Tutorial Chapter 12: What is informed consent and how is it documented?

Informed consent is at the core of the code of ethics governing the use of human subjects in research. The informed consent process ensures the voluntary nature of a subject's participation and the clear and full understanding of procedures, risks and benefits of participation, and rights as a subject.

Although informed consent is generally documented in writing and by the signature of the subject, the consent form is just part of the process by which investigators ensure that subjects understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate.

Thus, Investigators are responsible for:

• assessing the subject's understanding of the explanation given, ensuring the appropriateness of the setting and circumstances surrounding the request to participate
• responding fully and honestly to any questions or concerns potential subjects might have
• providing sufficient time and privacy for potential subjects to decide whether or not to participate

Investigators must also consider the additional requirements that may be necessary for the consent process used for protected populations. For example, minors must have parental or guardian permission to participate in research and must also, as discussed in the previous chapter, provide consent or assent, depending on the age of the child, to become subjects.

Consent/Permission Form Information

The following information must be included in all consent forms and permission forms:

• a statement that the study involves research and an explanation of the purpose(s) of the research
• names and contact information of the investigator(s), of the faculty sponsor, including institutional affiliation and status
• Contact information for each investigator and faculty sponsor including school and department, phone number (including a local phone number if the work is to be done out of the United States), university and email addresses
• a description of the procedures to be followed, what the subject will be expected to do, and whether there are any procedures which are experimental
• how long participation will take, including how many sessions will be held if more than one will be needed
• a description of any benefits to the subject or to others which may reasonably be expected from the research, or, more commonly, since the benefits of research to the subjects are usually tenuous at best, a statement that there will be no direct benefit to the subjects
• a description of any reasonably foreseeable risks or discomforts to the subject, including any intervention which may be offered, OR the statement that there are no risks beyond those of everyday life
• for research involving more than minimal risk, a clear description of the risks and where further information may be obtained (note that no research with minors involving more than minimal risk may be carried out unless it holds the prospect of direct benefit to the subject)
• if the research involves more than minimal risk, a statement concerning the availability of medical treatment or compensation in the event of physical injury resulting from participation in the research. The statement should include the information that:
1. New York University cannot provide either medical treatment or financial compensation for any physical injury resulting from the subject’s participation in the research; and
2. that inquiries concerning this policy may be made to the principal investigator or the UCAIHS email (ask.humansubjects@nyu.edu or call (212) 998-4808).
• if applicable, a disclosure of appropriate alternative procedures or courses of treatment, if any, that may benefit the subject
• a description of any incentives (monetary or otherwise) that may be available to the subject for participation, and information on what the subject will be entitled to, if anything, if they do not complete the study
• a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits (if the subjects are in an educational setting, a statement that non-participation, participation, or withdrawal from the study will have no effect on the academic status or grades of the subject)
• a statement describing how and to what extent the confidentiality of subjects’ identity and any information about them will be protected and how records identifying the subjects will be maintained so as to preserve that confidentiality
• an explanation of any limits of confidentiality, for example, from participation in a focus group, for mandated reporting to the appropriate authorities of indications of harm to self, children, or others, or from any chance that identification of subjects might be possible because of the context of the research, a small sample size or the like
• an offer by the investigator to answer questions concerning the study at any time during or after the study
• whom to contact to report a research-related problem or injury to the subject (usually the investigator and, if applicable, the faculty sponsor)
• a statement, including contact details, that information on subject’s rights as a research participant may be obtained from the UCAIHS
• if audio or videotaping is involved, a statement that the subjects will be taped and that they have the right to review the tape and request that all or any portion of the tape be destroyed (parental permission forms, however, should not offer parents the right to review their child’s tapes)
• if subjects might be quoted by name or in any way that might make them identifiable, an attribution statement authorizing (or refusing) this use of their names and/or verbatim responses
• if the research is sponsored by or associated with a commercial enterprise, e.g. product evaluations or clinical trials, the name(s) of the research sponsors.

Exceptions and Waivers

The UCAIHS may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent provided that the investigator documents and justifies in the Application for Review that:

• the research involves no more than minimal risk to the subject;
• the waiver or alteration will not adversely affect the rights and welfare of subjects;
• the research could not practicably be carried out without the waiver or alteration;
• the subjects will be given additional pertinent information after participation, whenever appropriate.

Under Federal regulation, the UCAIHS may waive the requirement for investigators to obtain a signed consent form for some or all subjects if it finds:

• the only record linking the subject and the research is the consent document and the principal risk is potential harm resulting from a breach of confidentiality. (Each subject must be asked whether she/he wants documentation linking her/him to the research. The subject's wishes will govern.) OR
• the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases where documentation requirements are waived, the UCAIHS may require investigators to give subjects a Project Summary, which is a written statement about the research that includes all the elements of informed consent but does not require the subject's signature.

Tacit Consent

Tacit consent, in which participation in itself is considered consent, does not involve the use of a consent form. Tacit consent may be used for anonymous surveys and questionnaires where the completion of the instrument is deemed to constitute consent.

Chapter Review

Question 1

Investigators are responsible for ensuring that informed consent is obtained from all subjects prior to their participation.

• True
• False

Question 2

Once an appropriate consent form has been provided, it is the subject's responsibility to read and understand it.

• True
• False

Question 3

Minors may be involved in research (select all that apply):

• if they agree
• with parental permission
• with their teacher's permission
• never

Question 4

Which of the following are elements of informed consent (select all that apply)?

• description of research purpose and procedures to be undertaken
• University and investigator identifiers
• an offer to answer any questions
• a description of any risks
• all of the above

Question 5

Investigators may promise confidentiality to members of focus groups or other group interviews or situations.

• True
• False

Next Chapter: How must researchers deal with protected populations?