Guidance on Not Human Subjects Research Determinations

Purpose: to provide answers and general guidelines for frequently asked questions (FAQs) about ��Ƶ projects that involve the collection and/or analysis of data from living human individuals

Scope: this guidance applies to projects undertaken by all investigators affiliated with ��Ƶ, including faculty, staff, and students at all ��Ƶ campuses

What is a “Not Human Subjects Research Determination?”

When appropriate, the Office of Research Compliance (ORC) may provide a “not human subject research (NHSR)” determination. But what does this mean?

Simply, it means the ORC has determined that the project does not require further review or oversight by our office or the Institutional Review Board (IRB) because at least one of the following characteristics applies:

The project does not meet the federal definition of research, which is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

The project does not meet the federal definition of human subjects. According to federal regulations, a human subject is a living individual about whom an investigator conducting research:

Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

What Are Some Examples of Projects that May Not Be Defined as “Research?”

Literary Criticism

Biographies of single individuals

Legal research

Public health surveillance

General historical scholarship about individuals who are dead

Journalistic activities that focus on specific individuals and that do not intend to generalize to a larger population beyond the site of data collection or the specific subjects studied

Oral history interviews that are not part of a larger project to draw generalizable conclusions about a group or population through systematic investigation

A project interviewing three or fewer individuals may qualify as a case study and be eligible for a not human subjects research determination on that basis.

A project using oral history as the methodology to produce a study of a single individual may be eligible for a not human subjects research determination because it could be a biography focused on the specific individual about whom the information was collected.

If the activity involves collecting and using information about individuals for the purpose of drawing generalizations about such individuals or a population of which they are members, then the activity likely does not qualify for a not human subjects research determination, based on the revised Common Rule’s definition of “research.”

Program evaluations or quality improvement projects that seek only to assess the effectiveness of a program and are not designed to attempt to draw conclusions about similar programs or program participants elsewhere

Case studies of three or fewer patients

Personal ethnographies or autobiographies of individual investigators in which the investigator is only using personal recollections and not interviewing or soliciting information from other people

What Does “Generalizable” Mean?

A key part of the federal definition of research is the word “generalizable.” This is not defined in the federal regulations and different universities may offer different guidance about how to interpret the term. At ��Ƶ, we describe “generalizable” projects as studies that are designed and conducted with the intention of 1) drawing conclusions that have some general applicability1 and/or 2) applying the findings to populations beyond the subjects enrolled.

Another way to think about the question of generalizability is whether one intends to contribute to larger scholarly conversations about a topic. For example, an ��Ƶ program evaluation collecting data about a local program but also framing its conclusions in terms of how other similar programs elsewhere should change based on its results would probably be determined to be “research.”

When Does a Project Involve “Human Subjects?”

If the project is research, then the ORC evaluates whether:

Is there an interaction or intervention between the researcher and the individual?

Does the project involve the collection or use of private identifiable information or biospecimens?

If neither of these are true, then the project likely does not involve human subjects.

My Project is Only an Anonymous Survey, so Do I Have Human Subjects?

“Interaction” does not need to be direct. Online anonymous surveys, for example, often disseminate a survey link and survey respondents can complete the survey without ever talking to or communicating with the researcher. However, this is still considered an interaction under the federal definition of human subjects.

My Project is Only a Secondary Analysis of Existing Data, so Do I have Human Subjects?

It depends. Using existing records can mean that human subjects are involved if the records include identifiable information, or if a combination of data about specific variables could allow an investigator to reidentify living individuals. For example, if an investigator accesses and analyzes a dataset with information about very specific demographic characteristics of a group of people from a sparsely populated area or limited population, it is quite possible that the investigator could reidentify the people who provided the original data, even if no direct identifiers such as names were included with the dataset. If an investigator planned to reuse a dataset about ��Ƶ faculty that included job titles, departments, and courses they had taught in the last five years, this would likely allow the investigator to reidentify individuals, and a project of this kind would likely be determined to involve human subjects by the federal definition. Accessing records that contain identifiable or potentially identifiable information, even if you do not plan to record any of the identifiers, does constitute the involvement of human subjects.

The ORC may determine that a project does not involve human subjects if a researcher receives a truly anonymous/deidentified data set, if the data 1) never had identifiers 2) has had all identifiers removed and, if a master code linking the data to identifiers exists, the researcher cannot access this code and/or 3) the data is truly publicly available to anyone but includes identifiers.

