It's now easier to be inclusive

Complying with a federal mandate to include women and minorities in clinical research is easier, thanks to an expanded array of grant-preparation resources available to center investigators.

An enhanced Grant and Contract Administration site on the Internet directs scientists to helpful links and to Fred Hutchinson staff who can provide assistance to those whose research is affected by the federal guidelines.

Requirements for inclusion of women and minorities in clinical trials were set in the 1993 National Institutes of Health (NIH) Revitalization Act, which aimed to balance research burdens and benefits among different populations.

But the final deadline for compliance with the act was not until Jan.1 of this year, a date that caught some investigators by surprise, said Bre Jefferson, manager of administration and operations for Grant and Contract Administration.

"We've had a few investigators whose NIH grants were returned to them because of insufficient information related to the inclusion of women and minorities," she said.

Additional information

"That's why we have included additional information on our Web site and have been working with the scientific divisions to ensure that affected investigators have the information and resources they need to complete their grant applications."

The regulations affect research studies that involve human subjects in which an investigator has direct contact with the participants or patients. Examples of such research include therapeutic interventions, clinical trials, epidemiologic and behavioral studies and health-outcomes research.

Studies exempt from the law include those involving human-tissue samples that cannot be linked to living individuals.

Investigators whose research studies are affected are required to submit documentation with their grants that details:

• Participant selection criteria and rationale
• Rationale for exclusion of any populations
• Enrollment dates
• Outreach plans for recruitment
• Proposed study composition using appropriate National Institutes of Health forms

Researchers may not claim cost as a reason for exclusion of an underrepresented group.

Incomplete grant applications will be returned to investigators prior to scientific review. Typically, an investigator is given four to five days to address deficiencies. Inclusion plans deemed unacceptable during the peer-review process will be reflected in priority scores.

Since the inclusion guidelines were established in 1993, the federal government has since revised its standards and forms for reporting race and ethnicity data.

Two data forms

The change has caused confusion among investigators, who must choose between two inclusion-data forms when preparing grant applications, Jefferson said.

"Our Web site now has information that will help investigators select the appropriate forms for their studies," she said.

Jefferson emphasized that grants subject to inclusion requirements must contain descriptions of outreach efforts to recruit and retain women and minorities. The Grant and Contract Administration site houses links to helpful center and NIH outreach resources.



'Which form should I use for reporting inclusion data on women and minorities?'

Investigators must choose one of two forms for reporting inclusion of women and minorities in their research studies.

The newer form (known as the 5/01 table) includes two ethnic categories (Hispanic or Latino and not Hispanic or Latino) and five racial categories (American Indian or Alaska native, Asian, black or African American, native Hawaiian or other Pacific Islander and white).

An older form (the 4/98 table) does not distinguish between ethnic and racial categories. So, which form should you use?

• New grant proposals or competing continuation proposals involving collection of new or added data must use the 5/01 table.
• New proposals or competing continuation proposals with no plans to collect new or additional data may use either the 5/01 or 4/98 table. Investigators should choose the form that best fits their data.
• Non-competing applications (progress reports) for grants that began before fiscal year 2002 may use the 5/01 or 4/98 table. Investigators should choose the form that best fits with their data.

Internet abounds with resources to include women and minorities in studies

The address for the Grant and Contract Administration Web site, with links to center and NIH resources for inclusion of women and minorities in research studies, is centernet.fhcrc.org/CN/science/minority_portal. The site was created with help from Internet Services and External Relations and Communications. Information on the site includes:

• U.S. census and demographic data.
• Statement describing the center's commitment to inclusion of women and minorities in research.
• Cancer and disease statistics by gender, race and ethnicity.
• Examples of successful outreach efforts by center investigators.
• Center specialists available to assist with outreach efforts.
• Links to relevant NIH sites.

Visit the NIH's "Inclusion of Women and Minorities as Participants in Research Involving Human Subjects - Policy Implementation" page at http://grants2.nih.gov/grants/funding/women_min/women_min.htm.

Want more help?

• Grants and Contracts Administration (206-667-4868, gmail@fhcrc.org) can assist investigators with questions regarding NIH grant application forms. The address for the Grant and Contract Administration Web site, with links to center and NIH resources for inclusion of women and minorities in research studies, is centernet.fhcrc.org/CN/science/minority_portal. The site was created with help from Library and Internet Services and the External Relations and Communications departments.
• Winona Hollins-Hauge (206-667-1246, whauge@fhcrc.org), community outreach manager, supports recruitment efforts, from referrals to community leaders to assistance in accessing underrepresented populations through participation in health fairs.
• Dr. George Counts (206-667-7452, gcounts@fhcrc.org), senior adviser on special populations for the HIV Vaccine Trials Network, serves as informal adviser to the center as it expands efforts to increase minority participation and will consult with division representatives to field scientific questions related to minority recruitment on clinical studies.
• Scientific division point persons: Marcea Kato, Basic Sciences Division (206-667-2577, mkato@fhcrc.org); Elizabeth Egan, Clinical Research Division (206-667-5229, eegan@fhcrc.org); Dr. Brian Reid, Human Biology Division (206-667-6792, bjr@fhcrc.org); Rosemarie Keenan, Public Health Sciences Division (206-667-4267, rkeenan@fhcrc.org).