 Medicine
at Michigan The Women’s Health Registry — a database
that’s unique to U-M — is a list of women who’ve
volunteered themselves as potential research subjects. The idea
grew from the results of a survey that U-M investigators used
to identify obstacles that stood in the way of women’s
health research. Two prominent responses were clear. One: People
needed more funding. Two: It was hard to find female subjects
who fit the studies and would commit themselves to participate
from beginning to end.
In response to the funding problem, the Women’s Health
Program centralized information that’s helpful to investigators,
creating a clearinghouse for funding announcements. Previously,
it was only by chance that researchers got the right announcement
at the right time.
The answer to the second problem — finding appropriate
female subjects who were willing to participate and stay to
the end — took a bit more creativity.
It was obvious that women in the community were interested
in participating: of the 6,000 calls that the Women’s Health
Program gets each year, about 10 percent are women looking for
research studies to participate in. The Program also tried one
week of local advertising — on radio and in print media
— and more than 600 women enrolled in what became known
formally as the Women’s Health Registry. Since that first
effort, the number of women in the Registry has grown to more
than 900, about 800 of whom live within a hundred miles of U-M.
And because of the Registry’s presence on the Web, there
are volunteers from as far away as Israel and Norway. Eleven
investigators have applied to use it in its pilot phase, and
four have already enrolled women to participate in their studies.
How the Registry Works
The Women’s Health Registry is a collaborative effort
of the U-M Center of Excellence in Women’s Health and the
Center for Clinical Investigation and Therapuetics, a Medical
School initiative. Together the team has devised a system to
qualify, sort and link volunteers and investigators in the Registry
database.
The potential subject simply fills out a form that asks for
demographic information and health history. The number of women
interested in volunteering — and the fact that enrollment
is free — has produced a registry that houses a huge database
of women with highly diverse characteristics.
Investigators are required to apply, and a committee reviews
applications closely. Researchers have to prove that they have
funding to complete their studies, then they must provide inclusion-exclusion
criteria that the Registry team can use to search the database.
When a woman matches the criteria necessary for entering an
investigation, the Registry team sends a letter saying she has
qualified for the study. The letter also contains a one-paragraph
description on which the woman must base her decision to be
contacted or not. The woman has 10 days to contact the Registry
if she wishes not to be contacted regarding this study. If the
woman decides to participate, the Registry releases her name
to the investigator.
At that point, the Registry withdraws from the process –
it becomes the investigator’s responsibility to do additional
screening and enrollment. But the investigator has to report
every two weeks to tell the Registry who has enrolled and who
hasn’t, because if someone chooses not to enroll, she goes
right back into the pool. If a woman does enroll, then she’s
out of the pool until that study is finished — a woman
in the Registry can participate in only one study at a time.
Juliet Rogers points out that investigators can’t use
information from the Registry as a random sample, because it
isn’t. “The point of it,” she says, “is
to help investigators find a proportion of their sample population.”
Privacy, of course, is a huge issue. Those who oversee the
Women’s Health Registry take every precaution to meet —
and sometimes surpass — the legal requirements for protecting
each person’s privacy.
For more information about the Registry, call toll-free
at 1-877-220-0694 or visit the Registry Web site at
http://www.womenshealthregistry.org
Also:
Bitter Pills The Long Struggle To Achieve
Equality In Women's Healthcare
Ten Ways Gender Differences Can Affect
Health
The Women’s Health Program: Making
A Differences Through Education and Information
Lydia Pinkham had company in pioneering
improvements in women’s health
The Women’s Health Registry
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