Chapter 2 – Think About the Purpose of Your Project
Think about the purpose of your project so that you can help determine whether you are performing human subjects research.
- Question 1 – Is it Research?
- Question 2 – Does it Involve Human Subjects?
- Research and Human Subjects as Defined by FDA Regulations
- Human Subjects Research at OSU
Research projects involving human subjects require either review and approval by an IRB or a determination that the research is exempt from IRB review. The first question a researcher should consider with respect to IRB review is whether the research project fits the definition of research, and if so, whether it also involves human subjects. In light of the responsibility to protect human subjects and the potential regulatory consequences of not obtaining IRB review and approval, investigators should err on the side of caution and consult with ORRP when uncertain whether a study constitutes human subjects research.
The following sections provide regulatory definitions to consider when determining whether a project involves “human subjects research,” as well as some examples. In addition, the federal Office for Human Research Protections provides “Chart 1: Is an Activity Research Involving Human Subjects?” at Human Subject Regulations Decision Charts.
DHHS regulations define research as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d)). As described in the Belmont Report, “…the term ‘research’ designates an activity designed to test a hypothesis [and] permit conclusions to be drawn… Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective.”
“Research” generally does not include operational activities such as defined practice activities in public health, medicine, psychology, and social work (e.g., routine outbreak investigations and disease monitoring) and studies for internal management purposes such as program evaluation, quality assurance, quality improvement, fiscal or program audits, marketing studies, or contracted-for services. This definition of research generally does not include journalism or political polls. However, some of these activities may include or constitute research in circumstances where there is an intent to contribute to generalizable knowledge.
Some examples of common activities that are not considered “research” as defined by DHHS regulations:
- Data collection for internal departmental, school, or other university administrative purposes. Examples: teaching evaluations and customer service surveys. Service surveys issued or completed by university personnel for the intent and purpose of improving services or programs of the university or for developing new services or programs for students, employees, or alumni are not considered to be research, as long as there is no intent to generalize the findings, and the privacy of the participants is protected, confidentiality of individual responses are maintained, and survey participation is voluntary. This includes surveys by professional societies or university consortia. Note: If at a future date, an opportunity arose to contribute identifiable or coded survey data previously collected for an administrative purpose to a study with an intention to produce generalizable knowledge, IRB review may be required before the data could be used in the new project.
- Independent contract for activities carried out for an external agency. Examples: personnel studies, cost-benefit analyses, customer satisfaction studies, biological sample processing (for a fee and not for authorship or other credit), public park usage, IT usage, and software development.
- Quality improvement projects. These are not generally considered research unless there is intent to contribute to generalizable knowledge beyond the use of the data derived from the project internally to improve or alter the quality of care or the efficiency of an institutional practice. If the data are to be re-examined or reanalyzed and/or new information surfaces that could be used to contribute to generalizable knowledge, an application must be submitted for IRB review or exemption. Any individual who is unsure whether a proposed quality improvement project would be considered research (as defined above) should contact ORRP for guidance.
- Consultant activities. Such activities are not considered research when consultants do not obtain, receive, or possess the identifiable private information of research participants. Other examples (that are not research) include performing commercial services for investigators and informing prospective participants about the availability of research. Note: The examples above are not an all-inclusive listing. For further information, see Engagement of Institutions in Research.
A human subject is defined by DHHS regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information” (45 CFR 46.102(f)(1)(2)). Relevant Definitions
- Living individual refers to data/specimen(s)/information collected from live subjects. Cadavers, autopsy specimens, or specimens/information from subjects now deceased are not living individuals and are not human subjects.
- Intervention includes physical procedures by which data are gathered, or, manipulations of the participant or the participant’s environment for research purposes.
- Interaction refers to communication or interpersonal contact between an investigator and a participant. This includes face-to-face, mail, and phone interactions, as well as other modes of communication.
- Individually identifiable means the identity of the participant is or may be readily be ascertained by the investigator or the investigator’s staff, or is associated with the information.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been provided for specific purposes by an individual that the individual can reasonably expect will not be made public. Examples of private information include medical or academic records or personal journals.
