Informed Consent: Process + Documentation

Informed consent is fundamental to insuring the continuous and adequate disclosure of research risks and benefits. Informed consent is an educational process between the investigator and the participant. The process begins with the initial presentation of a research activity to a prospective human subject by the investigator (or a member of the study/research team) and continues through the end of the research activity and the closing of the research study. Most subjects make their decision regarding whether to participate in research during the initial contact. The researcher should avoid the potential for any misunderstandings and provide the subjects with sufficient time to reflect on the nature of their proposed participation.

The second step in the consent process is the presentation of a written consent form to individuals who express an interest in participating in the study, unless the research qualifies for an exception, waiver or alteration of documented informed consent. Written informed consent is not always necessary or appropriate in some educational, social and behavioral science research (see section 5.3 below for waivers and exceptions). When written informed consent is appropriate, a member of the study team should insure that the subject reads and understands the consent form. Federal regulations require that all consent form statements describe the nature of the research and the request for human subjects' participation in language that is understandable to each potential subject. Consent forms should avoid technical jargon or terminology that is not defined; the forms should also adjust for educational backgrounds, mental abilities and ages of the intended participants.

All subjects who agree to participate in a study should be provided their own copy of the signed consent form. Signatures of both the participant and the investigator (or study team member) are required.

The consent process does not end with the signing of the informed consent form.

Research is an ongoing process, which involves the constant re-evaluation of current information and procedures. Therefore, investigators are ethically obligated to keep subjects apprised of issues related to their participation in the study as appropriate. Any new information or changes in procedures that affect the participants should be presented to them in writing; in most cases this will involve the signing of a new consent form or a revision of the original form.

Sample consent and assent forms are available at the Trinity IRB website [link to come]. Many disciplines have their own consent form guidelines or templates which you may use. Consult professional association web sites appropriate to your research (e.g., APA for Psychology). 

  • 5.1 Description of Informed Consent Form

  • 5.2 Elements of Informed Consent 

  • 5.3 Exceptions, Waivers and Alterations 

  • 5.4 Documenting Informed Consent

  • 5.5 Short Form Alternative

  • 5.6 Parental Consent 

  • 5.7 Assent By Children 

  • 5.8 Limits on Confidentiality 

  • Informed Consent Resources

5.1 Description of Informed Consent Form

The consent form provides potential research subjects sufficient written information to decide whether to participate in a research study based on an explanation of the proposed research and the nature of the participation that is requested of them.

The form should be easily identified in bold text as "Consent to Participate in Research" at the top of the first page. The title of the research should be descriptive and not overly technical. Section headings should be used to identify the basic and any additional elements of informed consent.

Once approved, the consent form reviewed by the IRB is the only one that can be copied and administered to research participants. Any changes to approved consent forms must be submitted to the IRB as proposed modifications prior to their use. 

5.2 Elements of Informed Consent

The federal requirements for informed consent are found at 45 CFR 46.116. Unless an exception, waiver, or alteration applies, written consent forms shall include the following points of information:

·             a statement that the study involves research;

·             an explanation of the purpose of the research and the expected duration of the subject’s participation;

·              a description of the procedures to be followed;

·              identification of any experimental procedures;

·             a description of any reasonably foreseeable risks or discomforts to the subject;

·             a description of any reasonably foreseeable benefits to the subjects or to others;

·             a description of alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

·             a description of whether and how confidentiality of records and data linked to the subject will be maintained;

·             a statement that participation:
°  is voluntary; that refusal to participate will not be penalized; and that the subject may discontinue participation at any time without penalty;

·             for research involving GREATER than minimal risk, an explanation of what medical treatment or professional services are available should injury occur and whether any compensation is available for these services;

·             for research that involves GREATER than minimal risk, the investigator is required to include a statement regarding the rights of research subjects: "By signing this consent form, you are not waiving any legal claims, rights or remedies because of your participation in this research study.”

·         a final statement identifying the investigators and how to contact them for answers to questions about the research or research subjects’ rights or to report any difficulties or injuries; and  the name and phone number of the IRB chairperson (or another individual as designated by the IRB), in the event of complaints or other participant concerns.

Additional elements of informed consent, when appropriate, may include:

  • a statement to the participant that a particular treatment or procedure may involve risks that are currently unforeseeable;

  • a description of anticipated circumstances under which the participant's involvement with the study may be terminated by the investigator without regard to the subject’s consent;

 

  • an explanation of any additional costs to the participant from involvement in the study;

  • a description of the consequences of a participant's decision to withdraw from the study and procedures for an orderly termination of participation;

  • a statement that significant new findings developed during the course of the study that may relate to the participant's willingness to continue in the study will be provided to the participant; and

 

  • a description of the approximate number of participants involved in the study.

  • if incentives such as financial payments will be offered for participation in research,

  • the investigator must describe the manner and circumstances under which the incentive will be provided;

  • incentives must not be described as benefits and should not constitute the reason for "voluntary" participation;

  • the amount of the incentive must be commensurate with the time, effort or expenses of participation;

  • financial payments must be pro-rated in the event of termination; and

  • there must be reasonable alternatives to financial payments.

