Informed Consent Overview - Module 1m Sec 3


Module 1 Objectives
The Process

Basic Principles
A Brief History
What Research Must Be Reviewed
IRB Review Criteria

Basic Principles

To discern the key components of informed consent, you need to
understand the ethical issues of research involving human subjects. The
principles of autonomy, beneficience, and justice are basic to these
ethical issues and merit your consideration.


Autonomy means that each person should be given the respect, time,
and opportunity necessary to make his or her own decisions. Prospective
participants must be given the information they will need to decide to
enter a study or not to participate. There should not be presure to

The principle of autonomy requires that protection be given to
potentially vulnerable populations such as children, the elderly, the
mentally ill, or prisoners. Individuals in these groups may be incapable
of understanding information that would enable them to make an informed
decision about study participation. They are considered
potentially "vulnerable." Consequently, careful consideration
of their situation and needs is required and extra care must be taken to
protect them. For example, how will you assess the diminished capacity of
an elderly individual, who will be the guardian, and how and when will you
involve another individual as guardian in the process?



Beneficence obligates the researcher to secure the well-being of
all study participants. It is your responsibility to protect
participants from harm, as well as ensure that they experience the
possible benefits of involvement. Balancing risks and benefits is an
important consideration. The key, according to the 1979 Belmont Report
on the protection of human subjects, is to "maximize possible
benefits and minimize possible harms."

When do the benefits to society outweigh the possible risks of research?
This is an ethical question that researchers face. The peer review
process and the principle of beneficence help you answer this question
and protect your research participant's rights.



he ethical considerations of risks versus benefits raise the
question of justice. Who should bear the risk of a study and who should
receive its benefits? The concept of justice may be questioned when we
attempt to decide who will be given an opportunity to participate and who
(and for what reason) will be excluded. Are some classes or persons being
selected simply because of their availability, their compromised position,
or their manipulability while others are not? Keep the following tips in
mind when selecting prospective participants:

  • Participants should not be selected due to class, socioeconomic
    status, or rece unless justified by study objectives.
  • Women have been underrepresented in certain research studies
    because of the risks associated with child-bearing. Now researchers must
    justify why women are not included in a study population. Failure to
    provide scientifically sound arguments for the exclusion of one gender, is
    grounds for denial.
  • An existing doctor-patient relationship requires consideration of the
    potential for power-based coercion when expanding that relationship to
    include investigator-subject. Provision, or adjustments, might need to be
    made to attempt to equalize the roles.
  • Teacher-student relationships always carry a perception of inequality
    in roles. The informed consent process should reflect the precautions
    taken to balance the relationship and guard against even the perception of

Justice is a difficult and complex ethical issue. However, attempt at all
times in your study to distribute the risks and benefits fairly and
without bias.


Keep the principles of autonomy, beneficence, and justice in mind when
you are selecting participants, obtaining consent, and conducting your
study. The responsibility to protect and inform research participants is
ultimately yours and cannot be ignored or delegated. Although you may
delegate various tasks to certain team members, you cannot delegate the
responsibility of protecting and informing participants of their rights.