IRB and ERC Checklist: What to Submit

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IRB and ERC Checklist: What to Submit

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Checklist for Annual/Continuing Review

EXEMPT REVIEW ERC	EXPEDITED REVIEW IRB	FULL REVIEW IRB
ERC Application Form	IRB Application Form	IRB Application Form
2 CITI Training certificates for principal investigator, co-investigator(s), sponsor and assistants	2 CITI training certificates for principal investigator, co-investigator(s), sponsor and assistants	2 CITI training certificates for principal investigator, co-investigator(s), sponsor and assistants
Participant Letter OR Parental Participant Letter and Assent Letter/Script Note: Research w/ prisoners may never be exempt; research w/ minors is rarely exempt.	Consent Form OR Parental Consent Form and Assent Form/Script	Consent Form OR Parental Consent Form and Assent Form/Script
Permission letter for access to data or recruitment of participants (includes permission at Marywood University)	Permission letter fo access to data or recruitment of participants (includes permission at Marywood University)	Permission letter for access to data or recruitment of participants (includes permission at Marywood University)
Survey instruments, interview questions or data collection forms; include rationale for selection of standardized instruments	Survey instruments, interview questions or data collection forms; include rationale for selection of standardized instruments	Survey instruments, interview questions or data collection forms; include rationale for selection of standardized instruments
UPDATED 12/19/2012: For researcher-developed instruments or questions, evidence of review by 1 professional in the field of study; Professional must have a Master's degree or higher, must not be the sponsor/advisor, and must not serve on the thesis or dissertation committee.	UPDATED 12/19/2012: For researcher-developed instruments or questions, evidence of review by 1 professional in the field of study; Professional must have a Master's degree or higher, must not be the sponsor/advisor, and must not serve on the thesis or dissertation committee.	UPDATED 12/19/2012: For researcher-developed instruments or questions, evidence of review by 1 professional in the field of study; Professional must have a Master's degree or higher, must not be the sponsor/advisor, and must not serve on the thesis or dissertation committee.
Recruitment materials: Advertisements, brochures, flyers, e-mail solicitation messages or other recruitment materials (includes SONA ads).	Recruitment materials: Advertisements, brochures, flyers, e-mail solicitation messages or other recruitment materials (includes SONA ads)	Recruitment materials: Advertisements, brochures, flyers, e-mail solicitation messages or other recruitment materials (includes SONA ads)
If research includes an international population: Please see our policies and procedures about international research. International research may only be exempt if it meets exemption criteria.
If research includes use of documents written in a language other than English: Once 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; Please see our policies and procedures about non-English speaking participants.
If research includes no consent form signature (expedited or full only), an altered consent form 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 policies on Informed Consent for full details.
If research includes use of Personal Health Information (PHI) by a covered entity: the covered entity's HIPAA form, or a waiver request in accordance with HIPAA rules, shown on the Department of Heath and Human Service's Health Information Privacy webpage

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 consent, 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.)

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