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IRB and ERC Checklist: What to Submit

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  • IRB and ERC Checklist: What to Submit

Return to IRB Instructions
Return to ERC Instructions
Checklist for Annual/Continuing Review

 

EXEMPT REVIEW
ERC
EXPEDITED REVIEW
IRB
FULL REVIEW
IRB

ERC Application Form

The form is found on our ERC page

IRB Application Form

The form is found on our Forms & Instructions page.

IRB Application Form

The form is found on our Forms & Instructions page.

2 CITI Training certificates for principal investigator, co-investigator(s), sponsor/advisor and assistants

See our Mandatory Training policy.

2 CITI Training certificates for principal investigator, co-investigator(s), sponsor/advisor and assistants

See our Mandatory Training policy.

2 CITI Training certificates for principal investigator, co-investigator(s), sponsor/advisor and assistants

See our Mandatory Training policy.


Participant Letter

OR

Parental Participant Letter and Assent Letter/Script

Forms are found on our ERC page.

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

Consent Form

OR

Parental Permission Form and Assent Form/Script


Forms are found on our Forms & Instructions page.

Consent Form

OR

Parental Permission Form and Assent Form/Script


Forms are found on our Forms & Instructions page.

Permission letter for access to data or recruitment of participants (includes permission at Marywood University)

A template is found on our ERC page

Permission letter fo access to data or recruitment of participants (includes permission at Marywood University)

A template is found on our Forms & Instructions page.

Permission letter fo access to data or recruitment of participants (includes permission at Marywood University)

A template is found on our Forms & Instructions page.

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

A template is found on our Forms & Instructions page.

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.

A template is found on our ERC page.

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.

A template is found on our Forms & Instructions page.

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.

A template is found on our Forms & Instructions page.

Recruitment materials: Advertisements, brochures, flyers, e-mail solicitation messages or other recruitment materials (includes SONA ads).

See our Recruitment Policy.

Recruitment materials: Advertisements, brochures, flyers, e-mail solicitation messages or other recruitment materials (includes SONA ads)

See our Recruitment Policy.

Recruitment materials: Advertisements, brochures, flyers, e-mail solicitation messages or other recruitment materials (includes SONA 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:
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 Non-English Speaking Participants Policy.

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 Informed Consent Policy 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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