General Requirements for Informed Consent
The following information shall be provided to each subject in seeking informed consent. Information should be presented in a language understandable to the subject. Please note this represents the minimum information to be given a potential subject; the SAR/RRC may request that additional information be provided. The informed consent form must be on Boston University letterhead, pages numbered, with the title of the study, the primary investigator’s name, and date at the top of each page. A statement should be included indicating the subject will receive a copy of the form.
The SAR/RRC approved informed consent is stamped/initialized by the chair of the SAR/RRC Committee. Only the approved form may used. Any changes to the informed consent must be resubmitted to the SAR/RRC for review.
The Informed Consent Document must include the following items, which can be separated into paragraphs with the headings as suggested below:
- Purpose: 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, and identification of any procedures which are experimental. (45 CFR 46.116 [a])
- Risks: A description of any reasonably foreseeable risks or discomforts to the subject. (45 CFR 46.116 [a])
- Benefits: A description of any benefits to the subject or to others which may reasonably be expected from the research. (45 CFR 46.116 [a])
- Compensation: Monetary or other compensation provided to the subject for participation in the research project are not necessarily considered benefits. A separate compensation section, specifying the amount, when provided, how prorated, if at all, for partial completion of participation is recommended. The separate compensation paragraph can be included after the benefits section in the Informed Consent Document.
- Alternative Treatments: A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. (45 CFR 46.116 [a])
- Confidentiality: A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. (45 CFR 46.116 [a]) The subject should be made aware of who is expected to have access to information that can identify the subject. If assurances are made that research information will be treated confidentially, it is advisable to indicate that confidential information will not be disclosed “unless required by law or regulation.” This is advisable because, under many circumstances, the disclosure of research data can be lawfully compelled by subpoena, and it is important not to promise confidential protection where it cannot be guaranteed. The foregoing exception is particularly important to include in consent forms where the disclosure of the research information could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
Required Information Sample Paragraphs for Informed Consent Forms
- Confidentiality: “All information will be held in strict confidence and may not be disclosed unless required by law or regulation. Any reports or publications will not identify individual participants by name or initials.” “The interview and questionnaire data will be treated confidentially and may not be disclosed, unless required by law or regulation. Interview and questionnaire data will be stored in locked files and destroyed at the end of the research. Results will be published only in aggregated form (for example, tables of information.)“
- 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. (45 CFR 46.116 [a]) The following is a standard paragraph developed by the CRC/IRB in consultation with University legal counsel: “I understand that in the event injury occurs resulting from the research procedures, medical treatment will be available at area hospitals. [For Boston University students who are research subjects, treatment will be available at the Boston University Student Health Service (881 Commonwealth Avenue)]. However, no special provision will be made for compensation or for payment for treatment solely because of my participation in this experiment. I understand that this paragraph is a statement of Boston University’s policy and does not waive any of my legal rights.”
- Contact Information: 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. (45 CFR 46.116 [a]) The following is a standard paragraph adapted by SAR/RRC from the CRC/IRB in consultation with University legal counsel: “If you have any questions regarding the research or your participation in it, either now or any time in the future, please feel free to ask them. The research team, particularly (your name/ faculty advisor’s name), who may be reached at (your phone number/ faculty advisor’s phone number), will be happy to answer any questions you may have. You may obtain further information about your rights as a research subject by calling Kenneth Holt, chair of the Sargent College Research Review Committee, at 617-353-7501. If any problems arise as a result of your participation in this study, including research-related injuries, please call the Principal Investigator, (PI /faculty name), at (PI/faculty phone number) immediately.”
- Voluntary Participation: 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. (45 CFR 46.116 [a])