Women's Health Research Registry

NCT00574314 | Terminated

• 2 other identifiers: IRB# 42694269
• Study Type: observational
• Target: 839
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

women; Registry

Study Arms (1)

Women

Women with varying backgrounds

Other: No Intervention

Interventions

No Intervention OTHER

Participants will be consented.

Women

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult English-speaking women

You may qualify if:

• Adult women
• English speaking

You may not qualify if:

• We do not include children.
• We do not include non-English speaking subjects at this time.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

Location

Study Officials

• C. Noel Bairey Merz, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 17, 2007
• Study Start: July 1, 2004
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)