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

o 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.


utonomy 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 participate.

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?



eneficence 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 coercion.

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.

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