Research Participants' Views on the Ethics of Clinical Research

Pilot Study Investigating Research Participants' Views on the Ethics of Clinical Research

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.

Study Overview

• Status: Completed
• Conditions: Rheumatic Diseases

Detailed Description

In an effort to better understand ethical concerns about clinical research, this pilot study aims to explore the utility of a series of questions asking about views of research from the perspective of minority and economically disadvantaged research participants. Cognitive interviews will be conducted in English and Spanish with 10 participants of the NIAMS CHC at the Upper Cardozo Clinic in Washington DC. The interviewer will ask participants about their own experiences as well as some hypothetical research studies. Questionnaires will ask participants about their general views of the clinical research, perceived risks and benefits of research, alternatives to 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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20009
      • NIAMS Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• INCLUSION CRITERIA:

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.

Study Plan

How is the study designed?

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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. Erratum In: Cancer 2001 Mar 15;91(6):1187.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 17, 2007
• Study Completion: September 8, 2010

Study Registration Dates

• First Submitted: April 4, 2007
• First Submitted That Met QC Criteria: April 4, 2007
• First Posted (ESTIMATE): April 5, 2007

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: September 8, 2010

More Information

Terms related to this study

• Keywords: Decision Making; Survey; Vulnerability; Trust
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: 999907073; 07-CC-N073