The methods used to obtain consent may vary. They should be designed to fit the nature of the research, the nature and magnitude of the risks involved, the research setting, the nature of the subjects who will participate and the requirements of applicable policies, laws and regulations. If appropriate justification is given, a verbal or passive consent process may be approved by the HSRB.
In order to obtain informed consent, Federal regulations require that certain information must be provided to each subject:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
When appropriate, one or more of the following elements of information shall also be provided to each subject:
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
- Any additional costs to the subject that may result from participation in the research;
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
- The approximate number of subjects involved in the study.
The HSRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the HSRB finds and documents that:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
According to the Belmont Report, "Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied." As stated in University Policy #2060, "no investigator may involve a human being as a subject in research unless the investigator has obtained informed consent of the subject or the subject's legally authorized representative." The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.
Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. In addition, Title 45 Code of Federal Regulations, Part 46 requires "the information that is given to the subject or their representative shall be in language that is understandable to them."
Assent of children and the consent of their parents
Children must provide assent to participation when, in the judgment of the HSRB the children are capable of providing assent.
- Children are defined in the U.S. Department of Health and Human Services regulations 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(a).
- Assent is defined as the voluntary "affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent" 45 CFR 46.402(b).
In determining whether children are capable of assenting, the HSRB will take into account the age, maturity, and psychological state(s) of the children, either individually or as a group. Children under age 8 may give assent verbally or, in cases involving infants or very young children, by the act of participating. Children who can read (typically those 8-18 years old) should provide assent by signing a written form unless HSRB approves a different process.
In addition to the assent of the children, regulations require legally effective informed consent from the parent(s) (the child's biological or adoptive parent) or the legally appointed guardian (authorized under applicable State or local law to consent on behalf of a child) of all children who are participants in research. The consent of just one parent or guardian is allowed if the research presents no greater than minimal risks or if it holds out the prospect of providing direct benefits to the child. If the research presents greater than minimal risks and no prospect of direct benefit to the individual child, the consent of both parents or guardians is required, unless one parent or guardian is deceased, unknown, not legally competent, not a legal custodian or not reasonably available.
Informed consent in ethnographic or field research
Fieldwork and ethnographic research typically involve observation of and interaction with groups of subjects in their own environment, often over long periods of time. It may not be possible to specify in an informed consent statement the detailed contents of the research, as it is often an emerging process. In addition, differences in language and culture may preclude the use of a written or formal consent agreement. If appropriate justification is given, the HSRB may waive the requirement for formal, written consent in these cases. The American Sociological Association and the American Anthropological Association have developed guidelines that address ethical issues in field and ethnographic research, including informed consent. Investigators conducting this type of research may wish to consult their discipline's professional society or accepted practice for similar guidelines when designing a protocol for research involving human subjects.