Institutional Review Board (IRB) An- Najah University

1. Institutional Review Board (IRB) An-Najah University Dr. Aidah Abu Elsoud Alkaissi An-Najah National University Nursing College

2. The history of Institutional Review Boards (IRB) • Is a product of the attempts at improving the ethical conduct of biomedical research. • These attempts started in 1945 after the post World War II Nuremberg Code addressed issues of unethical human experimentation (1). • Details of these issues were later more extensively formulated in the International Ethical Code of the Declaration of Helsinki in 1964 (2). • These efforts accelerated and matured after the public disclosure of the infamous Tuskegee study conducted on 399 impoverished African American share croppers between 1932 and 1972 in Tuskegee, Alabama, USA (3). (1)Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, vol. 2, pp. 181-182.,                Washington, D.C.: US Government Printing Office, 1949. (2) Declaration of Helsinki (1964) Adopted by the 18th World Medical Assembly, Helsinki, and Finland. June 1964. Available on line at www.cirp.org/library/ethics/helsinki/. T (3) Twenty Years After: The Legacy of the Tuskegee Syphilis Study. The Hastings Center Report 22 ( No. 6, November/December 1992): 29-40.

3. The Tuskegee syphilis experiment • The Tuskegee syphilis experiment(also known as the Tuskegee syphilis study or Public Health Service syphilis study) was a clinical study conducted between 1932 and 1972 in Tuskegee, Alabama, by the U.S. Public Health Service. Investigators recruited 399 impoverished African-Americansharecroppers with syphilis for research related to the natural progression of the untreated disease.[1]

4. The Tuskegee syphilis experiment • The Public Health Service, working with the Tuskegee Institute, began the study in 1932. Nearly 400 poor black men with syphilis from Macon County, Ala., were enrolled in the study. For participating in the study, the men were given free medical exams, free meals and free burial insurance. They were never told they had syphilis, nor were they ever treated for it. According to the Centers for Disease Control, the men were told they were being treated for "bad blood," a local term used to describe several illnesses, including syphilis, anemia and fatigue.

5. The Tuskegee syphilis experime • The 40-year study was controversial for reasons related to ethical standards, primarily because researchers failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for the disease. Revelation of study failures led to major changes in U.S. law and regulation on the protection of participants in clinical studies. Now studies require informed consent (with exceptions possible for U.S. Federal agencies which can be kept secret by Executive Order[2]), communication of diagnosis, and accurate reporting of test results.

6. The Tuskegee syphilis experime • By 1947 penicillin had become the standard treatment for syphilis. Choices might have included treating all syphilitic subjects and closing the study, or splitting off a control group for testing with penicillin. Instead, the Tuskegee scientists continued the study, withholding penicillin and information about it from the patients. In addition, scientists prevented participants from accessing syphilis treatment programs available to others in the area. The study continued, under numerous supervisors, until 1972, when a leak to the press resulted in its termination. Victims included numerous men who died of syphilis, wives who contracted the disease, and children born with congenital syphilis.

7. The history of Institutional Review Boards (IRB) • The Tuskegee Study was undertaken by the US Department of Health In order to study the late complications of syphilis without treatment. • The study continued for years after effective antibiotics were in common use (3). • The study was terminated only after the press uncovered it and brought to public attention (3&4).  • This and other issues led to the Belmont Declaration in 1978, and eventually human subject protection turned into law in 1991(5).   • Subsequently, this led to the requirement by most international medical journals that a condition of publication of clinical studies is that they must have approval of the local IRB (6). (4) Consortium of Social Science Associations (COSSA) (2001-2003) “Protecting Human Research Participants: a compilation of stories from COSSA Washington Update regarding the oversight of human research participants. “ Available online at http://www.cossa.org/hsbackground.htm#social. (5) National Commission for the Protection of Human Subjects of Biomedical Research. 1979. The Belmont Report: Ethical principles and guidelines for protection of human subjects of research. (6) Washington, DC: US Government printing press. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. JAMA. 2000: 284: 3043 – 3045.    

8. A crucial part of any medical research institution is its Institutional Review Board (IRB) • The main function of the IRB and its jurisdictional responsibility include: • Protection of the right and welfare of individuals involved in human research; • Assurance of the scientific merits of submitted proposals; • Validity of informed consent as signed by patients in these proposals; • Adjudication المقاضاةof the ethics of the submitted proposals; • Monitoring of the ongoing trials; • Monitoring of completed and ongoing research records.

9. Formation of IRB at An-Najah University: • As a leading educational institution in the Middle East, An-Najah University will benefit from the formation of an Institutional Review Board (IRB). • The Board will have the authority to approve, disapprove or make recommendations to proposed clinical research proposals to be conducted at An-Najah University or its affiliated institutions. • In order to familiarize research workers with issues leading to formation and function of IRB, the National Institute of Health (NIH) has developed an on line course which is now internationally required by IRB’s and applicants for IRB approval applications. • Until the creation of an alternate internationally adopted IRB education body, An-Najah University will require members of IRB and clinical investigators submitting a proposal to obtain a certificate from the National Institutes of Health (NIH) by completing the online course on Human Participant Protections Education for Research Teams (http://cme.nci.nih.gov).

10. Compositionof IRB at An-Najah University: • The An-Najah IRB will be composed of twelve members representing the Colleges of Medicine, Pharmacy, Nursing, Basic sciences, Arts, Engineering and Physical Education colleges. • It will also have a university attorney who is familiar with local regulations, as well as two lay individuals who are familiar with human research. • The committee will also include a member of the clergy. • There will also be an Ex-Officio non- voting member who will represent the administration (Dean of the College of Medicine). • The Board will be chaired by DrSamarGhazal, MD, who has been charged with IRB development at the institution. • To ensure familiarity with research issues and the issues that led to the formation of the Board, all members will complete the on-line course on Human Participant Protections Education for Research Teams (http://cme.nci,nih.gov).

11. Application procedure: • Prior to applying for IRB approval, the principal investigator لباحث الرئيسيas well as other members of the applying team must complete the on-line course on Human Participant Protections Education for Research Teams (http://cme.nci.nih.gov) and include a copy of their certification with their submission. • The initial application, available on An-Najah IRB website (irb@annajah.edu), is completed and the submitted electronically to the same site (attachment #1). • The initial submission should be accompanied by a completed consent form, available electronically with the IRB application (attachment #2).

12. Meetings of committee: • Initially, the Board will meet every other month and review all applications. • As the need arises, the Board will meet monthly. • The schedule for the meetings for the entire year will be circulated on the first of August the prior year. • Additional meetings, as the need arises, will be announced as needed.

13. Reasons for IRB reviews of research involving human subjects: • To ensure that human subjects are not placed at undue risk; • To ensure that human subjects are granted uncoerced consent بدون إكراه موافقة to participate; • To ensure and help to protect validity of research findings; • To comply with internationally accepted standards.

14. Research requiring IRB approval: • Research involving human subjects; • Research using records gathered on human subjects; • Research involving human tissue collected at or sent to the institution. This includes research that falls into any of the following categories: • research conducted by University faculty, staff or students; • research performed on University premises; • research which involves University faculty, staff or students; • research which involves the completion of an award, degree or course; • research which involves multiple institutions in which the University is participating 

15. Research not requiring IRB approval: • Research of existing literature; • Quality assurance studies whose goal is the improvement of care at the institution; • Interviews of individuals with questions focusing on things and not people; an example would be questions focusing on policy; • In case of confusion regarding the need for IRB review, the Board can be contacted on a phone number to be assigned soon.