Some activities and materials that do not involve “human subjects” as defined above:
- Observational studies of public behavior. These studies, including television and, in some cases, Internet chat rooms, do not involve human subjects when there is no intervention or interaction with the subjects, and the behavior is not assumed by the subjects to be private.
- Studies based on data that are publicly available but individually identifiable. Use of these data does not constitute human subjects research, provided that the record sets are freely available to the broad public. Note: Investigators should contact ORRP if they are uncertain as to whether the data qualify as “publicly available.”
- Data sets without individual identifiers. Example: publicly available census data. Also, studies based on data previously collected for non-research purposes do not involve human subjects when individuals are not individually identifiable (e.g., data such as service statistics, school attendance data, crime statistics, or election returns).
- Coded private information or biological specimens. Uses of data or specimens that were not collected for the currently proposed project do not involve human subjects when the data/specimens cannot be linked back to the individuals from whom these were obtained. Also, when the holder of the data/specimens has access to the identity of the individuals (e.g., names, addresses, record numbers), the research can be said not to involve human subjects if the investigator enters into an agreement with the data/specimen provider that prohibits the identity of the subjects from being released to the investigator under any circumstances. Note: When an “Investigator Agreement” of this type is used, investigators must seek verification from ORRP that the project does not involve human subjects. See Guidance on Research Involving Coded Private Information or Biological Specimens for more information.
Both “research” and “human subjects” are defined differently in Food and Drug Administration regulations, which apply to research supported or regulated by FDA. Studies involving drugs, medical devices, foods and color additives, dietary supplements (with a nutrient content or health claim), infant formulas, and electronic products (e.g., microwaves, cell phones) are FDA-regulated.
FDA regulations define a clinical investigation as “any experiment that involves a test article and one or more human subjects” that is either:
- Subject to the requirements for prior [data] submission to the FDA, or
- Intended to be submitted to (or held for inspection by) the FDA as part of an application for a research or marketing permit.
A clinical investigation may also be referred to as research, clinical research, or a clinical study. A non-clinical laboratory study is not considered to be a clinical investigation (21 CFR 56.102(c)).
A human subject is defined by FDA regulations as “an individual (a healthy individual or patient) who is or becomes a participant in research, either as a recipient of the test article or as a control.” A human subject also includes an individual on whose specimen an investigational device is used (21 CFR 56.102(e)).
Activities in any of the following categories are considered to be research involving human subjects and must comply with federal regulations and Ohio State policies for the protection of human subjects:
- Studies that collect data through intervention or interaction with individuals. Examples include: surveys, interviews, focus groups, audio or videotaping, blood drawing, invasive and noninvasive measurements and specimen collections.
- Studies that involve investigational or approved drugs (other than an approved drug used in the course of medical practice).
- Experiments testing the safety or efficacy of medical devices (including in vitro diagnostics).
- Studies using individually identifiable private information (even if the information was not collected specifically for the study in question).
- Studies that use bodily materials such as cells, blood, urine, tissues, hair, and other specimens (even if one did not collect these materials for the study). However, such research does not involve human subjects when the materials/data are coded and the investigator (via formal agreement) does not have access to the coding systems, as described above.
- Studies that produce generalizable knowledge about categories or classes of subjects from individually identifiable information.
- Studies that use human participants to evaluate environmental alterations. Examples include: habitat modifications to a person’s living or working space and test environments.
For additional examples, see HRPP policy Research Involving Human Subjects.
If an investigator is unsure whether the project is research involving human subjects, the PI should provide sufficient information about the activity to determine whether it represents research involving human subjects and submit it to an ORRP Protocol Analyst for review. The designated ORRP Protocol Analyst will make one of three determinations and will notify the PI as follows:
- The proposed activity is not research involving human subjects and may be conducted without further IRB review or exemption; or
- The proposed activity is research involving human subjects and meets the criteria for IRB exemption; or
- The proposed activity is research involving human subjects and requires IRB review.
Upon receipt of complete information, determinations regarding review requirements are usually made within five business days. Projects determined to be research involving human subjects require documented IRB approval or exemption, as described below, before starting any research activities, including advertising, recruitment, and pilot studies. “Retroactive” IRB approval or exemption is not permitted under federal regulations and university policy.