Required Reviews and Approvals
- 1. When is IRB Review Required?
At UH, all activities that may qualify as human subjects research must be submitted to the UH Institutional Review Board (IRB). The IRB will make a determination of whether the activity requires IRB review. Anyone making Human Subject Research Determinations should be knowledgeable about the human subject protection regulations. The Office for Human Research Protections provides tools to help decide if an activity is research involving human subjects that must be reviewed by an IRB.
Let’s take a closer look by first answering the question: Are you performing research?
Research is defined as a systematic investigation designed to contribute to generalizable knowledge.
Then answer the question: Are you doing that research on human subjects?
The human subject must be a living, identifiable human being where an intervention or interaction is taking place between the researcher and that human subject OR if using their identifiable private information.
When those things exist together, that is when you need review and approval by an IRB.
What about Case Reports, Quality Improvement and Other Activities?
Case Reports typically highlight interesting treatment, presentation or outcome of medical information typically reviewed retrospectively, on no more than three patients. See the UH IRB Policy, Case Reports for more information.
If you want to present or publish Case Reports outside of University Hospitals or Case Western Reserve University, the case report mustbe submitted to the UH IRB for a determination.
Quality Improvement is generally limited to implementing a practice to improve the quality of patient care, and collecting patient or provider data regarding the implementation of the practice for clinical, practical or administrative purposes.
Other Activities That May Require IRB Review include ‘Exempt’ Research Activities
Exempt research activities still require a protocol for review, but if the activity is deemed “exempt” it will not require IRB oversight unless it is changed from its present form. UH IRB will require review every six years for exempt studies if still active.
See the UH IRB Policies Exempt Human Research and Case Reports for more information.
- 2. PHI for Research & Data Security
Protected Health Information (PHI) means information created or received by a UH entity related to (a) the past, present or future physical or mental health or condition of a patient; or (b) payment for the provision of health care to a patient that is transmitted or maintained in any form or medium. PHI contains identifiers, such as demographic or insurance information, medical record number, physician, admission date or photographic images, for which there is a reasonable basis to believe the information can be used to identity a patient. Any individually identifiable information of a person deceased more than 50 years is not PHI.
There are three reasons you may access PHI under HIPAA law:
If you are accessing patient information for RESEARCH purposes you MUST have either:
- An IRB-approved protocol that specifically states what information you are accessing and how any recorded data will be securely stored; or
- An approval from the UH privacy officer to access patient information for work preparatory to research (see UH Research SOP GA 102: Use and Disclosure of Protected Health Information Preparatory to Research).
If you are preparing a research protocol, developing a hypothesis or trying to identify prospective research participants, UH Research SOP GA 102 applies.
To determine if you have an appropriate population for your proposed research study, you can:
- Contact the UH Quality Center to obtain de-identified, aggregated data from inpatient visits
- Follow UH Research SOP GA 102 to obtain the specified data
To request aggregate feasibility numbers for a prospective study, email the research IT team with your need. The team will work with you to provide a general count of patients that fit the criteria of your study. (*No detailed patient information can be provided at this time). The team will also provide a lead time as to when you can expect that information.
Once you have determined that you are pursuing a study, please reach out again to the Research IT team in the pre-administration phase. This allows the team to guide you in designing the methods by which you handle the data before you present the study to an IRB.
Our research IT team will set up a time to discuss the study. In many cases we will involve UH Compliance and UH IT Security.
Security is involved to help determine if the methods of data collection, storage, transfer, remote storage and destruction are compliant with our internal corporate policy. Even if your data will be stored and managed by an external entity it is still governed by UH policy.
Later, upon IRB approval, we will work with the Enterprise Reporting Team to provide the data requested.
Research credentialing is required for all non-UH employees engaging in research at UH and must be renewed annually. For details on this process, refer to UH Research SOP GA 103: UH Research Credentialing.
