Pine Street Foundation

Institutional Review Board (IRB)

Every year, an increasing number of clinical studies on alternative, complementary, and integrative (CAM) therapies are published in the mainstream medical literature. Ideally, these studies would be critically reviewed by an Institutional Review Board (IRB) prior to commencement. Furthermore, that IRB should be specialized to focus on complementary and alternative medicine. Many institutions have their own IRB, but an important issue in current research is the lack of IRBs concerned specifically with CAM research. To meet this need, the Pine Street Foundation has established the first-ever Institutional Review Board specifically focused on the ethical oversight of clinical trials on complementary and alternative medicine. Our IRB is registered with the Office for Human Research Protections, which is part of the National Institutes of Health (NIH). Our IRB number is 3082. Our Federal Wide Assurance (FWA) number is 8970. For optimal ethical review, all of the Pine Street Foundation's own research projects are independently reviewed by an external and independent Institutional Review Board.

WHAT IS AN IRB?
An Institutional Review Board (IRB) is an administrative group established to protect the rights and welfare of human research subjects recruited to participate in medical research activities. An IRB provides ethical and safety oversight for medical research.

The federal regulations mandating research oversight by IRBs originally grew out of ethical and legal lessons learned, in part, from the Nuremberg Trials following World War II and the Tuskegee Experiment that ended in 1972. These regulations help to ensure that people participating in research can do so safety and with full informed consent. They are based on three key ethical principles:

Respect for Persons: Requires full informed consent by research participants. Informed consent requires that research participants have full information on the study's risks and benefits, that researchers confirm participants fully comprehend those risks and benefits, and that participation is voluntary. Subjects must be given sufficient information on which to decide whether or not to participate, including the research procedures, their purposes, anticipated risks and benefits, alternative procedures when therapy is involved, and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research.

Beneficence: The principle of beneficence - maximizing benefit while minimizing risk - requires that researchers protect individual subjects against risk of harm. All possible harms should be considered, including physical or psychological pain or injury, social harm, loss of privacy, and economic harm through loss of job if health information is publicly disclosed. The societal benefits that might be gained from the research should also be considered.

Justice: The principle of justice mandates that the selection of research subjects must be the result of fair selection procedures and must also result in fair selection outcomes.

All research supported or conducted by federal governmental agencies, such as the National Institutes of Health (NIH), is required to have IRB oversight. Medical institutions that receive federal funding are also required to have such oversight. The IRB has the authority to approve, require modifications in, or disapprove all aspects of clinical research. The IRB makes its decisions to approve research independently of the organization within which it is established.

 

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