What Requires an IRB?

What Requires an IRB Review?

All human subjects research, and all other activities, which in part involve human subject research, regardless of sponsorship, must be reviewed and approved by the CUNY IRB, or registered exempt by the Office of Sponsored Programs and Research prior to initiation. The application and information is at https://sph.cuny.edu/research/hrpp/. This includes all interventions and interactions with human subjects for research, including advertising, recruitment and/or screening of potential subjects. Additionally, use of state death data records must be reviewed and approved by the CUNY IRB prior to initiation. Please review the information below to understand what activities meet the definition of human subjects’ research.

 

Definition of Human Subject Research

Human subject research is any research or clinical investigation that involves human subjects.

Investigators conducting human subject research must satisfy the U.S. Department of Health and Human Services regulations [45 CFR Part 46] and Food and Drug Administration regulations [21 CFR Part 50 and 56] regarding the protection of human subjects, as applicable. When considering whether an activity meets the definition of human subject research per DHHS regulations, one must consider two definitions: research and human subjects.

Research is as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

A systematic investigation is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.

Examples of systematic investigations include:

  • Surveys and questionnaires
  • Interviews and focus groups
  • Analyses of existing data or biological specimens
  • Epidemiological studies
  • Evaluations of social or educational programs
  • Cognitive and perceptual experiments
  • Medical chart review studies

Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations). However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to “generalizable (scholarly) knowledge” makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.

Examples of activities that typically are not generalizable include:

  • Biographies
  • Oral histories that are designed solely to create a record of specific historical events
  • Service or course evaluations, unless they can be generalized to other individuals
  • Services, courses, or concepts where it is not the intention to share the results beyond the CUNY SPH community
  • Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
  • Quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the UCI community.

A human subject is as a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; and/or (2) identifiable private information.

Intervention includes both physical procedures by which data are gathered (e.g., 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.

Note: Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval.

If you plan to do research that involves a drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act, please review the information provided at the following link to the FDA regulations:

http://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl

Educational Activities that are not Human Subject Research

Although all human subject research requires prior institutional approval, not all data gathering by students constitutes human subject research. To be research, an activity must be designed with the intent to develop or contribute to “generalizeable knowledge.” Clearly, some classroom activities are designed to teach research techniques and have no such intent.

Simulations of human experimentation and course-assigned data collection do not constitute human subjects research if the activities are designed for educational purposes only; and if:

the data will not be generalized outside the classroom (reporting of data within the class is acceptable because the activities were performed solely for teaching purposes); and

the data will not result in a master’s thesis, doctoral dissertation, poster session, abstract, or other publication or presentation; and

the student volunteers or other participants are clearly informed that the activities are an instructional exercise, and not actual research.

Exceptions Any activity that is a clinical investigation or involves medical intervention or procedures, even when they are a part of a course curriculum, always constitutes human subject research and requires prior IRB review and approval.

Educational Activities that are Human Subject Research

If an instructor determines that there is a possibility that a student’s proposed research project may result in a formal presentation or publication, he/she should recommend that the student submit the project for IRB review before beginning the study.

There may be instances when a student or instructor wishes to use data for research that was previously collected for educational purposes. An application should be submitted to the IRB when a student or instructor wishes to analyze the data with the intent of contributing to generalizable knowledge.

Examples:

An instructor is surprised at some of the unique findings that appeared when students completed surveys as part of a classroom activity. The instructor would like to do additional analysis on the data and submit it for presentation or publication when the course ends. The instructor’s intent has changed and an IRB application will now be necessary because the instructor will now be analyzing existing data that was collected for a non-research purpose.

A master’s student wishes to conduct research in the hopes of having publication(s) to list on her application to a doctoral program. She plans to devise an experiment, enroll subjects, analyze the results and write a manuscript. This is human subject research. Prior IRB review and approval is necessary.