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Minutes

Secretary’s Advisory Committee on Human Research Protections
October 27-28, 2009 – Arlington, Virginia

Table of Contents

Welcome and Opening Remarks
Issues and Remarks from the OHRP Director
NIH’s Efforts to Promote the Harmonization of Clinical Research Studies
DISCUSSION
AAHRPP Revised Standards for Accreditation
DISCUSSION
Report of Subpart A Subcommittee (SAS)
DISCUSSION
ACTION
Public Comment
Opening Remarks
Remarks of Principal Advisor to the Assistant Secretary for Health (ASH)
Panel: Enhancing Informed Consent
Remarks by Eric Kodish: Enhancing Informed Consent: Lessons from Studies in Childhood Cancer
Remarks by Laura B. Dunn: Enhancing Informed Consent Process for Research: “The Answer is We Don’t Know”
Remarks by Millie Solomon: A Multimedia Approach to Informed Consent
Remarks by Cindy Brach: AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research
Remarks by Ann Partridge: Returning Research Results to Study Participants
DISCUSSION
Consideration of Recommendations
ACTION
Panel: Community-Based Participatory Research..
Remarks by Puneet Sahota: Community Based Participatory Research: Considerations for IRBs
Remarks by Sarena Seifer: Innovative Models and Emerging Issues in CBPR
Remarks by Margaret LeCompte: Sometimes What Seems Unfamiliar and Strange Ends up Almost Being Business as Usual
Remarks by Sarah Flicker: Community-Based Participatory Research
DISCUSSION
Public Comment
References

TUESDAY, OCTOBER 27

 Welcome and Opening Remarks

Barbara Bierer, M.D., Chair

The Chair recognized the contributions of departing SACHRP member Suzanne Pattee, who is joining the staff of the Food and Drug Administration (FDA). Her honesty, enthusiasm, and willingness to speak up will be missed.

Dr. Bierer also commented that new SACHRP members to replace Dr. Botkin and Dr. Genel, whose terms expired, have not yet been approved.

The minutes of July 21-22 were approved. One SACHRP member commented that the table on p. 4 is not entirely clear; however, it was agreed that the table stands as presented at the meeting and cannot be changed.

 Issues and Remarks from the OHRP Director

Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections (OHRP)

Dr. Menikoff reported on OHRP activities. The Division of Education was in New York City last September 11 for the Research Community Forum and received good feedback on its contributions. The Division of Compliance has been involved in research compliance actions and is clearly “on the job.” The Division of Policy has implemented a new joint FDA/OHRP registration system for Institutional Review Boards (IRBs), and the system is now functioning. OHRP is also working on draft guidance on the subject of Continuing Review. A few weeks ago, OHRP also issued Frequently Asked Questions (FAQs) on the important topic of how to determine whether a study is exempt.

NIH’s Efforts to Promote the Harmonization of Clinical Research Studies

Philip M. Budashevitz, R.Ph., M.A., CAPT, U.S. Public Health Service, Associate Director, Clinical Research Policy Analysis and Coordination Program (CRpac), National Institutes of Health (NIH)

Note: PowerPoints for all presentations by speakers are posted on the OHRP Web site.
Please see these resources for more detailed information.

 

CAPT. Budashewitz explained that a focus of the CRpac program is to promote the streamlining and harmonization of regulations and policies related to clinical research. It considers how to align regulations and policies more closely, develops common definitions for key terms, and issues “Points to Consider” and white papers to shed light on regulatory issues that affect the research community. CRpac coordinates closely with both FDA and OHRP in the U.S., as well as working with other countries and multilateral organizations. It has made contributions in the areas of adverse event reporting, the use of alternative IRB models, informed consent, privacy and confidentiality, and research using specimens and data.

DISCUSSION

SACHRP members asked for clarification and comments from the speakers on a variety of issues.

Clearance of Points to Consider and other Education Documents. CAPT. Budashewitz explained that CRpac does not issue guidance, but develops “Points to Consider” and other educational documents. The clearance of these documents occurs through both formal and informal technical reviews involving FDA, OHRP, and the HHS Office for Civil Rights (OCR). Documents are also reviewed by the Office of the General Counsel. These documents are nonbinding but are intended to be informational and educational.

Task Forces. The Federal Adverse Event Task Force (FAET) is composed of representatives of seven agencies who have the authority to commit their agencies to specific actions. The trans-HHS Task Force on Harmonization of Ethical and Legal Policies Related to the Use of Human Specimens and Data in Research (HELPS) is a technical group that represents the interests and viewpoints of various operating divisions within HHS. HELPS looks at issues and proposes ways to increase harmonization, but the agencies themselves are responsible for prioritizing and taking action on HELPS’ suggestions. An ex officio representative of the Indian Health Service (IHS) commented that the IHS is interested in being involved in HELPS to ensure that some culturally based differences in the handling of tissues and specimens are considered. NIH representatives welcomed IHS’ participation.

Harmonization. Dr. Strauss asked CAPT. Budashewitz whether he thought the proposed new SACHRP subcommittee on harmonization would be helpful, given that efforts at harmonization are underway at the Federal level and that agencies seem to have good communication mechanisms. CAPT. Budashewitz noted that CRpac had benefited greatly from previous work by SACHRP and from its continued discussion and prioritization of human subjects protections issues. It is useful to hear from people outside the government about the impact of issues related to harmonization. CAPT. Budashewitz suggested that it would be useful for SACHRP to prioritize harmonization issues and propose solutions for the agencies to consider.

Ms. Bledsoe added that because there is so much work to be done in this area, prioritization is a helpful contribution. Ms. Christna Heide of OCR commented that although there is a good deal of discussion of harmonization among agencies, the perspective of the research community on how issues should be prioritized would be helpful.

Dr. Menikoff observed that harmonization is a very large task that extends beyond HHS. He wondered whether SACHRP, which is funded by OHRP, is the right entity to address these issues. He was concerned that bringing in others to address problems already under discussion would complicate rather than facilitate the process of resolving issues. Dr. Strauss suggested that the committee’s work might inform and assist other efforts. Other members clarified that the committee would not do the actual work of harmonization, but rather would seek to facilitate and inform these efforts.

Members briefly explored whether it would make more sense to locate such an effort within NIH. However, CAPT. Budashewitz noted prioritization of harmonization issues would work best with the involvement of SACHRP. Ensuring adequate funding for the subcommittee was a concern for several SACHRP members. Dr. Bierer wondered whether OHRP’s budget limitations would mean that the subcommittee would lack the resources and membership it will require to engage productively in a challenging mission. The Chair understands that OHRP may be able to support a committee with only five members, which she believes may not be enough to represent the parties who should be at the table for the discussion SACHRP envisioned. SACHRP was informed that NIH cannot contribute to an OHRP committee.

Dr. Menikoff agreed that prioritization of issues related to harmonization would be a focused goal the subcommittee could reasonably be expected to accomplish.

