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Checklist for Annual/Continuing Review

 

EXEMPT REVIEW
ERC
EXPEDITED or FULL REVIEW
IRB

ERC Application Form

IRB Application Form

2 CITI Training reports (modules shown) for principal investigator, co-investigator(s), sponsor/advisor and assistants; See our Mandatory Training policy.

  • Human Research Course
  • Responsible Conduct of Research Course

2 CITI Training reports (modules shown) for principal investigator, co-investigator(s), sponsor/advisor and assistants; See our Mandatory Training policy.

  • Human Research Course
  • Responsible Conduct of Research Course

ERC Informed Consent Form (formerly called Participant Letter)

Note: Prisoner research may never be exempted; research involving children
(under age 18) usually does not qualify for exemption due to regulatory exceptions to interview, survey or observational research where investigators are involved in activities.

IRB Informed Consent Form or Legally Authorized Representative Informed Consent Form

Children: IRB Parental Permission Form and Assent Form/Script (if applicable)

Permission letter: Recruitment or access to data (includes Marywood University)

Permission letter: Recruitment or access to data (includes Marywood University)

Survey instruments, interview questions or data collection forms; include reliability and validity and rationale for selection of standardized instruments

Survey instruments, interview questions or data collection forms; include reliability and validity and rationale for selection of standardized instruments

For researcher-developed instruments or questions, evidence of review by 1 professional in the field of study

Note: Professional must have a Master's degree or higher and not be affiliated with the study (e.g., advisor, serving on thesis or dissertation committee, etc.).

For researcher-developed instruments or questions, evidence of review by 1 professional in the field of study

Note: Professional must have a Master's degree or higher and not be affiliated with the study (e.g., advisor, serving on thesis or dissertation committee, etc.).

Recruitment materials (advertisements): Flyers,  e-mail solicitation messages, brochures, social networking or website posts, or other recruitment materials (includes SONA system ads) - See our Recruitment Policy.

Recruitment materials (advertisements): Flyers,  e-mail solicitation messages, brochures, social networking or website posts, or other recruitment materials (includes SONA system ads) - See our Recruitment Policy.


If research includes an international population:

Please see our International Research Policy. International research may only be exempt if it meets exemption criteria.


If research includes use of documents written in a language other than English:

After the English versions have been reviewed by the IRB or ERC and appropriate modifications have been made and approved, the documents in the 2nd language and certification from an independent translator indicating that materials are an appropriate translation of the approved English versions;
See our Non-English Speaking Participants Policy.

For full or expedited only, if research includes no consent form signature, an alteration of any elements of informed consent (e.g. for deception research), or no consent form:
Include the appropriate waiver request form, either a Waiver of Documentation of Informed Consent or Waiver or Alteration of Informed Consent.
See our Informed Consent Policy for full details.


If research involves obtaining Personal Health Information (PHI) from a HIPAA covered entity:

A HIPAA authorization form to be signed by the participants for research use/disclosure, OR evidence of a waiver of the authorization for research use/disclosure by the organization's privacy board or IRB, OR a request to waive authorization by our IRB. If you are working only with existing records, you may also enter a data use agreement with the organization for use of a limited data set (restrictions apply). See the
Department of Heath and Human Service's Health Information Privacy web page for details about HIPAA and research.

 

 

ANNUAL/CONTINUING REVIEW
ERC or IRB Annual/Continuing Review Request Form
Clean copies (not stamped) of the most recently approved versions of informed consent or participant letter,
parental permission, assent forms/scripts, HIPAA forms, waiver requests and any advertisements.
Additional documents are not needed if ONLY data analysis is taking place and nothing else has changed since the last approval.
Any new documentation or additions (e.g.new tools or forms, new co-investigators or assistants with respective training certificates, etc.)