IRB Policies and Procedures

Policies and Procedures

ETSU Institutional Review Board for the Protection of Human Subjects Policy

HRPP Standard Operating Procedures Manual - August 2026

August 2026 HRPP SOP Manual - Substantive Changes

• Study Staff Training (SOP 100-40)

  • The PI is responsible for making sure the study staff have completed all required training (e.g., HIPAA, COI, GCP, etc.) before allowing them to engage in the research.
  • The HRPP will only be verifying CITI HSR training and other SOP required training (such as blood borne pathogen training when applicable) for study staff that require IRB oversight.
  • For HIPAA studies, the HRPP will no longer be verifying HIPAA training and will instead defer to the covered entity providing access to their PHI to enforce and verify training or other credentials before granting access.
• External Study Sites (SOP 300-30)

  • The IRB submission form will no longer require evaluation of performance site engagement for exempt studies and will require only a summary of where activities occur with appropriate documentation of site permission or support.
  • The SOPs now state that ETSU does not enter into reliance agreements for exempt studies.
• Exempt Study Review (SOP 300-40)

  • ETSU will no longer utilize limited IRB review for exemptions. If a study involves recording of sensitive, identifiable data where disclosure of the responses outside the research would reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation, it will not be granted an exemption.
  • Modifications are now only required to be submitted if the change is substantive and could alter the exemption status, risk assessment, or ethical considerations, or as specified in SOPs for specific changes. All changes must be documented in the study records and summarized at administrative check-in.
    1. Changes that would NOT require a modification include increasing the number of participants, adding/removing study staff (other than PI), correcting typos, adding survey measures that align with what was already approved, adding a recruitment method that uses the same approved message, etc. Changes like these can be implemented without IRB approval and should be documented in study records for disclosure at admin check-in.
    2. Changes that WOULD require a prospective modification approval include:
       1. Adding new identifiable data elements or access to new records or biospecimens
       2. Adding new performance sites or collaborating institutions
       3. Adding or changing study sponsors and/or funding sources
       4. Adding deception and/or incomplete disclosure
       5. Changing something that ultimately reduces privacy/confidentiality
       6. Bringing in HIPAA/FERPA applicability or other regulatory/legal/local-context concerns
       7. Adding any vulnerable, stigmatized, or marginalized populations
       8. Adding new methods of data collection (e.g., adding a focus group when the study was only approved for online survey)

  • If the PI is unsure whether a modification is or is not required, please reach out to the HRPP office for guidance.

  • Prospective participant agreement is generally required when the exempt study involves interaction with the participants, and written study details should be provided using a Participant Information Sheet or similar approach. We are moving away from calling this an ICD or consent, since informed consent is a regulatory requirement for non-exempt research only. Sample information sheets and a list of required content have been published here, but there will not be a standardized template.
    • Exempt studies do not have to comply with regulatory requirements for Parental Permission, and the IRB will not require written parental permission for every exempt study. There is more flexibility for exempt studies and how they involve parents or caregivers.
  • If a study needs a robust informed consent process to be considered ethical and approvable, it is not eligible for exemption.
• New SOP- §46.118 Designations for Grant Applications (SOP 300-50)

  • HRPP staff may review and grant 118 Determinations (45 CFR 46.118) for federally sponsored studies that lack definite plans for human subjects involvement and need documentation to proceed with account set up and study initiation. It confirms the institution's awareness of potential human subjects research but does not authorize any research activities or interactions/interventions with human subjects until IRB review and approval are obtained.