 AAHRPP Revised Standards for Accreditation

Marjorie Speers, Ph.D., President and CEO, Association for the Accreditation of Human Research Protection Programs (AAHRPP)

Dr. Speers reported that AAHRPP’s revised accreditation standards would:

  • Strengthen identification and management of financial conflict of interest,
  • Emphasize international research,
  • Recognize the role of the community,
  • Focus on data and safety monitoring,
  • Elevate the importance of resources for Human Research Protection Programs (HRPP), and
  • Emphasize continuous quality improvement.

The speaker said she believed, and many accredited programs believe, that participant protection has improved as a result of accreditation. There is also evidence that recipients of NIH’s Clinical and Translational Science Awards (CTSAs) who are accredited find that collaboration among their institutions is facilitated by having a common language and procedures. She observed that accreditation and Federal oversight were complementary but distinct functions, both of which are helpful to the regulatory community.

DISCUSSION

SACHRP members had an opportunity to raise questions and comment on the presentation.

When you consider multisite or international research as part of an accreditation effort, how do you get beyond what is written on paper to what is actually happening on the ground? How do you determine whether or not appropriate oversight is occurring? The IRB in the U.S. needs to know a great deal about the country where the research is being conducted, including relevant laws and the local culture. Among other things, we look at the resources they have on the research site and the ways they ensure that local investigators are qualified to do what is asked of them.

What is your view of the value of accreditation internationally, especially in less developed countries such as Uganda? Issues regarding accreditation internationally are not that different from local ones; we also have resource-poor institutions in the U.S., while a number of emerging countries, such as China, are fairly wealthy. The Centers for Disease Control (CDC) and NIH have engaged in instructive efforts to build capacity in other countries through research networks.

How does your organization address the problem of “mission creep” in human subject protection programs? AAHRPP does point out to institutions when they are doing more than they have to. We may find, for example, that activities that are not human subjects research are treated as if they were, that exemption categories are not well used, or that research that could be expedited is not being expedited. We do not consider this to be a deficiency, however.

You mention that you do not audit ethical decisions, but isn’t that where the rubber meets the road? Do you look at decisions about what research can be expedited, for example? AAHRPP does review judgments made in a sample of protocols and point out when an institution’s decisions are aberrations from the norm. For example, reviewers consider whether the IRB understands what “minor” means and whether IRBs are using exemptions appropriately.

What have you observed about harmonization and the difficulties IRBs may be having in this area? It is clear that institutions are struggling with issues related to harmonization and would benefit from an explanation of how they should proceed when rules differ.

 Report of Subpart A Subcommittee (SAS)

Dan Nelson, M.S., CIP; Elizabeth A. Bankert, M.A, SAS, Co-Chairs

Mr. Nelson reported that SAS is making steady progress, and the serious participation by a number of ex officio members has helped “immeasurably.”

Definition of Investigator. Mr. Nelson reviewed problems with OHRP’s current definition of "investigator" in reference to research involving specimens of tissue as “anyone involved in conducting the research.” If individuals who provide coded information or specimens collaborate on other activities related to the conduct of this research with the investigators who receive them, this person is considered to be “involved in research” and the activities must be defined as human subjects research, even though the second investigators cannot ascertain individuals’ identities. SAS held that there are many circumstances where a secondary use of coded information or specimens would not constitute human subjects research, were it not for the peripheral involvement of the individual who gathered the original data or specimens.For example:

  • The original collector is involved as a coauthor on resulting manuscripts or listed on grants in recognition of his/her work in obtaining the data or specimens, but with an agreement that prevents release of the coding key to secondary users;
  • The original collector joins with others to form a centralized repository, with no continued personal access to identifiers;
  • A professor provides a coded dataset for a graduate student to use in secondary analyses, with no intention or reason to share identifiers.

SAS members agreed that:

  • Under these circumstances, current OHRP guidance defines the original collector as an “investigator” in the secondary use, even though their role may still effectively be limited to “solely providing” coded information or specimens.
  • This interpretation is overly restrictive, poorly understood, and therefore variably applied by IRBs and investigators. Even among SACHRP members, the interpretation was not clear and its implications had not been realized fully.
  • The 2004 guidance by OHRP has provided a valuable mechanism for investigators and IRBs to focus on activities where risk to subjects is a legitimate concern, but this particular element works counter to that goal and does not contribute meaningfully to human subject protections.

SAS made the following recommendation on the definition of “Investigator”:

  • OHRP should revise its interpretation of who is considered an “investigator” in secondary use of coded information or specimens to exclude those individuals who are providing such information or specimens, even if they are involved in analysis of aggregate data or publication of results, provided the secondary users are unable to readily ascertain the identity of subjects.
  • Mechanisms to support this interpretation could include (a) the presence of an agreement that prohibits release of the key from the original provider to secondary users; or (b) the existence of a repository or banking system that prohibits the secondary users from access to identifiers.
  • The intent is to support a conclusion that secondary uses under such circumstances do not constitute research involving human subjects (as defined under 45 CFR 46.102(f)) and therefore do not require IRB review and approval, in keeping with OHRP’s “Guidance on Research Involving Coded Private Information or Biological Specimens.”

DISCUSSION

The following key points were made by SACHRP members during the discussion of this recommendation that followed:

  • Is it enough if the original collector just “promises” not to share the key with the secondary user?
  • For this to work, the original collector must not be using the key or code the researcher retains in any way in his or her activities.
  • If the original collector collects a series of samples and gives them to a secondary user, who then gives them back to the original user for an assay only he or she can do, an “honest broker” and additional steps will be needed.
  • The assumption is that the specimens were originally collected for another purpose.
  • This scenario can occur within a single institution.

Dr. Strauss asked about the following scenario: If the original user sends coded specimens with no identifiers to another institution for a related assay, does the IRB of the receiving institution have to review the research? An OHRP staff person responded that the key difference between this scenario and the original one is that the secondary user is performing related research. Therefore, the overall research activity does involve human subjects research. The issue of engagement would need to be addressed at each institution, at least one of which would definitely be engaged in research.

Dr. Strauss observed that if a researcher can ascertain identities and just “agrees not to look,” this appears unenforceable. Mr. Nelson responded that the original researcher is, in this scenario, doing things for which the code is not relevant. A SACHRP member stressed that it should be clear that the secondary user is collecting specimens for a different purpose that does not require the code.

Suggestions for revision included:

  • The words “without identifiers” should be added, even though this is included what “coded” means.
  • It should be clear whether the same mechanisms would apply within the same institution as well as between institutions.
  • It should be clear that the secondary user is using the data for a different purpose than the original purpose.
  • It should be clear that the role of the secondary user does not require an ability to identify data, either by the original collector or by the secondary user.
  • It should be clear when and whether IRB review is required.
  • There should be precision about what constitutes an “agreement.”
  • It should be clear that the published material cannot be decoded by the original investigator. (“Trust isn’t enough.”) A variety of mechanisms can be used to achieve this end, including recoding or the use of an “honest broker.”

ACTION

The recommendation regarding the definition of “investigator” was tabled, and SAS was asked to bring back a revised recommendation that addresses members’ concerns and questions.

Limited Data Set. Mr. Nelson said SAS wished to confirm that “recognizing that institutions, IRBs and investigators are frequently faced with applying both the Common Rule and the HIPAA Privacy Rule, OHRP does not consider a Limited Data Set (as defined under HIPAA) to constitute individually identifiable information under 45 CFR 46.102(f)(2).” Dr. Menikoff confirmed that this was OHRP’s opinion.

FAQs. SAS presented several Frequently Asked Questions (FAQs) on tissue banks at the July meeting of SACHRP. SACHRP approved some FAQs at the July meeting. However, the committee asked SAS to add responses that specifically addressed the implications of each scenario for the HIPAA Privacy Rule. SAS consulted with representatives of the Office for Civil Rights (OCR), which is responsible for administering the HIPAA Privacy Rule regulations, to develop the additional answers regarding the implications of each scenario for the HIPAA Privacy Rule.
SACHRP took the following actions:

FAQ # 1 (Approved by SACHRP July 22, 2009)
Tissue biopsies were obtained for clinical diagnostic purposes, which have now been satisfied. The hospital pathology department is willing to provide a portion of the remaining biopsy specimens to an investigator who will perform research assays. In order to allow matching with relevant clinical information, the specimens will be provided with identifiers such that the investigator can readily ascertain the identity of subjects.

Is consent of the patient from whom the biopsy was taken (or waiver of consent) required for the secondary research use?

HIPAA Issues for FAQ #1.Assuming the hospital is a HIPAA covered entity, the use or disclosure of patient identifiers for the research purpose would also require a HIPAA authorization from the patient or a waiver of authorization by an IRB or Privacy Board.

ACTION:

SACHRP approved the addition to FAQ #1.

FAQ # 2 (Approved by SACHRP July 22, 2009)
Tissue biopsies were obtained for clinical diagnostic purposes, which have now been satisfied. The hospital pathology department is willing to provide a portion of the remaining biopsy specimens to an investigator who will perform research assays. The specimens will be coded such that the investigator will not be able to readily ascertain the identity of individuals.

Is consent of the patient from whom the biopsy was taken (or waiver of consent) required for the secondary research use?

HIPAA Issues for FAQ #2.If the information associated with the specimen is de-identified in accordance with the HIPAA Privacy Rule, neither authorization nor waiver of authorization is required, because it would no longer be considered Protected Health Information.

Note, however, that information associated with the specimen that is not individually identifiable per OHRP guidance (i.e., coded) may not necessarily be de-identified for HIPAA Privacy Rule purposes. For example, the coded information may not be considered to be de-identified under the Privacy Rule if the code is derived from a patient identifier or certain data elements, such as dates of service or zip codes, remain with the information. Thus, the use or disclosure of the information for research may still require a form of HIPAA permission, such as a HIPAA authorization, IRB or Privacy Board waiver of authorization, or, if the information constitutes a “limited data set,” a data use agreement with the recipient of the information.

ACTION:

SACHRP approved the addition to FAQ #2 with the changes shown above in bold italics.

FAQ # 3
Blood samples were obtained for research purposes, with informed consent of the subjects, and the original study has been completed. The samples remain under the control of the original investigator. Another investigator wants to use a portion of the remaining samples to perform research completely unrelated to the original study.

If the original consent stated that “. . .your sample will only be used for research on diabetes,” but the secondary user is interested in studying schizophrenia, can the samples still be used if provided to the secondary user in a coded fashion?

Response.The secondary use of de-identified or coded samples is not research involving human subjects under 45 CFR 46. Nevertheless, the original investigator and his/her institution have made an agreement with the subjects about use of their specimens, and have an obligation to honor that agreement.

Institutions should establish mechanisms to determine whether secondary uses are compatible with the original informed consent; this could involve consultation with the IRB that approved the original research, or review by some other body designated for these purposes.
Coding should not be used as a means to circumvent the original terms of consent. This is ethically problematic, even if this project is no longer considered to be research involving human subjects. It is not, however, an enforceable regulatory violation, because the regulations do not extend in perpetuity beyond the point a given research activity involves human subjects.

DISCUSSION

Dr. Strauss observed that the two diseases chosen actually are related, though SAS’s intention was to identify diseases that are presumed to be unrelated. He agreed to identify two different diseases for SAS’s reference.

Dr. Menikoff observed that while there may be no regulatory violation in the instance described, he did not want to send a message that consent is irrelevant and that promises made to subjects don’t matter. Mr. Nelson said SAS was in complete agreement that this may not be ethical (the recommendation states that it is “ethically problematic”) but that SAS concluded it should not be considered a regulatory violation. The burden of fulfilling any obligation to the donors is entirely on the original investigator.

Dr. Bierer asked Dr. Menikoff whether OHRP saw a difference between the scenario described and one that involved use of excess clinical specimens. Dr. Menikoff observed that society is making a collective judgment for beneficence reasons that the use of excess clinical specimens for other purposes is acceptable. He held that the tissues at issue in FAQ #3 would not be available unless the patient had agreed to their use for a specific purpose. However, the Chair responded that the client also agreed to certain uses when the clinical specimens were provided. Dr. Menikoff stated that the consent form should have specifically said, in effect, “we have the right to deidentify the sample and use it for whatever we want.” A SACHRP member said that in the near future there will be greater emphasis on how to explain prospective uses to participants.

In reference to HIPAA, Ms. Heide said that under the Privacy Rule the original investigator would be required to get an authorization to use and disclose information for the research study. If the material is deidentified, however, it is no longer considered protected information and is outside the scope of HIPAA.

Dr. Strauss raised the question of who legally “owns” the sample and whether it has a bearing on this scenario. Dr. Menikoff said that most people have concluded that once you have given away a specimen, you no longer “own” it. The central issue remains the understanding under which the specimen was provided and the extent to which that should govern future uses.

SACHRP agreed to revise the third bullet of the original recommendation as follows:

Coding should not be used as a means to circumvent the original terms of consent. This is ethically problematic, evenif the original project is over and the secondary use is no longer consideredto be research involving human subjects. It is not, however, an enforceable regulatory violation, because the regulations do not extend in perpetuity beyond the point a given research activity involves human subjects.

ACTION

The recommendation regarding FAQ #3 was passed unanimously as revised. Ms. Pattee agreed to draft a separate recommendation for SACHRP’s consideration to the effect that the committee does not consider the action described to be a regulatory violation.

Moving on to FAQ #4, Mr. Nelson stressed the importance of “getting this one right”; it will make future FAQs simpler if SACHRP is proceeding on solid ground.

FAQ # 4
It is increasingly common to collect and store specimens for future unspecified research.

How broad can this consent be without requiring investigators to obtain additional consent for specific uses? Alternatively, how specific must this consent be to allow for future use of biospecimens? 

Response.There is a tension between the desire to be as specific as possible when informing subjects of what will be done, and the reality that specifics are, by definition, not known at the time of consent.

Many institutions and IRBs have found it prudent to be general enough in the consent form to give subjects a reasonable idea of the types of research that might be conducted in the future and the associated risks, but without placing unreasonable restrictions on what the research might be. Thus, subjects can be informed that future studies may involve genetic research, drug development, or searching for links between genes and environmental factors like diet or lifestyle, or between genes and diseases. While examples might be given of specific diseases (e.g., cancer, diabetes, heart disease), being overly-specific or restrictive in this regard may result in problems later, when investigators propose other uses. IRBs and investigators should consider the downstream implications before promising subjects that “your specimens will only be used for research on XYZ.”