Send completed form to ResearchIT@UHhospitals.org
- 3. Conflict of Interest (COI) Disclosure & Management
Follow UH Policy CE-8 and CE-20, which states that UH employees and affiliated physicians must disclose financial interests and other activities that may be perceived as a conflict of interest. This is critically important not only to the integrity of the research, but also to the trust established with study patients participating in research. Follow the guidelines for disclosure detailed in the policy. Requests to participate in outside activities are submitted through the COI Smart Application for review by the UH Compliance and Ethics Department in conjunction with the UH Research Center.
- 4. Contracts and Agreements
Which states that UH employees and affiliated physicians must disclose financial interests and other activities that may be perceived as a conflict of interest. This is critically important not only to the integrity of the research, but also to the trust established with study patients participating in research. Follow the guidelines for disclosure detailed in the policy. Requests to participate in outside activities are submitted through the COI Smart Application for review by the UH Compliance and Ethics Department in conjunction with the UH Research Center.
There are several very important concepts to be aware of:
- If you know that you are conducting research, then you will either need a contract or approval from the UH Institutional Review Board (IRB) to proceed without a contract.
- If you are not sure that the work you are doing qualifies as research, it is your responsibility to contact the UH IRB for a determination and approval to proceed.
- Principal investigators and other study personnel should never sign a contract or letter of agreement without approval from the UH legal department. If you have any questions about a document, please contact your grants and contracts representative who will determine if legal review is required.
- A contract is always required if you are sending UH data to any person or entity outside of UH.
If you want to send or receive data or are invited to participate in a study, be sure to think about these three questions.
- Is this clinical research?
- Do I need a contract?
- Do I have proper approvals in place to move forward?
- 5. Department Review and Additional Required Reviews
Departmental Review Committees are charged with reviewing research for scientific merit, rigor and integrity. Additionally, these groups review the research for protocol feasibility and resource utilization at a departmental and institutional level. This review must be completed prior to submitting the protocol to the IRB for review. See IRB Policy, Approvals Needed Before Submission, Appendix A-10 Departmental Review of Protocols, and Appendix A-11 Additional Required Reviews. Your study may require approval from Information Technology, the Law Department, Radiation Safety and other ancillary departments.
Keep in mind that all patient facing research materials must be submitted to the IRB for approval and all materials containing the UH logo must be approved by the UH Brand Center.
- 6. Coverage Analysis
Coverage analysis is a uniform method of analyzing the items and services provided in a research study to determine if the item or service can be appropriately billed to Medicare or other insurances. That determination is based upon national and local governmental guidance. National guidance is part of the CMS Clinical Trial Policy and details what trials are approved for coverage, what services in those trials are approved, and how to bill correctly for these services. Contact your research finance specialist and read Research SOP SP 202: Coverage Analysis & Clinical Budget Development Process Flow for more information and about your role in the process.
- 7. Submit to the FDA
Contact the Regulatory and FDA Support Core for help submitting your project to the FDA or help determining the type of submission required. The Regulatory and FDA Support Core provides comprehensive services to investigators across a full spectrum of activities to ensure success with required FDA submissions.
- 8. Submit to the IRB
Once you are ready to submit your study to the IRB, there are several options available to our researchers depending on the type of research that you are doing.
The UH IRB is the primary IRB for biomedical research, with three committees and weekly meetings. We also have a Reliant Review process which involves the UH IRB and other external IRBs that work together to oversee multicenter research with a more streamlined approach. We have agreements in place with other local and statewide IRBs for Reliant Review. In addition we have an agreement in place with Chesapeake IRB, an independent centralized IRB appropriate for industry sponsored, multi-centered studies.
All IRB submissions are completed electronically and you should see the respective webpages for more detail or contact the UH IRB.
Regardless of the IRB you use, the federal regulations that apply are the same:
- Under the U.S. Department of Health and Human Services and under which we have our federal wide assurance (FWA): a very important set of regulations that the IRB use to approve research.