The Noninstitutional Review Board: What Distinguishes Us from Them?Author(s): Erica HeathSource: IRB: Ethics and Human Research, Vol. 20, No. 5 (Sep. - Oct., 1998), pp. 8-11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563733 .

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IRB under the waiver at a medical cen- ter only one mile from her home.

23. My use of the informed consent "model" is intended to refer to a deep and rich understanding of the process of informed consent. The model is sometimes described in reference to six goals: (1) promoting individual autonomy; (2) respecting human dignity; (3) encouraging professional self-scrutiny; (4) pro- moting rational decisionmaking; (5) avoiding deceit and coercion; and (6) educating the public. Such goals seem to stand in stark contrast to the persuasion and promotion pre- sent in the advertising model. See Capron AM: Informed consent in catastrophic disease research and treatment. University of Pennsylva- nia Law Review 1974; 123:341-438, and note 5, Comments to the Rule, 1997:51500.

24. The temptation to disguise or downplay the research may follow from the best of intentions, but good disclosure must be authentic. Brochures for church members should not include superfluous scripture; a service offered to a community in the short-term should not be made to appear to be long-term or unencumbered, but identified as a collateral benefit of the research. And maudlin cries to "help save lives" are disrespectful and irresponsible.

25. The ability to consent only to fur- ther participation and the FDA's determination to keep subjects' data and review their medical records even if they opt out of further par- ticipation in the study come to mind as uncomfortable aspects of the rule. See Federal Register 1996; 26: 51519-20.

26. CABs have been discussed else- where. For example, see note 21, Levine et al. 1996. See also Melton G, Levine R, Koocher G, Rosenthal R & Thompson W: Community con- sultation in socially sensitive re- search: Lessons from clinical trials of treatment for AIDS. American Psychologist 1988; 43(7):573-81; Senterfitt JW: Collaboration with constituent communities in the HIV Cost and Services Utilization Study (HCSUS) [Abstract]. Annual Meeting 1996: 13, 22-23.

27. I place the term "consent" in quota- tion marks here to distance myself from the undesirable use of it as a transitive verb.

The Noninstitutional Review Board: What Distinguishes Us from Them? by Erica Heath

n IRB that is based outside an institution such as a

medical center, hospital, or college can be known by many names: central IRB, commercial IRB, contract IRB, external IRB, for-profit IRB, independent IRB, nonlocal IRB, professional IRB, or, the term I will use here, noninsti- tutional review board (NIRB).

Although NIRBs review studies under the same regulations as in- stitutionally based review boards, many observers view the two kinds of IRBs as categorically different. What distinguishes NIRBs from the more traditional IRB within an institution? Below are 10 distin- guishing features to consider. In some ways, IRBs and NIRBs are in fact quite similar; in others, NIRBs truly are distinctive.

IRBs are institutionally bound; NIRBs are not. "Institu- tional review boards" arose in re-

sponse to the requirement that for all grants to an institution, a high- ranking official of that institution would assure the NIH's Office for Protection from Research Risks (OPRR), in writing, that the insti- tution would internally review each funded activity to ensure pro- tection of human subjects.

The ensuing regulations incor- porated this line of thinking. It was considered a given that all IRBs were in institutions (thus the "I" in IRB)-defined as "any public or private entity or agency (including federal, state, or other agencies)"-- such as hospitals, colleges, and universities.

Some IRBs are part of a public entity such as a publicly funded college or university, or an agency such as a state department of health or a federal bureau. Other IRBs are part of private entities- such as private colleges or univer- sities, or private corporations such as large, investor-owned managed care organizations. There are also IRBs in pharmaceutical companies and medical device companies. Some physicians in private practice

have been encouraged to set up their own IRBs to review their re- search, the professional corpora- tion being the institution involved.

NIRBs also exist within a par- ent institution; none are totally free-standing. Most of the parent entities are corporations, which are usually small and privately held; a few of the parent entities are not-for-profit corporations. A few NIRBs are components of con- tract research organizations (CROs); they review research gen- erated within their institution.

The parent institution in every one of these instances is a business unit responsible for the proper op- eration of their IRB. Somewhere in the parent institution someone is concerned with paying taxes and insurance, marketing, negotiating contracts, hiring employees, and reviewing satisfaction with the outcomes. Often the IRB members have little comprehension of the work it takes to operate an IRB.