Does my Project Really Have “Human Subjects” if I’m Asking for Information that Isn’t About People?

It depends. If you are interviewing people to gather information about something other than the individuals themselves, your project may not be about “human subjects.” An example of this kind of scenario would be interviewing a small group of employees to gather information about their organization’s policy on a particular topic. In this scenario, questions framed like “What is your organization’s policy on parental leave” would probably not lead to a project being deemed to include “human subjects.” However, if a question were reframed as “What do you think of your organization’s policy on parental leave,” then that is a question about the interviewee and not a question about the organization -- and would likely lead to a project determined to include “human subjects.”

I’m Only Using Posts from Social Media, so Does My Project Really Have “Human Subjects?”

It depends. Projects that only involve the passive collection and analysis of publicly available social media posts would most likely be deemed as “not human subjects research,” because investigators with these kinds of projects are not interacting or intervening with the people who created the posts or accessing “private” information per the federal definition of human subjects. However, if an investigator is also proposing to interact with people on social media or to access posts that are not “public” – for example, posts from a private Facebook group or a “secret” subreddit - then that investigator is likely planning a project that would involve human subjects.

I Don’t Think My Project is Research with Human Subjects. Do I Have to Submit Anything in Cayuse?

��Ƶ faculty, staff, and students are not required to obtain a “not human subjects research” determination. However, you may request one in Cayuse Human Ethics. Students working on class projects should not submit in Cayuse for a “not human subjects research” determination unless their course instructors specifically advise them to do so.

If submitting for a “not human subjects research in determination” in Cayuse, read the questions in Section 1 of the “Initial Submission” form carefully and provide an explanation as to why the project either 1) does not meet the definition of research or 2) does not meet the definition of human subject. Please include details about the intent and scope of the project and, if applicable, the source and original collection (research, non-research) of the de-identified data to be used. If someone holds a key code linking data to identifiers, please state who holds the key and attest that no Ohio researchers will have access to it. Letters of support from the data owner may be requested at the discretion of the ORC.

Journals and conference organizers may request a copy of a formal NHSR determination before accepting a manuscript or presentation. The ORC cannot issue a “Not Human Subject Research” determination if a project has already been completed. Likewise, the IRB cannot review or approve a project that has already been completed. Investigators who foresee the potential need for formal NHSR determination are therefore strongly advised to submit for an NHSR determination before beginning a new project.

What Else Should I Keep in Mind for a Project that is “Not Human Subjects Research?”

Even when the project does not meet the federal definition of research, certain ethical best practices should still be followed. If you will be interacting with individuals (for example, a survey that will be used to conduct a program evaluation), a clear explanation of the project should be provided, agreement to participate should be obtained, and appropriate provisions for confidentiality should be used. If ORC has determined that the project does not meet the definition of research, the word “research” should not be used in the project materials.

Other regulations and institutional policies may still apply to your project, for example, FERPA or HIPAA regulations. The ��Ƶ Privacy Office is available should you have questions that are beyond the purview of the ORC.

Can I Still Publish or Present My Findings if My Projects Receives a “Not Human Subjects Research Determination?”

Yes, you can present or publish findings from a project that received a not human subjects research determination. If the project received the NHSR determination on the basis that it did not constitute “research” by the federal definition, presentations or publications must clearly describe the purpose of the project as something other than research (quality improvement, program evaluation, etc.) and avoid drawing generalizable conclusions.

What is the Difference between an “Exempt” Protocol and a “Not Human Subjects Research” Determination?

A “Not Human Subjects Research” determination means that the ORC determined the project as it was described in the original submission did not constitute human subjects research by the federal definition. An exempt protocol does involve human subjects research and involves study procedures that fit into one or more of the federally defined exempt categories.

I Am Changing Something About a Project that Received an NHSR Determination; Do I Need to Submit Anything in Cayuse?

Projects that receive NHSR determinations in Cayuse, but that are being modified in ways unrelated to the definitions of human subjects research, do not require investigators to submit a modification in Cayuse. An example would be a program evaluation project that is adding a new staff member as an investigator. However, if the investigator were proposing a change to a project that could mean it would no longer be eligible for an NHSR determination, then the investigator should submit a new protocol in Cayuse for review. An example of a change that would necessitate a new submission in Cayuse would be if a study team wanted to use data from such a program evaluation project in a new way that would be potentially generalizable going forward.

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