Women's Health Research Registry

Women have been disproportionately underrepresented in clinical research. Few of the many
drugs approved by the FDA have been adequately tested in women. Most common health conditions
experienced by both women and men are managed by treatments that have been developed and
tested most in men.

A new barrier to enrolling women in clinical trials is in effect: HIPAA (the Health Insurance
Portability and Accountability Act). The positive benefit of HIPAA—protecting a person's
health information from abuse—is laudable, but it comes at a cost: it will deny investigators
the benefit of access to chart (medical record) review in order to gather data to answer
clinical questions. In the past, investigators were allowed access to patient's charts
because the hospital consent form included a clause indicating that the patient's information
may be used for research.

The investigators propose to overcome this crisis and challenge with a proven method of
identifying individuals who would be willing to consider participating in a clinical trial:
The Women's Guild Health Research Registry. In keeping with the focus of the Women's Health
Program, we would propose to enroll only women. The registry will allow qualified
investigators to identify potential study participants. This idea has been effective at
improving the quantity and quality of women able and willing to participate in trials.

The investigators will also allow other approved sites to utilize the Registry via the
approved procedure of submitting an IRB approved protocol which will be reviewed by our
Internal Review Committee. This protocol's inclusion/exclusion criteria will be used to query
the database for eligible participants. The participants will be contacted by the Registry
staff to ascertain their interest in this research protocol and their agreement to release
their contact data to the investigator will be obtained.

Investigators will be charged at the time they approach the registry for assistance. The
charge is intended to cover the cost of maintaining the registry now that initial funding has
been exhausted.