Research

The researcher must ensure that the circumstances under which consent is sought will provide the participants (or their representative) with sufficient opportunity to consider whether or not to participate. The circumstances must also minimize the possibility of coercion or undue influence that might be experienced by the participants. Many times the situation of the participants may be inherently coercive. Restriction of freedom of choice may also occur due to confinement in a mental hospital or in a jail, penitentiary, or correctional institution.

Participants in any of these categories are not excluded from research; rather, the researcher must make special efforts to ensure that potential participants are given every opportunity to exercise free choices in consenting to participate in a research project. 

Broadly, the informed consent document communicates to the prospective research participant:

• the purpose, procedures, risks and benefits of the study
• the participant's rights while participating in research
• the freedom to decline to participate without undue influence or any prejudice or penalty

If applicable for research involving more than minimal risk, the available alternative treatments or counseling must be explained. The individual will also be given the opportunity to obtain further information and answers to questions related to the study. The consent form should serve as a written summary of the exact information that was presented to the prospective participants before their agreement to participate in the study. As such, it will provide a useful reference for both the participant and the researcher.

Adults

Written consent is required from people who are at least 18 years old, function normally in society, and who are able to read and understand an Informed Consent Document. The ideas of mental and physical normalcy focus on the ability of the participant to provide truly informed and voluntary consent. Variations from this norm may include disabilities, diseases, or other circumstances of the participant.

Children or minors

There are several requirements for obtaining informed consent to conduct research involving children through age 12, and minors, age 13-17. Special attention must be given to the child's age, his/her ability to understand what is asked of him/her, and his/her relationship to a parent or guardian. In all cases, the researcher must demonstrate respect for the rights of the participant within the proposed consent procedures that should be developmentally appropriate to the age and circumstances of the participant.

Consent of parent or guardian

Permission (informed consent in writing) is required for all children and minors who participate in research, along with the assent of the child or minor. (Exception: when a waiver is granted by the IRB.)

Very young children

For children below school age (e.g., infants, toddlers, and preschoolers) the researcher should give explanations that match the level of understanding. In many instances, the children's nonresistant behavior may be interpreted as assent, but the researcher must use special care to discontinue the participation of children who appear to experience undue stress from the research procedures. A written copy of the proposed script for presenting an explanation and request for participation in the research must be submitted to the IRB as part of the procedure/protocol. (Exception: when a waiver is granted by the IRB.)

Child's assent

In addition to written parent/guardian consent, an elementary school age child should provide agreement to participate. The explanation to the child should contain elements of consent expressed in a form the child can understand. A conversational question-and-answer setting is often necessary to achieve this goal. In addition, the child's assent should be positive, that is, not merely lacking dissent (refusal). If the child is old enough to provide a signature, investigators are required to obtain a signed assent form. A written copy of the proposed script for presenting an explanation and request for participation in the research must be submitted to the IRB as part of the procedure/protocol. (Exception: when a waiver is granted by the IRB.)

Adolescent's (minor's) written assent

For people age 13-17, a written agreement is needed (in addition to written parent/guardian consent). People in this age group usually can read and comprehend a well-constructed assent form. However, the researcher should use supplementary verbal explanations wherever needed. (Exception: when a waiver is granted by the IRB.) Children who are wards of the state and adults with compromised abilities may participate in research only under very limited circumstances with the written consent of a guardian or court-appointed advocate for the duration of the research.

Research category-full board review

When research involves greater than minimal risk, the participant needs a reasonable description of the risks in order to decide whether or not to participate. The list should be constructed so that real risks are neither minimized nor overstated. Projects with risks should also list protection measures used to lower the risk potential or to ensure safety while the participant encounters the risks. If a project presents one or more notable risks, a statement about possible injuries must be included in the informed consent document.

Research category-expedited review

All research in this category requires the use of informed Consent Documents.

Research category-exempt from periodic continuing review
Most projects in this category use informed consent documents, but some research may not. Whenever appropriate, the IRB recommends the use of a cover letter to inform participants. A copy of the cover letter or a written description of verbal instructions, questionnaire, survey outline (written or verbal), and any other documentation must be submitted with an application to the IRB.

Additional measures are required if some or all the participants could be vulnerable to coercion, manipulation, or other unreasonable influence. For example, the following people or situations require additional safeguards:

• research being conducted with Native American people or groups. Additional review by the appropriate tribal entity may be required.
• projects proposing to ask or observe participants concerning their opinions, behaviors, and/or experiences regarding the following high-risk, sensitive topic areas:
• sexual behavior, AIDS or HIV, incest, rape, date rape, sexual molestation, or abuse
• substance use and/or abuse of legal or illegal drugs
• contraception, pregnancy, or abortion
• children up through the age of 12, and minors from age 13 up through 17
• any aspect of a participant's mental health. This includes people who are mentally challenged with acute or severe physical or mental illness, e.g., suicide, depression, and compulsive behaviors such as gambling, smoking, eating disorders or behaviors. Consent is required from all participants. Additional written consent may be required from a patient advocate (a state or county official who monitors the progress of some ill people).
• religious orientation and views
• regarding veterans and/or wartime experiences
• prisoners—sensitivity to privacy and other individual concerns is required;participation will have no effect upon their parole or treatment
• infants, fetuses, pregnant women, and human in vitro fertilization
• the elderly (people who are 65 years of age and older)
• people who are very sick, such as those with a life-threatening illness
• people residing in institutions such as group homes, half-way houses, and nursing homes
• people with economic disadvantages, such as those who are homeless and those receiving public assistance, food stamps, or other aid
• people of minority ethnic or racial backgrounds

Although the regulations specifically mention only certain special categories of participants, the overall intent is clear. The researcher has special responsibilities whenever the potential participants of research have special features or circumstances that might affect their ability to give informed and voluntary consent to participate in research. Since there is no way to anticipate every situation, extreme care must be used to respect and safeguard the rights of potential participants in the process of obtaining informed consent.

