NINDS Summer Student Award Nominee Statement

The NIH Revitalization Act of 1993 reintroduced the participation of women of childbearing potential in clinical research. The purpose of this act was to ensure that information would be available that specifically addressed the safety of drugs and procedures in relation to women. Yet including this vulnerable population required that new safety measures be included in study designs. Currently there is no standardized approach for outlining the risks to and protection measures for women and fetuses in protocols. Our project aims to assess how NIH intramural clinical trials have handled the inclusion of women of childbearing potential, and to recommend a standard approach that can eventually be implemented across the institutes.

We reviewed NIH intramural protocols and corresponding consent and assent forms. We gathered information regarding risks to women and fetuses, risks to future fertility, pregnancy testing, pregnancy management, contraception requirements, counseling offered, and issues concerning girls of reproductive age. I organized a server to be used by the reviewers, where we stored electronic copies of protocols and consents and assisted with the design of a tracking system, allowing for frequent and easy updating of the study's progress. With the tracking list, I was able to coordinate the work of the other reviewers. Data obtained during the review of protocol documents were entered into forms I helped develop with the NICHD Clinical Trials Database team. Of 591 identified active NIH intramural clinical trials, 501 protocols were selected for review; 90 were excluded because they were off-site, were deemed minimal risk or excluded women. Currently 37 protocols have been completely reviewed. Two members of the project independently reviewed each protocol. I also helped oversee the reconciliation of discrepancies when they arose.

Although this only represents a small fraction of protocols we plan to review, we have already noticed significant trends. We have found that consent forms often do not address the risks to women and fetuses for all risky procedures in the study. While a majority, 35 out of 37 protocols, performed pregnancy testing, few made it clear how a pregnancy during a study would be handled. In reference to minors of reproductive-capacity, it appears that many investigators feel discussing pregnancy testing and use of contraceptives in assents to be uncomfortable or unnecessary. Yet it is vital to the safety of these young women and unborn fetuses that they be aware of risks and be duly protected.

In a subset of the study, I am focusing on the use of contraception as a safety measure for women of childbearing potential in clinical trials. I will present a poster discussing my findings entitled "Reducing risk to women of childbearing potential in Clinical Trials in the Intramural Program - Contraceptive Recommendations." I have noted so far that while many protocols require contraception usage, few specifically state acceptable methods and types of contraception. No protocol reviewed thus far discussed the provision of contraception.

Further review will allow us to develop concrete methods of approach for contraception and other issues concerning the inclusion of women of childbearing potential in clinical trials.