irbs and scientific expertise

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IRBs and Scientific Expertise Author(s): Daniel H. Schwartz Source: IRB: Ethics and Human Research, Vol. 4, No. 3 (Mar., 1982), p. 9 Published by: The Hastings Center Stable URL: http://www.jstor.org/stable/3564331 . Accessed: 12/06/2014 20:42 Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at . http://www.jstor.org/page/info/about/policies/terms.jsp . JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range of content in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new forms of scholarship. For more information about JSTOR, please contact [email protected]. . The Hastings Center is collaborating with JSTOR to digitize, preserve and extend access to IRB: Ethics and Human Research. http://www.jstor.org This content downloaded from 91.229.248.187 on Thu, 12 Jun 2014 20:42:18 PM All use subject to JSTOR Terms and Conditions

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Page 1: IRBs and Scientific Expertise

IRBs and Scientific ExpertiseAuthor(s): Daniel H. SchwartzSource: IRB: Ethics and Human Research, Vol. 4, No. 3 (Mar., 1982), p. 9Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564331 .

Accessed: 12/06/2014 20:42

Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at .http://www.jstor.org/page/info/about/policies/terms.jsp

.JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range ofcontent in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new formsof scholarship. For more information about JSTOR, please contact [email protected].

.

The Hastings Center is collaborating with JSTOR to digitize, preserve and extend access to IRB: Ethics andHuman Research.

http://www.jstor.org

This content downloaded from 91.229.248.187 on Thu, 12 Jun 2014 20:42:18 PMAll use subject to JSTOR Terms and Conditions

Page 2: IRBs and Scientific Expertise

March 1982

GET TERS 'Exculpatory Language' in Consent Forms

HHS's general requirements for in- formed consent as they appear in the Federal Register for January 26th, 1981, contain in ? 46.116 the following statement: "No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or re- leases or appears to release the inves- tigator, the sponsor, the institution or its agents from liability for negli- gence.

No one can take exception to this. However I have seen several consent forms which include the disclaimer. One of them says "By signing this con- sent form, I have not waived any of my legal rights or released this institution from liability for negligences (sic.)." Another form contains the following statement signed by the investigator and placed below the patient's signa- ture: "This consent form includes no exculpatory language through which the subject is made to waive any of his legal rights to release the institution from liability for negligence."

When the I.R.B. of which I am Chair- man receives protocols from the United States, of which there are many, there is some reluctance to alter the consent form. Some of them are models but some could be improved, particularly by replacing or explaining the big words. The exculpatory clauses quoted above have no place in the consent form. If the consent form contains the "basic elements of informed consent" set out in ? 46.116(a) then of necessity it will have no exculpatory provisions. The disclaimer seems to me to be very close to the statement "We want to as- sure you' that we are not taking advan- tage of you." This should go without saying.

W.F. Bowker Institute of Law Research

and Reform University of Alberta Edmonton, Alberta

IRBs and Scientific Expertise

Robert Levine's article in the Decem- ber issue of IRB ("Can (or Should) the IRB Assume the FDA's Function at Early Stages of the IND Process?") raises the question of the scientific ex- pertise of IRB members. I shall com- ment on this matter without reference to the question of whether the IRB should assume any of FDA's functions.

Montefiore Hospital and Medical Center has had for over 25 years a Re- search Committee consisting of senior scientists representing the various dis- ciplines in which research is done in this institution. This committee re- views all grant applications with the aim of determining their scientific merit. Formally, the actions of the committee are recommendations to the President, who virtually always ac- cepts them. Thus, while it does not have official authority to approve or disapprove an application, de facto such authority resides in the commit-

tee. It approves 10% of applications without recommending changes; makes recommendations for changes in 80%; and, in 10% of cases, it either disapproves or recommends major re- visions.

The IRB will not consider any appli- cation until it has been approved by the Research Committee. The IRB's po- sition is that it cannot make a valid risk-benefit assessment until qualified scientists have assessed the likelihood and magnitude of benefit.

This system has worked very well here. Apparently, not many other insti- tutions have a similar system.

Daniel H. Schwartz Associate Director Montefiore Hospital and Medical Center The Bronx, New York

CALENDAR

MARCH 29 and APRIL 22 The National Institutes of Health and the Food and Drug Administration will sponsor two one-day seminars on the protection of human subjects, to be held at the Sidney Farber Cancer Institute in Boston (March 29) and the Shamrock Hilton Hotel in Houston (April 22). Charles Mc- Carthy and Philippe Cardon of the Office for Protection from Research Risks (OPRR), and Stuart Nightingale of the FDA, along with various workshop leaders, will discuss the federal regulations concerning research with human subjects. For more information, call Joan Rachlin (Boston) at (617) 367-4992, or Paula Knudson (Houston) at (713) 792-5048.

MARCH 30-31 PRIM&R will hold a conference on "Issues in Clinical Re- search: New Challenges and Practical Problems." The meeting will be held at the Harvard School of Public Health, and will focus on issues such as IRB responsibility for reviewing drug research, monitoring, legal issues in drug and device research (including informed consent and consent forms), drug re- search in special populations, drug studies with normal volunteers, drug stud- ies abroad and the acceptance of consequent data for NDA purposes, collaborative studies, the design of clinical trials, and the non-affiliated re- search project and the independent IRB.

PRIM&R has set aside a limited number of scholarships, as well as a limited number of spaces for the press. For further information or a complete pro- gram, please contact Joan Rachlin, Executive Director, PRIM&R, 15 Court Square, Suite 340, Boston, MA 02108; (617) 367-4992 or 367-2829.

APRIL 6 A one-day workshop sponsored by NIH/FDA will be held at New York Univesity, 40 West 4th Street, New York City, to discuss the newly instituted HHS regulations concerning the protection of human subjects involved in bio- medical and behavioral research. Among those persons who will serve as fac- ulty/discussion leaders for the workshop are Dr. Robert Levine (Yale University), Dr. Charles MacKay (OPRR, HHS), Dr. Philippe Cardon (OPRR, HHS), Carol Levine (Hastings Center), Vanessa Merton (Hastings Center and NYU Law School), and other officials from the NIH and FDA.

The director of the workshop is Dr. Arthur Caplan, Associate for the Human- ities at The Hastings Center. There will be no registration fee and the work- shop is open to all persons with an interest in the topic. However, the workshop enrollment will be limited to 125 persons. Those wishing to attend must contact Dr. Caplan at Box Z, The Hastings Center, 360 Broadway, Hast- ings-on-Hudson, New York, 10706, prior to March 31, 1982, for further infor- mation and registration materials.

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