Informed Consent: General

The default is signed, written consent; the IRB expects that written consent will be obtained from all participants, unless a justification is provided.

The regulations require that the following information must be conveyed 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; and steps the researcher has in place to mitigate those risks.  Typical risks could include:  sensitive topics, or questions that evoke an emotional response, the risk of a breach of confidentiality;
  
  
• a description of any benefits to the subject or to others which may reasonably be expected from the research; (Note: there are typically no direct benefits to participating in minimal risk research.  Compensation is not a benefit and should be listed in it's own separate section of the consent form);
  
  
• Steps to ensure confidentiality of research records (e.g. a statement of who will have access to data, protection and security measures for data such as the use of pseudonyms, data encryption, password protection(s), and secure storage of all data including audio, video, and photos as applicable);
  
  
• If collecting/using private identifiable information or identifiable biospecimens, include a statement indicating whether that data will: a) be retained (either with identifiers or de-identified) for future research OR b) not be retained for future research (i.e., it will be destroyed following completion of the current project)
  
  
• Any compensation (e.g. parking pass, gift cards, extra credit, etc.).  Ensure that the amount or type of compensation is not coercive
  
  
• an explanation of whom to contact for answers to pertinent questions about the research (PI or study team) and research subjects’ rights (the IRB); 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.

Written consent forms can be created with the help of the Consent Form Wizard.

The requirement to ensure that all participants provide informed consent can be waived if appropriate justification is provided.

Waiver of signed consent

The requirement to obtain signed, written consent from participants can be waived, and an alternate consent process can be approved.
An alternative consent process can be:

- An oral consent process: This would require an oral consent script be provided to the IRB and be read to participants; participants will provide verbal consent to participate and a signature will not be collected.

- An online consent process: An electronic consent form which includes a button or other way for participants to indicate their consent to participate.

Alteration of required elements of consent

In certain circumstances, it may be appropriate for the IRB to approve a consent process that only includes some of the required elements of consent.

For questions or more information regarding the requirement of informed consent, please consult IRB Guidance: Informed Consent