On some occasions, incentives may be offered that involve meeting a research participation requirement for a Trinity College course or earning extra credit for a Trinity College course. When this is the case, the investigator may use the consent form to collect information, so that the relevant Trinity College course may be identified and the relevant instructor may be notified.

No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waie or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. 

5.3 Exceptions, Waivers and Alterations

Written informed consent is not always appropriate in some educational, social and behavioral science research, e.g., some ethnographic, field, or qualitative research studies. The Trinity College IRB may provide a waiver, an exemption or otherwise approve alterations of documented informed consent if the investigator justifies that:

  • The research involves no more than minimal risk; and

  • The waiver or modification will not adversely affect the rights and welfare of the subjects; and

  • The research could not be practicably carried out without the waiver or modification; and

  • Whenever appropriate, the subjects will be provided with additional, pertinent information after participation.

When applying for exceptions, waivers or alterations, the investigator must explicitly address each of the conditions above and propose alternative measures for obtaining and documenting informed consent. Deception research must always include a request for a waiver of consent and documentation since the research could not be practicably carried out without a waiver. 

5.4 Documenting Informed Consent

Informed consent shall be documented by having the subject (or legally authorized representative) sign the written consent form and receive a copy. The investigator or research team member must also sign the consent form.

The IRB may waive the requirement to obtain a signed consent form if it finds either:

1.                   That the only record linking the subject to the research would be the consent form and the most serious risk would be breach of confidentiality (each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern); or

2.                   That the research involves no more than minimal risk and involves no procedures for which written consent is normally required outside of the research context;

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

For research studies of minimal risk involving the use of questionnaires, the required elements of informed consent may be included in an introductory letter or information attached to the instrument which includes a statement that completion and submission of the questionnaire (hard copy or electronic) will constitute consent to participate in the study. 

5.5 Short Form Alternative

The IRB may also approve the use of a "short form" of consent, described in 45 CFR 46.117 (b) (2).

The investigator prepares and submits the short form for review by the IRB stating that the elements of informed consent will be presented orally to the subject or the subject’s legally authorized representative. When this method is used, there must be a witness to the oral presentation. The IRB must approve a written summary of what is to be said to the subject or the subject’s representative.

Copies of this summary must be signed by the witness and the investigator obtaining consent. The short form document itself must be signed by the subject or representative and the witness. The subject or representative signs only the short form but will be provided copies of both the short form and the written summary.

A checklist for the "short form" may be found on the IRB Forms [link needed] page. 

5.6 Parental Consent

If a subject in Connecticut is under eighteen years of age, the consent of the subject’s parent or guardian is required, unless the subject is married or emancipated by court order. Parental or guardian consent must be documented in writing.

If the research does not involve greater than minimal risk, the permission of one parent is sufficient.

If the research involves GREATER than minimal risk, consent of both parents must be obtained unless one parent is deceased, unknown, incompetent, not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. (See 45 CFR 46.408(b))

Parental consent may be waived by the IRB if it is not a reasonable requirement to protect the subjects (for example, neglected or abused children). However, the investigator requesting the waiver must propose an alternative mechanism for protecting the children who will be participating in the study. 

5.7 Assent by Children

Assent means a child's affirmative agreement to participate in research. In all instances where children are capable of providing assent, the investigator shall develop a separate assent form written in language appropriate to the educational level of the child. As a guideline, children age seven and older are considered capable of assenting. Sample assent forms for use by children and minors are available on the IRB Forms page.

In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with 45 CFR 46.116. 

5.8 Limits on Confidentiality

In general, any information obtained in connection with research that identifies particular subjects must remain confidential and may be disclosed only with written permission from the participant(s) or as required by law. Consent forms should detail the extent to which confidentiality will be protected and how specific records identifying the participant(s) will be maintained and kept secure and ultimately how and when they will be destroyed, if applicable. The more sensitive the research material, the greater the care required in obtaining, handling, coding, storing and securing the data.

Depending on the subject matter of the research, there may be limits to the investigator's promise of confidentiality to the subject(s). For example, most states require persons who know or have a reasonable suspicion that a child is being abused or neglected to report such suspicion to local law enforcement personnel. Therefore, if the research might reveal child abuse, the consent form should include a statement that under Connecticut law, the privilege of confidentiality does not extend to such information and the investigator is required to report known or suspected child abuse to the appropriate authorities.

For information concerning certificates of confidentiality, Trinity researchers should contact the IRB Chair. Federal law allows researchers to apply for an advance grant of confidentiality known as a "Certificate of Confidentiality." If granted by a federal agency, these certificates provide protection against compulsory disclosure, such as a subpoena, for research data about sensitive issues, e.g., illegal conduct, alcohol or drug use, mental health, or sexual practices or preferences. 

Informed Consent Resources

Link to NIH Resources on Informed Consent Forms
(http://www.hhs.gov/ohrp/policy/consent/index.html)