Informed Consent Overview - Module 2m Sec 2

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Module 2 Objectives
Introduction
Selecting Participants
Describing Research
Discussing Participation
Ensuring Readability
Assessing Understanding
Quiz


Selecting Participants

R
ecruitment 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.


Doctor-Patient

D
octor-patient relationships between the investigator and participants should be avoided, when possible, to eliminate any power-based coercion. Patients can say no to someone they do not expect to see in the future, but it is very difficult for people to say no when they rely on someone for ongoing medical 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.


Teacher-Student

S
pecial consideration of recruitment is also needed for instances when an instructor wants to include his or her students in a research study. The teacher cannot assume everyone in the class wants to be involved in the study. Students must be assured that their grade is not affected by their participation, and they should be able to decline participation without penalty.

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.


Employees as participants

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olleagues, subordinates, or peers should never be placed in a compromising situation with perceived retribution for not being a research participant. Recruiting through advertisements or a third party is a better strategy for avoiding coercion.


Proxy

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hen a participant is not of legal age or is deemed incompetent to consent to treatment, it is necessary for a proxy (family member, guardian, or friend) to decide consent.

Children
In justifying using children in your study, you must document the specific benefits the child will encounter. A parent or guardian must act as the proxy for the child and complete a parental permission form. Children also need to give their "assent." Assent is the affirmative agreement to participate in the study if the child is able to comprehend aspects of the research. You must develop a separate assent form. Try to tailor the assent document to the understanding of the child. Reasonable descriptions of discomfort should be included. Children can not give consent to research that entails risks that surpass the benefits.

Example

Elderly
Participants that have diminished vision or hearing can oftentimes overcome the problems and consent themselves.

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.


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