NIH offers informed consent checklist
NIH offers informed consent checklist
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The Office of Protection from Research Risks of the National Institutes of Health in Bethesda, MD, reports that informed consent should include the following elements:
-A statement that the study involves research.
-An explanation of the purpose of the research.
-The expected duration of the subject’s participation.
-A description of the procedures to be followed.
-Identification of any procedures that are experimental.
-A description of any reasonably foreseeable risks or discomforts to the subject.
-A description of any benefits to the subject or to others that may reasonably be expected from the research.
-A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
-A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
-For research involving more than minimal risk, an explanation as to whether any compensation and medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained.
-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.
-A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
-Additional elements as appropriate. These are required unless internal review board concurs otherwise:
• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable.
• Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.
• Any additional costs to the subject that may result from participation in the research.
• The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
• A statement that significant new findings developed during the course of the research, which may relate to the subject’s willingness to continue participation, will be provided to the subject.
• The approximate number of subjects involved in the study.
• Documentation of the informed consent checklist.
Except as provided waiver of request form section (see p. 77), informed consent shall be documented by the use of a written consent form approved by the internal review board (IRB) and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form.
Informed consent may be obtained in either of the following ways:
Written: A written consent document that embodies the elements of informed consent required by the informed consent checklist. This form may be read to the subject or the subject’s legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.
Oral: A short-form written consent document, stating that the elements of informed consent required by the informed consent checklist have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.
Waiver of request for signed form requires the following:
• The only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern.
• The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
• In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
• The IRB will have latitude to approve a consent procedure that alters or waives some or all of the elements of consent.
An IRB may approve a consent procedure that does not include or alters some or all of the elements of informed consent set forth in this article, or it may waive the requirements to obtain informed consent, provided the IRB finds and documents the following:
• The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and it is designed to study, evaluate, or otherwise examine:
public benefit or service programs;
procedures for obtaining benefits or services under those programs;
possible changes in or alternatives to those programs or procedures;
possible changes in methods or levels of payment for benefits or services under those programs.
• The research could not practicably be carried out without the waiver or alteration.
• The research involves no more than minimal risk to the subjects.
• The waiver or alteration will not adversely affect the rights and welfare of the subjects.
• The research could not practicably be carried out without the waiver or alteration.
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Sources
• The National Institutes of Health is seeking comments on a proposed policy, Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts. The NIH is seeking comment not only from NIH grantees, but from the full range of academic, not-for-profit, government, and private-sector participants in biomedical research and development. Comments should be addressed to: Research Tool Guidelines Project, Ms. Barbara M. McGarey, JD, NIH Office of Technology Transfer, 6011 Executive Blvd., Suite 325, Rockville, MD 20852-3804. Fax: (301) 402-3257. E-mail: [email protected]. Comments must be received by NIH on or before August 23, 1999.
• Office of Protection from Research Risks, National Institutes of Health, 6100 Executive Blvd., Suite 3B01, MSC-7507, Rockville, MD 20892-7507. E-mail: [email protected]. Web: www.nih.gov/grants/oprr.
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