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:

• Informed Consent Process Types
• Informed Consent Requirements

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.

• Biomedical General Consent Form
• Biomedical Parent/Guardian, LAR, & Adolescent (age 13-17) Consent Form
• Biomedical Signed Consent Form Waived (Process Not Waived) Form

 

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.

• Social Behavioral General Consent Form
• Social Behavioral Parent/Guardian, LAR, & Adolescent (age 13-17) Consent Form
• Social Behavioral Signed Consent Form Waived (Process Not Waived) Form

 

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.

• Child Assent Form (ages 7-12)

 

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.

• Participant Letter for Anonymous Surveys (Signed Consent Form Waived, Not Consent Process)

 

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.

• Short Form Consent

 

Participant Recruitment Guidance & Requirements

Recruitment Material Requirements

Recruitment materials must include ALL required elements.

Required Elements:

• All flyers must have 3” by 3” blank/light colored space in the top right-hand corner to allow for electronic approval stamping.
• Study title.
• The word “research.” Make it clear that this is a research study.
• “New York College of Health Professions”
• The PI’s name.
• A contact name with either a phone number or e-mail address.
• Eligibility criteria, if applicable, should be noted briefly. Especially if payment depends on meeting these criteria. For example, “English speaking only,” “Women only,” etc.
• State whether participants will be paid for their time and effort. The amount of payment may be included, but should not be the most prominent element on the page and should not seem excessive considering the nature of the project.

Recommended Elements:

• Purpose of the study.
• What is expected of the participant.
• The time commitment.
• The location where the research will take place.

  *If your Recruitment Flyer does not include all the required elements, it will be sent back to you for revision.

 

Vulnerable Populations

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.

• Vulnerable Populations

 

Miscellaneous Forms/Letters

Translation Verification

Submitting Translated Documents for Review by

the IRB

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.

• Translation Verification Form

 

Translation Requirements

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.

• Model Site Approval Letter
• Template Site 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.

HIPAA Forms

• HIPAA Authorization Forms
• • NYCHP Authorization for Use and Disclosure of Protected Health Information in Research
  • Instructions for Preparing the Authorization For Use and Disclosure of Protected Health Information in Research Form

• Notice of NYCHP Privacy Practices
• Acknowledgement of Receipt of Notice of Privacy Practices
• Documentation of Good Faith Efforts
• IRB Guidance on Research versus Educational Activity
• NYCHP HIPAA Authorization for Educational and Related Purposes
• Accounting of Disclosures for Research
• IRB Waiver of Authorization Form
• IRB Research on Decedent’s Information Without Authorization Form
• IRB Review Preparatory to Research Form (Clinic Workforce Version)
• IRB Review Preparatory to Research Form (NYCHP Affiliate-Outside Researcher Version)
• IRB Review Preparatory to Research Form (Non-NYCHP Researcher-Outside Researcher Version) – Request for IRB to Waive Patient Authorization
• 42 CFR Part 2 Addendum Form
• HIV Records Addendum Form
• Mental Health Records Addendum Form

 

UP/AE/SAE Reporting

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

• OHRP – Guidance
• FDA – Guidance

 

• Unanticipated Problems (non FDA research) are considered to include any incident, experience, or outcome that meets all of the following criteria:
  • Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related outcomes, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
  • Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research; and
  • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
• For FDA governed research, please note that the criteria of an Unanticipated Problem is slightly different.
• • Unexpected
  • Serious
  • Would have implications for the conduct of the study (e.g., requiring a significant, and usually safety-related, change in the protocol such as revising inclusion/exclusion criteria or including a new monitoring requirement, informed consent, or investigator’s brochure).
• Serious Adverse Events are defined as follows:
• • Death
  • Congenital Anomaly/Birth Defect
  • Hospitalization Required or Prolongation of a Hospitalization
  • Life Threatening Event
  • Significant or Persistent Disability/Incapacity

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:

• Unanticipated Problems and Adverse Event Report Form