FOR COMMENT

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On October 16, 2001, a statement was published in Almanac (https://almanac.upenn.edu/archive/v48/n08/OR-HumanSubj.html) setting down guidelines for Institutional Review Board (IRB) review of research in the social and behavioral sciences.

As promised in that statement, we commissioned a Working Group "to propose guidelines for the ethical use of human subjects in sociobehavioral research at the University of Pennsylvania". The Working Group has now submitted their report titled "Report of the Working Group on Human Subjects Research in the Sociobehavioral Sciences" which is published below.

The report contains a number of recommendations; we shall be reviewing them and undertaking to implement many of them in the course of the next year. Comments on the report may be sent via e-mail by September 24, 2002 to nathansn@mail.med.upenn.edu.

Report of the Working Group on Human Subjects Research in the SocioBehavioral Sciences

May 2002

Current University policies, based on agreements with the Federal government, require that all research involving human subjects be subject to review by our Institutional Review Board [IRB] system. Under the Federal government's regulations at 45 CFR 46, research is defined as "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

The requirement for IRB review extends to research conducted by faculty, staff, research fellows, and students, whether funded or unfunded. While researchers in bio-medical sciences have long been accustomed to human subjects review procedures, many social and behavioral researchers have not previously been aware of, nor held to these formal requirements.

In response to the questions of policy and implementation raised by the application of human subjects review procedures to the sociobehavioral sciences, in Fall 2001 the Vice Provost for Research and the Chair of the Faculty Senate appointed a working group comprised of University faculty drawn from several different schools and departments who represent the variety of social and behavioral disciplines across the University. The Working Group was charged to consider principles that guide the ethical conduct of behavioral and social science research on human subjects, and to offer recommendations for improvements in the human subjects review policies and practices at the University.

Foremost in our discussions was the recognition that compliance with University and federal rules requires the efficient processing of reviews. The University can not expect researchers to cooperate with the review system if it can not perform in a timely and appropriate manner. Efforts in this direction are ongoing, and have already resulted in the establishment of an IRB devoted to social and behavioral research. In addition, the IRB has developed a streamlined procedure for processing and approving exempt research. A new form for requesting exemption of a research project has been posted to the Office of Regulatory Affairs (ORA) web site along with a diagram of what constitutes an exempt study. Still, further steps need to be taken if the process of applying for and receiving IRB approval is to be truly efficient.

Equally important, we believe that the community of sociobehavioral researchers at the University and throughout the country are at the early stages of a fundamental shift in our approach to human subjects research. Many of us were educated and began our research careers at a time when these issues were neither explicitly addressed nor formally imposed on our professional practices. We must take steps to incorporate the evolving principles of ethical research practice in our teaching and our research. Over time, as future cohorts of researchers are trained to incorporate these principles and procedures into their practices the role of the IRB system will become both more widely understood and less burdensome on researchers and on IRB members.

As the Working Group proceeded to consider various domains of sociobehavioral research several themes emerged that led to a set of analyses and recommendations. Chief among these are an emphasis on the importance of instituting educational efforts that would bring current as well as future researchers into fuller awareness of the issues surrounding the ethical use of human subjects in sociobehavioral research. As will be explicated below, we are in favor of the development and implementation of web-based tutorial and certification systems analogous to those now mandated by the Federal government for researchers funded by NIH in the biomedical sciences.

A second primary focus of our deliberations was the question of where the line should be drawn between research that should and research that should not be subject to IRB review, even under the "exempt from full review" criterion [usually, if somewhat misleadingly, referred to as "exempt research"]. As we shall discuss below, we believe that it is important both for efficiency and for the credibility of the review system that we define an appropriate threshold below which research need not be submitted even under the exempt category. At the same time, we need to re-affirm the legally mandated requirement that all research involving human subjects that rises above this threshold be submitted for IRB review, if only under the exempt category. Here, too, we would emphasize that such recommendations become more compelling and persuasive when coupled with the implementation of appropriate tutorial and certification systems to insure that they are properly understood and followed.

I. Education and Certification

While human subject protection issues may not be as prominent in the sociobehavioral sciences as they are in the medical sciences, there is increasing pressure from inside and outside the University for sociobe-havioral scientists to address these issues explicitly in their research. This involves a need for a change of culture in the way investigators in a variety of sociobehavioral fields typically engage in research with human beings. Most notably, sociobehavioral scientists may have to submit their research for IRB approval, which involves a layer of review previously not imposed on many of them. To help investigators embrace the increased emphasis on human subject issues, the University should make available the tools to educate its faculty, students and other personnel involved in research activities. In addition, the University has a responsibility to monitor and document that its investigators are properly educated in the ethical conduct of human subjects research. The following recommendations pertain to these new responsibilities faced by the University.

