What are my rights?

The following is the Experimental Subject’s Bill of Rights. This information is required for subjects in some states; however, some IRB’s feel that all study subjects should have this information for reference. Study personnel is available to answer study related questions, however, those pertaining to subject’s rights listed below should be addressed to our IRB Chairperson, Henry Driscoll, M.D., at (304) 696-7320 during regular working hours of 8 a.m. to 4:30 p.m.

EXPERIMENTAL SUBJECT’S BILL OF RIGHTS

1. To be told what the study is trying to find out.

2. To be told what will happen to me and whether any of the procedure, drugs, or devices are difference from what would be used in regular practice.

3. To be told about the frequent and/or important risks, side effects or discomforts of the things that will happen to me for research purposes.

4. To be told if you can expect any benefit from participating and, if so, what the benefit might be.

5. To be told the other choices I have and now they may be better or worse than being in the study.

6. To be allowed to ask questions about the study, both before agreeing to volunteer and during the study.

7. To be told what kind of medical treatment is available if you have any problems.

8. To refuse to participate at all or to change my mind about participating after the study is started. This decision will not affect your right to receive the care you would receive if you were not in the study.

9. To receive a copy of the consent form.

10. To be free of pressure when deciding whether you wish to agree to be in the study.

THE INFORMED CONSENT AND INSTITUTIONAL REVIEW BOARD;
THEIR ROLE IN PROTECTING SUBJECT RIGHTS

What is a consent form?

The Informed Consent document contains the required information as found in and required by the United States regulations regarding the protection of human subject (Code of Federal Regulations, Title 21, Part 50 – Protection of Human Subjects). As required by this regulation, the informed consent must be reviewed and approved by an Institutional Review Board (IRB).

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is any board, committee or other group which reviews, approves, and does continuing review of biomedical research involving human subjects. The primary purpose of such review is to guarantee the protection of the rights and welfare of the human subjects.

IRBs were established as the result of unfair treatment of human subjects. Prior to this, other committees existed as a requirement of the United States Public Health Service (USPHS) policy established in 1965. IRBs are regulated by the Food and Drug Administration and the National Institutes of Health (NIH).

What does an IRB mean to you?

The purpose of the IRB is to inform and protect human subject through the information provided in the informed consent document. Therefore, the IRB is acting as a supporter for the research subject. This means that the IRB, during its review of the informed consent document, has the right and responsibility to ensure that the research subjects is fully informed of the procedures involved in the study as well as the risks and other treatments that are available if participation in the study is refused.

How can you tell that and IRB has reviewed and approved a study?

The stamp of your study documents reflect that Marshall University IRB has approved the study. It is an FDA requirement that the study design (protocol), informed consent, any advertisements, and other instructions to the subject (Subject Instructions) be reviewed and approved by an IRB.

Marshall University IRB, the IRB for our studies.

Marshall University IRB meets regularly to review protocols. Four review committees representing local institutions meet jointly to review, consider, and approve studies taking place at each institution, and also other local institutions that don’t have a local IRB. The committees represent Marshall University IRB (representing the School of Medicine and University Physicians & Surgeons, Inc.), Cabell Huntington Hospital IRB, St. Mary’s Hospital IRB, and VA Medical Center Human Studies Subcommittee. Members of the committee include representatives from the various institutions and people who work in the community.

FDA regulations require that the committee have at least five members with varying backgrounds to provide complete and adequate review of research activities.

To fulfill these requirements the IRB currently includes physicians, pharmacists, Ph.Ds., other health professionals, and lay members (non-scientific).

The name and telephone numbers of the Chairperson is available in every informed consent document. You may contact the Chairperson with concerns regarding your rights as a subject.