Surrogate Consent to Take Part in Research - 16.305 (HRP-502e) - Interventional Research Consent Form Template

Sep 1, 2026

This interventional research consent template supports obtaining surrogate consent on behalf of an adult with impaired decision-making capacity. It defines the scope of “interventional research” and structures the document into participant consent, surrogate consent, and a follow-up section for individuals enrolled under prior surrogate consent if decision-making capacity is regained. Included guidance instructs researchers to remove non-applicable scenarios, use a 6th–8th grade reading level, and complete key study fields such as research title and principal investigator information.

LanguageEnglish

CategoryForms

FormatDOCX

Pages14

Reading Time5 min

AccessFree to download

SURROGATE CONSENT TO TAKE PART IN RESEARCH

Form purpose for interventional research

Form sections

Instructions for completing the consent document

Title of research and investigator information

SECTION I. PARTICIPANT CONSENT

Who is conducting this research?

Sponsor and manufacturer placeholders

Why the research is being done

Who may take part

Why you were asked to take part

Research duration and participant numbers

What you will be asked to do

[USE YOUR DEPARTMENT LETTERHEAD] SURROGATE CONSENT TO TAKE PART IN RESEARCH This template [16.305 (HRP-502e)] should be used when obtaining consent from a surrogate on behalf of an adult with impaired decision-making capacity to take part in interventional research—research in which participants are assigned to receive one or more interventions and manipulations of the participant or the participant’s environment that are performed for research purposes so that the investigators can evaluate their effects (e.g., clinical trials, CBT, Behavioral Modification studies, or randomized outcome studies). This form has 3 sections: PARTICIPANT CONSENT TO TAKE PART IN RESEARCH – outlines the important details about research for which you seek consent from a surrogate to enroll an adult lacking decisional capacity. The form should be reviewed with both the individual and surrogate who represents them, as practicable. SURROGATE CONSENT – to be reviewed and signed by the legally authorized representative (also known as LAR or surrogate) to give consent on behalf of the individual lacking decision-making capacity. CONSENT FOR INDIVIDUALS ENROLLED UNDER PRIOR SURROGATE CONSENT – to be completed by the research participant if/when they regain decision-making capacity to give (or decline) consent to continue in the research. This part is not applicable if the participant does not regain decision-making capacity (or never possessed capacity). INSTRUCTIONS: [BLUE] highlighted text provides instructions to guide you in constructing the consent document. [GREEN] highlighted text provides different scenarios/options. Delete all instructional text and scenarios that are not applicable to your research before uploading the document to e-IRB+. The consent document should be written at a 6th to 8th grade reading level. For more information about the surrogate consent process, go to HYPERLINK "https://research.rutgers.edu/researcher-support/research-compliance/human-research-protection-program/hrpp-guidance-topics"HRPP GUIDANCE Surrogate Consent Process. NOTE: If the research is conducted, supported, or otherwise subject to regulation by any Federal Department or agency, such as Dept of Defense, Dept of Energy, Dept of Justice, Dept of Education or Environmental Protection Agency, additional protocol plans may be required. [ HYPERLINK "https://research.rutgers.edu/researcher-support/research-compliance/human-research-protection-program/toolkit" \l "tab=panel-4" Go to HRPP Toolkit 1.003 (HRP-103a) Standard Operating Procedures to learn more.] Visit the HYPERLINK "https://research.rutgers.edu/researcher-support/research-compliance/human-research-protection-program/toolkit" Human Research Protection Program Toolkit | Rutgers Research to obtain referenced Toolkit Forms & Templates Visit the HYPERLINK "https://research.rutgers.edu/researcher-support/research-compliance/human-research-protection-program/hrpp-guidance-topics" HRPP Guidance Topics | Rutgers Research to obtain referenced Guidance documents. Contact the IRB Office at HYPERLINK "mailto:irboffice@research.rutgers.edu" \h irboffice@research.rutgers.edu if you need further assistance. TITLE OF RESEARCH: [Add the Title of the study here.] Principal Investigator: [Add the PI’s name and credentials here (i.e. M.D., Ph.D., etc.)] SECTION I. PARTICIPANT CONSENT A person who takes part in research is called a research or study participant. In this section, “you” always refers to the individual who will be the research participant. The information in this consent form will provide more details about the research and what will be asked of you if you choose to take part in it. If you have any questions now or during the research, if you choose to take part, you should feel free to ask them and should expect to be given answers you completely understand. After all your questions have been answered and you wish to take part in the research, you will be asked to sign this consent form. You a

FAQs

When should this surrogate consent template be used?

Use it when obtaining consent from a surrogate on behalf of an adult who lacks decision-making capacity to take part in interventional research.

What are the three sections of the form?

The form includes: Participant Consent to Take Part in Research, Surrogate Consent, and Consent for Individuals Enrolled Under Prior Surrogate Consent (completed only if capacity is regained).

What instructions apply before submitting the document to e-IRB+?

Remove all instructional text and scenarios that are not applicable, ensure the consent document is written at a 6th to 8th grade reading level, and complete the required study title and principal investigator information.

Sep 1, 2026

Upload by Sophia Brooks