Recommendations:

1. Education for human subject protection: We recommend that the University develop educational tools for helping personnel become familiar with the issues of human subject protection, in particular as they pertain to the sociobehavioral sciences.

2. Minimal education requirement [certification]: We recommend that the University institute a requirement that all personnel (faculty, research fellows, students, and staff) engaging in research have documented education regarding human subject protection. At the minimum, such education should involve an explanation and illustration of when it is appropriate for investigators to decide that their research does not require IRB review, even at the exempt level. We also recommend that newly recruited faculty be required to have documented education in the University's human subject protection regulations as part of their appointment process.

3. Monitoring and documentation: We recommend that the University set up a system to monitor and document its personnel's education with regard to the protection of human subjects and the ethical conduct of research involving humans.

Suggestions for Implementation at the University

A. Develop a web-based tutorial for educating sociobehavioral researchers about the ethical conduct of research involving human subjects. This tutorial should have a generic component as well as parts specific to different fields within the sociobehavioral sciences [e.g. survey research, ethnographic research, experimental research, etc.]. This tutorial should have a specific component dealing with debriefing of experimental subjects.

B. Develop an electronic IRB protocol submission system that guides sociobehavioral researchers through all issues potentially pertaining to their research while they are preparing the protocol submission. This could be accomplished by (a) tailoring the submission system for specific branches of sociobehavioral research, (b) linking the submission procedure to the web-based tutorial referred to under suggestion A, and (c) providing a web page on the ORA website with regularly updated links to professional societies' web pages about (field-specific) human subject protection and ethical conduct of research issues.

C. Spin off a new working group that will collaborate with the PennERA development group to implement suggestion B.

D. Produce a brochure highlighting the present working group's recommendations that the University decides to implement. This brochure should be distributed broadly across the University and include the Schools of Medicine and Nursing, since some of the recommendations may affect these Schools as well.

E. Provide personnel with certification of completed components of education in human subject protection, ethical conduct of research, and/or IRB regulations.

F. Encourage faculty and other personnel to become members of the IRB. This would have several benefits: personnel become more intimately familiar with the issues of human subjects research, and the University may improve its ability to promptly review submitted research protocols. Such service to the University should be rewarded appropriately. The Provost and the deans of research intensive schools should articulate their strong support for IRB service by faculty members. Service on the IRB should be counted favorably and explicitly towards evaluation for tenure and/or promotion. In certain circumstances IRB service might be grounds for a course-release.

G. Provide additional training for IRB staff regarding human subject protection in the sociobehavioral sciences. This training should also focus on efficient and efficacious review procedures that will benefit both the IRB and the investigators in terms of turn-around time, required effort and validity of protocol reviews.

II. Survey Research

Survey research typically raises few concerns with respect to human subjects. In its simplest form, sampled subjects are approached for their responses to batteries of items. Forms of approach--interviewing--may be face-to-face or over the telephone; or questionnaires may be self-administered, as through the mail or via the Internet. Recording of responses may be by means of "pen-and-pencil," by tape recording, or with the assistance of a computer. After the data collection process, the researcher will analyze these data by statistical methods, ranging from tabulation to the application of generalized linear models.

In common practice settings, the costs of participation to respondents are generally low in an absolute sense: a small amount of subjects' time only. Benefits to participation variously include financial remuneration, access to study results, and/or the opportunity to express opinions. In Institutional Review Board (IRB) terms, risks are generally minimal, and benefits generally outweigh the risks. Risks to participation are those attendant to the release of information garnered by the survey that may embarrass or otherwise harm the human subjects, especially if individuals can be identified from the reported study results. These risks can often be mitigated by following standard research practices and professional ethics published by the professional society of the discipline at hand. Evolving practices and technologies within survey research can complicate the assessment and mitigation of costs and risks to participants. These include panel studies, in which respondents are contacted on repeated occasions; and record linkages, e.g., of survey data to administrative records.

Recommendations:

4. IRB review in exemption category: We recommend that, by default, survey research be considered exempt from IRB review if protection of the confidentially of research subjects is adequately demonstrated (which does not necessarily involve submitting the survey instrument to the IRB). In addition, all other applicable criteria for exemption of IRB review must be fulfilled (e.g., the research must not involve vulnerable populations). This recommendation is consistent with the already existing regulation CFR 46.101.b (1--4), but we wish to make it explicit that submitting the survey instrument should not be necessary.

5. Waiver of written consent: We recommend that human subjects responding to a survey be considered to have given informed consent if the research is exempt from IRB review. In addition, in order to qualify for a default waiver of written consent, a research protocol must have been presented to the IRB showing that (a) the human subjects will be informed of all applicable elements of consent prior to responding to the survey; and (b) all the criteria for exemption of IRB review are fulfilled. Here, too, this recommendation is already covered by existing regulation CFR 46.116, but what is new is the ‘default' aspect of the waiver of written consent. Investigators presenting a protocol for review in the exemption category and requesting a default waiver of consent without providing the survey instrument, must have documented training in the issues concerning human subjects protection in survey research.

