Recruitment of participants needs to be done in a nonbiased, non-power-based manner. It is important that none of the participants ever feel that if they do not participate in the study, they will be penalized. Convenience should not be the sole factor in the selection of participants. All avenues of recruiting participants should be investigated. The following relationships can be potentially troublesome for informed consent and have important points to be considered for ongoing care.
Participants often depend on physicians to make treatment recommendations, and then they defer to the physician's professional knowledge and judgement. They may not read the consent document fully because the physician has already explained the procedure orally, and they consider the doctor the primary source for information.
There is a need to clearly distinguish the treatment from the research involvement and to exercise caution that the physician's influence does not dictate the subject's consent decision.
Researchers may fail to identify the need for informed consent if the study is not perceived to have physical or psychological risks. Students may not see it this way. Participants, including students, have the right to refuse involvement in a research project even if there is no identified risk.
If the person is deemed to be incompetent, such as in the case of Alzheimer's disease or other brain diseases, the investigator must seek the consent of a proxy. The proxy may not know the wishes of the participant regarding research studies but should try to decide in the way the person would have decided. Investigators should ask proxies if they think that participants would have decided in the same manner if they were competent.
In either case, a proxy should discuss the decision with family members and/or the medical staff caring for the person. Even if the participant has been judged incompetent, the person should be considered competent to refuse.