Future uses of identifiable specimens should be reviewed by the IRB, which should determine whether the research is compatible with original terms of consent, or whether additional consent may be required.

Alternatively, the creation of a repository with an oversight committee and “honest broker” mechanisms that distribute specimens to investigators in coded fashion can remove subsequent uses from IRB review, to the extent they no longer constitute human subjects research. In these cases, special attention should be given upfront to ensure that the repository (which is human subjects research and does require IRB approval) is established with policies and procedures to effectively manage subsequent uses in keeping with what the IRB approved.

HIPAA Issues.This scenario raises a number of HIPAA-related issues for institutions that are covered entities under the Privacy Rule.

While consent under 45 CFR 46 can be broader than a specific research study, an authorization under the HIPAA Privacy Rule must be study-specific. How specific must that authorization be? How can health information associated with specimens be used and disclosed from a research repository when specific research uses are unknown at the time the information is collected?
There are two separate activities to consider when a HIPAA covered entity is collecting and storing identifiable health information in a research repository for future unspecified research:

  1. a covered entity’s use or disclosure of protected health information (PHI) to create the repository; and
  2. the release of PHI from the repository for a future research purpose.

There are a number of ways health information can move into and out of a research repository, including those established for future unspecified research. In this scenario, it is assumed that the repository will contain PHI and that authorization will be obtained to create it. With reference to the two separate activities in this scenario:

  1. An authorization for research use and disclosure of PHI under the HIPAA Privacy Rule must be study-specific. However, the authorization may state that the purpose of the authorization is to create a research repository or database.
  2. Health information can then be subsequently used and disclosed from the research repository in one of several ways:
    • With study-specific authorization
    • With waiver of authorization by an IRB or Privacy Board
    • Preparatory to research (with certain representations)
    • Use of a HIPAA De-identified Dataset*
    • Use of a Limited Data Set (with data use agreement)
    • Research solely on decedents (with certain representations)

DISCUSSION

SACHRP members confirmed that the interpretation of implications related to HIPAA is based on OCR-provided guidance. Dr. Menikoff observed that the language was somewhat vague, but “okay.” Ms. Bledsoe noted that the example given is only one model for the various ways in which information can enter and leave a repository.

ACTION

FAQ #4 and responses were approved unanimously without changes.

Mr. Nelson observed that FAQ #5, which was approved at SACHRP’s July meeting, does not have HIPAA implications and was therefore not reconsidered by SAS.

FAQ # 6
Blood samples were obtained for research purposes, with informed consent of the subjects, and the original study has been completed. The samples remain under the control of the original investigator. Another investigator wants to use a portion of the remaining samples to perform research unrelated to the original study.

If the sample is identifiable to the secondary user, is this considered to be human subjects research under the purview of the IRB? If so, what are the consent considerations?

Response.Yes. This is human subjects research under the purview of the IRB. The IRB should consider whether the secondary use is compatible with the original terms of consent given by the subjects.

HIPAA Issues.A HIPAA authorization for research must be research-study specific. Thus, assuming a HIPAA covered entity is involved, a new HIPAA authorization would be required for the subsequent unrelated research use or disclosure, or another form of HIPAA permission obtained (e.g., waiver of authorization).

ACTION

The FAQ was approved unanimously without discussion.

FAQ # 7
Blood samples were obtained for research purposes, with informed consent of the subjects, and the original study has been completed. The samples remain under the control of the original investigator, who now wants to collaborate with another investigator to perform research unrelated to the original study.

If the original consent was silent on the question of subsequent uses, is informed consent (or waiver of consent) required before the sample can be used for other purposes?

Response.Yes. Under these circumstances, the IRB should consider the original terms of consent, and determine whether a waiver might be appropriate or whether additional consent is required.

The criteria for waiver of consent under 45 CFR 46.116(d) include that the research involves no more than minimal risk; the waiver would not adversely affect the rights and welfare of subjects; the research could not practicably be carried out without the waiver; and whenever appropriate, the subjects will be provided with pertinent information after participation.

Points to consider in applying these criteria include the nature of the research; the protections in place to maintain privacy and confidentiality (e.g., coding, limited/controlled access, honest broker mechanisms); the change in level of risk, if any; the ability to locate or contact subjects; risk of introducing bias into the research ; potential anxiety or confusion for subjects; the number of subjects; the length of time since specimens were first collected; and the likelihood that subjects would object to the proposed secondary use, based on the nature of original collection.

DISCUSSION

SACHRP members agreed that #9 and #10 are different scenarios with different issues; to avoid confusion, they should not be combined. SAS was encouraged to consider presenting them as a single FAQ with parts a and b, but SACHRP members agreed that they would not need to reapprove the FAQs if this were done.

A member asked how the IRB could approve a new study without a protocol. Mr. Nelson said that #9 stipulates that there is a new protocol and a new review. This provision can be reiterated in #10.

ACTION

FAQ # 10 was approved unanimously.

FAQ # 11
An academic medical center has established a centralized tissue bank of identifiable specimens, in order to make those specimens available to a wide variety of researchers.

Can excess clinical specimens be automatically moved with identifiers to the bank after their original purpose has been served, even if there was no research consent obtained from the patients?

Response.The creation of this bank is human subjects research activity and requires IRB review and approval, which should include the policies and procedures under which the bank will be managed, the control of specimens, and the types of research to be conducted. Because this is human subjects research, the IRB may also consider whether a waiver of consent is appropriate under these circumstances.

The criteria for waiver of consent under 45 CFR 46.116(d) include that the research involves no more than minimal risk; the waiver would not adversely affect the rights and welfare of subjects; the research could not practicably be carried out without the waiver; and whenever appropriate, the subjects will be provided with pertinent information after participation.

Points to consider in applying these criteria include the nature of the research; the protections in place to maintain privacy and confidentiality (e.g., coding, limited/controlled access, honest broker mechanisms); the change in level of risk, if any; the ability to locate or contact subjects; risk of introducing bias into the research ; potential anxiety or confusion for subjects; the number of subjects; the length of time since specimens were first collected; and the likelihood that subjects would object to the proposed secondary use, based on the nature of original collection.

DISCUSSION

Dr. Lux felt that the response did not answer the question posed, while Dr. Menikoff found it “vague” and “highly generic.” Mr. Nelson observed that the scenario simply “acknowledges what has been going on forever.”

Ms. Bledsoe suggested the following revision to the beginning of the response in order to clarify that consent is required unless conditions for a waiver can be met:

The creation of this bank is human subjects research activity and requires IRB review and approval, which should include the policies and procedures under which the bank will be managed, the control of specimens, and the types of research to be conducted.Because this is human subjects research, consent would be required, unless the IRB determines that a waiver of consent is appropriate under these circumstances.

