Research Participants' Views on the Ethics of Clinical Research

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00457041
First received: April 4, 2007
Last updated: September 9, 2010
Last verified: September 2010
  Purpose

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.


Condition
Rheumatic Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study Investigating Research Participants' Views on the Ethics of Clinical Research

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 11
Study Start Date: January 2007
Estimated Study Completion Date: September 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457041

Locations
United States, District of Columbia
NIAMS Community Health Center
Washington, District of Columbia, United States, 20009
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00457041     History of Changes
Other Study ID Numbers: 999907073, 07-CC-N073
Study First Received: April 4, 2007
Last Updated: September 9, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Trust
Decision Making
Vulnerability
Survey

Additional relevant MeSH terms:
Rheumatic Diseases
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 21, 2014