Research Participants' Views on the Ethics of Clinical Research

National Institutes of Health Clinical Center (CC)

Status: Completed

Conditions: Rheumatic Diseases

Study type: Observational

Funder types: NIH

Identifiers

NCT00457041

07-CC-N073

999907073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.