A Survey of IRB Concerns about Social and Behavioral ResearchAuthor(s): Joan E. Sieber and Reuel M. BaluyotSource: IRB: Ethics and Human Research, Vol. 14, No. 2 (Mar. - Apr., 1992), pp. 9-10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564539 .

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March-April 1992

group or others easily intimidated by medical personnel would be cause for concern.

As a first step, we recommend that the Code of Federal Regulations be amended to require that the frequency with which potential sub- jects refuse to participate in clinical studies be recorded. This step is consistent with basic concepts of quality assurance employed else- where in industry and medicine. Once statistics describing expected rates of refusal to participate in clinical trials have been accumu- lated, participation refusal rates for all clinical trials should be examined as part of their IRB periodic review, as described above. Refusal rates significantly lower than expected should prompt careful scrutiny to be certain that potential subjects are not being subjected to decep- tion, coercion, or other factors which might impair truly informed consent.

Acknowledgments The authors thank Dr. Daniel McGee for his critical reading of the manu- script. This work was supported in part by an American Cancer Society Clinical Oncology Development award and a generous gift from the Dick Thurman Memorial to Dr. Shimm, a Law College Support Grant to Professor Spece, and by NCI/DHHS Cancer Center Support Grant CA-23074.

References 1. Shimni, DS, and Spece, RG, Jr.: Industry

reimbursement for entering patients into clinical trials: Iegal and ethical issues. An- rnals ofntemalMedictne 1991; 115: 148- 51.

2. Barofsky, I, and Sugarbaker, P: Deter- minants of patient participation in ran- domized clinical trials for the treatment of sarcomas. Carcer Cnicalkdials 1979; 2: 237-46.

3. Annman, K, et al.: Selection bias in clinical trials. AmerionaunaloqfClin~ioa On-ol- ogy 1985; 3: 1142-47..

4. Quoi E, Fink•stei H,Wolkve, N, and Kreisaian, F Treatment of small-cell hng cancer on protocol Potential bias of results. Aneric fJounal ofnCidcal Oncd- ogy 1986; 4: 1313-20.

5. McNeil, B, Pauker, SG, Sox~ H, IVersky, A The elicitation of preferences for alterna- tive therapies. NEJM 1982; 306: 1259-62.

6. Penman, D, et al: Infkrmed consent for in- vestigational chemotherapy: Patients' and physicians' perceptms. bJonal ofCinical Onooiogy 1984; 2: 849-55.

7. Simes, R, et al.: Randmised compaison of procedures forobtainig informed con- sent in clinical trials of treatment for can- cer. Britst Medical Joumal 1986; 293:1065-68.

A Survey of IRB Concerns about Social and Behavioral Research by Joan E. Sieber and Reuel M. Baluyot

After more than a decade and a half of existence, social and behavioral science IRBs and their constituen- cies have gained much practical un- derstanding of how to implement the federal regulations for human research, but some areas of inves- tigator behavior remain prob- lematic. Many IRBs provide workshops for their new members and for departments that are ex- periencing difficulty applying the regulations. However, it is not al- ways obvious how to direct such educational programs.

In connection with the prepara- tion of a book on social and be- havioral science, a survey was con- ducted in which IRB chairs were asked what issues concerned them and needed to be covered in the book, and what solutions they had devised for meeting educational needs at their institution. The par- ticipants were IRB administrators who review social and behavioral research and for whom addresses were known to the Office for Protec- tion from Research Risk and were supplied to us. Of the 103 surveys mailed, 78 responses were received. Some respondents discussed the survey with their committee and re- ported the committee's consensus on each survey item, while others responded unilaterally. The findings offered useful guidance in rounding out the coverage of the book, and may be helpful to IRBs and to those organizations charged with educat- ing and guiding IRBs and scientists who study human subjects.

Respondents were asked to indi- cate the prevalence of the following problems on a three-point scale (very, somewhat, not at all): unclear protocols; insensitivity to issues of privacy; alternatives for ensuring confidentiality; coercion; alternative consent methods; defects in consent statement--omits important ele- ments, includes unimportant detail, violates rules of effective language usage, fails to address possible risks; no apparent faculty supervi-

Joan E. Sieber is professor of psychology at California State University, Hayward; Reuel M. Baluyot is an advanced undergraduate stu- dent at California State University, Hayward.

sion of student protocols; no evi- dence of investigator qualifications; protocol appears thrown together; protocol treated as a bureaucratic evil, not as a planning tool; obvious benefits that might be offered to subjects are not offered.

Respondents were also asked to indicate on a five-point scale (most, much, average, little, least, omit) how much attention should be devoted to each of the following re- search topics in Planning Ethically Responsible Research: AIDS-be- havior modification, community in- tervention, prevention; research in schools, business organizations, community settings; research on children, minority populations, the elderly; research using data generated by others; deception re- search; research on illegal behavior; surveys and interviews; clinical case studies; educational testing; physi- cal and physiological qualities; so- cially sensitive research; and dual- role relationships -participant/ob- server, researcher/ satisfier of gatekeeper who controls access, professor/ researcher, therapist/re- searcher, employer or supervi- sor/ researcher, health-care special- ist/researcher, and researcher/in- tervener.

