This section provides investigators with essential guidance, necessary forms, and consent templates to effectively complete their Institutional Review Board (IRB) protocol submissions.
ATTENTION: The IRB Office has updated all the Informed Consent Templates to include a standard NYCHP IRB Letterhead. Beginning May 11, 2023, all submissions are required to use the new Informed Consent Templates provided on this page.
The Consent Guidance & Templates
Guidance for Informed Consent
We offer two categories of consent forms: Social Behavioral and Biomedical. Choose the type that aligns with your research study.
Biomedical Templates: These templates should be used for biomedical research studies. In such studies, one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other controls) to evaluate the interventions’ impact on biomedical or behavioral health-related outcomes.
Social Behavioral Templates: If your study does not fit the criteria for biomedical research, please utilize the Social Behavioral templates. These are primarily designed for those conducting social, behavioral, or educational research.
Guidance for Consent Forms:
Understanding the Readability Level of Consent Documents
The aim of informed consent is to provide potential research participants with adequate information to make an informed decision about participating in a research study. If a participant cannot comprehend the consent document, they cannot effectively give their consent to participate in the study.
For additional details, refer to the NYCHP IRB guidance sheet on the Readability Level of Consent Documents.
To assess the readability level of a document, use the following website: https://readabilityformulas.com/free-readability-formula-tests.php. Please pay attention to the output of The Flesch-Kincaid Grade Level, as it measures the readability score of your document.
Biomedical Consent Document Templates
A biomedical research study refers to a study where one or more human subjects are proactively assigned to one or more interventions, which may encompass a placebo or other control measures. The primary aim of such a study is to assess the impact of these interventions on biomedical or behavior-related health outcomes.
Social Behavioral Consent Document Templates
This template is primarily utilized by researchers conducting social, behavioral, or educational studies that do not meet the requirements for using the biomedical template.
Assent Form Template (for children ages 7-12)
This form must be used to secure assent from child participants aged 7-12, and a Parent/Guardian must express their consent by signing the corresponding Parent/Guardian Consent Form. For children aged 13-17, this Child Assent Form should not be used; instead, they should provide their signature at the bottom of the Parent/Guardian Consent Form.
Participation Letter Template for Anonymous, Single-Occurrence Surveys
This template is designed for studies that meet ALL of the following conditions:
Investigators are seeking an IRB waiver for the requirement of obtaining participants’ signatures on the consent form.
The research involves a single, anonymous survey, either conducted in-person or online.
If a study fulfills the first criteria but not the second, researchers will need to utilize the suitable Waiver of Documentation of Informed Consent Template.
Short Form Consent Template
This form is designed for studies that satisfy ALL of the following conditions:
The study qualifies as a biomedical research study. This type of research prospectively assigns one or more human subjects to one or more interventions (which may include placebo or other control) to assess the interventions’ effects on biomedical or behavioral health-related outcomes.
The majority of participants to be enrolled in the study are English speakers. However, there may be potential participants who cannot understand the consent form in English.
For additional details about the use of the Short Form and the template itself, please access the document provided below.
Participant Recruitment Guidance & Requirements
Recruitment Material Requirements
Recruitment materials must include ALL required elements.
*If your Recruitment Flyer does not include all the required elements, it will be sent back to you for revision.
The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects. Individuals in these groups may be considered potentially vulnerable because they may not be able to make informed decisions for themselves, they may be in situations in which they can easily be manipulated, or they may be a convenient and readily available study population. Click the link below to view descriptions of different populations that NYCHP IRB policy provides special protections.
Submitting Translated Documents for Review by
If the study will be conducted in languages other than English, translated documents must be submitted via the Amendment Form after the investigator has received final approval of their New Protocol Submission
Form. The Translation
Verification Form, listed below, must be attached to your Amendment Form in
order to submit translated documents to the IRB for review.
For protocol submissions that may be reviewed at the Exempt or Expedited Review procedures:
The IRB permits investigators, who have native or professional level fluency in reading and writing the target language, to translate consent materials and instruments themselves. They must sign the Translation Verification Form listed above and provide details regarding their qualifications to conduct the translations.
For protocols requiring a Full Review procedures:
All documents that are to be translated must be translated by a certified translator unless this requirement is waived by the convened IRB. The certified translator must provide documentation of the certified translation.
ATTENTION: Electronic translator applications (such as Google Translate) are not appropriate for generating translated documents and will not be accepted by the NYCHP IRB.
Site Approval Letter
Documentation of permission to conduct your study at a non-NYCHP site must be attached to your New Protocol Submission Form. A study site can grant conditional approval pending final approval from the NYCHP IRB. This language is included in the template provided below. Researchers may provide this template to study sites to assist them with drafting an approval letter.
Certificates of Confidentiality
The privacy of the research subjects may be protected through the issuance of Certificates of Confidentiality. These Certificates of Confidentiality provide protection against compelled disclosure of identifying information about subjects enrolled in sensitive biomedical, behavioral, clinical, or other research. This protection is not limited to federally supported research.
Learn more about Certificates of Confidentiality.
Unanticipated Problem/Adverse Event Reporting
Unanticipated Problems, Adverse Events (AE) and Serious Adverse Events (SAE) must be reported to the IRB in a prompt manner by investigators. The IRB has established definitions, a reporting process, and policy related to unanticipated problems and adverse events that is available on the policies page.
Guidance Documents on Unanticipated Problem and Adverse Event Reporting
Unanticipated Problems and Adverse Events must be reported to the IRB Office within 5 working days. Serious adverse events must be reported to the IRB Office within 24 hours.
Unanticipated Problems, Adverse Events, and Serious Adverse Events are to be reported using the following form: