This information is collected because it is important for documentation purposes, as a certification letter will available if the project does not constitute research requiring IRB review. The certification can be saved and printed for your records. The certification can also be given to individuals requesting documentation that IRB review of the project is not required (e.g. individuals providing data for the project, funding sources, Research & Sponsored Programs, journal editors, etc.) so the information provided here should include sufficient detail such that the certification can be matched to the project.
Project Information Collected
- Name of Project Lead/Investigator
- Title of Project
- Brief Description of Project/Goals
- College/Center through which the project will be conducted
Q1: Will the project involve testing an experimental drug, device (including medical software or assays), or biologic?
The Research Decision Tool is based on the definition of research pursuant to the Common Rule (45 CFR 46.102(d)). The purpose of this question is to determine whether federal regulations beyond the Common Rule, such as FDA regulations, need to be applied to a project. If the answer to this question is “Yes,” IRB review is likely required. Please contact the IRB for additional guidance.
Q2: Has the project received funding (e.g. federal, industry) to be conducted as a human subjects research study?
The purpose of this question is to determine whether the project has received funding to be conducted as a research study and not, for example, quality improvement or program evaluation. If you are unsure, consider contacting your program officer for the funding or funding entity to determine whether the funding source requires a specific level of IRB review and oversight. If the funding source considers the project to constitute human subjects research, this MUSC IRB QI/Program Evaluation Self-Certification Tool is not a sufficient indicator of whether IRB review is required. If the answer to this question is “Yes,” IRB review may be required. Please contact the MUSC IRB for additional guidance.
Q3: Is this a multi-site project (e.g. there is a coordinating or lead center, more than one site participating, and/or a study-wide protocol)?
This question is intended to determine whether the project is limited to local activities or whether multiple sites are conducting the same activities. The latter is an indication that the results may be generalizable. If multiple institutions are conducting the activities, it’s less likely that the outcomes will be used for quality improvement or program evaluation at the local institution. As a result, for multi-site projects, this MUSC IRB QI/Program Evaluation Self- Certification Tool is not a sufficient indicator of whether IRB review is required. If the answer to this question is “Yes,” IRB review may be required. Note that, in some cases, MUSC personnel work with a community partner on a local QI/program evaluation project; in these instances, a “not research” determination may still be applicable. In this case, please contact the MUSC IRB for additional guidance.
Q4: Is the primary intent to conduct a systematic investigation designed to contribute to generalizable knowledge (e.g. testing a hypothesis; randomization of subjects; comparison of case vs. control; comparative effectiveness research; or comparable criteria in alternative research paradigms)?
The focus of this question is to evaluate the primary intent and design of the project.
- Simply publishing or presenting the results of a QI project does not make it research. The key question is what the primary intent of the project is from the outset. If the primary intent of the project is not generalizability (e.g., it is program evaluation/practice improvement related to a specific initiative) OR the project is not designed in a way that the findings would be generalizable (i.e., limitations to project design), then the answer to this question is "No".
- The design of the project plays a key role in determining intent. If the project is standardized using systematic research methodologies with strong external validity in order to obtain reproducible results, then it would be considered research. If the intended outcome is simply to report on what happened at the institution/program, this does not indicate research design or intent as it may or may not be generalizable outside of the institution.
Q5: Will the results of the project be published, presented or disseminated outside of the institution conducting it?
The purpose of this question is to determine whether, at the outset of the project, the intention is to disseminate results outside of the institution or program conducting the project. If there is no intention for disseminating results outside of the institution or program conducting the project, the answer should be “No”. Lack of dissemination of information is generally a strong indicator that a project does not constitute research. If there is a potential for results to be disseminated outside of the institution or program conducting the project, then the answer is “Yes”. Note that program evaluation and QI projects can be published or presented, but they should not be described as research studies. Squire Guidelines provides additional information
Q6: Is the project intended to improve or evaluate the practice or process within a particular institution or a specific program?
If the intention upon designing and conducting the project is not to improve or evaluate a specific practice/program, then the answer should be "No" which indicates research intent and IRB review is likely required.
This question is also trying to identify the specificity of a project, hence the use of “particular institution” or “specific program”. If it is being conducted in a multi-site context with a common protocol across sites, then the results could be generalizable and thus constitute research. In this case, the answer should be "No" which indicates research intent and IRB review is likely required.
Depending upon your responses, you may receive the following results:
- “STOP HERE. IRB review is likely required. Please access the MUSC IRB website or call 792-4148 if additional assistance required.”
This result means that the questions were answered in such a way to indicate that the project may constitute research requiring IRB review. For additional guidance, review HRPP 3.8 Quality Improvement Projects Policy and Procedures, which provides a more comprehensive description of the differences between research, QI and program evaluation. If this additional resource does not help answer the self-certification tool questions in a way that indicates the project is not research, please contact the MUSC IRB for additional assistance.
If no “STOP HERE” message appears
IRB Review is not required because, in accordance with federal regulations, your project does not constitute research as defined under 45 CFR 46.102(d).
This result means that the questions were answered in such a way that the project does not constitute research requiring IRB review and oversight. Please print a copy of your survey responses and determination letter to save with your files, as it serves as documentation that IRB review is not required for this project. If publishing or presenting the results of this project in future, please ensure it is not classified or identified as a research study. Finally, if the project changes in any way that might affect the intent or design, please complete the MUSC IRB QI/Program Evaluation Self-Certification Tool again to ensure that IRB review is still not required.