Research Under The IRB’s Purview

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Overview

Researchers based in any of a wide range of disciplines may conduct human subject research with a behavioral, educational and/or with another social science type of focus. The following examples illustrate common types of human subject research. In all cases, it is the IRB’s responsibility (and not the responsibility of the individual investigator(s)) to determine if the proposed research activity falls under the purview of the IRB, which requires formal review and approval. These are examples only and not intended as an exhaustive list of all types of human subject research.

  1. Social, Behavioral, and Educational Research: Social Research involves the scientific study of how people and groups interact. This research may explore social behavior and mental processes but with an emphasis on how humans think about each other and how they relate to each other. Behavioral Research is the scientific study of the interactions and activities of people in naturalistic settings. The focus of this type of research can include both the exploration of the decision processes and individual functioning. Educational Research often involves the scientific study of how humans (both adults and children) learn in various educational settings, while examining the effectiveness of educational interventions, or attempting to understand the constructive teaching methods or curricula, in addition to investigating the social psychology of academic settings (i.e., schools as an organization).

The goal of social, behavioral, and educational research is similar to that of biomedical research -- to establish a body of knowledge and to evaluate interventions -- but the content and procedures often differ. Social, behavioral, and educational research involving human subjects focuses on individual and group behavior, mental processes, or social constructs and usually generates data by means of surveys, interviews, observations, focus groups, studies of existing records, and experimental designs involving exposure to some type of stimulus or environmental intervention.

  1. Clinical Research. Clinical research involves the evaluation of biomedical or behavioral interventions related to disease processes or normal physiological functioning. (These types of studies are usually reviewed by the Rutgers Health Sciences IRB)
  2. Biomedical Research. Biomedical research involves research (i) to increase scientific understanding about normal or abnormal physiology, disease states, or development; and (ii) to evaluate the safety, effectiveness or usefulness of a medical product, procedure, or intervention. Vaccine trials, medical device research, and cancer research are all types of biomedical research. (These types of studies are usually reviewed by the Rutgers Health Sciences IRB)
  3. Ethnography Research. Ethnography research involves the study of people in their natural environments where people live and work or in any other surrounding where people interact (such as a hospital where a parent interacts with a healthcare professional who is caring for a sick child). It is a set of research methods and techniques used in various disciplines such as anthropology, geography and sociology, among other fields. The main ethnographic method requires a well-trained researcher using skilled observations of people by immersing him or herself in diverse environments, cultures, and populations in order to study a particular phenomenon. The ethnographic researcher begins his or her research by establishing a relationship with people in various social contexts. These techniques allow for the researcher to begin interacting with others either through direct participation or by direct observation. The researcher may also observe people’s dialogue to uncover their attitudes, beliefs, perceptions, and values, as well as the unspoken cultural patterns that shape either the individual’s behavior or the norms of a given culture.
  4. Oral History. Oral History activities are typically designed to record, preserve and at times, interpret specific historical events or the experiences of individuals. If the oral history activities, such as open-ended interviews, are done without any intent to draw conclusions or generalize findings, then this research would NOT constitute “research” as defined in 45 CFR 46. Having said this, there are times when there are oral history activities, such as a systemic investigation involving open-ended interviews, that are designed to develop or contribute to generalizable knowledge (e.g., the creation of archives to provide a resource for others to do research) that WOULD constitute “research” under 45 CFR 46. These types of activities would then require formal review and approval by the IRB before such activities could begin.
  5. Epidemiology Research. Epidemiology research targets specific health outcomes, interventions, or disease states and attempts to reach conclusions about cost-effectiveness, efficacy, interventions, or delivery of services to affected populations. Some epidemiology research is conducted through surveillance, monitoring, and reporting programs (e.g. those employed by the Centers for Disease Control and Prevention (CDC)).  Other epidemiology research may review past medical, public health, and/or other records. Because epidemiology research often involves the aggregate examination of data, it may not always be necessary to obtain individually identifiable information. When this is the case, the research may qualify for an exemption or expedited review. 
  6. Pilot Studies. A pilot study is typically defined as an initial or smaller-scale investigation or a study to either test out new experimental designs (including survey or instrument development) or methods of treatment. Pilot studies are synonymous with feasibility studies, where the investigation proposed is planned to identify various issues (e.g., relating to design of an instrument, analysis of power concerns and recruitment strategies) to determine that the larger study of the same subject matter has the greatest potential to successfully test the intended research hypotheses. Pilot studies involving human subjects are considered human subject research and require IRB review. A researcher planning to conduct a pilot study must provide sufficient details to address how a smaller scale investigation is worth pursuing with a goal of obtaining results that may add to the generalizable knowledge while minimizing any anticipated risks to the subjects. There must be a well-detailed literature review and most importantly, the researcher must justify the need for the number of subjects required.
  7. Repository Research. Research that utilizes stored data (retrospective or prospective data, various outcome measures or artifacts, photographs and recordings) or materials (cells, tissues, fluids, and body parts) from individually identifiable living persons qualifies as human subject research, and requires IRB review. When data or materials are stored in a bank or repository for use in future research, the IRB will need to review a protocol detailing the repository’s policies and procedures for obtaining, storing, and sharing its resources, for verifying informed consent provisions, and for protecting subjects’ privacy and maintaining the confidentiality of data. The IRB may then determine the parameters under which the repository may share its data or materials with, or without, IRB review of individual research protocols.
  8. Quality Assurance Activities. Quality assurance activities attempt to measure the effectiveness of programs or services. Such activities may constitute human subject research, and require IRB review, if they are designed or intended to contribute to generalizable knowledge. Quality assurance activities that are designed solely for internal program evaluation purposes with no external application or generalization may not require IRB review. In the event that a disagreement arises about whether a quality assurance activity constitutes human subject research, the IRB, not the individual investigator, will determine when IRB review of such activities is required

Examples Of Research Under the IRB’s Purview

  • A psychologist studying interpersonal behaviors in a group of individuals with mental disorders;
  • A computer scientist or an engineer engaged in collecting information about various human performance characteristics and/or limitations or studying the human factors related to a newly designed artifact;
  • An instructor evaluating classroom techniques or activities with the intent of publishing the findings;
  • A nurse researcher surveying African American adults about their attitudes toward organ donation;
  • A researcher analyzing archival or prospectively collected records or data with or without identifying a subject, but without directly interacting with a human subject. For example, chart reviews or database reviews;
  • An historian engaged in gathering oral histories recording Vietnam Veterans’ experiences with the war and Post Traumatic Stress Disorder (PTSD), which also include an interpretation of these events to generalize findings to influence public policy;

*This is not an exhaustive list.