When most people hear the phrase “Informed Consent,” they think of the legal document that explains the study and contains the required dated signatures. However, informed consent is first and foremost a continuing process. This includes a person voluntarily agreeing to participate in a research study after being fully informed about it via verbal discussion with study staff, followed by documentation in a written, signed, and dated informed consent form. A participant’s consent will be continually sought during the course of the study, and the participant will be notified of any changes to the study, along with any other pertinent information that may influence their decision to remain in the study.
The participant must sign and date the informed consent document before taking part in any study procedures. Signing the consent form is NOT the final step in the informed consent process. The participant may withdraw consent and decline to participate in the study at any time before or after signing the consent document until their participation in the study is completed. The general requirements for informed consent in federally funded research are spelled out in 45 CFR 46.116 and 21 CFR 50.20. All researchers must ensure that the process of obtaining informed consent from study participants not only conforms to federal, state, and local regulations but also respects each individual’s right to make a voluntary, informed decision.
The consent document should include the following:
- State that the study involves research.
- Briefly explain the purpose of the research, the reason(s) why the person is being invited to participate, and the expected duration of the person’s participation in the study.
- Describe the procedures or interventions to be carried out, identifying which procedures are investigational and which might be provided as standard care in another setting.
- Explain the use of research methods such as randomization and placebo controls.
- Describe any foreseeable risks or discomforts to the participant. Estimate how likely it is that these risks and discomforts will occur.
- Describe the steps that will be taken to prevent or minimize risks or discomforts to the participant.
- Describe the steps that will be taken to prevent or minimize risks or discomforts to the participant.
- Describe any benefits to the participant or to others that the research may reasonably be expected to produce. Estimate how likely it is that these benefits will occur.
- Disclose any appropriate alternative procedures or courses of treatment that may benefit the participant.
- Describe the extent to which records will be kept confidential and provide examples of people or organizations that may have access to research records (e.g., hospital personnel, study sponsors, staff of the U.S. Food and Drug Administration).
- For research that involves more than minimal risk, explain and describe any compensation and any medical treatments that are available if participants are injured as a result of participation in the study, where further information can be obtained, and who should be contacted in the event of a research-related injury.
- Explain who should be contacted for answers to questions about the research and the participant’s rights (including the name and phone number of the principal investigator).
- State that participation in the study is voluntary and that declining to participate or deciding to withdraw at any time will involve no penalty or loss of benefits to which the participant is otherwise entitled
- State that the participant’s signature will indicate that he or she has decided to participate in the study, having read and discussed the information presented to him or her about the research.
- Provide any other information that prospective participants might need to make an informed decision about whether or not to participate in the research study.
SPECIAL REQUIREMENTS CONCERNING THE CONSENT OF PREGNANT WOMEN
When a research activity involves pregnant women as participants:
- Both mother and father must be informed about any potential impact of the research on the fetus.
- Both mother and father must consent to the woman’s participation in the research.
However, the father’s consent is not required in the following circumstances:
- The purpose of the research is to meet the health needs of the mother.
- The father’s identity or whereabouts cannot be determined.
- The father is not reasonably available.
- The pregnancy resulted from rape.
If either parent is unable to consent because of availability, incompetence, or temporary incapacity, the informed consent of one parent will suffice provided the criteria in the previous bullet points are not met.
Consent of a legally acceptable representative of either or both parents does not suffice for informed consent. Additional protections for pregnant women involved as participants in research are set forth in 45 CFR 46 Subpart B.
SPECIAL REQUIREMENTS CONCERNING THE CONSENT OF CHILDREN
The CFR defines
Children as: “…persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” (45 CFR 46.402). The legal age for consent in most states is 18; persons under age 18 are considered minors. Additional protections for children and minors involved as participants in research are set forth in 45 CFR 46 Subpart D.
When children or minors are involved in research, both the assent of the child or minor and the permission of his or her parent(s) are usually required.
Permission means the agreement of parent(s) or a legal guardian to the participation of their child or ward in research.
Assent means a child’s agreement to participate in research. Failure to object is not assent.
In most cases, both parents must give their permission for their child or minor’s participation in research. However, exceptions to this requirement are permitted in certain circumstances. An exception is also permitted in the case of an emancipated minor.
Although children may be legally incapable of giving informed consent, they may nevertheless be able to assent to or dissent from participation in research. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if:
The research does not involve interventions that are likely to benefit the participants, and the child can understand what it means to be a volunteer for the benefit of others.
A child’s assent should be sought when the child is capable of providing such assent, taking into account his or her age, maturity, and psychological state. The age that a child needs to attain to give assent varies from state to state. In certain circumstances, the IRB may determine that research can proceed without the assent of the children involved.
CONCLUSION
Informed consent is a process by which a person voluntarily agrees to participate in a research study after being fully informed about it.
The informed consent document should contain all of the information that the participant needs to make an informed decision about participating in the study.
The participant’s signature on the informed consent document confirms his or her voluntary agreement to take part in the study.
The general requirements for informed consent in federally funded research are spelled out in 45 CFR 46.116 and 21 CFR 50.20.
Some states have enacted requirements for informed consent that go beyond federal regulations.
All researchers have a responsibility to ensure that the process of obtaining informed consent or assent from study participants not only conforms to federal, state, and local regulations but also respects each individual’s right to make an informed decision voluntarily.
The first step in the process of informed consent is preparing the consent document and supporting documents for presentation to the Institutional Review Board that must review and approve the study and consent document.
The IRB must review and approve the consent document before the study can begin.
Consent documents should be written in non-technical language that the proposed participants would understand. The language should be consistent with the proposed participants’ educational level, cultural views, and familiarity with research.
The information that must be provided in an informed consent document is specified in 45 CFR 46.116, 21 CFR 50.20, and ICH GCP 4.8.10.
The legal age for consent in most states is 18; persons under age 18 are considered minors. Additional protections for children involved as participants in research are set forth in 45 CFR 46 Subpart D.
In most cases, both parents must provide permission and the child himself or herself must assent to the child’s participation in research.
If a person is unable to provide informed consent, a legal representative may give permission for the individual to participate in research in some circumstances. Only one person gives consent. If the participant is capable and is not court ordered legally incompetent, then he or she should sign.
If the participant is not capable or is legally incompetent, then the legal representative or guardian should sign.
A child and the parents sign, but minor children assent, parents provide permission, and legal guardians consent.
Participants must not be coerced or unduly influenced. Coercion occurs if an individual perceives that he or she could be harmed or punished for refusing to take part in a study. In some cases, coercion may occur subtly and unintentionally.
The value of an incentive for participation in a study should not be so high that it could be considered an undue influence on an individual’s decision to participate.
It is important to ensure that the process of obtaining informed consent from human participants is carried out carefully and with vigilant attention to every detail.
Failure to comply with general requirements for informed consent (45 CFR 46.116) and documentation of informed consent (45 CFR 46.117) may result in suspension of a study as well as fines and penalties.
