Potential research participants must be given all available information that might reasonably be expected to influence their willingness to participate as research subjects. Investigators need to help them to understand fully the nature of the study being conducted and the research risks and benefits associated with it so they can make an informed decision on participation. This information should be provided in a culturally appropriate manner and in language understandable to the subject or his/her authorized representative. As a general guide, an eighth-grade reading level is desirable in any written documents. In addition, the informed-consent materials should be free of any language which appears to waive any of the subject's legal rights or release the investigator and/or sponsor from liability for negligence.
NIH-funded studies should follow the format and contain standard language as required by NIH. For more information see Guidelines for Writing Informed Consent Documents (http://ohsr.od.nih.gov/info/sheet6.html).
If you have questions about specific elements of informed consent, or if you would like to have a consent form reviewed before it is sent to the NIEHS Institutional Review Board as part of a formal application package, please contact David Resnik (resnikd@niehs.nih.gov), Biomedical Ethicist, Office of the Scientific Director, NIEHS, at (919) 541- 5658.
Informed Consent Checklist
Comments
Introduction
Statement that the study involves research
Description of study goals and purposes
Name of principal researcher(s)
Name of sponsor(s)
Procedures and Subject Involvement
Expected duration of the subject's participation
Approximate number of subjects involved
Description of procedures (where applicable: description of research vs. clinical procedures)
Possible Risks and Benefits
List of reasonably foreseeable risks and discomforts
Statement that some risks may be unforeseeable
List of reasonably foreseeable benefits
Alternative procedures or treatments
Costs and Compensation
Description of all costs to the subject that may result from participation in the study
Description of any recruitment incentives, medical treatments, or compensation available to subjects
Confidentiality
Statement that confidentiality will be maintained to the extent possible by law
Description of procedures for maintaining confidentiality and protecting subject privacy
Contact Information
Name and telephone number of contact person for questions about the research study
Name and telephone number of contact person for questions about subject rights as a research subject
Where applicable: name and phone number of contact person in case of medical complications
Subject Rights as a Research Participant
Statement of voluntary participation
Statement of right to withdraw at any time without penalty or loss of benefit
Where applicable: policy on termination of subject participation without subject approval
Where applicable: policy on disclosure of research findings and clinically relevant information
General Issues
Is the language used in the informed-consent materials understandable to subjects?
Will subjects have the opportunity to ask questions about the study and their participation in the study?
Are the informed-consent materials culturally appropriate for the study population?
Where applicable: are there plans to obtain the assent of participating children?
Where applicable: are there plans to recruit individuals with questionable capacity for consent?
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