How to Write an Informed Consent Form
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For a list of the basic and additional elements of the 2018 Common Rule, see the updated document on the basic elements of informed consent. HIPAA allows UCSF researchers/staff to access, use, create, or disclose the individual`s Protected Health Information (IHP) for research purposes. Review your Notice of Approval (initial or ongoing review) to see if subjects need to sign a HIPAA Authorization Form! Where appropriate, subjects should be informed of the circumstances in which their participation may be interrupted by the examiner without the subject`s consent. Subjects should also be informed of safe shutdown procedures and ordered if they decide to withdraw the study before the end of the study. Submit this form to the IRB as another study document. (Word) Blank template with key common rule information revised in 2018 and other required consent elements presented as section headers; contains instructions and the recommended language. It is strongly recommended that you modify this template to create a project-specific consent document for your study for review and approval by the IRB. If the consent document and HIPAA authorization are combined into a single form, the ICF must also include all the requirements for HIPAA written approval, the IRB consent form templates contain all the necessary elements and help create a readable document. An example of a consent form is available on this website, showing where regulatory requirements have been included in our consent template. With the prior approval of the IRB, alternative methods of sharing information about a study may be used to complete the consent process or, in rare cases, to replace a consent document. These approaches include the use of audiovisual material, brochures, drawings and information published on a specific website. Witness signatures are required by federal regulations in very limited circumstances and may be required by the IRB to ensure an appropriate consent process for certain research studies. In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., document consent to participate), unless the IRB has waived the consent requirement or documentation requirement (signature).
The human subjects of your project must participate voluntarily because they have been sufficiently informed about the research. Readability tools are available free of charge at – www.storytoolz.com/readability. The best estimate of how difficult it is to read consent forms and other health-related content is the smog scale. Routine fMRI study? Refer to the fMRI Guidelines to review the study criteria and download the IRB-HSBS fMRI consent template. Informed consent is a process, not just a document. The ITC informs potential participants about the purpose, procedures, risks and benefits of participation, serves as a guide during discussions with the examiner and as a reference source for participation. Add applicable information about other procedures or treatment cycles that may be beneficial to the potential subject if they refuse to participate in the study or withdraw from the study. Social/Behavioral Research – If the remuneration for participation in the research is an additional course credit, explain that the instructor offers a reasonable alternative way to obtain additional course credits. A number of formatting techniques have been shown to improve readability. All of this has been integrated into the CHOP templates for consent forms.
The informed consent document should briefly and succinctly describe the research as presented in the IRB application. Explain the study orally to the potential topic, provide all relevant information (objective, procedures, risks, benefits, alternatives to participation) and give the potential participant ample opportunity to ask questions or raise concerns. Do not read the consent document verbatim, but paraphrase the information to improve understanding and allow questions throughout the process. For some studies, it would be appropriate to involve family members or close friends in the process. .