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V.02 |
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The Process of Informed Consent |
Objective
The CPHS shall review and approve all processes for obtaining and documenting informed consent from human subjects. In the event that the investigator requests a waiver or alteration of the consent process, procedures are in place to review such a request. As a point of clarification, the consent process begins when a potential research participant is initially contacted.
Policy/Procedure
I. In order to approve research covered by this policy, CPHS shall determine that informed consent will be appropriately documented, in accordance with, and to the extent required by the regulations.
II. Unless waived by CPHS, informed consent shall be documented by the use of a written consent form.
A. The consent form must be approved by CPHS, and:
1. Signed and dated by the participant or the participant’s legally authorized representative, and
2. Signed and dated by the individual obtaining consent.
B. A copy of the signed consent form shall be given to the person signing the form.
III. Unless waived by CPHS, the consent form is a written consent document that embodies the elements of informed consent as noted in the regulations and HRP PP V.01. The short form allowed by the regulations is not in use at this institution.
A. This form may be read to the participant or the participant’s legally authorized representative.
B. The investigator shall give either the participant or the representative adequate opportunity to read the informed consent form before it is signed.
IV. The information in the protocol matches the information in the informed consent document regarding the purpose, risks, and benefits of the research.
V. CPHS affixes the approval and expiration dates to all approved informed consent documents and stipulates that copies of these dated documents must be used in obtaining consent.
VI. The written informed consent document should embody, in language understandable to the participant, all the elements necessary for legally effective informed consent. Participants who do not speak English should be presented with an informed consent document written in a language understandable to them.
VII. A verbal approval does not satisfy the requirement for a signed consent document. However, it is acceptable to send the informed consent document to the legally authorized representative by facsimile and conduct the consent interview by telephone when the legally authorized representative can read the consent as it is discussed. If the legally authorized representative agrees, s/he can sign the consent and return the signed document to the investigator by facsimile.
VIII. Illiterate persons who understand English may have the consent read to them and “make their mark”, if appropriate under applicable state law.
IX. Unless waived or altered, no investigator may involve a human being as a participant in research covered by this policy unless the investigator has obtained the legally effective informed consent of the participant or the participant’s legally authorized representative.
A. An investigator shall seek such consent only under circumstances that:
1. Provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate.
2. Minimize the possibility of coercion or undue influence.
A. The information that is given to the participant or the representative shall be in a language understandable to the participant or the representative.
1. The oral presentation should be in a language understandable to the participant.
B. No informed consent, whether oral or written, may include any exculpatory language through which the participant or the representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
1. The consent process does not communicate that specimens are “donated”.
2. The consent document must explain whether there is compensation available in case of injury but must not waive or appear to waive the rights of the participant or appear to release those conducting the study from liability for negligence.
3. The informed consent document should indicate when no system has been set up to provide funds for study related injuries. The preferred wording is “either you or your insurance will be responsible for paying the costs,” or similar wording that explains the provisions or the process.
C. CPHS should be aware of who will conduct the consent interview.
D. CPHS should also be informed of such matters as the timing of obtaining informed consent and of any waiting period (between informing the participant and obtaining the consent) that will be observed.
E. The consent process should provide ample opportunity for the investigator and the subject to exchange information and ask questions.
F. For tissue banking or repository activities, CPHS makes determinations concerning the informed consent process for research using such samples.
X. CPHS may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided that CPHS finds and documents that:
A. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
1. Public benefit or service programs;
2. Procedures for obtaining benefits or services under those programs;
3. Possible changes in or alternative to those programs or procedures; or
4. Possible changes in methods or levels of payment for benefits or services under those programs; and
B. The research could not practicably be carried out without the waiver or alteration.
C. The research is not subject to FDA regulation.
XI. CPHS waiver of elements of informed consent.
A. CPHS may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided that CPHS finds and documents that:
1. The research involves no more than minimal risk to the participants;
2. The waiver or alteration will not adversely affect the rights and welfare of the participants;
3. The research could not practicably be carried out without the waiver or alteration;
4. Whenever appropriate, the participants will be provided with additional pertinent information after participation;
5. The research is not subject to FDA regulation.
B. Where DHHS regulations require specific findings on the part of CPHS, the committee should document such findings in the minutes of the CPHS meeting, including protocol-specific information justifying each CPHS finding.
XII. CPHS waiver of signed consents
A. The CPHS may waive the requirement for the investigator to obtain a signed consent form for some or all of the participants if it finds either:
1. That all of the following are true:
a) The only record linking the participant and the research would be the consent document.
b) The principal risk would be potential harm resulting from a breach of confidentiality.
c) Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
d) The research is not subject to FDA regulations.
2. That all of the following are true:
a) The research presents no more than minimal risk of harm to participants.
b) The research involves no procedures for which written consent is normally required outside the research context.
3. In cases where the documentation requirement for informed consent is waived, the CPHS may require the investigator to provide participants with a written statement regarding the research.
4. CPHS has written policies and procedures that describe the criteria for waiving or altering informed consent (section X and XI above).
5. Where DHHS regulations require specific findings on the part of CPHS, such as approving a procedure which waives the requirement for obtaining a signed consent form, CPHS should document such findings in the minutes of the CPHS meeting, including protocol-specific information justifying each CPHS finding.
XIII.
The CPHS may require that a research intermediary from
the Office of Research Support Committees be used for select studies (e.g. high
risk studies).
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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
) AAHRPP Evaluation Instrument
For Site Visitors (http://www.aahrpp.org/Documents/D000043.PDF
) 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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