ACTION

SAS agreed to continue work on this FAQ and bring it back to SACHRP. A member noted that we need to “to flesh it out” and “make certain it is user friendly.”

SACHRP also agreed to follow the historical norm that all 27 FAQs will be completed and sent as a group rather than sending them in groups as they are completed.

The Chair thanked SAS for its work on an important product.

Public Comment

There was no public comment.

WEDNESDAY, OCTOBER 28

Opening Remarks

Barbara Bierer, M.D., Chair

The Chair informed SACHRP that later in the day, some carryover business from Tuesday’s meeting will be addressed.

Remarks of Principal Advisor to the Assistant Secretary for Health (ASH)

Don Wright, Advisor to Assistant Secretary to Health (ASH) .

Dr. Wright expressed gratitude for SACHRP members’ time and effort. Noting that the “heavy lifting” is often done at the subcommittee level, he said he was pleased to see SACHRP addressing the issue of harmonization. He also expressed appreciation for Ms. Pattee’s “valuable contribution” and “unique perspective.”

DISCUSSION

Dr. Bierer thanked Dr. Wright for his attentive presence at the meeting. She noted that SACHRP members are enthusiastic about the opportunity to identify and prioritize significant areas of disharmony among regulations. SACHRP was also impressed with the contributions NIH has made in addressing related issues and simplifying requirements for investigators as much as possible.

Dr. Strauss expressed concern that OHRP’s strained budget might hamper the work of the subcommittee on harmonization. Dr. Wright said he shared SACHRP’s concern about OHRP’s lean budget; however, HHS is currently operating under a Continuing Resolution and does not know its new budget. He hopes that the agency will know its budget by the Christmas break. He assured SACHRP that its previous recommendation regarding OHRP’s budget was received and understood. He further stressed that the proposed new SACHRP subcommittee is “enormously important.”

Panel: Enhancing Informed Consent

Eric Kodish, M.D., Cleveland Clinic; Laura B. Dunn, M.D., University of California, San FranciscoDr; Millie Solomon, Ed.D.., Education Development Center and Harvard Medical School; Cindy Brach, M.P.P., Agency for Healthcare Research and Quality; Ann Partridge, M.D., M.P.H., Dana Farber Cancer Institute

Dr. Bierer observed that SAS has often sought to address issues related to the rights of participants in consent process, including addressing the expectations, roles, and responsibilities of all concerned. The assembled panel has been asked to speak to the following specific charge:

Lengthy informed consent documents have become legion, but don’t necessarily serve to enhance communication of the process, procedures, timelines and risks of human subjects research. How can informed consent be improved? It is often suggested that the use of executive summaries and pre-consent education would be valuable to potential participants, while mid-study “checks” would improve understanding of participating subjects. Is there any data to suggest these added processes actually improve subject understanding? What is or should be best practice? Finally, the role of follow up, the process and impact of end-of-study communications to research participants, the community and the public has not been sufficiently explored. Would sharing results at the end of study impact research participant understanding, community engagement, and public trust? This panel will discuss the various tools and mechanisms that can be used to augment the form, understanding and substance of informed consent.

Remarks by Eric Kodish: Enhancing Informed Consent: Lessons from Studies in Childhood Cancer

Dr. Kodish discussed findings of the Project on Informed Consent (PIC), ?conducted 1999-2002, which included direct observation of Informed Consent Conferences with Parent Interviews. The study found that half of parents did not understand the concept of randomization despite oral and written communication. He noted that, on a conceptual level, understanding choice is more than just understanding that trial participation is voluntary; it requires that parents/patients have a clear appreciation of the alternative(s) to study participation. Yet, one-third of the parents in the study did not understand that they had a choice between participating in the study and receiving therapy outside the study.

The PAGIC Model sought to increase parents’ understanding of their options through increased interactivity and the use of a variety of presentation methods, including graphics. They found that parents asked more questions in the new process, and that asking questions was associated with improved parental understanding. He stressed the importance of bidirectional communication in the consent process. While more research is needed, he suggested the following lesson may hold:

  • With attention to sequence, choreography and communication science, we can improve the informed consent process.

Remarks by Laura B. Dunn: Enhancing Informed Consent Process for Research: “The Answer is We Don’t Know”

Dr. Dunn made the following recommendations based on her research:

  • Test for understanding of risks;
  • Ask what the subject expects and hopes for in terms of benefits;
  • Assess perceptions of risks and benefits to ascertain if risks may be underestimated or benefits overestimated;
  • Ask about motivations for participation;
  • Retest later (in ongoing protocols); and
  • Highlight key differences between research and usual clinical care.

She concurred strongly with the conclusions of an Institute of Medicine (IOM) panel regarding the need to “revitalize” the consent process:

The informed consent process should be an ongoing, interactive dialogue... involving the disclosure and exchange of relevant information, discussion of that information, and assessment of the individual’s understanding of the discussion. The informed consent conversation(s), as well as the written consent document, should not be obscured by language designed mainly to insulate the institution from liability. Rather, the process should ensure that participants clearly understand the nature of the proposed research and its potential risks and benefits to them and society (IOM, 2002: Responsible Research: A Systems Approach to Protecting Research Participants).

She felt that tools to assess consent capacity, many of which are now available on the Internet, are often appropriate and helpful.

Remarks by Millie Solomon: A Multimedia Approach to Informed Consent

Dr. Solomon observed that the literature is mixed on whether or not multimedia tools can enhance comprehension in the informed consent process. Some of the studies that show the greatest impact have been with the most vulnerable prospective participants. Multimedia presentations can improve the understanding, inclusiveness, transparency, and standardization of the consent process. Stop points can allow questions and interaction between the potential subject and the investigator.

She described findings of the North Carolina Registry Informed Consent Project, which used an “e-consent” tool that included video. She observed that most people preferred the video presentation, but at least 20 percent of participants also wanted a printed reference. The study also found that more of those who saw the video, which sought to tap feelings of altruism, said they were likely to join the study. The presentation was designed so that it could always be interrupted to allow questions.

Remarks by Cindy Brach: AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research

Ms. Brach stated that the Agency for Healthcare Research and Quality (AHRQ) had developed a toolkit to address the problem that informed consent, as currently practiced, involves the use of complex forms, the lack of a standard process, and an absence of meaningful verification of understanding. She pointed out that while U.S. adults, on average, read at an 8th grade level, the average informed consent form is written on the 12th grade level. Further, many health service researchers are concerned about HIPAA and how it is overlaid over the existing informed consent process, confusing the issue of what subjects are really agreeing to.

The toolkit includes a model process for obtaining written consent, sample easy-to-read consent documents, a certification tool to improve the quality of the process, and links to resources. The language used in the simplified forms was cognitively tested, and the toolkit was taken through a mock informed consent and authorization process to ensure its usability. Sample language used in the form is as follows:

  • We are asking you to be in a research study.
  • You do not have to be in the study.
  • If you say yes, you can quit the study at any time.
  • Please take as much time as you need to make your choice.
  • Your medical care will not change in any way if you say no.