When hard copy photos or audio/video/computer data, tapes, storage disks, etc. will not be destroyed or erased at the end of the research project, the Informed Consent Documents must advise the participant of that fact, because his/her identity will be associated with the information provided. 

A waiver may be granted when participants are not at risk and there are protections for anonymity when:

• the research involves no more than minimal risk to the participants and meets the requirements of Exempt from Periodic Continuing Review (IRB Reference Document)
• the omission or alteration of standard informed consent procedures will not affect adversely the rights and welfare of the participants
• the research could not be carried out practicably without the omission or alteration
• the participants will be provided with additional pertinent information after participation

This process is recommended for those projects that are exempt from periodic continuing review, both to preserve anonymity and to eliminate the need for maintaining and storing informed consent forms for three years following completion of the project. The participant must also be given a clear and free choice to accept the invitation to participate or to refuse without prejudice or penalty. If participants are students, patients, or employees of an institution in which research is being conducted, they must be informed that nonparticipation or withdrawal from the study will not affect their grade, treatment, care, or employment status, etc.

A waiver may be granted for research in three situations:

Benefit and service programs

The research's purpose is demonstrating or evaluating:

• federal, state, or local benefit or service programs that are not themselves research programs
• procedures for obtaining benefits or services under these programs
• possible changes in or alternatives to these programs or procedures
• if the research could not be carried out practicably without the waiver

Biased results

A researcher desires to withhold from the participant some information about the project that, if known by the participant, would bias the results of the study. Ordinarily, the researcher will plan a debriefing session after completion of the participant's participation in order to provide the participant with the missing information, and give the participant the options of including his/her data in the study or having it destroyed. In no case should a researcher seek to withhold information about the research or the participant's role solely to reduce the chances of refusal to participate by potential participants.

Sole identity

The IRB determines that:

• the only record linking the participant and the research would be the informed consent document and the principal risk would be the potential harm resulting from a breach of confidentiality
• the research presents no more than minimal risk of harm to participants and involves no procedures for which written informed consent is normally required outside the research context

This type of waiver applies especially to anonymous interviews (including face-to-face and telephone interviews) in which the investigator's sole knowledge of the identity of the interviewee would come from the informed consent document. (Source: 45 CFR 46.117)

A waiver of informed consent procedures does not imply waiver of the researcher's responsibility to obtain consent from the participant. In all cases, the researcher must provide the participant with a statement of the research that includes all relevant elements of informed consent. When an Informed Consent Document is waived and it is practical, participants should be given a cover letter that outlines the purpose and procedures of the project, with a statement such as "completion of the survey and/or return of the questionnaire indicates consent to participate in the study.

The age, maturity, and psychological state of the participants must be taken into account by the principal investigator when creating an assent form and the verbal presentation to obtain oral assent from such participants. Before research begins, the IRB must approve copies of the assent form, the parent/guardian consent form, and the script of a verbal explanation that will be presented to potential participants who are children, minors, or adults with compromised abilities.

Obtaining oral consent from functioning adults

If oral consent is necessary due to an adult's limited literacy or language comprehension, the participant or his/her legal representative will be asked to sign a short form stating that the basic consent form elements have been orally presented. Both the short consent form and the oral presentation must be approved by the IRB. A witness must also be present for this presentation and must sign both the short form and a written summary of the oral presentation. The participant or his/her legal representative must be furnished with a copy of both signed documents. A written copy of the proposed script for presenting an explanation and making a request for participation in the research must be submitted to the IRB as part of the procedure/protocol.

Signed informed consent forms are legal documents, and the researcher has legal responsibilities in handling them. In compliance with federal regulations, consent documents must be retained for a period of three years following the completion of the research. They should be stored in a secure location that is accessible to the university or federal officials in case serious questions arise. Access to these documents should be limited to:

• those persons who have a need to know their contents, ordinarily the principal investigator and key personnel
• a representative of the IRB (usually the chair)
• the Human Research Protections Administrator on behalf of the university
• authorized federal officials

Informed consent documents become part of the IRB file of a project and are subject to federal audit. Therefore, the IRB will review carefully both the content of and the storage provisions for all consent forms. The IRB must have the following detailed information:

• the exact location
• the method of storage
• the names and titles of individuals (other than university and federal officials) who have access to the consent documents

A principal investigator who leaves the university prior to the end of the three-year retention period for informed consent forms should notify the IRB of this fact, specifying the new location of the consent documents. If consent documents are maintained by a graduate student or research assistant, they must be turned over to the responsible faculty member after data collection is completed. A change of location within the university that results in a new storage place for consent forms should also be reported to the IRB.