Human Subjects Research 匿名研究法定授权代表知情许可模板

Sep 1, 2026

Informed permission form template for anonymous Human Subjects Research, structured to request authorization from a legally authorized representative for individuals over 18 who cannot provide consent independently. The template reflects updated Federal regulations and university policy by requiring clear, understandable information for a reasonable person, with an 8th-grade reading level recommended for general adults. It includes sections on study purpose, voluntary participation, procedures, risks and mitigation, anonymous information protection, dissemination plans, compensation options, benefits, and required contact information. It also specifies eligibility constraints for IRB submission.

LanguageEnglish

CategoryForms

FormatDOCX

Pages3

Reading Time1 min

AccessFree to download

Permission Form Sections

Eligibility and Consent Requirement

Study Purpose and Voluntary Participation

Procedures and Expected Duration

Risks and Risk Mitigation

Confidentiality and Information Protection

Compensation and Incentives

Benefits and Contacts

Documentation of Permission

This informed permission template provides an outline to follow when creating a permission document that complies with the new Federal regulations on Human Subjects Research and University policy. This permission template is intended for situations where the researchers are seeking permission from a Legally Authorized Representative to include an individual above the age of 18 who is not capable of providing consent on their own in an anonymous study. ( HYPERLINK "https://research.illinoisstate.edu/_resources/includes/Revised%20Regulations%20Informed%20Consent%20Checklist.docx" \o "Click here to download the consent checklist." Click here to view the consent checklist) The elements required in a permission form are similar to what is required in a consent form. The new rules require that permission forms include all information that a “reasonable person” would need to know before deciding whether or not they would like to participate. The language in the form must also be understandable to the target population. An 8th grade reading level is recommended for the general adult population. The IRB will be looking more closely at reading level under the new regulations. Key information will vary from study to study, so the template language should be modified accordingly. ***To be eligible for review the template cannot include this first informational page and all shaded text must be either replaced or deleted before submitting*** You are being asked to allow the person you represent to participate in a research study conducted by [Name and Title of Researcher(s) (The name of the Principal Investigator (PI) must also be listed here)] [Department and Institution]. The purpose of this study is to [Insert brief study description]. This study is funded by [Indicate sponsor if externally funded (delete this sentence otherwise)]. Why are we asking for your permission? We are seeking your permission because you are the legally authorized representative of the person that we would like to include in a study. The researchers would like to include the person you represent in a study because [Provide eligibility Criteria here (e.g. age or status)]. Their participation in this study is voluntary. Neither you nor the person you represent will be penalized if either of you choose to skip parts of the study, not participate, or withdraw from the study at any time. [If the research would occur when they are receiving other services) indicate what the person they represent would do if they did not participate in this study (e.g. receive the same instructions but not include their data in the study or complete an alternate activity).] What would they do? If you choose to allow this person to participate in this study, [Describe what the participant is expected to do]. In total, this person’s involvement in this study will last approximately [Indicate how long the participant would typically be actively engaged in the study. If multiple sessions will occur, state how many sessions and the approximate duration of each session]. Are any risks expected? [Describe any risk or discomforts that the participant may experience. If no specific risks are reasonably foreseeable, indicate “We do not anticipate any risks beyond those that would occur in everyday life”]. To reduce these risks, [Describe what will be done/provided to reduce and/or manage any risks/discomforts]. Will their information be protected? The responses from the person you represent will be anonymous; nothing that will identify them will be linked to their responses. The findings from this study may be presented in [Describe how the research may be disseminated and in what form the information will be disseminated]. Will you or the person you represent receive anything for participating? ***Delete this section if no compensation will be offered*** By [Describe what would need to be done to be compensated], [Indicate who will be offered the compensation] will be offered [Indicate wh

FAQs

When is this informed permission template used?

Use it when researchers seek permission from a legally authorized representative to include an individual over 18 in an anonymous study who cannot consent independently.

What information must the permission form include under the new regulations?

The form must include all details a “reasonable person” would need to know before deciding whether to participate, and the language must be understandable to the target population, with an 8th-grade reading level recommended for general adults.

How does the template address anonymity and information protection?

It states that responses from the legally authorized representative are anonymous and that nothing identifying the representative will be linked to their responses; it also asks how findings may be disseminated.

Sep 1, 2026

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