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V.01 |
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Elements of Disclosure for Informed Consent |
Objective
The University of Texas Health Science Center at Houston (UTHSC-H) Committee for the Protection of Human Subjects (CPHS) shall review all informed consent documents and processes to assure that the required elements of informed consent are present. The CPHS should also systematically evaluate how consent information will be communicated during the consent process and what information will be disclosed. The CPHS has written policies and procedures that describe the required elements of disclosure for informed consent.
Policy/Procedure
I. In seeking informed consent, the following information shall be provided to each participant.
A. A statement that the study involves research.
B. An explanation of the purposes of the research.
C. An explanation of the expected duration of the subject’s participation.
D. A description of the procedures to be followed.
1. If measures to prevent pregnancy should be taken while in the study, that should be explained.
E. Identification of any procedures that are experimental.
F. A description of any reasonably foreseeable risks or discomforts to the participant.
1. If relevant animal data are available, the significance should be explained to potential participants.
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 participant will be maintained.
J. A statement that notes the possibility that specific regulatory authorities may inspect the records.
K. For research involving more than minimal risk, an explanation as to whether any compensation is available if injury occurs, and if so, what it consists of, or where further information may be obtained.
L. For research involving more than minimal risk, an explanation as to whether any medical treatments are available if injury occurs, and if so, what it consists of, or where further information may be obtained.
M. An explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, including the physical address and a 24-hour phone number for the PI and a phone number for the Office of Research Support Committees.
N. An explanation of whom to contact in the event of a research-related injury to the participant.
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 subject is entitled.
1. Language limiting the participant’s right to withdraw from the study should not be permitted in consent documents.
II. When appropriate, one or more of the following elements of information shall also be provided to each participant.
A. A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), which are currently unforeseeable.
B. Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent.
1. An unexplained statement that the investigator and/or sponsor may withdraw participants at any time, does not adequately inform the participants of anticipated circumstances for such withdrawal.
2. A statement that the investigator may withdraw participants if they do not “follow study procedures” is not appropriate. Participants are not in a position to know all the study procedures.
3. Participants may be informed that they may be withdrawn if they do not follow the instructions given to them by the investigator.
C. Any additional costs to the participant that may result from participation in the research.
1. CPHS should consider that some insurance or other reimbursement mechanisms may not fund care that is delivered in a research context.
D. The consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant.
1. An unexplained statement that the participant will be asked to submit to tests prior to withdrawal does not adequately inform the participants why the tests are necessary for the participant’s welfare.
E. 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.
1. When it is anticipated that significant new findings that would be pertinent to the participant’s continued participation are likely to occur during the participant’s participation in the study, the CPHS should determine that a system or a reasonable plan, exists to make such notification to participants.
F. The approximate number of participants involved in the study.
III. CPHS may require that information, in addition to that specifically required by applicable regulation, be given to the participants when in CPHS’s judgment the information would meaningfully add to the protection of the rights and welfare of participants.
IV. CPHS follows applicable Federal, State, or local laws, which require additional information to be disclosed in order for informed consent to be legally effective.
V. PHS policy requires that where HIV testing is conducted or supported by PHS, individuals whose test results are associated with personal identifiers must be informed of their own test results and provided the opportunity to receive appropriate counseling unless the situation calls for an exception under the special circumstances set forth in the Policy. This procedure should be described in the Informed Consent Document.
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Applicable Regulations and Guidelines 21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html
) 21CFR 56( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html
) 38CFR 16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html
) 45CFR 46 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html
) ICH E6 (http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB
) OPRR letter dated May 5,
1995 - Subject: Exempt Research and
Research That May Undergo Expedited Review (http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc95-02.htm
) OHRP
Guidance on the Involvement of Prisoners in Research dated May 23, 2003 (http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.pdf |
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