Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent
Study Details
Study Description
Brief Summary
This protocol seeks to better understand the various factors which influence an HIV infected individual's decision to participate in clinical research, and especially how the offer of payment influences the decision to participate and understanding of the risks, benefits and purpose of the research. Subjects will be HIV infected individuals participating in or being screened for participation in intramural HIV studies being conducted by the NIAID, CCMD, and NCI. Willing subjects will be recruited from studies that offer payment and comparable studies that do not pay. The primary methodology is an interview via a survey schedule. Use of the interview schedule will be preceded by a focus group of about 7-10 individuals and pretesting of the survey instrument. Paid and unpaid subjects will be compared with respect to motivations, understanding, willingness to withdraw, and sociodemographics.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This protocol seeks to better understand the various factors which influence an HIV infected individual's decision to participate in clinical research, and especially how the offer of payment influences the decision to participate and understanding of the risks, benefits and purpose of the research. Subjects will be HIV infected individuals participating in or being screened for participation in intramural HIV studies being conducted by the NIAID, CCMD, and NCI. Willing subjects will be recruited from studies that offer payment and comparable studies that do not pay. The primary methodology is an interview via a survey schedule. Use of the interview schedule will be preceded by a focus group of about 7-10 individuals and pretesting of the survey instrument. Paid and unpaid subjects will be compared with respect to motivations, understanding, willingness to withdraw, and sociodemographics.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Those HIV seropositive subjects participating in or being screened for participation in selected NIAID or NCI intramural HIV studies will be eligible for participation in this study.
Eligible subjects are those willing and able to provide their own informed consent.
No subjects that are unable to speak English or are unable or unwilling to communicate with investigators for any reason.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Warren G. Magnuson Clinical Center (CC) | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Institutes of Health Clinical Center (CC)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Ayd FJ Jr, Calabresi P. Motivations and rewards for volunteering to be an experimental subject. Clin Pharmacol Ther. 1972 Sep-Oct;13(5):771-81.
- Bigorra J, Baños JE. Weight of financial reward in the decision by medical students and experienced healthy volunteers to participate in clinical trials. Eur J Clin Pharmacol. 1990;38(5):443-6.
- Ross MW, Jeffords K, Gold J. Reasons for entry into and understanding of HIV/AIDS clinical trials: a preliminary study. AIDS Care. 1994;6(1):77-82.
- 980131
- 98-CC-0131