FAQs

1. When is UM considered engaged in human subjects research, and what does that mean for IRB review?

UM is considered engaged when it is the primary awardee or when UM personnel interact with participants, obtain identifiable information, or obtain consent. When UM is engaged, UM IRB review or an approved reliance arrangement is required to ensure consistent participant protections. UM makes its own determinations for exempt research.

2. Does the intent to publish a Non-Human Subjects Research (NHSR) project mean that project is considered research?

No. Per OHRP, “the intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research.” Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may qualify as research even if there is no intent to publish the results.”

3. What if I need an official letter from the IRB letting me know I don’t need IRB approval?

If you need documentation confirming that your project did not require IRB approval, you must submit the project to the Human Subject Research Office (HSRO) inbox (HSROletterrequest@miami.edu) for an official determination providing an abstract and a completed certification (https://umiami.qualtrics.com/jfe/form/SV_9uwdrgzSWC9tiPY). HSRO can issue a written determination letter when a project is determined to be Not Human Subjects Research or otherwise does not require IRB review. Informal confirmation by the investigator is not sufficient for journals, sponsors, or funders. To avoid confusion, NHSR projects should not be referred to as research in publications and presentations.

4. What is the difference between Human Subjects Research, Exempt Research, and Not Human Subjects Research?

5. If my project does not need IRB approval (including QI and case reports), do I still need to submit supporting materials like consent forms for review?

HSRO does not provide a consent template for projects not deemed to be human subjects research. Most clinical consent forms may allow the use of non‑identifiable data or photos under the section for “educational purposes.” Please confirm with your department to ensure that such permission is included in their current consent form.

6. What happens if my project is truly research, and the project was not submitted to IRB? What if something changes and now it is research?

If the project was not assessed up front as research, the data may not be usable and journals/professional conferences may not accept the work.  If a NHSR project evolves into human subjects research, then the research will need to undergo IRB review through IBIS. A human subjects research application should be submitted before research activities take place. In your updated submission, standard care/processes, NHSR activities, and research components should be clearly distinguished.

7. I believe my study qualifies under one of the 8 categories of exemption. Do I have to submit to the IRB?

According to University of Miami policy, researchers are not permitted to self-exempt. Submission to the IRB in IBIS is required for initial review to confirm the exempt status of the study. Submit all participant facing materials to the IRB for review and approval. Some materials may be submitted later prior to use if they are not ready at the time of initial review (e.g., recruitment materials).

1. Who can serve as PI and manage study submissions?

Qualified investigators may serve as PI based on institutional criteria and role. Studies may be submitted and managed by the PI or an approved proxy, ensuring accountability throughout the research lifecycle. Eligibility exceptions are reviewed to maintain appropriate oversight. More information can be found in section 1.4 of our Investigator’s Manual.

2. Can an investigator(s) be a participant in their own study?

Investigators should avoid participating in their own research due to potential conflicts of interest and the risk of actual or perceived bias in overseeing their own participation.  If the study offers a prospect of direct benefit that would not otherwise be available to the PI, the situation will be referred to the IRB and institutional leadership for further evaluation.

3. What documents does the IRB review, and how should they be submitted?

The IRB reviews materials that directly relate to participant understanding and protection, including consent documents and patient-facing materials. Submissions should be clear, current, and include tracked changes for revisions. This approach supports efficient review and accurate communication with participants.  For data collection sheets, the IRB reviews only reviews these forms for retrospective studies only, not prospective.

4. What templates should I use for my protocol and consent?

Use the table below to identify the correct protocol template. Select the option that best matches your study design. 

 For additional guidance, investigators are encouraged to contact the Human Subjects Research Office prior to submission.* 

Use the table below to identify the correct consent template. Select the option that best matches your study design. 

 For additional guidance, investigators are encouraged to contact the Human Subjects Research Office prior to submission.* 

5. What format should I use for supporting materials in my IBIS submission?

Submit documents in Microsoft Word whenever possible. This allows HSRO staff to add comments and edits directly using tracked changes. 

1. Does my study require an IND or IDE, and when do exemptions apply?
   Your study requires an Investigational New Drug (IND) or Investigational Device Exemption (IDE) if it involves an unapproved drug or device, or an approved product used outside its FDA‑approved indication, population, dose, or route.

2. Is a separate consent document required if I plan to audio or video record research participants
   
   No. Florida law requires the consent of all parties to record audio when there is a reasonable expectation of privacy. This requirement may be met by including clear audio and/or video recording language in the main informed consent provided the consent form clearly explains that audio and/or video recording will occur, what will be recorded, and how the recordings will be used, stored, and protected. A separate consent may be used at the investigator’s discretion; however, this is discouraged for additional paperwork burden.

1. Why was my submission withdrawn, and what happens next?

Withdrawals are an administrative step used to pause review when required information, revisions, or approvals are incomplete or there the study team has not responded in a timely manner. Studies do not start over after withdrawal and return to the same reviewer once resubmitted. This process is not punitive; rather, it supports timely, thorough review and helps ensure participant protections are addressed before approval.

2. Should revised documents show track changes in modifications?

Yes. All revised documents must be submitted with tracked changes enabled. This allows HSRO and IRB staff to efficiently review updates. 

