Informed Consent Overview - Module 2m Sec 2


Module 2 Objectives

Selecting Participants
Describing Research
Discussing Participation
Ensuring Readability
Assessing Understanding

Selecting Participants

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.


Doctor-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.


Special 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

Employees as participants

Colleagues, 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.


When 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.


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.



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

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