OHRP asked to review repositories and 'previous consents' in expedited review guidance.

BOSTON -- OHRP is being to determine how repositories of information and "previous consents" will be handled under the agency's proposed expedited review procedures for IRBs.

The discussion of the agency's "Categories That May be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure" was among the most well-attended sessions at PRIM&R's annual HRPP conference here. The specific material for which comments are being sought is the category description of research that may be expedited. There are several review categories in the document.

Susan Fish, professor of Biostatics and Epidemiology at the Boston University School of Public Health and chair of the Public Policy Committee at PRIM&R, moderated the packed session, and agreed to take the issue of repositories and "previous consents" back to OHRP for consultation. However, institutions and individuals were urged to contact the agency with any specific concerns or suggestions about any of the review categories.

OHRP declined an invitation to be present at the workshop, citing that its presence would not be helpful at an information and comment-gathering event, but that once all comments have been collected and studied a representative will participate in a future conference to summarize findings and explain decisions.

Workshop participants had to be reminded several times that none of the changes change the fundamental nature of this document; nothing implies that any of these categories will not be reviewed; rather, this is a determination of which reviews may be expedited, and which will require a full review by the IRB.

An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

OHRP is specifically requesting input for two review criteria, though it was underlined that everything else is open for input from anyone.

The first specific change pertains to Category 5, which reads:

"Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). It was noted that some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101 (b)(4)."

This listing refers only to research that is not exempt. At issue in this category is the comma after "collected": the clause pertaining to non-research purposes is unclear as to whether it applies to materials collected from past research or only to materials collected for future research. "At the very least," noted Fish, "there are divergent opinions as to what it means."

The category was then parsed by the workshop with a great deal of discussion. Examples were finally issued to help make sense of what it is saying.

In the first section, one wants to use data that one has already collected for one purpose to ask another question about it: if so, it is expeditable. Relating to the second section, if one wishes to do a prospective review of future data that will be collected naturally as part of an intake process, that review is also considered expeditable.

The proposed revision from OHRP would make the following clear that it applies to research that is non-exempt, and that the materials have previously been collected for non-research purposes, or that the materials have been collected for other research, or that the materials will be collected in the future for nonresearch purposes.

The discussion then centered on the need for clarification pertaining to previous informed consent.

Attorneys at the workshop expressed particular concern over the latter point and several examples were put forth for cases where it could be problematic.

For example, does original consent preclude future use? If broad consent (i.e. "we might use it for future research") is obtained, is that the same as the document's "currently proposed research?

The issue, said attorney Enrique Mendez of Walter Reed Medical Center, Washington, D.C., is that of "use regulation" versus "access regulation."

Mendez posited that if you have access, you can use, but the usual rules for access privileges still apply.

Regarding this category, Fish was asked to take two issues back to OHRP concerning that nothing in the category speaks to the issue of how it relates to repositories, and second, that it's unclear how it interfaces with previous consents given.

The other specific category where input is being requested is Category 7, which reads:

"Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101 (b)(2) and (b)(3). This listing refers only to research that is not exempt.)"

In this case, the changes have to do with additions to both sections of the category. To the first section, pertaining to individual or group characteristics or behavior, the Secretary of the Advisory Committee for Human Rights Protection is proposing the addition of research on "affective states" and "interpersonal relationships."

The "affective states" proposed addition provoked a great deal of discussion - and some argument - in the workshop. The second addition is to the methodology section: in addition to the tools listed, the proposal is to insert "participant," and "ethnographic evaluation." These latter additions were found acceptable by workshop participants.

Another addition, however, provoked a number of comments. Here, the second clause would read: "Research employing methods commonly used in ( ... )," with workshop participants querying, "Who defines what is commonly used?"

Other participants asked for clarification of the whether or not the section calls for research that meets both sets of criteria. The first section, Fish pointed out, refers to purpose; the second section to methodology. "Research could pertain to both instances of the category but doesn't need to," she said.

A further discussion started with one participant's observation that there is nothing in this category document that addresses the issue of observation versus participation. Fish noted that this issue comes into risk assessment and that it is outside of the purview of the question.

Another discussion questioned some of the specifics of the category, but the questioner was reminded that even before these categories for expedited review can be considered, a project has to go through the accepted regulatory design in that it has to be research, it has to be human subjects research, and it has to be noninvasive. In other words, the research needs first to conform to general rules and meet the minimal risk criterion.

This led into a discussion of expeditable research categories in general and Fish was quick to repeat that all research activities have to fit into one or more of the nine categories in the human subjects guidance document, and that otherwise the activity is not expeditable and must go to a full board review.

Fish then opened up the floor to discussion of, or questions about, other categories. One participant raised some concerns about category six ("Collection of data from voice, video, digital, or image recordings made for research purposes") and asked about process for informed consent in this instance.

Another participant initiated a discussion about Category 9, which reads: "Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified."

There appeared to be consensus at the workshop that there is some conflict about what research falls under category nine and that clarification about that point seems necessary; Fish agreed to bring that to OHRP's attention.

She stressed that research can fall into more than one category - videotaping a focus group, for example, might fall under both category six and category seven - and that all possible categories should be documented when requesting an expedited review.

Fish also invited participants to share with colleagues OHRP's request for input on category clarification.

Interested parties may access the guidance document here: http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm Comments may be left at: http://www.hhs.gov/ohrp/requests/

By Jeannette Cezanne New England Correspondent