One of your authors was once involved in a research study where a newly developed pain drug was being tested. All participants completed a series of tasks intended to represent various types of somatic pain (e.g., a sharp, fast pain, a dull ache, etc.), and were asked to report how much pain they experienced during each task. The pain series was completed both during an initial visit to the lab, and during a second visit about a week later. Prior to completing the tasks during the second visit, participants received either the new pain drug, or a placebo. What primary ethical guidelines apply to this experiment? Would any other guidelines apply if the study participants were made up of a group of patients actively receiving treatment for a pain disorder?
The primary ethical guidelines that apply to this experiment include;
ii) to evaluate the potential for undesirable physical or psychological effects occurring during the research,
iii) to decide whether the proposed research should be the subject of regular review.
(iv) the committee should be appropriately constituted and normally should include scientists, health care practitioners and lay members.
Other guidelines apply if the study participants were made up of a group of patients actively receiving treatment for a pain disorder because;
a. Healthy subjects and patients must be able to decline, or to terminate, participation at any stage without risk or penalty whatsoever.
b. In any pain research, stimuli should never exceed a subject's tolerance limit and subjects should be able to escape or terminate a painful stimulus at will.
c. Potential participants should be informed fully about the goals, procedures and risks of the study before giving their consent.
d. Written consent must be obtained to indicate that the subject understands the nature and purpose of the proposed study, has had the opportunity to ask questions and agrees to participate on a voluntary basis.
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