Studying benefit in gene transfer research

IRB Ethics and Human Research

Volumn 23, Issue 2, 2001, Pages 13-15

  Henderson, Gail E ^a,b   King, Nancy M P ^a  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; EMPIRICAL APPROACH; EMPIRICAL RESEARCH; ETHICS; GENE THERAPY; GENETICS AND REPRODUCTION; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; METHODOLOGY; RISK ASSESSMENT;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH; GENETICS AND REPRODUCTION;

CLINICAL TRIALS; CONSENT FORMS; DATA COLLECTION; EMPIRICAL RESEARCH; GENE THERAPY; HUMANS; INFORMED CONSENT; RISK ASSESSMENT;

EID: 0038344094     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3563781     Document Type: Article

References (7)

1. King NMP. Rewriting the "Points to consider": The ethical impact of guidance document language. Human Gene Therapy 1999; 10:133-9.
2. Churchill LR, Collins ML, King NMP, Pemberton S, and Wailoo K. Genetic research as therapy: Implications of "gene therapy" for informed consent. J Law Med Ethics. 1998; 26:38-47.
3. The social construction of benefit in gene transfer research. NHGRJ #1 RO1 HG 02087-01. We assembled a research team with a range of disciplines, training, and expertise (sociology, law, philosophy, research oversight, medicine, and nursing): Larry Churchill, Ph.D., Arlene Davis, J.D., R.N., Daniel Nelson, M.S., Michael Galloway, Ph-D., and Benjamin Wilfond, M.D.
4. King NMP. Defining and Describing Benefit Appropriately in Clinical Trials, J Law Med Ethics 28; 332-343 (2001).
5. We plan to examine responses to Appendix M of the NIH Guidelines for Research involving Recombinant DNA whenever possible, rather than complete research protocols. Appendix M is a series of questions asked of investigators, the answers to which usually summarize each protocol effectively.
6. Daugherty CK, Ratain MJ, Grochowski E, Stocking C, Kodish E, et al. Perceptions of cancer patients and their physicians involved in phase I trails. Journal of Clinical Oncology 1995; 13: 1061-1071.
7. As we submitted our project to the IRB review process at UNC and NIH, and began recruiting survey subjects, a number of challenging ethical issues have arisen. Many of us are experienced IRB members and administrators, and being on the other side of the table has been an enlightening exercise.