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Required Elements of Informed Consent

1. Required (*can be omitted if there are none):
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.

2. For FDA-related research only:
a. A statement that notes the possibility that the FDA may inspect records.

3. 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 LAR 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 which are currently unforeseeable.
b. A statement that if the participant is or may become pregnant the particular treatment or procedure may involve risks to the embryo or fetus that are currently unforeseeable.
c. Anticipated circumstances under which the subject’s participation may be terminated by the researcher without regard to the participant’s consent.
d. Any additional costs to the participant that may result from participation in the research.
e. The consequences of a participant’s decision to withdraw from the research.
f. Procedures for orderly termination of participation by the subject.
g. A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant.
h. The approximate number of participants involved in the research.
i. The amount and schedule of all payments to the participants.

Office of Vice President and Associate Provost for Research and Graduate Studies • Lehigh University • 7 Asa Drive, Bethlehem, PA 18015 • (610) 758-2585