An Executive Committee System for IRBsAuthor(s): David A. BlakeSource: IRB: Ethics and Human Research, Vol. 4, No. 9 (Nov., 1982), pp. 8-9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564513 .

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An Executive Committee System for IRBs by David A. Blake

Since 1965 The Johns Hopkins Uni- versity School of Medicine and The Johns Hopkins Hospital have jointly maintained an Institutional Review Board known as the Joint Committee on Clinical Investigation (JCCI). This committee has functioned to review and approve all clinical research on be- half of both institutions for the primary purpose of protecting human subjects. Throughout its seventeen years, the JCCI has utilized an executive commit- tee (the subcommittee) to coordinate and facilitate the review and approval process.

The JCCI has 19 voting members who represent the wide variety of disci- plines in which clinical research is con- ducted at these institutions. There are 13 physicians, two nonphysician scien- tists, one nurse, an administrator, and two "otherwise unaffiliated," or lay, members. The full committee meets twice monthly. A typical agenda con- sists of 15 new protocols and 20 annual reviews, along with miscellaneous amendments to and modifications of already approved studies. Currently, there are approximately 900 approved studies on file with the committee. Of that total, nearly one-third involve in- vestigational drugs and the majority of the rest involve invasive biomedical re- search. Approximately 10% of the stud- ies reviewed are surveys and epi- demiologic research. The subcommit- tee procedure was developed in order to handle this relatively large volume of complex biomedical research.

The review process is conducted as follows. The investigator completes a Research Project Notification form (RPN). The RPN consists of a cover sheet providing essential administra- tive information and approval signa- tures, and an attachment of not more than three additional pages describing the rationale, protocol, and risks of the study. In addition, the proposed con- sent form is included. The RPN is for- warded to the JCCI office after ap- proval has been obtained from the department chairman. Properly com- pleted RPNs are mailed each week to all members of the JCCI along with a comment sheet. Members are urged to return any comments within two weeks. Upon receipt of a majority of comment sheets, the RPN is presented

to the subcommittee for further review at its weekly meeting. The subcommit- tee consists of the chairman of the JCCI, the associate dean for research, the chairman of the Radiation Safety Committee, a representative of the Pharmacy & Therapeutics Committee, an internist, and a psychiatrist. All sub- committee members are active in clin- ical research and are full voting mem- bers of the JCCI. The subcommittee reviews comments by the membership and makes a provisional decision on the RPN. The decision is either to defer action and request additional informa- tion or to recommend the protocol be placed before the full committee for ap- proval.

If deferral is indicated, the chairman writes to the principal investigator re- questing further information or consid- eration of some modification in the protocol or consent form. In addition, the subcommittee has been authorized to perform expedited review. Under the expedited review guidelines, the sub- committee approves studies involving minimal risk, annual reviews and minor amendments. The subcommit- tee formulates the agenda for full com- mittee meetings. Copies of all pertinent correspondence between the subcom- mittee and an investigator are mailed to each member of the JCCI in prepara- tion for the semi-monthly meeting. Of- ficial actions of the JCCI (other than expedited review) occur only at the convened meetings of the full commit- tee in which a quorum of members must be present. The full committee re- views recommendations of the sub- committee for approval of projects for which all issues raised have been an- swered satisfactorily through corre- spondence. These recommendations are generally accepted, although defer- ral may occur if additional questions are raised. The remainder of the full committee meetings are used for direct discussions between the committee and principal investigators in those in- stances where concerns have not been resolved through written correspond- ence or where a difficult ethical issue must be fully discussed and resolved.

The JCCI has found that use of an executive subcommittee has been helpful in coping with the large and complex volume of protocols requir- ing review at the Johns Hopkins Medi- cal Institutions. As a result of the interim activities of the subcommit-

tee, a majority of time at meetings of the full JCCI can be applied to resolv- ing substantive issues of scientific or ethical concern. Furthermore, the sub- committee serves a triage function by providing a tiered approach toward review which maximizes the value of deliberations at the full committee meetings. Thus, the full committee discussions are focused on difficult is- sues with a minimum of attention de- voted to trivial matters. Another ad- vantage of this system is that, despite the heavy workload, every committee member reads and provides critical input to every new research proposal involving significant risks to human subjects. By acting as a consolidating and triaging organ of the full commit- tee, the subcommittee pursues issues raised during initial full committee re- view by mail, and acts to resolve the issues with the principal investigator on the committee's behalf. Consul- tants from the medical faculty and from outside the Institution are asked liberally to contribute expert opinion when scientific conclusions are ques- tionable. The consent form is per- fected through correspondence with the investigator. Often, the investiga- tor will amend the original protocol in response to concerns raised by the subcommittee. This dialogue between the subcommittee and investigator often prompts an evolution of the pro- posal toward a final form which will be acceptable to the full committee.

The overall objective of these proce- dures is that each of the 19 committee members has the opportunity to re- view the protocol before committee meetings, thus providing a broad re- view base. By insisting on a three-page limit to protocols, it is logistically feasible to distribute copies to all members. A shortcoming of this ap- proach is that often it becomes neces- sary to request additional information from an investigator, information which may have been contained in a full grant application. However, expe- rience has shown that this deficit is more than balanced by the improved clarity in addressing the essential fea- tures of a study, with special emphasis on the ethical issues and human sub- jects protection.

It is of interest to contrast the execu- tive committee approach with the pri- mary reviewer mechanism.'2 Per- ceived advantages of the primary reviewer system is that easily resolved problems are solved without corre- spondence. A major disadvantage is that only one committee member may have considered a project thoroughly in advance of a committee meeting.

