Compliance with New Federal Regulations

To comply with the assurances filed with HHS and FDA, IRBs are required to adjust their policies and procedures to conform with newly promulgated federal guidelines and procedures. In order to do so, either the staff of IRBs or the office of legal counsel for the institution must be responsible for knowing when such guidelines or regulations are issued. The IRBs must then incorporate any such changes into their operations and advise investigators of the new requirements.

An example of one guideline of particular relevance to clinical drug trials is the Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, which the FDA published on July 22,1993 (57). This guideline was developed to address a growing concern that the drug development process was not producing adequate information about the effects of drugs in women. One reason for this deficiency was the 1977 FDA guideline, General Considerations for the Clinical Evaluation of Drugs, that excluded women of child-bearing potential from participation in early studies of drugs.

The revised guideline, adopted in 1993, withdrew the restriction on the participation of women of child-bearing potential in early clinical trials. It stated instead that, in accordance with good medical practice, women should be counseled against becoming pregnant during the trial and should be advised to take appropriate precautions to avoid pregnancies.

The FDA stated that the change in the policy set forth in the guidelines would not by itself cause IRBs to alter restrictions they might impose on the participation of women of child-bearing potential. It did state, however, that IRBs have broader discretion to encourage entry of a wide range of individuals into the early phases of clinical trials. Additionally, the FDA urged IRBs ''to examine carefully study protocols to see whether entry criteria needlessly exclude women or other groups in the target population of the drugs, or set up entry criteria that are difficult for women to meet'' (58).

The guidelines on the participation of women in clinical drug trials are similar to those published in 1989 to ensure that elderly patients would be included in clinical drug studies (59).

Another example of a guideline of relevance to IRBs reviewing clinical drug trials is the procedures for IRB review of National Institutes of Health (NIH) multicenter clinical trial protocols that include NIH-approved sample informed-consent documents. The procedures state:

(1) The Office of Protection from Research Risks (OPRR) now requires that each local IRB receive a copy of the NIH-approved sample consent document and the full NIH-approved protocol as a condition for review and approval of the local informed consent documents.

(2) Any deletion or substantive modification of information concerning risks or alternative procedures contained in the sample informed con sent document must be justified in writing by the investigator and approved by the IRB.

(3) The justification for an approval of such deletions or modifications must be reflected in the IRB minutes. For trials sponsored by the National Cancer Institute (NCI), investigators must forward copies of such IRB-approved changes, with their justifications, to the appropriate Cooperative Group headquarters (60).

The directive quoted above, issued by the OPRR, asserts that the policy contained in it does not reflect any change in the OPRR's policy concerning the importance of local IRB review. Rather, it reiterates the requirement that ''[e]ach IRB must continue to review all protocol and informed consent documents with the greatest of care, regardless of any prior review at the national level'' (61).

These two examples illustrate that IRBs must remain current with federal guidelines and regulations and be prepared to implement them when they become effective.

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100 Pregnancy Tips

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