA would not apply and (2) asking the institutional privacy board to determine what types of materials might appropriately be released. In addition, donors might be asked to provide written statements releasing materials for general use after a certain number of years. Future Unspecified Research. Under the Common Rule, people may donate tumors and other tissue to medical registries for future research studies and no further informed consents are required. However, under the Privacy Rule, researchers must get IRB waivers or donor authorizations for every study using the tissue. This creates a serious burden for researchers and is confusing to donors. The solution is for HIPAA and the Common Rule to be harmonized in this area. IRBs should be allowed to determine the adequacy of the first consent form and whether other protections are needed. If current practices continue, individuals will become increasingly reluctant to donate tissue, DNA, and data to CE registries and the new unregulated databank industry will flourish. Harmonization of HIPAA and Common Rule authorizations. Ms. Pollak made the following points:
SACHRP Discussion of the HIPAA Privacy Rule Dr. Prentice thanked the panelists for their informative and thought-provoking presentations. He noted that researchers at the University of Nebraska Medical Center have not had many problems with the Privacy Rule. The Center uses a form combining Common Rule consent and HIPAA authorization; the only research sponsors that have trouble with this are pharmaceutical companies. These sponsors are not CEs and do not have to comply with the Privacy Rule; however, the University Medical Center is a CE and must follow the Rule. The resulting conflicts have led to protracted legal negotiations, especially concerning contract language. He asked the panelists if they were familiar with this problem. In response, Ms. Pollak said that Hopkins has had similar problems and has successfully negotiated for the use of limited data sets or de-identified information or the inclusion of additional information in the authorization. Mr. Rothstein added that a uniform resolution for this type of problem is needed. Dr Prentice agreed. Dr. Hauser asked whether the HIPAA rules had adversely affected researchers’ ability to conduct safe clinical studies. Ms. Ehringhaus responded that, according to the AAMC survey, the need to use de-identified data increases the possibility for errors in data interpretation. In addition, survey respondents noted that retrospective research using treatment records was made more difficult by HIPAA. Ms Kornetsky asked Ms. McAndrew whether many HIPAA-related complaints involved research studies. Ms. McAndrew explained that “research study” is not among the categories used to analyze complaints. She speculated that research studies accounted for few complaints; however, some of the categories, such as “impermissible use of information” could include research studies. Ms. McAndrew added that, during the Rule comment periods, a great deal of concern was expressed about protecting personal data in research studies. Mr. Adams asked Ms. McAndrew about progress being made in harmonizing the Privacy and Common Rules. Ms. McAndrew replied that conversations are underway to facilitate harmonization. Dr. Khin-Maung-Gyi asked how the Common Rule might be strengthened so that it might be used instead of the Privacy Rule in studies conducted under HHS or FDA authority. Ms. Pollak suggested that OHRP and FDA might provide guidance that would require researchers to disclose the types of information they would be collecting and how it would be used. Alternatively, the Privacy Rule might be amended to ensure that specific items related to subject privacy are included in the informed consent documents. The list of required privacy protection items would be shorter than the list currently required under the Privacy Rule. Ms. Ehringhaus reported that AAMC favors the latter solution. Mr. Barnes outlined two scenarios and asked Ms. McAndrews specific questions about them.