The kit, which was prepared with the input from OHRP and OCR, is available at the following location: http://www.ahrq.gov/fund/informedconsent/

Remarks by Ann Partridge: Returning Research Results to Study Participants

Dr. Partridge observed that no routine mechanism is in place in most research enterprises to share study results. Only limited data exist regarding how to share results or how patients react to the information. She said that there was an ethical basis for returning results, based on principles of respect for persons and justice. Benefits of offering results may include:

  • Improving patient/physician communication,
  • Patient satisfaction,
  • Quality of care,
  • Potential impact on future health, and
  • Perception of research itself.

The speaker reminded SACHRP that patients have written angry editorials about learning results from newspapers rather than from their physicians. There are concerns, however, that patients may receive results they do not want to receive or suffer anxiety because they are asked to relive a difficult time, learn they were in an “inferior” study arm, or discover that they or their child is at increased risk for health problems. She suggested that educational and psychosocial support should be offered when results are conveyed that may cause such anxiety. The speaker also proposed addressing the issue of how returns will be shared, and the patient’s preferences in this regard, as part of the consent process.

DISCUSSION

SACHRP members took the opportunity to raise questions and discuss issues with panels.

How do you adjust to the different informational needs and desires of participants?What about the prospective subject who says, “thanks for the 13-page consent form, but I’m happy to do this study if you think I should.” A speaker responded that even if the prospective participant is willing simply to trust the doctor’s guidance, it is important to proceed with informed consent. However, there is no need to “hammer” people with more information than they need to make a decision.

Another speaker suggested that it is especially important that people understand they are making a choice, and there are alternatives to study participation. They also need to understand potential benefits and harms. When the person approaching the prospective subject is the doctor, the doctor should be careful to stress that participation in the study is not a recommendation, but an opportunity, and that there are other choices. Ms. Brach said that the AHRQ toolkit suggests that, to avoid confusion, whenever possible, the doctor should not be the one who approaches the subject about study participation.

Another speaker queried, “What are you doing with a 13-page consent form you’re not willing to go over?” This suggests, she said, that its purpose is not really to facilitate informed consent.

How much is good enough? What does it mean to be informed?Perhaps this involves thinking more carefully about the content and then developing an empirical process that assesses understanding. A speaker suggested that IRBs ask researchers to identify the crucial elements for subjects to understand about their study and how they plan to assess whether subjects do understand them. Another observed that a promising approach to developing improved informed consent processes is for investigators to team with educators and communicators.

One could envision a day when part of the IRB protocol is “what is your plan for returning results to participants.” What do you think would be the burden to IRBs, investigators, and participants? The burden to participants is fairly modest. They should know they can say “no thank you.” In the greater scheme of things, the burden to the system is also relatively modest. While the mechanics of informing subjects may appear costly, these costs are relatively small compared to the cost of enrolling an individual in the study. We can always study the burden and find ways to do this efficiently. The Chair noted that http://clinicaltrials.gov/ has been a “game changer” in this regard.

Dr. Partridge noted that when results are returned to participants, it is important that persons who are distressed by what they learn should know who to contact. Dr. Budashevitz added that FDA has a new initiative on public health risk communication, especially in regard to adverse events, that is highly relevant.

In the course of longitudinal epidemiological trials such as the National Children’s Study, there may be emerging findings that a reasonable person may want to consider in making behavioral lifestyle changes. How could these be handled? In the Nurses Health Study, over 120,000 nurses are being followed. While individual results are not returned, participants receive a newsletter biannually. The newsletter talks about what has been learned from the nurses in plain language. See http://centers.nationalchildrensstudy.gov/ummc/NewsEvents/newsletters/Pages/Hinds_County_MS_Winter2011.pdf

Our IRB was approached regarding the prospective cost of returning results. How do you suggest estimating these costs? Conrad Fernandez, at Dalhousie University, put together a cost projection related to returning results (Fernandez, Skedgel, & Weijer, 2004). He was “guesstimating.” Dr. Partridge said she informs participants of findings from studies at the Dana Farber Cancer Institute through a relatively simple process. She drafts language and confers with advocates to ensure that findings are expressed in a way that can be readily understood, then mails a letter to each participant. She commented that while envelopes and stamps cost money, the cost is relatively small compared to the entire expense of enrolling a person in a trial.

Should IRBs review assessment tools as part of their process? Dr. Dunn said it may be reasonable to ask the investigators how they will assess understanding of critical elements, but she did not think it was usually necessary for the IRBs to review detailed assessment materials.

The Education Development Center video contains the words, “this is a historical project.” Many IRBs would want to strike this language as unduly influential. How would you accommodate this type of response? Dr. Solomon responded that the video has been criticized from both sides – as potentially deterring participants by making risks so clear, or by encouraging their participation by emphasizing the value of study findings. She suggested that if the main reason for participation is indeed altruism, explaining the science behind the study seems important. She agreed that it is important to “make sure we got the balance right.” The speaker noted that a multimedia approach lends itself to large multi-site studies. However, it is also possible to use graphics instead of video, which would make it easier to adjust to criticism.

SAS is considering recommending the use of a feedback tool during the consent process to verify subject comprehension. Has this approach been validated? It has been researched in the clinical area, where it is sometimes called the “teach back” approach. It has been shown to increase understanding between doctor and patient.

Are the tools AHRQ has developed applicable in nonclinical studies? Yes, they should be directly applicable to a variety of disciplines.

How can we test the competence of researchers in applying innovative techniques to assure informed consent? Dr. Dunn said she was unaware of any standard assessment tools. Dr. Solomon suggested that “direct observation is the gold standard.” Spot checks using taped conversations would be helpful.

Consideration of Recommendations

Harmonization Subcommittee. Dr. Bierer explained that many SACHRP members wanted to amend the recommendation made at the July meeting regarding the establishment of a subcommittee on harmonization. They felt the objectives had not been crisply stated and the rationale for the recommendation should be more explicit. Dr. Strauss read a proposed amended version:

Recommendation.Harmonization of human subject protection issues will result in better allocation of resources that will serve to enhance human subject protection, facilitate research, and improve public health. SACHRP recommends establishment of a subcommittee to identify, prioritize, and propose directions for resolving areas in which harmonization and simplification in the guidance and regulation of HHS agencies and signatories under the Common Rule would be of benefit to the research community and contribute to the protection of research subjects. We appreciate the importance of this project to the research community, anticipate that it will help advance research of benefit to the patient community, and appreciate the support of the Secretary and her designees for this critical endeavor.

Dr. Goldkind (ex-officio for FDA), who was unable to be at the SACHRP meeting the previous day, was concerned that the subcommittee would be a duplication of effort. The Chair explained that the issue had been discussed and that it appeared that reviewing and prioritizing issues was found to be a contribution.

Dr. Goldkind then wondered whether it would be helpful to issue a Request for Information (RFI) to elicit topics of concern related to harmonization from the IRB community and other stakeholders before moving forward. CAPT Budashevitz observed that the options are not mutually exclusive; FDA could issue such an RFI, and the resulting information would inform the subcommittee’s deliberations.

ACTION

SACHRP unanimously approved the recommendation without changes.