Conclusion: All IRBs exist with- in a larger organizational frame- work; that is, an "institution."

IRBs act in accord with their institutional culture; NIRBs act in accord with theirs. IRBs in hospitals tend to review medical studies and to be concerned about research in the "soft" sciences. IRBs in academic medical centers

Erica Heath is president of Independent Review Consulting, San Anselmo, Calif.

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September-October 1998

encourage "cutting edge" studies and are willing to approve higher risk studies, although many dis- dain "marketing" studies. IRBs in colleges review and are comfort- able with studies by graduate stu- dents, but are concerned with any study posing physical risks.

IRBs also exist on many contin- ua in accord with their institutions. IRBs can have few or many mem- bers. The IRB can have one person loosely or not affiliated with that institution or have many out- siders. Some demand quality and some do not. Some are risk accept- ing and some are risk averse. NIRBs are no different and are found along the same continua.

Conclusion: There are many variations among IRBs, most of which are due to the corporate or institutional culture in which they are found.

IRBs are indirectly funded; NIRBs are paid directly. No IRB operates without costs-of person- nel and paper, lights and fax, phone and floor. There are two sources of funding to cover those costs: indirect and direct.

Institutions supporting both re- search and an in-house IRB can charge each grant a standard rate for indirect costs to take care of overhead, folding the cost of the IRB into overhead. Those same in- stitutions can charge a direct fee for costs of IRB review of all stud- ies not paying the standard indi- rect rate. An increasingly common practice is for institutions (or, oc- casionly, the IRBs themselves) to charge a direct fee for IRB review of all sponsored research.

Institutions without access to graht budgets can only charge di- rect rates. In this, they are little different from (grant-supported) institutions whose IRBs charge for review costs directly. Among NIRBs, it is made clear that it is the institution-not the IRB with- in it-that is invoicing and is being paid. Fees are charged in accor- dance with a set schedule or are negotiated for large jobs.

Conclusion: All IRBs have costs. Traditional institutionally based review boards are supported within an institution's operating budget,

through either direct or indirect fees. For NIRBs, the parent insti- tution for can charge direct fees only.

Members of IRBs are gener- ally volunteers; members of NIRBs are generally paid. Members of IRBs are usually "vol- unteered" to serve as part of their academic committee duties. There may be other perquisites as well, such as being relieved of responsi- bilities to serve on other commit- tees, and complimentary lunch or parking, but the remuneration is generally minimal. Service is con- sidered part of their salaried job.

Each IRB must have at least one member from outside the institu- tion. Occasionally, outside members are paid for their services-a con- sulting fee, an hourly rate, or a set fee and the always excellent meal-- but usually they are volunteers.

The reverse is true on NIRBs; almost all members are from out- side the institution with only one or, at the most, two members re- ceiving salary from the parent in- stitution. Like some of their coun- terparts on IRBs, these external members are usually paid for their service. Although information about specific amounts is usually proprietary, the remuneration is probably not enough to make any member wealthy. In all cases, pay- ment is linked to attendance, preparation, and agenda size, not to decisions made.

Conclusion: Compensation of nonsalaried IRB members occurs across all types of board. Many nonsalaried members of institu- tional boards are paid, as are al- most all nonsalaried members of independent boards.

IRB members have varied conflicts of interest; all NIRB members have financial con- flicts of interest.

Salaried IRB members. Al- though salaried staff are not paid specifically for their ser- vice as IRB members, they still face a host of nonfinancial conflicts of interest, such as

* those between the IRB's mis- sion (e.g., protecting individu-

als) and the institution's mis- sion (e.g., promoting research);

* the effect that acceptance or rejection of a very large grant might have on one's own or one's competitors' access to space, funding, students, and power;

* the need or desire to enhance or diminish the prestige or standing of one's own or an- other's department;

* the desire to assist a colleague who needs more publications.

These conflicts are found primarily within an academic or hospital IRB.

The one or two salaried mem- bers of an independent board have similar conflicts. They tend to know their clients and their prob- lems, to answer the calls from sub- jects, to assist with consent form writing, and to know the status of the accounts receivable. They have the human desire to keep good clients happy.

Paid external members. Most paid external members of review boards-whether IRBs or NIRBs- are active or retired professionals (doctors, lawyers, accountants, teachers or member of the clergy) who have time and who are accus- tomed to making difficult decisions. Their role is to bring an outsiders' eye to the review process.

