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Informed Consent in Research with Special Populations

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  • 0:06 Informed Consent Defined
  • 1:43 Child Participants
  • 3:00 Pregnant Women
  • 4:12 Adults with Impairments
  • 5:33 Inmates
  • 6:36 Summary
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Lesson Transcript
Instructor: Devin Kowalczyk

Devin has taught psychology and has a master's degree in clinical forensic psychology. He is working on his PhD.

There are people who need a little bit of extra protection because they are in a vulnerable state. These are people who need additional information because they are at some risk or because they cannot make decisions on their own. We will explore some of these special populations.

Informed Consent Defined

In the context of psychological research, informed consent provides participants with sufficiently detailed information on the study, so they can make an informed, voluntary and rational decision to participate. Since we will be looking at informed consent from a researcher's perspective, when I use the term 'informed consent,' I am referring to the physical form the participant would sign, as well as the information you as the researcher would give.

So, when participants give informed consent, that means they say they understand the risks and benefits based on your informed consent form and additional information. The form includes:

  • The purpose of the study
  • Expected duration
  • Procedures of the study
  • Information on their right to decline or withdraw
  • Foreseeable consequences of withdrawing or declining
  • Potential risk, discomfort or adverse effects
  • Prospective research benefits
  • Incentives, such as payments or rewards and
  • Whom to contact for questions

However, there are populations where this is not enough. Four of the most common populations where additional measures are required are children, pregnant women, adults with impairments and incarcerated individuals. Prior to contact with any of these special populations, a researcher must have his or her informed consent form approved by an Institutional Review Board. This is a group of researchers in an institution who review studies and consent forms before they are implemented to ensure protection of the rights and dignities of participants.

Children

Legally, a child is anyone under the age of 18, making them unable to give consent to be part of a study. However, there are ways to secure consent and to get the child to participate. Since a child is unable to give consent, the researcher has to obtain consent through the person who can give consent. This would be the parent or guardian providing parental permission. Obviously, a younger child cannot fully understand what they would be signing up for, and so it is the job of the parent to understand the risks of enrollment.

If a child is capable of understanding some of the experiment, it is often expected that the researcher will obtain assent, or a child's agreement to participate. Whether researchers are to obtain assent or not is up to the Institutional Review Board at the time of approval for the study. Typically, a child at least seven years old will be asked to provide assent to participate.

There is always the possibility that your study may involve an emancipated minor. This is decided by state law, with some states allowing an emancipated minor to make decisions as an adult. However, before a researcher begins his or her research, it is the duty of the Institutional Review Board to thoroughly examine the cost and risk of an emancipated minor's involvement.

Pregnant Women

The Office of Human Research Protection, a government department that created guidelines to ensure the rights, welfare and well-being of participants in research are protected, provides additional protection for pregnant women. You can think of it as a much bigger, government-sponsored Institutional Review Board.

Providing informed consent to a pregnant woman involves explaining in detail any possible risks that may come to the fetus by participating in the experiment. This includes information of prior research involving animal models and non-pregnant women. To perform experiments on a mother, a researcher must obtain legally effective informed consent, where both parents are required to consent when it involves the fetus, unless one is unable to provide consent. Studies focused on only the pregnant mother and not the fetus can provide consent without the father.

If a researcher comes into contact with a pregnant juvenile, the informed consent rules that apply to both pregnant women and children come into play, similar to an unemancipated minor. Basically, the protection of the children and fetuses are of the highest priority of the ethical code, laws and government departments.

Adults with Impairments

When we talk about adults with impairments, we are talking about individuals with cognitive and decision-making impairments. Decisionally impaired individuals are adults with diminished ability to make sound judgments due to flaws in their reasoning from psychiatric, organic, developmental or other disorders of a cognitive or emotional nature. Most often, these people have a caretaker, whether family or professional, who provides them with help. These caretakers can have a legal guardianship, meaning they are capable of making decisions for the impaired individual.

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