• HSRO‑returned documents will include tracked changes. 
• Keep Track Changes ON for all Word documents when resubmitting. 

Ensure that previous track changes are accepted and only applicable to the current modification request. 

3. I need to report something that happened during my study or new information. How do I do this?

RNIs include events or new information that may affect participant safety, rights, welfare, or research integrity. Any study team member may submit an RNI, but the PI is responsible for timely reporting. RNI reporting is not punitive and supports ongoing oversight and participant protection.

4. What is the difference between an RNI and a modification and when do they apply?

1. When is an institution considered engaged in human subjects research?

An institution is considered engaged in non‑exempt human subjects research when it is the primary awardee of externally sponsored funding or when its employees or agents interact with participants, obtain identifiable private information, or obtain informed consent for research purposes.

2. If UM is the primary awardee but all human subjects activities occur at another institution, is UM still engaged?

Yes. When UM is the primary awardee for non‑exempt human subjects research, it is considered engaged even if all human subjects activities are conducted by another institution. UM IRB approval or an approved reliance on an external IRB is required.

3. Does UM enter into reliance agreements for exempt research?

No. UM does not rely on external IRBs for exempt research. UM makes its own exempt determinations to ensure compliance with institutional policies and regulatory requirements.

4. What is ceded IRB review (reliance), and what is a reliance agreement?

Ceded IRB review, or reliance, is the transfer of IRB review and oversight responsibility from one IRB to another. This arrangement is documented through a reliance agreement (also called an IRB Authorization Agreement), which defines the responsibilities of each institution.

5. What is SMART IRB and how is it used?

SMART IRB is not an IRB. It is a national reliance platform and master agreement that facilitates and documents single IRB arrangements for multisite research, reducing the need to negotiate individual agreements for each study.

6. Who selects the single IRB for NIH‑funded multisite studies?

The applicant proposes the single IRB in the NIH application or proposal. Selection is typically based on the IRB’s expertise, capacity, or sponsor requirements.

7. How does the NIH single IRB policy apply to studies with both domestic and foreign sites?

For studies with both domestic and foreign sites, domestic sites are expected to rely on a U.S. single IRB. Foreign sites may use their local IRBs or ethics committees, consistent with NIH policy.

8. When may a site begin research when relying on a single IRB?

Local research activities may begin only after a reliance agreement is fully executed and the reviewing IRB has explicitly approved the site as a participating site.

9. Who is responsible for IRB oversight once a reliance arrangement is in place?

The reviewing IRB is responsible for regulatory IRB review and approval. The relying institution remains responsible for investigator compliance, institutional requirements, and local context obligations as defined in the reliance agreement.

10. How are amendments, continuing review, and reportable events handled under a single IRB?

All protocol modifications, continuing review submissions, and reportable events must be submitted to the reviewing IRB. The relying institution may also require notification to meet institutional or accreditation obligations.

11. Can local sites make changes to protocols or consent documents under a reliance model?

No. Only the reviewing IRB may approve changes to protocols or consent documents. Local sites may propose changes, but final approval must come from the reviewing IRB.

12. What local responsibilities remain with UM when relying on an external IRB?

UM remains responsible for local institutional requirements, including investigator qualifications, conflict of interest management, training requirements, and compliance with institutional policies.

13. Does reliance eliminate the need to submit information to UM during the conduct of the study?

No. Even when relying on an external IRB, UM may require submission of certain information to document oversight responsibilities, such as reportable events, external IRB determinations, or study status updates.

14. If an external investigator wants to recruit UM students or staff, is UM IRB approval required?

UM IRB approval is not required if UM is not engaged in the research. However, approval from other UM offices or departments may be required to permit recruitment activities on campus.

15. How is study closure handled when UM relies on an external IRB?

The investigator must provide documentation of study closure from the reviewing IRB. UM will document the closure in its records in accordance with institutional requirements.

16. Can I add an external collaborator to my study to share data?

Yes, but adding an external collaborator involves more than listing them on the protocol when data sharing or linkage is planned. The protocol must clearly describe the purpose of the collaboration, the data being shared, and how the data will be linked, secured, and used, applying the minimum necessary standard.

If identifiable data will be shared, IRB approval and appropriate data sharing agreements are required. Additional institutional requirements may also apply.

Investigators are encouraged to consult the following offices early to ensure regulatory, privacy, and data‑security requirements before sharing any data:

1. HSRO (IRB-related matters including reliance)
2. Office Research Administration (ORA)  - Clinical Trial Agreements (CTA), Memorandum of Understanding (MOU), in-bound Data Use Agreements (DUA) ONLY
3. Office of Technology Transfer – Material Transfer Agreements (MTA), outbound DUAs ONLY i.e. where UM (internal) data is being shared
4. Jackson Health System’s Office of Research Administration (ORA) -  (JHS studies)
5. UHealth Supply Chain – HIPAA Business Associate Agreements (BAA)
6. Research Privacy/Data Broker – General review & consulting on data sharing
7. UHealth Compliance/Privacy – Sharing of PHI , where it may also involve treatment and/or healthcare operations
8. Information Technology/Security – Technical assistance/methods for secure data sharing