As professionals, most are also accustomed to being paid for their services. Were their fee adjusted to have them reach a particular out- come (e.g., x for an approval or y for a disapproval), there would be serious conflict. No IRB has ever admitted to such a practice and it is most unlikely to exist. In almost every case members are paid either piece work (x for any initial review, y for a continuing review) or by the meeting (z to attend prepared). The potential conflict faced by a paid external member seems little different from that faced by any competent doctor or lawyer asked to render an expert opinion: each must occasionally deliver bad news to a client who seeks good news but also must pay regardless of the outcome.

Unpaid external members. The best of both worlds is to build a re-

Ui

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10

IRB view board of dedicated members who are not otherwise affiliated with the institution (e.g., owe it no

special allegience) and who are

willing to provide several hours of

quality work a week or a month for free. Unfortunately, such mem- bers, while they exist, are rare. It is even rarer for a person to sit on a for-profit IRB without pay.

Conclusion: All salaried and all

paid external members of all IRBs have potential conflicts of interest. Intra-institutional conflicts of mis- sion are possible in all settings. Money often is less important than

many other interests.

IRBs review local work; NIRBs review remote work. Al- though most studies reviewed in an academic center or hospital IRB will be carried out locally (e.g., within that facility), faculty mem- bers may also be looking at life in the Phillipines, HIV in Uganda, pesticides in a migrant labor camp, pregnancy in a high school, or asthma in the depressed area of town only a mile-and a large cul- tural gap-away. These are all "nonlocal" sites and need special consideration.

Almost all activity reviewed by an independent IRB is nonlocal- that is, it will not be carried out by or within the NIRB's parent insti- tution. Each NIRB has developed forms and procedures to review nonlocal issues. These can range from learning about the demo-

graphics of the area and of the tar-

get population, and asking more about adequacy of facilities, to on- site visits and more frequent "monitoring" through mailers, phone calls, and visits. Another "local" factor is investigator quali- fication. IRBs generally rely on credentialing processes and accept that if the person is on the faculty or staff, he or she possess the req- uisite licenses and qualifications. NIRBs must not only review for qualifications to conduct the par- ticular study, they must also es- tablish minimum qualifications.

Conclusion: Although many IRBs review nonlocal sites, for NIRBs consideration of "local" con- ditions within the investigator's in- stitution is a part of every review.

IRBs review single sites; NIRBs review multicenter re- search. Until recently it was high- ly unusual for an institutionally based review board (an IRB) to be

responsible for more than one site in a multicenter clinical trial. But as hospitals merge into systems, and their IRBs are merged into a

single unit, systemwide (central) IRBs are increasingly reviewing research to be carried out in multi-

ple centers, all within the system. Most such systemwide IRBs have

procedures to avoid redundancy in review.

NIRBs are often asked to re- view all sites for a multicenter trial that are not otherwise cov- ered by established boards. To have a separate IRB or a separate review of the study for each site would be redundant and costly. Thus NIRBs have each developed procedures for central review of

multiple sites in which the same

protocol will be conducted. Conclusion: Review of a single

protocol with multiple sites is a feature distinguishing both central IRBs whose jurisdiction is system- wide and NIRBs from traditional IRBs.

IRB applicants apply to that IRB because they must; NIRB applicants make a choice to use the NIRB. Some investigators have no choice about which IRB

they will use. Institutional IRBs have sole jurisdiction over all human subject activities within whatever jurisdictional boundaries have been set. Usually this means

any activity within the walls of the institution or conducted by full- time members of the institution wherever they are.

In contrast, investigators out- side institutions with IRBs have free choice; they have the ability

* to establish their own in-house IRB to review their own work,

* to seek an established institu- tional IRB that will offer cour- tesy services,

* or to "shop" among a number of independent IRBs.

It is here that the concept of an independent contract IRB arises.

The institution supporting the "contract IRB" enters into an agreement or contract with each client. The NIRB will review a study, document all decisions, re- main in compliance with the feder- al regulations, prepare for audits, and provide a quality service in re- turn for compensation at a set rate. It will be a "professional" IRB. If it is not, if it is capricious, too de-

manding or too lax, too slow to re- view or respond, an NIRB's clients have the right to abandon it and to seek the services of another review board. Institutional boards are im- mune to this market pressure.