Secondary use of tissue samples. Ms. Pattee introduced the following recommendation:

 Recommendation. In the case where secondary use of tissue samples is not compatible with the original consent for tissues that are de-identified, coded, or anonymized and are not readily identifiable, the samples are no longer subject to human subject regulations. Thus, there is no regulatory violation.

The discussion confirmed the following:

  • There is no current plan to request public feedback on the issue.
  • The recommendation will be sent to the Secretary along with the FAQs, but as a separate recommendation. The problem encountered was in placing this determination within the text of the response to FAQ #3.
  • Everyone agrees that the secondary researcher is not engage in human subjects research. The issue is the obligation of primary researcher who obtained the samples for a different purpose.

Dr. Menikoff clarified that OHRP does not hold that this instance is a clear violation of the regulations; however, there is some thought that the rules may be interpreted such that it would be a violation. He noted that the issue is substantial and the ethical arguments involved are strong.

ACTION

SACHRP approved the recommendation without changes. Seven members voted in favor, one was opposed, and one abstained.

Panel: Community-Based Participatory Research

Puneet Sahota, Ph.D., Washington University at St. Louis; Sarena Seifer, M.D., Community-Campus Partnerships for Health; Margaret LeCompte, Ph.D., University of Colorado at Boulder; Sarah Flicker, M.P.H., Ph.D., York University

The panel was asked to address the following charge:

In response to SACHRP’s recent identification of future priorities, this is the first of what may become several panels on regulatory perspectives on Community Based Participatory Research (CBPR). This initial discussion will have a broad focus, exploring the intersection of regulations and the nature of CBPR generally; questions to be explored include whether CBPR would benefit from regulatory guidelines or FAQs, and whether current human subjects regulations are overly onerous for CBPR investigators. The panel will also discuss specific ethical issues that present challenges to investigators and IRBs as they struggle to fulfill their respective roles in human subjects protections.

Remarks by Puneet Sahota: Community Based Participatory Research: Considerations for IRBs

Dr. Sahota commented on some of the unique considerations that arise doing research in Native American communities. She noted that many tribes have their own IRBs or research review committees, and the Indian Health Service Areas have their own IRBs as well. In addition, Tribal sovereignty may require additional review procedures. What it means to get the approval of the community will vary. In these unique circumstances, CBPR has become the “ethical gold standard” for conducting research within native communities. Many Native American communities will not approve research projects without full partnership, often including data ownership and publication review.

University-based IRBs face many challenges as they review protocols for CBPR. They will need to address issues such as:

  • Group risks and harms, such as risks to identified communities;
  • Risks for small communities (for example, reference to one elder with certain identifying characteristics);
  • Jurisdictional issues with Tribal IRBs;
  • Determining review sequence for multiple IRBs;
  • Handling changes requested by Tribal vs. university IRBs;
  • Determining when “research” actually begins on a CBPR project and when IRB review should occur (there is often a stage of informal collaboration during which study design occurs and instruments are developed);
  • Determining what constitutes a modification that must be reviewed (changes are often iterative as researchers interact with the community); and
  • Understanding the role of community member-researchers.

The speaker stressed the need for IRBs to become educated regarding:

  • Community-based participatory researchers;
  • How to collaborate effectively with Tribal review entities and IHS reviewers (changes required after Tribal review can lead to distrust);
  • The importance of CBPR for marginalized communities – for example, in building trust;
  • The process of collaborating with communities to develop research instruments and the likely need to accommodate in-course corrections and changes; and
  • Qualitative research methods.

Guidance from OHRP on how to review CBPR may be helpful to IRBs.

Remarks by Sarena Seifer: Innovative Models and Emerging Issues in CBPR

Dr. Seifer introduced the following definitions of CBPR:

...apartnershipapproach to research that equitably involves, for example, community members, organizational representatives, and researchers in all aspects of the research process; with all partners contributing their expertise and sharing responsibility and ownership to enhance understanding of a given phenomenon, and to integrate the knowledge gained with interventions to improve the health and wellbeing of community members (Israel B.A., Schulz A.J., Parker E.A., Becker A.B., 1998).

a collaborativeapproach to research that equitably involves all partners in the research process and recognizes the unique strengths that each brings. CBPR begins with a research topic of importance to the community with the aim of combining knowledge and action for social change to improve community health and eliminate health disparities (definition developed and adopted by the Kellogg Community Health Scholars Program based upon the definition above).

Scientific inquiryconducted in communities in which community members, persons affected by condition or issue under study and other key stakeholders in the community’s health have the opportunity to be full participants in each phase of the work – conception, design, conduct, analysis, interpretation, conclusions and communication of results (Federal Interagency Working Group on CBPR, 2003).

The speaker called attention to important resources on CBPR that are available on the Internet at no charge. These include:

  • The proceedings of an Educational Conference Call Series on issues that arise in reviewing CBPR (Grignon, Wong, & Seifer, 2008);
  • A curriculum focused on CBPR (The Examining Community-Institutional Partnerships for Prevention Research Group, 2006); and
  • A special edition of Journal of Empirical Research on Human Research Ethics focused on ethical issues in the review of CBPR (Shore, Worg, Seifer, Grignon, & Gamble, 2008).

The Community-Campus Partnerships for Health is also developing a new curriculum on community-engaged research, which is currently under review prior to being pilot-tested by IRBs. See references at the end of these minutes for the complete citation and Internet sites for these resources.

Dr. Seifer said that Community-Campus Partnerships for Health has become increasingly involved in issues related to CBPR as members continue to raise issues related to the difficulty they experience in having their projects approved by IRBs. As communities increasingly take ownership of projects, there is a need to look afresh at the interface between researcher and community. Institutions are trying to accommodate emerging CBPR models through such options as:

  • Boosting community participation on their boards;
  • Forming a specific committee to review CBPR;
  • Coordinating with the community on review (e.g., the University of New Mexico and the Navajo IRB);
  • Adopting guidelines to protect communities and address ethical issues related to CBPR (see CIBR, 2007) .

From the “community side,” emerging models include:

  • Community-based IRBs;
  • A community coalition can serve as the IRB for research by community members;
  • Community Health Centers forming their own IRB;
  • IRBs developed to review research within the city (e.g., Lawrence, Massachusetts).

A recent survey of community-based processes for ethical review of research (manuscript under review) found the following reasons communities established their own review process. These included:

  • To make sure community directly benefits from research (85%),
  • To make sure community is engaged in research process,
  • To protect community from possible research risks,
  • To respond to growing number of researchers asking to support or participate in their research, and
  • To set their own research agenda.

The speaker expressed the hope that NIH’s Clinical and Translational Science Awards (CTSAs) would strengthen the role of the community in research.

Remarks by Margaret LeCompte: Sometimes...What Seems Unfamiliar and Strange Ends up Almost Being Business as Usual

Dr. LeCompte defined CBPR as “research done jointly by a researcher in, and with, a community and the groups that constitute it.” Its key features are:

  • It involves building research partnerships with community organizations and individuals;
  • Problem identification, planning and implementation of the project, and dissemination of results is done with community collaborators;
  • Teaching and learning is reciprocal and shared by Principal Investigators (PIs) and community participants.
  • Power is shared by PIs and community research partners.

