Informed Consent

This website has been updated to reflect the Revised Common Rule, implemented on January 21, 2019.

Participants should be willing to take part in the study after being informed of all aspects of the study that might influence their decision to participate. Researchers are required to provide participants with the information that a reasonable person would want to have. Most research projects will satisfy this requirement by acquiring subjects' informed consent to participate in the study. Informed consent as a whole must present information in sufficient detail relating to the research and facilitate the prospective participant’s understanding of the reasons why one might or might not want to participate.

Key information essential to decision making should receive priority by appearing at the beginning of the consent document and being presented first in the consent discussion. Key information constitutes a concise and focused presentation of the information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.

The Basic Elements of Informed Consent

1. 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. 
2. A description of any foreseeable risks or discomfort to the subject. 
3. A description of any benefits to the subject or to others which may reasonably be expected from the research. 
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. 
6. For research involving more than minimal risk, an explanation as to whether any medical treatments or counseling are available if injury or distress occurs and, if so, what they consist of, or where further information may be obtained. 
7. An explanation of whom to contact for answers to questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. 
8. 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.
9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
   1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
   2. A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

In addition, where appropriate, one or more of the following elements shall be provided to the 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 form 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. 
• The approximate number of subjects involved in the study.

For research involving biospecimens:

• A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
• Whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Documentation of Informed Consent

Informed consent shall be documented by the use of a written consent form approved by the IRB. The informed consent form must be signed by each subject or the subject’s legally authorized representative before participation in the research. If the subject is under the age of 18, the consent form must also be signed by a parent or legal guardian. A copy of the written consent must be provided to the person signing the form.

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

1. The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or

2. 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; or

3. The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

Where the requirement of signed informed consent is waived, the researcher must provide written information to potential subjects that includes all the applicable elements of the informed consent form.

Informed consent documents and other printed information regarding the study provided to subjects must be written at a reading level appropriate to the study population. Furthermore, the researcher should plan for procedures on how to inform subjects who are functionally illiterate or not proficient in the English language. Informed consent documents, printed information about the study, and any translation of such documents must be provided to the IRB at the time of the initial review of the study.

Protection of Privacy

All information gathered in the course of a study must be kept confidential through coding or other means. Participants should be assured that their individual results will not be identified or used for any purpose other than that stated in the research proposal. If the information collected is potentially legally incriminating or publicly damaging, the researcher must ensure that participants' responses cannot be traced to their identities.

Debriefing

Participants must be fully debriefed (informed and their well-being ensured) after the completion of the research procedures. If the design necessitates deception or incomplete information, participants must be told the actual purpose of the study, the reason for the deception or omission, and be provided an opportunity to withdraw their data from the study if the subject so chooses. If giving complete information seems at odds with ensuring the participant's well-being, the researcher must explain and justify the chosen course of action to the IRB in the initial research proposal.