IRBs tend to grow short of needed skills; institutional review boards, charged with protecting subjects of clinical trials, may have to hire outside consultants

Article Abstract:

Issues are discussed regarding the National Institutes of Health Guidelines requiring that all research proposals involving recombinant DNA techniques be approved by an Institutional Biosafety Committee with expertise in the area of the proposed research protocol. Concern over insufficient institutional review board expertise in biosafety led to these guidelines.

Human experimentation in medicine, Human medical experimentation

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Clinical trial conflicts apply to investigators, too; FDA is scrutinizing physicians, as well as sponsors, with financial interests in testing

Article Abstract:

FDA requirements regarding the management of clinical trial conflicts are discussed. Approaches such as multiple investigators, objective endpoints and their measurement by someone other than the investigator, and blinding may minimize the potential for bias. The FDA may refuse to consider the data at all if inadequate measures have been taken.

Pharmaceutical research

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Clinical trial conflicts apply to investigators, too; FDA is scrutinizing physicians, as well as sponsors, with financial interests in testing

Article Abstract:

Compliance guidelines for investigators with a proprietary interest in drug research to follow are discussed. How conflicts of interest are handled will be one of the indicators of a study's reliability.

Management

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