The following information was ob- tained about each IRB: proportion of social/behavioral protocols; num- ber of initial reviews yearly; number of IRB members who are social scientists; and nature of institution served by the IRB (primarily under- graduate, some masters degree pro- grams, PhD programs in many de- partments, other). The relationship between type of IRB and other re- sponses to the survey was first ex- amined to determine whether differ- ent types of IRBs perceive the prob- lems differently or whether it was appropriate to combine the data from all respondents.

Within our sample, the percent of social/behavioral protocols ranged from under 5 percent to 100 per- cent, the number of initial reviews yearly (not counting reviews of re- vised protocols) ranged from 10 to over 500; the number of social scientist IRB members ranged from one to 13; and the institutions were

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IRB

about equally divided as to type, except that four were "other," i.e., not a regular academic institution.

IRBs that review mostly social and behavioral research do not perceive their problems differently compared to those that review mostly other kinds of research (typically biomedi- cal) except in one area-they want more information on handling is- sues of deception research. To de- termine whether these two groups differed in their perception of the quality of all protocols received, an index of protocol adequacy was developed. The following key vari- ables were identified as charac- terizing generally lower quality pro- tocols: protocol is unclear; protocol shows no apparent faculty supervi- sion (on student protocols); protocol appears thrown together at the last minute; and protocol is treated as a bureaucratic evil, not as a planning tool. The ratings signifying the de- gree to which each of these four issues was perceived to be a problem were summed for each respondent. These index scores of IRBs that re- view mostly social/behavioral re- search versus those that review mostly other kinds of research were compared and found not to differ. The presence of graduate programs was also unrelated to scores on the index of protocol quality, and to IRB perception of individual problems.

The number of social/behavioral scientists on the IRB was unrelated to the percentage of social science protocols reviewed. The composition of the IRB did not appear to make a difference in the reported perception of IRB problems. That is, IRBs with a larger number of social scientist members did not perceive problems differently from those with a smaller number of social/behavioral scien- tist members.

Because of the uniformity of find- ings across these categories of IRBs and institutions, the results were pooled across all respondents.

The following protocol problems emerged as major, in descending order of perceived seriousness:

* Consent statement omits im- portant elements

* Protocol is treated as a bureaucratic evil, not as a planning tool

* Protocol is insensitive to appro- priate alternative consent methods

* Protocol is unclear to the non- specialist

* Protocol is unclear

* Consent statement violates rules of effective language use

* Protocol appears thrown to- gether at the last minute

* Consent statement fails to address possible risks

The following topics were con- sidered to warrant the most atten- tion in the forthcoming book, in de- scending order of perceived impor- tance:

* Research on illegal behavior (e.g., child abuse, drug use, prostitution, needle exchange)

* Research on children * Socially sensitive research " AIDS research * Research involving deception * Research on minority popula-

tions * Research on the elderly * Research conducted in schools * Behavior modification research * Research in community set-

tings All of the dual-role relationships

were regarded as deserving atten- tion in the book. The most important in descending order of importance were:

* Professor/researcher (studying own students)

* Researcher/intervener (e.g., the researcher learns that an HIV-infected subject is sexu- ally active; what intervention, if any, is appropriate?)

* Health care specialist/re- searcher (studying own patients)

* Therapist/researcher (study- ing own clients)

Solutions to Problems

As an open-ended question, re- spondents were asked what useful solutions they have found to the problems faced by IRBs. We received a wide range of responses, a sum- mary of which is available from the first author upon request. Among the most interesting points raised by respondents were:

1. A key problem is the failure of department chairs and deans to oversee the process of developing adequate student and faculty proto- cols. One solution is to give work- shops for chairs, deans, and inter- ested faculty.

2. Some IRB chairs give work- shops, lectures, colloquia, or specially organized meetings to in- form department heads and others about research ethics and IRB re-

quirements. Other chairs make themselves available to faculty for advice and consultation upon re- quest.

3. Some IRBs have developed ex- tensive hand-outs for students and faculty and offer seminars for stu- dents.

4. One office of research provides a graduate student assistantship to a student to assist the IRB with education and processing of proto- cols.

5. Some institutions have a stand- ard protocol form that provides detailed instructions on each aspect of protocol development, and ends with a checklist to help the appli- cant ascertain that the classical blunders have been avoided. Some include sample consent letters along with this packet.

6. Some institutions have pre- pared an IRB handbook or guide that advises the applicant on all key areas of concern; others have a lending library of books that the applicants may borrow.

Conclusion

The survey reported here found a combination of perennial issues of concern to IRBs. Consent issues, poor risk assessment, unclear pro- tocols, and protocols that are thrown together are key problems. The areas perceived as most in need of coverage in a forthcoming book are: research on illegal behavior, on children, on socially sensitive top- ics, AIDS, research involving decep- tion, and research on minority populations. The dual-role relation- ships regarded as most in need of examination are professor/re- searcher, researcher /intervenor, health care specialist/researcher, and therapist/researcher. IRB chairpersons reported various in- novative approaches to providing needed education to students and faculty investigators at their institu- tions.

Acknowledgments

Support provided by National Science Foundation Grant BBS-8911646: Development of a Practical Guide to Planning Human Subjects Research is gratefully acknowledged. We also ex- press our appreciation of Mary Innis, who conducted the data gathering for this project.

Reference

1. Sieber, JE: Pmkntig hily Responsible Researt (Newbury Park Calif: Sage Pub- lications, 1992).

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