   
• New SOP – Criteria for IRB Approval (SOP 400-10)

  • Instead of repeating the IRB Approval Criteria throughout SOPs, this section details what the IRB considers to make determinations about approval, requested changes, etc.
  • The SOP now specifically requires justification when intentionally excluding vulnerable, stigmatized, or marginalized populations that would otherwise be eligible for a study such as excluding non-English speakers or pregnant people. Lack of resources, inconvenience, or doing so just to avoid compliance are not sufficient justifications.
• Continuing Review and Administrative Check-In (SOP 400-40)

  • For exempt studies where the admin check-in goes 60 days past due, the study will be administratively closed.
  • For non-exempt studies with admin check-in that goes 60 days past due, the incident will be referred for noncompliance with the IRB, and the IRB may revoke the admin check-in and require continuing review or other appropriate CAPA plan. If an investigator demonstrates a pattern of failure to submit timely admin check-in (or continuing review), it would be an example of continuing noncompliance.
  • Studies that go before the full board for initial review, even if ultimately determined to be minimal risk, must undergo full board continuing review for the first year (unless there hasn’t been any enrollment).
  • Continuing review is required for studies that involve biobanking or repositories and ETSU as IRB for external sites.
• Humanitarian Use Devices (HUDs) (SOP 400-100)

  • HUD treatment protocols that take place at Ballad Health are to be reviewed by the BH IRB. If the HUD is being used for research, it’s subject to ETSU IRB approval similar to any other clinical device investigation.
• Recruitment of Research Participants (SOP 600-10)

  • Submissions must justify four or more attempts to directly contact individuals for recruitment. Frequency and number of attempts must be described in the submission.
  • Submissions must detail plans for accessing PII/PHI for recruiting, recording identifiers during recruitment and maintaining lists of those that declined, and what will be done with the PII/PHI when it’s no longer needed for recruitment. Information obtained or recorded during recruitment and eligibility cannot be used for research without consent.
• New SOP - Electronic Signatures for Informed Consent (SOP 600-40)

  • This SOP establishes the expectations and requirements for legally effective and compliant electronic informed consent (eIC). Consent processes that do not use a legally effective electronic consent process must request a waiver of documentation of consent (e.g., using an “I agree” button).
• Study Staff Role Definitions and Oversight (SOP 700-10)

  • The SOP has incorporated definitions for study staff role types based on what we have historically used in OneAegis including Principal Investigator, Co-investigator, Research Assistant, and Coordinator. Faculty Mentor was already defined and generally remains the same. Consultant is not defined and is being removed as an option in OneAegis.
    • The SOP includes PI eligibility requirements that should be confirmed by the Faculty Mentor or Department Head signatory during their review.
  • The SOP has implemented a stratified approach to approving study staff on an individual study basis:
    1. Exempt studies only need to identify a PI (and Faculty Mentor) in OneAegis, and PIs will be responsible for having a study staff delegation log on file that lists all study staff, their roles, training dates, and COI disclosure forms, as appropriate. Records are subject to audit. Exempt study staff will not have to be listed or approved in OneAegis any more. There is an option to identify a Research Coordinator for OneAegis access to submit and receive notices on behalf of the study team.
    2. Expedited studies must only list study staff involved in delivering a study intervention. This allows the IRB to confirm that they qualified to carry out the intervention such as blood draws, behavioral therapy, administration of drugs, etc. PI is responsible for tracking all study staff in their record using a delegation log similar to exempt. Records are subject to audit.

  • Full board studies require all study staff be identified in OneAegis and receive prospective IRB approval.

  • Submissions will continue to require the name and role of each person delegated to obtain informed consent, a general explanation of how the study staff is sufficient to conduct the study, and the PI to study staff communication plan.
• Emergency Use of an FDA-Regulated Test Article (SOP 700-40)

  • Emergency use protocols are expected to go through the IRB of the facility where the treatment takes place, and the ETSU IRB will review these if conducted in an ETSU facility.
• Noncompliance in Human Research (SOP 800-10)

  • Conducting research without IRB approval is serious noncompliance. This includes conducting research that would have been eligible for exempt status without prospective IRB review.
• New SOP – Sponsored Human Research (SOP 800-60)

  • Any study sponsor, funding arrangement, or contract/agreement must be reported to the HRPP to provide sufficient information to ensure regulatory compliance and allow the HRPP to confirm that the terms are consistent with the submission and meet program accreditation standards as applicable.