Non-Human Subject Research Review Request
A project that does not meet the definition of human subject research is not regulated or overseen by the IRB.
The University of Rochester IRB reviews projects conducted at the University of Rochester and its affiliates when they involve human subjects research, as defined by either FDA or DHHS regulations – regardless of funding source. Projects that do not meet either of those definitions are considered Non-Human Subject Research (NHSR).
If you wish to secure a formal determination of Non-Human Subject Research from the IRB, you must submit a Non-Human Subject Research request. If OHSP agrees that the project meets the non-human subject research criteria, you will be issued an NHSR determination letter. This is a good option if you are not sure whether your project is human subject research, and/or to provide documentation of IRB review for any future publications. The only way for the IRB to document an NHSR determination is via a determination letter once an application has been submitted.
Submitting an NHSR Request
If the PI believes the study does not meet, or may not meet, the definition of human subject research, a request for NHSR review should be submitted. To do this, use the Click IRB system and create a New Study application. Rather than attaching a protocol, complete the NHSR Review Request form. Attach the PDF version of the completed NHSR Review Request form in question #8 “Attach the protocol”. You do not need to attach a separate protocol. Continue through the Click application and “Submit” the application once completed.
The NHSR determination can be made based upon information in the NHSR Review Request form or based upon the information in the New Study application. If the PI is unsure whether the study will be considered NHSR or Exempt (for example), if a full protocol using the exempt template is submitted, the project will be reviewed based upon the standard human subject research definitions, regardless of the format in which it was submitted.
What does it mean if the study is determined to be NHSR?
If OHSP makes a Non-Human Subject Research determination, this means the IRB has no authority over that project. As such, the project is not subject to IRB policies. Therefore, the person who submits the NHSR application does not need to meet the PI eligibility criteria for IRB review, and an NHSR application can be submitted by anyone affiliated with URochester.
The NHSR determination relates to the specific project details, not the individual who submits it. This also means that CITI training is not required in order to conduct Non-Human Subject Research. The application does not need to include all study team members; however, ensure that the PI Proxy and main contact are added, if applicable.
No modifications will be accepted for studies that are determined to be NHSR. The IRB does not have authority over NHSR projects, so it is not necessary to update the application. However, if the change may turn the project into human subject research, a new study application should be submitted to ensure appropriate review is conducted.
What are some examples of Non-Human Subject Research?
Projects that involve the following in the drop-downs below are Non-Human Subject Research, so long as the project does not involve:
- A systematic investigation designed to develop or contribute to generalizable knowledge using human subjects, or
- A clinical investigation.
Additionally, the use of existing de-identified or publicly available datasets may not be considered human subject research.
Examples of non-human subject research
DHHS regulations do not apply to QI activities whose purposes are limited to “(a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes.”
These interpretations may be extrapolated to QI activities conducted in non-healthcare settings such as education, academia, or community.
If a project is originally initiated as a local QI project but the findings are of interest and the project investigator chooses to expand the findings into a human subjects research study, IRB review is required at that time.
The case report may only include three or fewer patients and cannot include any procedures conducted with prior research intent.
The author of the case report must protect the confidentiality of the patients. Waivers of authorization must be obtained, as necessary. Some journals may require documentation of consent by the patient.
Program evaluation is a systematic method for collecting, analyzing, and using information to answer questions about projects, policies, and programs, particularly about their effectiveness and efficiency. Findings are expected to direct improvements to the program or project, rather than contribute to generalizable knowledge, and so do not meet the definition of research.
Internal management projects, market evaluations, competitive analyses, and analyzing aggregated or fully anonymized customer data fall outside the scope of IRB review.
Many internal business analyses are designed for a specific company or local market decision rather than to expand universal scientific or academic knowledge.
Class projects designed for educational purposes that teach research methods or demonstrate course concepts do not meet the definition of research. The activities take place within the term of the course and are not intended to create new knowledge or contribute to generalizable knowledge. Instructors have an obligation to ensure students involved in course projects meet professional and ethical standards.
Public health surveillance activities conducted, authorized, or ordered by a public health authority are not human subject research. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.
“Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected” and not on generalizing the information or findings to other individuals have been “deemed not to be research” when all conditions are met. [45 CFR 46.102(1)(1-4)]
“OHRP draft guidance explains how scholarly and journalistic activities must be conducted solely for the primary intent of the activity in question to not be considered human subjects research. For example, an oral history project being done solely for collecting oral history interviews for archiving in a repository to be made available to the public for future use and historic preservation would not be considered research. However, a project that is designed to contribute to generalizable knowledge that happens to involve the use of oral histories and is being conducted for both purposes (i.e., contributing to generalizable knowledge and collecting oral history interviews), whether the interviews will be deposited into an archive, may still meet the definition of research and require IRB review (DHHS, 2018a)”.
I intend to publish the results. Does that mean that my project is research?
The intent to publish does not necessarily mean that the project fits the definition of research. While results from a non-research project may be published, the term research should not be used in the publication. An alternative would be to call the activity “quality improvement initiative” or “program evaluation.”
What are the expectations when conducting a project that is Non-Human Subject Research?
Researchers are expected to adhere to ethical principles for non-human subject research projects, including the following when appropriate:
- Sound design and procedures: Good design ensures that the research produces valid, reliable, and interpretable results. Poorly designed studies can lead to misleading conclusions, even if the project is considered non-human subject research.
- Informed consent: Although an activity may not constitute human subjects research, the University of Rochester expects that consent will be obtained when appropriate. The consent document should not use the word “research.”
- Privacy and confidentiality protections: Projects using protected health information (PHI) must still follow HIPAA regulations for authorization and confidentiality protection, including projects using PHI about non-living individuals.