Waiver of Documentation for Informed Consent


A waiver of documentation of informed consent is a request whereby a signed consent document is not required. Examples include online, verbal, and implied consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form. There are three circumstances when the IRB may waive the requirement to obtain a signed consent form:
The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she want documentation).
The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews).
The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm and the research presents no more than minimal risk of harm to subjects

PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.
 

 
 

FAQs

How do I obtain Ideate access?

Account access?

Email ideate@cuny.edu the following information:

(1) Full Name
(2) CUNY campus and affiliation (faculty/adjunct faculty/full-time staff/post-doc student)
(3) CUNY email address
(4) CUNY PORTAL username (NOT CUNY FIRST)

Technical issues?

Email ideate@cuny.edu and include screenshots as appropriate.

Include in your email:
PI name, submission type, study title, protocol number, description of issue.
 

When should I submit my research proposal to the HRPP?

Exempt or expedited review and approval: 30 - 45 days before you intend to start your research.

Convened/full IRB review (Greater than minimal risk research): at least 90 days before you intend to start your research.

Who are vulnerable populations in research?

Minors (children under 18 years of age), wards of the state, prisoners, fetuses, pregnant women or individuals that have a diminished mental capacity are considered vulnerable subjects. 

What are the CITI education requirements?

  1. Basic course: All key personnel involved in human subjects research must complete the CUNY-­‐required modules of the CITI on-­‐line training in the protection of human subjects (basic course) prior to IRB approval of a new or continuing review application, or an amendment application that requests addition of key personnel.
  2. Refresher Course: On-­‐line training certificates will be valid for three years. Key personnel are required to take the CITI training in the protection of human subjects (refresher course) every 3 years following completion of the basic course.
  3. Key personnel are defined as the Principal Investigator, co-­‐investigators and research personnel who interact directly with human subjects or who have access to private information related to human subjects during the course of a research project. Key personnel also include faculty sponsors /advisors who provide direct oversight of research with human subjects or research using private information about human subjects.
  4. ALL research personnel must provide an active HSR CITI completion certificate in each application. Upload certificates as evidence of completion to the Attachments tab in Ideate and label documents as CVs.

Who can act as the Principal Investigator (PI)?

  1. Full time CUNY faculty and staff and Research Foundation-CUNY staff
  2. Adjunct faculty
  3. Students and postdoctoral scholars (You must have a faculty member listed on the project as an advisor)

When is CUNY considered engaged in research?

CUNY is considered engaged in a particular human subjects research project when CUNY employees or agents obtain, for the purposes of the research project, (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

Is my project Human Subjects Research?

Use this checklist to determine if you require IRB review.

HSR Determination Checklist

Are there consent form templates?

Yes. Whether it is the standard documented consent, parental permission, child assent, or oral consent, there are CUNY templates to please use. These templates include the required elements of consent and institutional language that needs to be stated.

Unless discussed with the HRPP Director to use another form, please refer to these consent form templates for your project.

What is Ethnography?