The criteria for exemption from IRB review can be found on the application for exempt status form available on the website of the Office of Regulatory Affairs of the University of Pennsylvania. The criteria for a waiver of written consent can be found in the Standard Operating Procedures of the IRB of the University of Pennsylvania.

III. Secondary Data Analysis

The end of the archetypal research study is often not the end of the analysis of the data collected by the study. They may live on in the form of secondary data analysis. It is important to distinguish the secondary analysis of data from the practice of primary research. The practice of secondary data analysis typically raises no human subjects protection concerns and is properly considered to be below the standard for IRB review. In the following, the secondary analysis of data is understood to have the following characteristics: (1) no manipulation of human subjects; (2) no new data collection; and (3) no identification of research subjects. This last point follows from the practice of the initial investigator (whether another investigator or the same person as conducting the secondary analysis), who in releasing the data is presumed to have stripped identifiers so that the confidentiality of the subjects is assured.

In some secondary data files, it is not possible to assure confidentiality, and these data files are typically distributed with the explicit understanding that other researchers must abide by certain rules to maintain confidentiality. Such circumstances should continue to trigger IRB review. In these instances investigators should demonstrate to the IRB that their secondary data are free of subject identifiers or other features that raise the possibility of identification of human subjects, in order to obtain exempt status. If this cannot be demonstrated, then investigators should seek IRB approval for the secondary analysis of the data, through expedited or full-board review procedures.

Recommendations:

6. No IRB review required: We recommend adoption of National Human Research Protections Advisory Committee [NHRPAC, 2001] recommendation 1. Specifically, we recommend that research on a public use data file, that is, "non-identifiable data in a publicly available file" not be considered human subjects research, and therefore not be "under the purview of IRBs" [NHRPAC, 2001]. In addition, we recommend the inclusion of non-confidential public records in the definition of a "public use data file" regardless of whether the data in these non-confidential public records are identifiable. Implementation of this recommendation would require that the investigator is certified as per Recommendation 2.

7. IRB review in exemption category: We recommend adoption of NHRPAC, 2001 recommendation 6. Specifically, we recommend that research on a non-public use data file, that is, non-identifiable data in a non-publicly available or proprietary file be exempt from IRB review, unless vulnerable populations are involved. Investigators planning to study non-public use data files must demonstrate to the IRB that confidentially of research subjects is protected, either by direct evidence or by showing that the data supplier already received IRB approval in which non-identifiability was considered and confirmed (which does not necessarily involve submitting the survey instrument or the original consent forms to the IRB).

NHRPAC, 2001; Draft Recommendations Regarding Public Use Data Files, July 2001, NHRPAC Social and Behavioral Science Working Group.

Suggestions for Implementation at the University

H. Develop an application form for exemption from IRB review specific for survey research and secondary analysis of non-public use data files.

I. Provide guidelines to investigators about when and how to apply for a Certificate of Confidentiality.

IV. Evolving Research

In a broad class of research in the sociobehavioral sciences, the questions posed evolve in the course of investigation. This is the case, for instance, in ethnography, where research questions may only be clarified after a period of observation and where current findings drive the next steps in the study in an evolving manner. Typically, this class of research involves observation of human behavior in the field, with or without active participation by the investigator. While such studies may be common in the sociobehavioral sciences, they do not fit the stereotypical mold of the hypothesis-driven, fixed-protocol research that is central to existing regulations designed for the protection of human participants. For evolving research, such as ethnographic research, oral history, and focus groups, among others, guidelines for when to seek IRB review, and how to make the IRB review process efficient, can be given within the framework of existing regulations. The following recommendations are made for clarification of the roles of investigators and the IRB in the process of human subjects protection as it relates to evolving research.

Recommendations:

8. No IRB review required: We recommend that research involving only non-interventionist observations of publicly occurring behavior, for which no identifying information is included in the study records, be considered not to require review by the IRB. By default, this form of research does not pose risk to human subjects, making it unnecessary to have the IRB approve it, even under the exempt category. We also recommend that the definition of publicly occurring behavior be understood to include publicly accessible parts of the Internet.

9. Evolving research certification: Consistent with Recommendation 2, we recommend that a program be established whereby investigators can become certified to conduct ethically sound evolving research. Investigators should be allowed to use their certification as a reference for describing evolving research studies to the IRB. This should serve to eliminate the need to have investigators spell out the details of a dynamic study protocol. The IRB can be assured that the research will be conducted in ethically appropriate fashion, with full protection of the human subjects, when investigators state that research will be conducted within the confines of the ethical framework laid out in the certification program. It should be noted that different investigations by the same investigator(s) must be submitted to the IRB as separate research protocols, and cannot be seen as part of a single study evolving from one investigation into another.

