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Protection of Human Subjects & Constitution of IRB

BayBiotech.NET
Scope: the policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research.
This policy does not affect any state, local or foreign laws or regulations which may otherwise be applicable and which provide additional protections for human subjects.
Exclusions:
 Research conducted in educational settings, examples: research on education instructional strategies, on comparison among instructional techniques, curricula, or classroom management methods.
 Research involving survey procedures, interview procedures or observation of public behavior, unless information is recorded in such a manner that human subjects can be identified.
 Research involving the collection of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers.
 Research and demonstration projects which are conducted for the approval of department or agency heads, and are designed to study, evaluate, or examine:
Public benefits, procedures for obtaining benefits or services under those programs;
 Taste and food quality evaluation and consumer acceptance studies,
Institutional Review Board: Each and every institution engaged in research on human subjects has a review board to determine the compliance of submitted research proposal with local, state and federal regulations with main focus to protect violations of human subjects in terms of privacy and confidentiality of information. Such review boards are called IRB (Institutional Review Board) and as per NCI’s definition, “IRB is a group of scientists, doctors, clergy, and consumers that reviews and approves the action plan for every clinical trial. There is an IRB at every health care facility that does clinical research. IRBs are designed to protect the people who take part in a clinical trial. IRBs check to see that the trial is well designed, legal, and ethical, does not involve unnecessary risks, and includes safeguards for patients”.
According to Title 45, part 46 an IRB must constitute of the following:

(1) Each IRB shall have at least five members, with varying backgrounds of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice in safeguarding the rights and welfare of human subjects.

(2) In order to determine the acceptability of proposed research in terms of institutional commitments and regulations, applicable local, state and federal law, and standards of professional conduct and practice, IRB shall include persons knowledgeable in these areas.

(3) If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

(4) Every effort must be made to ensure that no IRB consists entirely of men or entirely of women.

(5) An IRB must not consist of entirely members from one profession.

(6) Each IRB shall include at least one member from scientific area and at least one member from nonscientific areas.

(7) IRB shall include at least one member who is not affiliated with the institution and is not part of the immediate family of a person affiliated with the institution.

(8) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest.

(9) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise.
For further readings, follow the link: http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdf

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