Required and Additional Elements of Informed Consent

You are here

1. Required for all research (*can be omitted if there are none/info is not applicable):

a. A statement that the study involves research.
b. An explanation of the purpose(s) of the research.
c. The expected duration of the subject’s participation.
d. A description of the procedures involved.
e. *Identification of any procedures that are experimental.
f. *A description of any reasonably foreseeable risks or discomforts to the participant.
g. *A description of any benefits to the participant or to others which may reasonably be expected from the research.
h. *A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
i. *A statement describing the extent, if any, to which confidentiality of records identifying the participants will be maintained.
j. An explanation of whom to contact for answers to pertinent questions about the research.
k. An explanation of whom to contact for answers to pertinent questions about the research participant’s rights.
l. *If applicable, an explanation of whom to contact in the event of a research-related injury to the participant.
m. Contact information for the research team for questions, concerns, or complaints.
n. Contact information for someone independent of the research team for problems, concerns, questions, information, or input.
o. A statement that participation is voluntary.
p. A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.
q. A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
r. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: (i.) A statement that identifiers might be removed from 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 studies without additional informed consent from the subjects or their legally authorized representative, if this might be a possibility; or (ii.) 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.

2. Required for FDA-related research only:

a. A statement that notes the possibility that the FDA may inspect records.

3. Required for research involving greater than minimal risk:

a. An explanation as to whether any compensation is available if injury occurs.
b. If compensation is available, what it consists of, or where further information may be obtained.
c. An explanation as to whether nay medical treatments are available if injury occurs.
d. If medical treatments are available if injury occurs, what it consists of, or where further information may be obtained.

4. Required for clinical trials:

a. The approval of the IRB.
b. The probability for random assignment into each treatment.
c. The participant’s responsibilities.
d. When applicable, the reasonably foreseeable risks or inconveniences to an embryo, fetus, or nursing infant.
e. The important potential benefits and risks of the alternative procedures or courses of treatment that may be available to the participant.
f. When there is no intended clinical benefit to the participant, a statement to this effect.
g. The monitors, auditors, IRB, and regulatory authorities will be granted direct access to the participant’s original medical records for verification of clinical trial procedures and data, without violating the confidentiality of the participant, to the extent permitted by applicable laws and regulations and that, by signing the consent document, the participant or their legally authorized representative is authorizing such access.

5. Additional information, to be provided to each participant, when appropriate:

a. A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the subject may become pregnant), that are currently unforeseeable.
b. Anticipated circumstances under which the subject’s participation may be terminated by the researcher without regard to the participant or legally authorized representative’s consent.
c. Any additional costs to the participant that may result from participation in the research.
d. The consequences of a participant’s decision to withdraw from the research.
e. Procedures for orderly termination of participation by the subject.
f. A statement that significant new findings developed during the course of the research that may relate to the participant’s willingness to continue participation will be provided to the participant.
g. The approximate number of participants involved in the research.
h. The amount and schedule of all payments to the participants.
i. 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.
j. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
k. For research involving biospecimens, whether the research will (if know) 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).