V. Exploratory Research

As part of their professional activities, investigators typically engage in exploratory research on a regular basis. Such research involves conceiving or refining a research question through harmless observation, casual conservation, browsing existing data, etc. IRB regulations stipulate that "research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [Federal Policy CFR 46.102(d)]. This raises the question whether and, if so, when exploratory research falls under the purview of the IRB. The following recommendation is made to clarify the role of the IRB in the review of exploratory research.

Recommendation:

10. IRB review required upon disclosure only: We recommend that exploratory research be considered not to require review by the IRB, even under the exempt category, if the following conditions are met:

a. The exploratory research does not involve any vulnerable populations (e.g., children, prisoners);

b. The exploratory research involves no interventions by the investigators;

c. The exploratory research participants are not identifiable from the study records;

d. The exploratory research data and results are not disclosed or published.

However, such research must be submitted to the IRB for retroactive review if/when the investigator anticipates or decides to disclose the data and/or results, or to submit them for publication--unless IRB review is still not required on other grounds (e.g., Recommendation 8, above). Such retroactive review should have the same procedures as if the study protocol had been submitted as a new study before the onset of the exploratory research. If the IRB does not give approval, and appeal of the IRB's decision does not change this, then the data and results cannot be disclosed in any form. If the investigator decides to begin a systematic investigation on the basis of exploratory research for which no IRB review was required, then a study protocol must be submitted for IRB review as per existing rules and regulations (unless IRB review is not required on other grounds). Investigators are advised not to wait until the last possible moment to seek IRB approval for their exploratory research.

Suggestions for Implementation at the University

J. Develop a web-based tutorial for educating field researchers about the ethical conduct of research involving human subjects.

K. Develop a web-based course to implement the certification program referred to in Recommendation 2 above.

L. Encourage course directors of courses on research methods or similar topics to help prepare students for taking the web-based course referred to in suggestion K above.

M. Educate the Office of Regulatory Affairs staff about what information to expect from the investigators of field research studies and how to apply the exempt and expedited categories of review to these studies.

N. Empower the IRB to give retroactive approval of exploratory research that has reached the threshold of systematic investigation where IRB review becomes necessary.

VI. Debriefing of Human Subjects

A frequently used technique in experimental sociobehavioral research and other fields of inquiry is the temporary manipulation of individuals' behavioral or perceptional states to measure or demonstrate a specific behavior, attitude or way of thinking. Often these manipulations involve deceiving experimental subjects about the purpose of the experiment, or about some trait or state of the subjects themselves (e.g., giving them false feedback about their performance). In other cases subjects might be exposed to messages intended to alter their beliefs or attitudes. In the typical instance, at the end of the experiment the true purpose of the research is revealed (e.g., subjects are informed of any deception about the purpose of the experiment, about their abilities or traits, or about the impact of the messages they were exposed to, etc.). It is generally assumed that subjects' temporary states are undone by means of such debriefing. While many research studies involve some kind of debriefing, little attention is commonly paid to whether or not the debriefing procedures accomplish the intended purpose (i.e., to undo the experimentally induced state). Yet, this issue may have important implications for human subject protection.

If debriefing is an issue, then presumably some part of the consent procedure was omitted (e.g., subjects were not told every aspect of the study, or they were purposely deceived about some aspects of the study). This requires a waiver of aspects of informed consent, which automatically triggers heightened awareness among IRB reviewers. Nevertheless, the discussion then often deals with whether or not that waiver is appropriate; it does not generally focus on the effectiveness of the debriefing procedure. Thus, heightened awareness of the debriefing issue may help to improve the ethical conduct of research on human beings. In some cases, particularly when a manipulation may lead to negative effects, it might be appropriate to require researchers to conduct follow-up investigations to assure that debriefing efforts have been successful.

Recommendation:

11. Review of debriefing: We recommend that specific attention be paid to the debriefing of subjects during the IRB review of experimental protocols. We also recommend that investigators be asked to address this issue specifically in their submitted study protocols and, particularly in the case of manipulations that may cause negative effects, to describe if and how the effectiveness of the debriefing methods they propose to use will be assessed.

Jeffrey Draine, Social Work
Martha Farah, Psychology
Melanie Green, Psychology
Larry Gross, Communications, Co-Chair
Kathleen Hall, Education
Mark Liberman, Linguistics
Deborah McGuire, Nursing
Mark Pauly, Health Care Systems
Pamela Sankar, Bioethics
Herb Smith, Sociology
Greg Urban, Anthropology
Hans Van Dongen, Psychiatry, Co-Chair
Susan Watkins, Sociology