Activities that meet the federal definition of ‘human subjects’ under 45 CFR 46.102(e) and ‘research’ under 45 CFR 46.102(l) require IRB review and approval, or a formal determination that the project is exempt. The IRB is responsible for determining whether activities and projects meet these definitions and when or whether IRB review and approval is required. These determinations are made by the IRB Chair or by another IRB member designated by the Chair.
All research involving human subjects that meets the criteria set forth in 45 CFR 46.102, irrespective of funding and/or funding source, conducted at Clark University and/or by any Clark University faculty, staff, or student (full-time/part-time status and/or undergraduate/graduate level), must be reviewed by the IRB. No human subjects research may commence until the IRB has reviewed and approved the protocol and issued a written notice of approval or exemption. There is no provision in federal regulations that allows for IRB approval of non-exempt research that has already been conducted.
The IRB applies two definitions of research depending on the type of project under consideration. If a project meets at least one of these definitions it is considered to be research for purposes of IRB review. The first definition is most commonly applicable to research conducted at Clark University.
Definition 1: Research
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Learn more here.
A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan. Systematic investigations ordinarily
- Attempt to answer research questions (for example, a hypothesis),
- Are methodologically driven (data/information are collected in an organized and consistent manner),
- Draw conclusions from the results.
The information is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:
- Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
- Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the project.
Definition 2: Research
The activity is Research if both of the following conditions are met:
- The intent of the activity is to develop information about a drug, medical device (including diagnostic tests), or biologic substance for submission to the federal Food and Drug Administration (FDA), and
- The activity involves the prospective physical use of drug, medical device (including diagnostic tests), or biologic substance, in a way that is not completely up to the discretion of a clinical practitioner.
Activities Not Defined as Research
The following activities are NOT defined as research, following §46.102(l):
- 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. Note that in some cases activities of this type (e.g., oral history or journalism) might include components that qualify as human subjects research under 45 CFR 46. Hence, researchers are strongly encouraged to contact the IRB before engaging in these activities to avoid inadvertent violations. Additional guidance on this topic may be found here. 
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. 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 (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Human Subject means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information, following §46.102(e).
- Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject.
- 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, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
- To be “human subject research” under 46.102(e), a study must be entirely or partly “about whom,” as opposed to being solely “about what.” If the study is wholly “about what,” it is not human subject research. For example, asking a bank manager to provide information on how many loans were made by a bank during the prior year would not constitute human subjects research.
Some Additional Examples Commonly Encountered at Clark University: Given the above definitions, the following are NOT considered to be human subjects research for purposes of IRB review requirements.
- Internal data collection conducted by Clark University (or faculty, staff, students) solely for non-research purposes (following the definitions above), such as data collected solely for internal program improvement or to inform institutional strategic planning, with no other research uses.
- Situations in which the institution solely permits use of its facilities to investigators from other institutions (with no other involvement of Clark personnel in the research) or when its employees or students participate as subjects in research conducted by individuals at other institutions.
- Interactions with individuals solely for purposes of obtaining methodological advice on how to conduct a project (i.e., “about what”), where these individuals are not subjects of the project (they do not provide study data). For example, asking an expert for guidance on how to use a microscope for a chemistry project does not constitute human subjects research.
- If a project meets the definitions of human subjects research described above, it must be submitted to the IRB using the Mentor IRB system for review following standard IRB Proposal Procedures.
- If a project involves human subjects and/or human subjects data but the investigator believes that it might not meet the definition of human subjects research, the IRB must determine if it qualifies as “human subjects research” and thereby requires IRB review. Investigators collecting human subjects data for research purposes cannot “self-exempt” (declare their own project as “Not Human Subject Research”). If there is any possibility that a project might be human subjects research, the IRB must be consulted to determine if the project requires review.
- To receive an official determination of whether a project is human subjects research, investigators should complete a protocol application using the Mentor IRB system. Mentor includes a set of path-dependent questions that allow the IRB to determine whether a project involves human subjects research and what type of review is required.
- Protocol submissions for “not human subjects research” determinations follow the same general procedures as other submissions in Mentor. However, responses to the full set of possible protocol application questions are not required for projects that do not meet the criteria for human subjects research. In such cases, Mentor only asks a limited set of path-dependent questions necessary for the IRB to make this determination. In addition, CITI training is not required prior to submitting a determination application of this type. If the project is determined to involve human subjects research, CITI training must be completed before the project is reviewed by the IRB.
- Upon receipt of the protocol submission in Mentor, the IRB Coordinator assigns the protocol to the IRB Chair for categorization, following IRB Proposal Procedures. As part of the initial categorization review, the Chair determines whether the project includes human subjects research.
- If the project is determined not to include human subjects research, a determination of “not human subjects research” will be made within Mentor. The IRB Coordinator then sends a formal notification of this determination to the investigator through Mentor. No further IRB review or approval is required.
- If the project is determined to include human subjects research, it is categorized by the Chair for further review and approval (or exemption) by the IRB, following standard IRB Proposal Procedures. Prior to this review, the investigator will be asked to complete any additional protocol sections in Mentor necessary to complete the IRB review, as a protocol revision request.
- Informal inquiries into whether IRB review and approval may be needed do not require submission of a protocol within Mentor. Informal inquiries may be directed to the IRB Office or Chair, who will provide guidance on whether a Mentor protocol submission is required. The IRB will retain records of these informal inquiries and their disposition.
As described by OHRP guidelines, “the objective of the activities in this category is to provide an accurate and evidence-based portrayal of the individuals involved, and not to develop generalizable knowledge. In some cases, these activities can be designed to affect those individuals’ reputations, and to deliberately expose the individuals to public scrutiny or even possible harm, such as losing their positions or employment. The human subject protection regulations were not intended to cover individuals who are the focus of such scholarly and journalistic activities. Consequently, the protections afforded by 45 CFR 46, including the requirement that risks to subjects be minimized, are inappropriate for these activities. For example, a journalist or a biographer might collect and present factual information to support their presentation of the character of an individual to show that the individual does not deserve the positive reputation he or she enjoys in society. Such fields of inquiry generally have their own codes of ethics. In contrast, 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 does not fit the parameters of this exception, and the activity may fall within the 2018 Requirements’ definition of “research.”