Conclusion: The free choice of unaffiliated clients to select their review board is very much a dis-

tinguishing feature. It creates a need for efficiency and quality, al-

though it also creates a require- ment to satisfy client needs.

IRBs rarely speak with spon- sors; NIRBs often do. Adminis- trators of most IRBs never speak with the representative of a spon- sor. It is their sincere and strongly held belief that the IRB should work with the investigator and the investigator should work with the

sponsor. In many cases, this re- sults in a game of "Telephone" or

"Gossip" that leads to false or mis-

leading information. NIRBs, which establish contrac-

tual relationships between their institution and sponsors, routinely break this chain, speaking often with sponsors. Although the ap- proval letters always go to individ- ual investigators, with whom NIRBs routinely communicate, NIRBs usually also send copies to the sponsor.

Conclusion: Independent NIRBs are more likely to communicate with sponsors.

IRB staff are in a bureau- cracy; NIRB staff are in a ser- vice profession. The orientation of the IRB staff toward an appli- cant is varied. Applicants who have no choice of IRB and who can only complain about efficiency tend to view their IRB as a bottle- neck and hurdle that they are not empowered to affect. Applicants who pay for a service and can

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September-October 1998

choose another service provider expect courteous, fast, profes- sional, educated service. They are empowered to make choices. Employees who do not adhere to the service or work ethic of that institution are much more easily fired.

Conclusion: It is much easier for the parent institution of an NIRB to engender a service ori- entation in their NIRB staff than for a larger bureaucracy.

Summary

Negative stereotypes and mis- conceptions about NIRBs have tended to obscure their similari- ties to IRBs. In almost every way, review boards that operate outside a standard "institutional" framework resemble those oper- ated institutionally. The most substantial distinguishing factor is the relationship between the review board and the applicant: clients work with a contract NIRB voluntarily; the institu- tional IRB's "clients" have no choice. A contract NIRB must serve by agreement, not fiat, and must face the possibility of clients leaving-just as doctors lose patients to other doctors and accountants to other accoun- tants. A contract NIRB must maintain its established reputa- tion. A dependent, institutional- ly based IRB will continue what- ever its skill or reputation.

The ten features noted here reflect the issues and challenges that confront both NIRBs and IRBs. Each can be debated, ar- gued, and developed further. They are offered to help shape consideration of the problems of both institutional and contract IRBs.

Back issues of IRB are available with discounts for large orders. For information on rates write to:

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A N N 0 T A T 1 0 N S

Byers, Peter H. and John Ashkenas. "Pedigrees-Publish? Or Perish the Thought?" American Journal of Human Genetics 63 (1998): 678-81.

The publication of genetic pedi- grees presents risks to human subjects, including subject identifi- cation, disclosure of genetic status, and consequent possible discrimi- nation. The authors suggest that researchers and institutional re- view boards ensure that subjects give informed consent to the publi- cation of pedigree information and that appropriate masking methods are incorporated into publications to promote subject anonymity.

Foster, Morris W., Deborah Bernsten, and Thomas H. Carter. "A Model Agreement for Genetic Research in Socially Iden- tifiable Populations." American Journal of Human Genetics 63 (1998): 696-702.

Foster et al. present a model to address the risks associated with genetic research on social groups, using the Apache Tribe of Okla- homa. Their method includes the identification of health care deci- sionmakers within the group, and communal discourse and agree- ment on the issues generated by the research. In an accompanying response (pp. 682-85), Philip Reilly

contends that this model should not be implemented for all social and cultural groups and addresses the issues concerning such imple- mentation. He suggests there are no ethical or legal obligations to obtain group permission, and the underlying issues of the risks as- sociated with genetic research for individual subjects and the groups of which they are members should be considered.

Juengst, Eric T. "Group Identity and Human Diversity: Keeping Biology Straight from Culture." American Journal of Human Genetics 63 (1998): 673-77.

With the emergence of popula- tion genetics research has come in- creased association of cultural and social groups with specific genetic traits. Groups may be concerned that participating in genetic re- search to explore this association may cause discrimination and stigmatization of group members. The author suggests that popula- tion genetic research should identi- fy populations for research at the genomic level instead of social and cultural levels, and that subjects should be informed of potential risks to such groups.

Marguerite Strobel Research Assistant

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