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November 1982

Members who are unable to attend a particular meeting have no opportu- nity for comment. In theory, the quality of the IRB review process is some function of the product of the number of reviewers, the reviewers' qualifications, and the thoroughness of their individual reviews. On this ba- sis it appears that the executive com- mittee mechanism offers the advan- tage of having the entire committee's major concerns brought to the inves- tigator's attention before the meeting and, in most cases, resolved without debate at the full committee meeting. In this way, the full committee spends its meeting time discussing difficult and unusual protocols that pose com- plex ethical questions.

A particularly beneficial feature of the subcommittee mechanism is coor- dination of review among various an- cillary institutional committees which often also must approve individual protocols. This facilitation is par- ticularly evident when reviewing pro- tocols involving drugs, devices, or ionizing radiation. Such projects must also be approved by the Pharmacy & Therapeutics Committee, the Commit- tee on Biomedical Devices, and the Committee of Radiation Safety, re- spectively. Investigators deal directly with only one committee-the JCCI. The JCCI is responsible for coordinat- ing the simultaneous review by other cognate committees. This arrange- ment minimizes unnecessary duplica- tion of effort and expedites resolution of conflicts between the committees.

There are perceived deficiencies in our system of review. Since much of the communication between the com- mittee and the investigator is by mail, the review process can be lengthy. The estimated nominal "turn-around time" is 20 to 30 working days. Some pro- tocols take much longer, but usually this is because of a slow response by the investigator. The subcommittee is the most expedient step in the process with a maximum time of five working days. Because deficiencies in the con- sent form are frequently the reason for correspondence with the investigator, the JCCI has made an extensive effort to assist investigators in avoiding the common pitfalls in writing consent forms. A key requirement for the effec- tive functioning of the subcommittee is the willingness of its members to com- mit substantial additional time and effort. Partial salary support is pro- vided to members of the subcommittee in recognition of this administrative effort. There is also a considerable ex- pense for secretarial support and re- lated costs to conduct this type of

review. The annual budget for the JCCI of approximately $130,000 for staff sup- port and salaries of subcommittee members does not appear to be out of line with other institutions having a similar work load; but it should be noted that the office support staff de- votes full time to the IRB's functions. Other institutions are able to split staff- ing needs between an office of research administration and an IRB. We be- lieve, however, that the support staff's interaction with the subcommittee has provided a smooth interface between IRB and investigators conducting clin- ical investigation. The subcommittee experience also serves as an excellent educational tool for acquainting inter- ested faculty with the sensitive issues of human subjects research, and with the scientific rigor required for prop- erly conducted human investigation.

As stated previously, the large vol- ume of protocols reviewed at these in- stitutions flows smoothly using an executive committee mechanism. The

system has been in place for many years, attesting to its viability. I do not suggest that the arrangement de- scribed in this article is the best IRB review system or that other systems should be dismantled and this one tried. Rather, I intend merely to pro- vide a sketch of a workable system with the hope that other institutions estab- lishing review procedures for review boards may profit from one institu- tion's experience.

REFERENCES 'Cohen, J. M.:The Benefits of Professional Staff

for IRBs, IRB: A Review of Human Subjects Research 3 (No. 6): 8-9, June/July, 1981.

2Levine, R. J.: Commentary: A Primary Re- viewer System, IRB: A Review of Human Sub- jects Research 3 (No. 6): 9, June/July, 1981

ACKNOWLEDGEMENT The author is grateful to Dr. Thomas R. Hendrix, Dr. N. Franklin Adkinson, and Ms. Barbara L. Starklauf for helpful comments on earlier drafts of the article. Also, they are largely responsible for developing the commit- tee procedures.

-TTERS-

The Burdens of Research in Prisons

Robert Levine correctly states that the issue of whether to permit research on prisoners has consumed the time and energy of many thoughtful and re- sponsible people over the years.' He unfortunately concludes that the reser- vations of many of these people are overly squeamish, that the issue is no longer worth debating, and that we are protecting prisoners from indefinable and thus nonexistent burdens. I take this comment as an example of the in- adequacy of reasoned academic exam- ination, which is shielded from experi- ence and reality.

The initial reference to Nazi experi- mentation is a somewhat disingenuous tactic. Even those most critical of our prisons and jails would agree that the horrors they contain are of a different kind, not of a merely lesser degree, than those created by Nazi Germany in their concentration camps. This image erects as a frame of reference the most depraved and perverted actions and policies of incarcerators. American prisons and jails are clearly not so like Nazi prison camps that research done there will be of comparable depravity. However correctional institutions, with their stated aims of confinement,

are inherently coercive (even if not in- tentionally destructive) and the intro- duction of research will add one more element to benefit the strong, punish the weak, encourage the extortionist, and further undermine fairness and even-handedness in adminstration.

Consider for example the following report from the March/April 1982 issue of The Angolite, the national award- winning prison news magazine edited by inmates Wilbert Rideau and Billy Sinclair, and published at the Loui- siana State Penitentiary at Angola. Un- der News Briefs:

Starving Them Out Louisiana pays its prisoners from two to five cents an hour for their la- bors, an amount grossly inadequate to meet their needs. To augment that income, many inmates sell their "plasma" twice weekly to the pri- vately-owned plasma company lo- cated in the Main Prison, getting $9.50 each time. The process involves the plasma firm drawing a pint of blood from the inmate, extracting the plasma, then returning the "red blood" back into the inmate. When- ever the bag containing the donor's blood accidentally bursts, prevent- ing the return of the blood into the

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