Research Participants' Views on the Ethics of Clinical Research

NCT00457041 | Completed

• 2 other identifiers: 99990707307-CC-N073
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will explore the usefulness of a series of questions asking about views of research from the perspective of minority and economically disadvantaged research participants. Racial and ethnic minorities are consistently under-represented in clinical research. This under-representation has been attributed primarily to an unwillingness to participate in research because of mistrust in the research establishment, especially in light of widely known historical examples of abuse. However, more recent data suggests that not being invited to participate in research, or stringent entry criteria, may contribute substantially to the low numbers of ethnic minority research participants. The perspectives of racial and ethnic minorities who are knowledgeable about or participating in research are important to understanding the kinds of vulnerabilities that exist and any important barriers to participation. People 18 years of age and older from the Cardozo clinic in Washington, D.C., who are enrolled in the National Institute of Arthritis and Metabolic Studies' natural history study are eligible to participate in this protocol. Participants are interviewed with questions about their own experiences in clinical research as well as some hypothetical research studies. Questions include participants' general views of clinical research, perceived risks and benefits of research, alternatives to research participation, the limits of what they would be willing to accept in research and types of research or research procedures they might perceive as unfair.

Conditions

Rheumatic Diseases

Keywords

Trust; Decision Making; Vulnerability; Survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years and older) from Cardozo clinic who are enrolled in the NIAMS natural history study will be invited to participate in this interview study. The sample will include men and women who are primarily African American and Hispanic. Participants will be eligible if they are able and willing to give informed consent and can participate in an interview in English or Spanish.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

NIAMS Community Health Center

Washington D.C., District of Columbia, 20009, United States

Location

Related Publications (3)

• Shavers VL, Lynch CF, Burmeister LF. Factors that influence African-Americans' willingness to participate in medical research studies. Cancer. 2001 Jan 1;91(1 Suppl):233-6. doi: 10.1002/1097-0142(20010101)91:1+3.0.co;2-8.

  PMID: 11148585 BACKGROUND

• Wendler D, Kington R, Madans J, Van Wye G, Christ-Schmidt H, Pratt LA, Brawley OW, Gross CP, Emanuel E. Are racial and ethnic minorities less willing to participate in health research? PLoS Med. 2006 Feb;3(2):e19. doi: 10.1371/journal.pmed.0030019. Epub 2005 Dec 6.

  PMID: 16318411 BACKGROUND

• Gross CP, Filardo G, Mayne ST, Krumholz HM. The impact of socioeconomic status and race on trial participation for older women with breast cancer. Cancer. 2005 Feb 1;103(3):483-91. doi: 10.1002/cncr.20792.

  PMID: 15597407 BACKGROUND

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 5, 2007
• Study Start: January 17, 2007
• Study Completion: September 8, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-09-08

Locations

US (1)