Research Subjects

Publication Title: 
Psychology, Health & Medicine

The Health Belief Model provides a framework to understand motivators for volunteering for medical research. Motivators can take the form of social and personal benefits. In this systematic review of review articles, we contrast motivators of participation in actual cancer trials to those in actual HIV vaccine trials. We retrieved eight review articles from 2000 to 2012 examining motivators to participation in actual cancer trials.

Author(s): 
Dhalla, Shayesta
Poole, Gary
Publication Title: 
IRB
Author(s): 
Ickovics, Jeannette R.
Epel, Elissa S.
Publication Title: 
The American journal of bioethics: AJOB

The Catholic Church proscribes methods of birth control other than sexual abstinence. Although the U.S. Food and Drug Administration (FDA) recognizes abstinence as an acceptable method of birth control in research studies, some pharmaceutical companies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health care institutions, leading to conflicts among institutional review boards, clinical investigators, and sponsors.

Author(s): 
Casey, Murray Joseph
O'Brien, Richard
Rendell, Marc
Salzman, Todd
Publication Title: 
The Journal of Medicine and Philosophy
Author(s): 
Battin, Margaret P.
Publication Title: 
The Journal of the Louisiana State Medical Society: Official Organ of the Louisiana State Medical Society

Prospective randomized trial is the gold standard in clinical research. Randomized trials tend to reduce and even eliminate investigator and patient bias. A poorly-designed or improperly randomized study involving human subjects that will not or cannot answer a scientific question is by definition unethical. However, a well-designed clinical trial is not inherently ethical. Physicians involved in a randomized trial must make the intellectually honest admission that the best therapy for the individual's disease is not yet known.

Author(s): 
Kardinal, C. G.
Publication Title: 
BMJ (Clinical research ed.)

OBJECTIVE: To investigate whether including a placebo arm in a clinical trial of hormone replacement therapy influenced women's stated willingness to participate. DESIGN: Quasirandomised, interview based study. SETTING: 10 group practices in the Medical Research Council's General Practice Research Framework. PARTICIPANTS: 436 postmenopausal women aged 45-64 who had not had a hysterectomy. MAIN OUTCOME MEASURES: Stated willingness to enter a trial and reasons for the decisions made.

Author(s): 
Welton, A. J.
Vickers, M. R.
Cooper, J. A.
Meade, T. W.
Marteau, T. M.
Publication Title: 
American Journal of Human Genetics

Biomedical researchers often assume that sponsors, subjects, families, and disease-associated advocacy groups contribute to research solely because of altruism. This view fails to capture the diverse interests of many participants in the emerging research enterprise. In the past two decades, patient groups have become increasingly active in the promotion and facilitation of genetics research. Simultaneously, a significant shift of academic biomedical science toward commercialization has occurred, spurred by U.S. federal policy changes.

Author(s): 
Merz, Jon F.
Magnus, David
Cho, Mildred K.
Caplan, Arthur L.
Publication Title: 
Bioethics

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision-making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress.

Author(s): 
Sanchez, S.
Salazar, G.
Tijero, M.
Diaz, S.
Publication Title: 
The Journal of School Health

Retaining school-aged study participants poses a major challenge in any longitudinal research study. Dropouts produce bias in the remaining sample and this loss may affect study findings and their interpretation. Dominant factors that influence retention in pediatric research studies include family versus individual participation, patient management strategies of study personnel, knowledge about the condition or therapy, age and gender factors, credibility within the community, monetary incentives, and altruism.

Author(s): 
Frank, Gail C.
Nader, Philip R.
Zive, Michelle Murphy
Broyles, Shelia L.
Brennan, Jesse J.
Publication Title: 
New Genetics and Society

This article considers how we should frame the ethical issues raised by current proposals for large-scale genebanks with on-going links to medical and lifestyle data, such as the Wellcome Trust and Medical Research Council's 'UK Biobank'. As recent scandals such as Alder Hey have emphasised, there are complex issues concerning the informed consent of donors that need to be carefully considered.

Author(s): 
Williams, Garrath
Schroeder, Doris

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