Ms. McAndrew replied that:
Mr. Barnes observed that the publication ruling could have a chilling effect on the dissemination of important scientific knowledge. Ms. Kornetsky added that case studies usually report rare occurrences and necessitate the use of unique identifiers. Therefore, OCR’s position on publication means that HIPAA authorization would be required for publishing most case studies. Ms. McAndrew responded that individuals should have some say in how their personal information is used. Mr. Rothstein added that it is appropriate to obtain authorization prior to publishing information that might lead to the identification of an individual, especially by the press or general public. International Activities Report Dr. Polan presented Office of Human Research Protections International Activities, the report she drafted with fellow SACHRP member Nancy Jones and:
Dr. Polan explained that the Report and presentation were meant to stimulate discussion and the possible appointment of a Subcommittee to further study international issues and draft formal recommendations. As part of the Report, the international study group developed three recommendations for SACHRP consideration:
Dr. Polan also identified more complex issues for SACHRP to address. These included:
Discussion of the International Activities Report Dr. Jones noted that international research is a growing field and suggested that funding agencies should be asked to justify their international research programs, with a focus on ethics issues. These are of particular concern because sponsors appear to be drawn overseas by the generally lower levels of regulatory requirements and costs. Other comments included the following:
SACHRP members noted that a proactive approach to the issue was needed. As a first step, a timeline for the discussion of international issues should be developed. Issues for Discussion by SACHRP: IRB Review of External Adverse Event Reports (AERs) (Ernest Prentice, Ph.D.) Dr. Prentice described IRB problems with AERs and outlined a potential solution. Problem: AER Overload Eight factual statements describe the current problem:
Proposed Solution Based on his experience in the field and discussions with representatives from key organizations, Dr. Prentice proposed components of a possible solution:
The protocol requires modification OR The consent form requires revision to disclose a new risk OR A problem exists that affects the study.
The PI should only notify the local IRB if: A protocol change is needed. The consent form requires revision.
Dr. Prentice also recommended that OHRP and FDA should promptly issue official guidance that is clear and consistent. This guidance should help research institutions/IRBs to interpret the Common Rule provisions that apply to the review of internal and external AERs. Roadblocks and Advantages. Roadblocks to implementing this solution include the following:
However, these are counterbalanced by the advantages, which include lower costs to pharmaceutical companies, research institutions, PIs, and IRBs. In addition: IRBs’ workloads would be decreased and resources would be available for other activities. IRBs would no longer need “police” the review process, but could return to their intended role as of being part of an institutional team sharing responsibility for research oversight. The Charge to SACHRP Dr. Prentice charged SACHRP with determining what the Committee could do to facilitate OHRP/FDA’s current efforts to develop guidance on AE reporting that protects human subjects and provides relief from the AER burden. He suggested that beneficial guidance be drawn from the comments of philosopher and physician Henry Beecher. In 1966, Dr. Beecher noted that the two most important components of ethical research using human subjects are: (1) informed consent and (2) the safeguard provided “by the presence of an intelligent, informed, conscientious compassionate, responsible investigator.” SACHRP Discussion of External AERs (NOTE: Dr. Khin-Maung-Gyi chaired this discussion.) Dr. Fisher thanked Dr. Prentice for his presentation. She noted that the proposed system makes funders ultimately responsible for providing information about patient protections, but gives PIs responsibility for making decisions about what is done with this information. She asked whether the PIs were qualified to make these decisions, and she observed that, for this system to work properly:
Dr. Prentice agreed that this would be the ideal system, but implementation would require changing regulations. In contrast, Dr. Prentice’s proposal would not require regulatory changes. Accountability would rest with the PIs; although they receive limited information, they are better positioned than the IRBs to decide whether action is needed. When PIs decide no action is needed, the data and their supporting analyses are filed. If action is needed, the data is forwarded to the IRBs. Dr. Fisher expressed concern that PIs and DSMBs would have different criteria for determining whether AEs were serious and warranted protocol changes. Dr. Prentice agreed that this was a legitimate concern. Ms. Kornetsky commended Dr. Prentice and observed that many IRBs already are using his proposed system to facilitate review. She suggested that PIs should provide IRBs with data safety management plans (DSMPs) and establish DSMBs. She also asked that IRBs add special DSM criteria to protect vulnerable populations. Dr. Prentice agreed with the latter stipulation, but noted that DSMBs do not operate in real time. Ms. Kornetsky and Dr. Prentice agreed that a mechanism would need to be put in place to ensure that potentially serious problems were reviewed quickly by DSMBs. MOTION: Dr. Hauser moved that the Committee recommend to the DHHS Secretary that OHRP and FDA should issue official guidance that facilitates the ability of research institutions/IRBs to interpret and apply 45 CFR 46.103(b)5 and 21 CFR 56.108(b)1 to the review of internal AERs and external AERs. He added that the final wording of the motion also should convey SACHRP’s sense of urgency about this. The word “promptly” might be inserted before “issue official guidance …” in the recommendation. DISCUSSION: Mr. Adams asked whether SACHRP should establish a Subcommittee to study the AER problem. Dr. Prentice observed that resolving the AER issue is a high priority. Both OHRP and FDA have been given copies of this presentation and additional information. Using the Subcommittee process would take a great deal of time and is not likely to provide additional important information for consideration by OHRP and FDA. Dr. Khin-Maung-Gyi asked OHRP and FDA for any comments on the motion. Dr Schwetz stated that OHRP is prepared to move on this issue as a high priority. Dr. Lepay noted that FDA is prepared to move ahead with the aspects of AERs that apply to IRBs. ACTION: Mr. Adams seconded the motion. SACHRP accepted the motion unanimously. Continued SACHRP Discussion of AERs (1) Dr. Lepay explained that Dr. Prentice’s proposal appears to comply with existing FDA regulations. Dr. Prentice reported that this model is being used at the City of Hope and at the University of Washington. Dr. Weiner and Mr. Adams noted that PIs may have conflicts of interest regarding defining and reporting serious AEs. Drs. Khin-Maung-Gyi and Prentice explained that OHRP and FDA guidance will address this issue. Dr. Fisher recommended that PIs provide the IRB with: (1) assurances that an independent DSMB will be used and (2) plans for its operation in various circumstances. Dr. Prentice reviewed the proposed AER process, focusing on the following points:
Public Comment John Mather, M.D. The Director of the Office of Compliance Review at the University of Michigan, Dr. Mather commended SACHRP on the AER recommendation. He asked that potential PI conflicts of interest be carefully reviewed, noting that these might be considerable when the PI is an employee of the company sponsoring the research. Dr. Mather also suggested that the SACHRP meetings include more frequent public comment sessions. Paul Goebel, CIP Mr. Goebel, Vice President, Chesapeake Research Review, Inc.,suggested that the informed consent documents be modified to help patients understand that they have options other than suing to resolve liability issues. Mr. Goebel also commended SACHRP for the AER recommendation and suggested that the guidance clearly explain to sponsors that not every AER must go to the IRB. Maura Keen, University of Minnesota Ms. Keen, although not speaking in her official capacity, did make comments based on her experiences supervising IRBs at the University of Minnesota. She urged SACHRP, OHRP, and FDA to provide guidance concerning how to advise research sponsors from the pharmaceutical industry that ask for IRB reviews with the goal of obtaining protection from potential liability. She also asked the three governmental entities to provide guidance regarding international research conducted in Canada and other developed countries. Continued SACRHP Discussion of AERs (2) Dr. Khin-Maung-Gyi observed that FDA has asked IRBs to review IND safety reports for potential human subject safety issues. However, IRBs are not able to serve as DSMBs. The forthcoming guidance should be viewed as an opportunity to clarify the roles of various entities in protecting participants. In response to a question from Dr. Prentice, Dr. Khin-Maung-Gyi explained that when an independent IRB is selected as the Board of record for a multi-center study, it can apply economies of scale to reviews. However, much like academic IRBs, the independent Boards may have difficulties obtaining and interpreting data from distant locations. Dr. Prentice noted that PIs are increasingly more likely to address AEs by modifying consent documents rather than modifying the protocol. Mr. Barnes cautioned against cluttering the consent form with language referring to risks that are not truly significant. He explained that only items meeting the standard of significant risk should be included in the consent form. Review of Previously Discussed Action Items Dr. Prentice summarized some of the near-term action items to be undertaken by the Subcommittees and SACHRP:
Litigation Issues SACHRP agreed to address the litigation issues summarized by Dr. Morreim. Mr. Barnes asked that SACHRP make any recommendations requiring Congressional action before the November elections. Dr. Prentice observed that no IRB has been successfully sued. He explained that the real impact of current litigation is on paperwork: documentation requirements are steadily increasing because research institutions take a defensive posture regarding possible suits. Other comments included the following:
It was agreed that consideration of litigation would be postponed. SACHRP will recommend that the IOM Clinical Research Roundtable review litigation issues. MOTION: A motion was made and seconded stating that the information presented by Dr. Morreim as well as the ensuing questions and answers, should be summarized and presented to the IOM Clinical Research Roundtable. ACTION: SACHRP passed the motion unanimously. Endorsement of the AAMC Recommendations Presented by Ms. Ehringhaus Dr. Fisher asked that SACHRP endorse the AAMC recommendations found in Ms. Ehringhaus’ presentation. The endorsement should include language explaining that these recommendations would help clarify and resolve Privacy Rule/Common Rule issues that otherwise would become unduly burdensome to OHRP and SACHRP in their deliberations. Mr. Barnes suggested that the recommendations be endorsed by SACHRP and then be amplified by interested SACHRP members, including himself. Dr. Prentice explained that SACHRP rules did not allow this. Ms. Kornetsky suggested that a group of SACHRP members draft a letter for consideration at the next meeting. SACHRP accepted this suggestion. Tissue and Data Repositories Noting that OHRP receives many questions concerning tissue and data repositories, Dr. Prentice proposed that the SACHRP address these issues. Ms. Kornetsky reported that a group of attendees at the upcoming Public Responsibility in Medicine and Research (PRIM&R) conference plan to draft a document pertaining to tissue and data repositories. Several SACHRP members will assist in drafting that document, which is to be ready in October. Dr. Prentice suggested that SACHRP defer discussion of this issue until after the PRIM&R document is presented this fall. At that time, it could become a platform for SACHRP discussion. The members agreed. Defining Research Dr. Prentice noted that it is becoming more difficult to determine what qualifies as research. This issue, which has become a challenge for OHRP, is being addressed by the Hastings Center. SACHRP members reported that the Center is looking at the issue from a perspective that might leave some SACHRP and OHRP concerns unaddressed. Dr. Schwetz reported that defining research, especially for public surveillance and quality assurance studies, is an on-going issue for OHRP. Ms. Kornetsky observed that defining research is an issue for many Federal agencies. MOTION: Ms. Kornetsky moved that a panel be developed to speak at the next SACHRP meeting. Mr. Barnes seconded the motion. DISCUSSION: Mr. Barnes recommended inviting Erin Mellon and Jeremy Sugarman to join the panel. Both of these individuals are experts in the field and have recently published articles on the topic in scholarly journals. Dr. Fisher suggested that a representative of the American Educational Research Association (AERA) also be invited to speak. ACTION: SACHRP approved the motion with one abstention (Felix Khin-Maung-Gyi). Applying a Biomedical Model to Behavioral and Social Science Research Dr. Prentice noted that concern about this issue, especially related to IRB reviews, is growing. Dr. Fisher added that a special concern in behavioral science research is defining “minimal risk.” Dr. Prentice suggested that Joan Seiber be asked to join any panel discussing this issue. Dr. Fisher remarked that minimal risk should be jointly discussed by the Subpart C and D Subcommittees with attention paid to the implications of Subpart A. She added that it might be appropriate for SACHRP to develop an agreed-upon definition with any needed modifications for all of the Subparts, before discussing:
Dr. Prentice observed that it might be effective to address the confusion in Subpart A related to minimal risk by using remedies that do not require notification of policy-making, but are based on the clear intent laid out in the 1981 Preamble to the FDA and HHS regulations. Ms. Odwazny explained how this might be done. Ms. Kornetsky added that minimal risk determinations made to clarify Subpart A might also be applied to Subpart D. Ms. Odwazny cautioned that defining minimal risk for the various Subparts would require a careful review of the regulations. Conflicts of Interest (COI) Dr. Prentice observed that institutions are making progress in addressing COI issues. He suggested that SACHRP wait until the institutions are further along in modifying their COI plans before determining what involvement might be appropriate for the Committee. The group concurred. Decisionally Impaired Subjects Dr. Prentice reported that OHRP is discussing how best to address issues related to the participation of decisionally impaired subjects in research. Dr. Khin-Maung-Gyi proposed postponing SACHRP discussion until OHRP had made further progress in its deliberations about including decisionally impaired subjects in research. Ms. Kornetsky asked that OHRP inform SACHRP about when it might be appropriate for the Committee to open this discussion. The members agreed to the proposals made by Dr. Khin-Maung-Gyi and Ms. Kornetsky. Subpart B Dr. Prentice noted that Subpart B may need to be rewritten. At a minimum, several issues, such as whether pregnant women have appropriate protections, need reconsideration. Mr. Barnes suggested that Drs. Polan and Jones, who have experience related to Subpart B, make a presentation on this issue. Dr. Jones explained that an analysis of Subpart B involves discussing many issues, including:
Drs. Prentice and Jones agreed that the term “embryo” as used in Subpart B, needs to be clarified. However, added Dr. Jones, this should not be an issue for SACRHP. MOTION: SACHRP members asked Drs. Polan and Jones to present a Subpart B panel. DISCUSSION: It was agreed that Drs. Polan and Jones will develop an agenda for review that might include guest speakers. ACTION: SACHRP unanimously approved the motion. Third Subcommittee No third Subcommittee currently exists. One may be created at the July meeting. July SACHRP Meeting The next SACHRP Meeting will be held on July 26 and 27 at the Sheraton Four Points Hotel in Washington, D.C. Other Issues NIH Collaborative Review of HRP Regulations Ms. Kornetsky raised questions about a press article reporting on an initiative at NIH to lead a collaborative review of Federal human subjects regulations; this review is an initiative of the NIH Roadmap and involves a range of issues of concern to NIH. She asked for more information on this review so that SACHRP could avoid duplicative efforts. Drs. Shore and Schwetz explained that this review evolved on a piecemeal basis from the NIH roadmap initiative. Dr. Amy Patterson, Director, Office of Biotechnology Activities, Office of Science Policy, NIH, discussed the initiative at the last SACRHP meeting. Dr. Shore added that:
Drs. Khin-Maung-Gyi and Jones asked for more information about the review and regular updates on the members’ progress. Minimal Risk Ms. Kornetsky noted that the pediatrics Subcommittee has been moving toward an absolute definition of minimal risk that might be inappropriate given that this issue must be addressed in a larger context. Ms. Odwazny will discuss this issue with OHRP and provide additional information to aid in Subcommittee discussions. Dr. Fisher asked that the Subcommittees be regularly updated by OHRP’s legal advisors concerning limitations that apply to their deliberations. She asked that a representative of the legal staff be present at all Subcommittee and Committee meetings. Adjournment Dr. Prentice thanked members of SACHRP and the public for their participation. Based on the performance of SACHRP and the Subcommittees thus far, he predicted that the July meeting would be fruitful and exciting. Secretary’s Advisory Committee on Human Research Protections Meeting March 29-30, 2004 Alexandria, VA ACTION ITEMS: Monday and Tuesday
Prepare recommended short and/or intermediate-term solutions for the July 2004 SACHRP meeting. Obtain additional legal input about providing special protections to individuals not at high risk for incarceration who enroll in a study and then are incarcerated.
Secretary’s Advisory Committee on Human Research Protections Meeting March 29-30, 2004 Alexandria, VA
Certification of the Summary of Minutes I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete. Ernest D. Prentice, Ph.D., Chair Date Last Revised: October 1, 2004 |
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