The subject of the study often is determined collaboratively between the researcher and the community; in fact, the study may be initiated by community members who seek out researchers to help them identify and solve problems. Such studies typically require preliminary fieldwork that is, the speaker asserted, “not part of the actual research project” and does not generate research data. She argued that it would be inappropriate to initiate IRB review during the phase of initial collaboration on the identification of issues to be researched.

Issues at the preliminary stage of collaboration between investigators and community members include:

  • The construction of a network of partners who will help with, support, be advocates for, and disseminate results from, the research project as it develops;
  • Development of a consensus over which issues to tackle;
  • Identification of the kinds of data needed to resolve problems ;
  • Construction of a plan for collecting the data; and
  • Identification of community members who will actually participate in the research process, methods for participation, and implications for training.

The speaker identified a number of problems that typically arise for IRBs unfamiliar with CBPR and suggested solutions (see PowerPoints). She suggested that IRBs can address such issues using strategies similar to those they normally bring to bear on research with vulnerable populations. These include:

  • Not counting on “standard” community members to represent the population’s concerns but recruiting informed members, just as they do for prisoners. The IRB should also assure that training of community researchers is adequate for this type of research;
  • Determining whether PIs have adequate plans to protect the identity of collaborating community partners; and
  • Determining whether researchers and their community participants have adequately assessed risks to participants and participant researchers and informed them of such risks.

Remarks by Sarah Flicker: Community-Based Participatory Research

Dr. Flicker observed that few protocols address the issue of risks or benefits that may exist on a community or social level. After illustrating the practice of CBPR in several examples (see PowerPoints), she highlighted the following issues:

  • People in the community should be adequately trained and supported to carry out their roles;
  • It is important to allow space for creative approaches for thinking through individual and communal informed consent;
  • Consider need for formalized support and supervision;
  • Recognize community strengths and show sensitivity to community challenges.

    She made two recommendations regarding human subjects protection:

    • Institutional review boards and researchers should be encouraged to adopt localized context-dependent strategies that attend to the unique vulnerabilities of their particular study populations.
    • Attention to flexibility, vulnerability, and community-specific needs is necessary to ensure appropriate ethical research practices that attend to the health and well-being of community members.

DISCUSSION

The Chair invited Dr. Trachtenberg, an ex officio representative of the Indian Health Service, to comment on the presentations and the issues they raised. Dr. Trachtenberg stressed the importance of ethical standards being in place for many types of disadvantaged communities. He said CBPR reflects the principles of respect for persons, beneficence, and justice. He was not sure he agreed with Dr. LeCompte’s assertion that preliminary research would not result in “generalizable knowledge” and therefore would not require IRB review. He added that it is sometimes difficult to find resources to involve communities in each phase of the research enterprise.

SACHRP members raised several questions with panelists.

How do you find the community? How do you identify someone who is authorized to give consent on behalf of the community? Dr. Flicker readily agreed that this is a key question. It is not always clear who can represent a community, though it is always relevant to consider who has brought the issue forward and who will be the focus of the study. It is sometimes helpful to talk with nongovernmental organizations that do grassroots work in the community. A “town hall” conversation is often helpful.

Dr. Sahota added that communities sometimes lack consensus on what constitutes a problem. Some community members may, in fact, have a vested interest in certain problems not being addressed. CBPR researchers do have to make this type of decision routinely and accept the consequences.

Dr. Seifer commented that researchers need to keep asking “who should be at the table?” at each phase of the project. It is important not to allow the difficulty of resolving the issue to paralyze the research.

Dr. LeCompte refers to participants being consented after the research occurs. Why would this be needed? This is relevant in situations in which the student might feel pressured to participate because the teacher has the power to grade them. In Colorado, sometimes a class is conducted and data collected as if it were part of normal practice. After the semester, when grades are posted, the participants are then asked for permission to use the data. The SACHRP member responded that it is important to think of creative ways to get consent ahead of time. Dr. Trachtenberg noted that this approach is often used in cases in which a new approach would be introduced in any case, and the only different thing that is occurring is that these data are being collected and analyzed.

I was impressed with how much Canada seems to have done in this area. Is this perception accurate? Dr. Flicker responded that a communitarian ethic is enshrined in Canada’s approach to human subjects research in communities, in part because well-publicized abuse of native populations has prompted a variety of conversations about community involvement. Another speaker observed that many Canadian community organizations are taking the initiative to do research on their own without academic partners. Dr. Sahota commented that guidelines developed in Canada are frequently applied in the U.S. There are many lessons to be learned from the CIHR guidelines and the process by which they were developed.

A SACHRP member commented that some CBPR issues may appropriately be referred to the new subcommittee on harmonization.

Public Comment

No comments were made.

References

Canadian Institutes of Health Research (2007). CIHR Guidelines for Health Research Involving Aboriginal People. Retrieved on November 4, 2009, from http://www.cihr-irsc.gc.ca/e/29134.html

The Examining Community-Institutional Partnerships for Prevention Research Group (2006). Developing and Sustaining Community-Based Participatory Research Partnerships: A Skill-Building Curriculum. Retrieved on November 4, 2009, from http://depts.washington.edu/ccph/cbpr/index.php

Fernandez C.V., Kodish E., & Weijer C. (2003). Informing study participants of research results: an ethical imperative. IRB 25(3):12-9.

Fernandez C.V., Skedgel C., & Weijer C. (2004). Considerations and costs of disclosing study findings to research participants.CMAJ 170 (9). Retrieved on December 7, 2009, from http://www.cmaj.ca/cgi/content/full/170/9/1417

Flicker S. & Guta A. (2008). Ethical Approaches to Protecting Adolescent Participants in Sexual Health Research: Alternatives to Parental Consent. Journal of Adolescent Health., 42(1), 3-10.

Israel B.A., Schulz A.J., Parker E.A., Becker A.B. (1998). Review of community-based research: Assessing partnership approaches to improve public health. Annual Review of Public Health 19:173-202.

Minkler, M. & Wallerstein, N. (2003) Community-Based Participatory Research for Health. San Francisco, CA: Jossey-Bass.

Shore N., Worg K.A., Seifer S.D., Grignon J., & Gamble T.N. (2008). Introduction to Special Issue: Advancing the Ethics of Community-Based Participatory Research. Journal of Empirical Research on Human Research Ethics. Retrieved on October 27, 2009 from http://caliber.ucpress.net/doi/pdf/10.1525/jer.2008.3.2.1?cookieSet=1

Grignon J., Wong K.A., & ?Seifer S.D. (2008). Ensuring Community-Level Research Protections. Proceedings of the 2007 Educational Conference Call Series on Institutional Review Boards and Ethical Issues in Research. Seattle, WA: Community-Campus Partnerships for Health. Retrieved on November 3, 2009 from http://depts.washington.edu/ccph/pdf_files/FinalResearchEthicsCallSeriesReport.pdf

 

Secretary’s Advisory Committee on Human Research Protections
October 27 and 28 , 2009
Arlington, 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.

 


Barbara Bierer, M.D., ChairDate