21 CFR 50

Question 1

Exception from General Informed Consent Requirements

Answer 1

1) Human subject is confronted by a life-threatening situation necessitating the use of test articles.
2) Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from the subject.
3) Time is not sufficient to obtain consent from the subject’s legal representative.
4) There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

Question 2

Timelines for exceptions to informed consent

Answer 2

1) the determinations of the clinical investigator shall be made, within 5 working days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.
2) the documentation required shall be submitted to the IRB within 5 working days after the use of the test article.

Question 3

Informed Consent cannot:

Answer 3

include exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or release or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

Question 4

Under 10 U.S.C. 1107(f)

Answer 4

President may waive the prior consent requirement for administration of an IND for a member of the armed forces in connection with the member’s participation in a particular military operation.

Question 5

Exception from informed consent requirements for emergency research (1)

Answer 5

Human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations is necessary to determine the safety and effectiveness of the particular intervention

Question 6

Exception from informed consent requirements for emergency research (2)

Answer 6

obtaining informed consent is not feasible because:
1) subjects will not be able to give IC as a result of their medical condition
2) intervention under investigation must be administered before consent from legally authorized representative is feasible
3) there is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation

Question 7

Exception from informed consent requirements for emergency research (3)

Answer 7

participation in the research holds out the prospect of direct benefit to the subject because:
1) subjects are facing a life-threatening situation that necessitates intervention
2) appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects
3) risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention of activity.

Question 8

Exception from informed consent requirements for emergency research (4)

Answer 8

the clinical investigation could not practicably be carried out without the waiver

Question 9

Exception from informed consent requirements for emergency research (5)

Answer 9

the proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact the LAR for each subject within that window of time, if feasible, to asking the LAR contacted for consent within that window rather than proceeding without consent. The investigator will summarize efforts made to contact LAR and make this information available to the IRB at the time of continuing review.

Question 10

Exception from informed consent requirements for emergency research (6)

Answer 10

IRB has reviewed and approved IC procedures and an IC document. these procedures and IC document are to be used with subjects or their LAR where feasible. IRB has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a subject’s participation in a clinical investigation.

Question 11

Exception from informed consent requirements for emergency research (7)

Answer 11

additional protections of the rights and welfare of the subjects will be provided, including:
1) consultation w/reps of the communities where clin. inv. conducted
2) public disclosure of risk/benefits to communities prior to initiation of clin. inv.
3) public disclousre of sufficient info following completion of clin. inv. like demographic characteristics of research pop & results
4) establishment of ind. data monitoring committee to exercise oversight
5) if IC not possible w/subject or LAR - investigator should try to contact family member

Question 12

If IRB finds that criteria for exceptions to IC not met, how long does IRB have to keep documentation that they sent to investigator and sponsor about this?

Answer 12

3 years after completion of investigation

Question 13

When IC not possible IRB is responsible for ensuring that procedures are in place to inform at the earliest the subject’s inclusion in the clinical investigation.

Answer 13

the subject, if incapacitated then LAR, if no LAR then family member. All have right to withdraw from clin. investigation at any time with no punishment.

Question 14

Elements of informed consent (1)

Answer 14

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

Question 15

Elements of informed consent (2)

Answer 15

a description of any reasonable and foreseeable risks or discomforts to the subject

Question 16

Elements of informed consent (3)

Answer 16

a description of any benefits to the subject or to others which may reasonably be expected from the research

Question 17

Elements of informed consent (4)

Answer 17

a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

Question 18

Elements of informed consent (5)

Answer 18

a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA may inspect records

Question 19

Elements of informed consent (6)

Answer 19

for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

Question 20

Elements of informed consent (7)

Answer 20

an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights and whom to contact in the event of a research-related injury to the subject

Question 21

Elements of informed consent (8)

Answer 21

a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled

Question 22

Additional elements of informed consent (1)

Answer 22

a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo/fetus if the subject is pregnant) which are currently unforeseeable

Question 23

Additional elements of informed consent (2)

Answer 23

anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent

Question 24

Additional elements of informed consent (3)

Answer 24

any additional costs to the subject that may result from participation in research

Question 25

Additional elements of informed consent (4)

Answer 25

the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject

Question 26

Additional elements of informed consent (5)

Answer 26

a statement that significant new findings developed during the course of the research which may related to the subject’s willingness to continue participation will be provided to the subject