Elements of Consent

Required Elements

All required elements of consent are required to be included in the process and the document. The WVU IRB approved templates were designed to include the required elements.

• Study involves research
• Purpose of the research
• Expected duration of participation
• Procedures and activities
• Identification of experimental procedures
• Any reasonably foreseeable risks or discomforts
• Any benefits to the subject or to others which may reasonably be expected from the research
• Any appropriate alternative procedures or courses of treatment that might be advantageous
• The extent, if any, to which confidentiality of records identifying the subject will be maintained
When appropriate, disclose any limits on confidentiality imposed by mandatory reporting and any possibility of loss of confidentiality due to media attention.  
• How to contact the PI  for:
  • questions
  • concerns
  • complaints
• How to contact someone independent of the PI for:
  • questions
  • concerns
  • complaints
  • subjects rights
• Whom to contact in the event of a research-related injury
• Participation is voluntary
• Refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled
• The subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
• One of the following statements about any identifiable private information or identifiable bio-specimens:
  • A statement that identifiers might be removed from the identifiable private information or identifiable bio-specimens and that, after such removal, the information or bio-specimens 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**
    or
  • A statement that the subject’s information or bio-specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.**

Additional Elements

The additional elements of consent are required when appropriate. Note that the WVU IRB Approved Informed Consent Documents were designed to include the additional elements.

• The research may involve risks to the subject which are currently unforeseeable
• The research may involve risks 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 stopped without the subject’s consent
• Any additional costs to the subject that may result from participation in the research
• The consequences of a subject’s decision to withdraw from the research
• Procedures for orderly termination of participation by the subject
• New findings that 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 Amount and timing of all payments
• A statement that the subject’s bio-specimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit**
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions**
• Whether the research will or might include whole genome sequencing**
• Amount, method and interval of all payments