Does Your Study Require IRB Approval?

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Overview

All research involving human subjects that meets the criteria set forth in (45 CFR 46.102 (d) and (f)), irrespective of funding and/or funding source, conducted at Rutgers University and/or by any Rutgers’ faculty, staff or students (full-time/part-time status and/or undergraduate/graduate level), must be reviewed by Rutgers’ Institutional Review Board (IRB). No research activities involving human subjects may commence until the IRB has reviewed and approved the protocol and issued a written notice of approval.

When to Submit

The Principal Investigator must submit their study/project to the IRB when he/she:

  1. conducts their own study; OR
  2. performs designated research-related activities and acts as an agent of Rutgers, as an institution, when engaged in human subjects research;

If a study involves Human Subjects and/or Human Subjects Data, the Principal Investigator must submit their project to the IRB to determine if the project qualifies as “Research” which requires IRB review and approval.

Important Notes

  • Investigators cannot self-exempt (declare their own study as “Not Human Subject Research”)!
  • Only the IRB can determine if your research is "Not Human Subjects Research" (meaning it does not require formal IRB Approval)
  • Once an activity is determined to involve Rutgers as an institution being engaged in human subjects research, whether it be involved in some aspect of the research, then research is required to be reviewed by Rutgers IRB.

OHRP's Human Subject Regulations Decision Charts

The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comment on these decision charts.

The Human Subject Regulations Decision Charts address decisions on the following:

  1. whether an activity is research that must be reviewed by an IRB;
  2. whether the review may be performed by expedited procedures, and;
  3. whether informed consent or its documentation may be waived;

Definitions

Research is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge". (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102)

Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102)

(1) Data through intervention* or interaction* with the individual, or

(2) Identifiable private information*

Engaged in Research (Institutional Level): Rutgers University is engaged in a non-exempt human subjects research project, when its employees or agents for the purposes of the research project obtain:

(1) data about the subjects of the research through intervention or interaction with them;

(2) identifiable private information about the subjects of the research; or

(3) the informed consent of human subjects for the research. An institution is not considered engaged in human subjects research when the institution permits use of its facility to investigators from another institution or when its agents only conduct the following activities.

* 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.

Human subject research governed by Federal regulations falls into one of two categories: Minimal risk or Greater than minimal risk.

Definition of Minimal and Greater Than Minimal Risk:

Minimal risk means “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Note that federal regulations only define minimal risk (45 CFR 46.102(i); 21 CFR 56.102(i)).

Therefore greater than minimal risk could be defined as anything determined to be above minimal risk.

Definition of Minimal Risk With Prisoners: Note that minimal risk is defined slightly differently when the research involves prisoners as subjects: minimal risk is then defined as “the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons” (45 CFR 46. 303(d)).

Research Under The IRB’s Purview

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)
  1. 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)
  1. 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.
  1. 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.
  1. 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. 
  1. 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.
  1. 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.
  1. 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.

Examples of Rutgers University Engaged in Human Subjects Research* **

  • Rutgers University receives an award through a grant and all research activities involving human subjects are performed by employees or agents at another institution.
  • An RU faculty member performs invasive or noninvasive procedures (collection of blood, utilizing physical sensors, implantation of medical devices) for research purposes.
  • An RU staff member interacts with a subject through direct communication, such as administering a survey for research purpose.
  • An RU medical resident, on behalf of the principal investigator, obtains informed consent of human subjects, for research that will be conducted at University Hospital.
  • An RU student obtains private information or specimens from any source for research purposes. This includes, but is not limited to: observing or recording private behavior, using, studying or analyzing private information or specimens provided by another institution or already in the possession of the investigator.
  • RU Faculty member is given a subcontract to assist on a funded project. RU Faculty subawardee will help be a consultant as to provide expertise, will develop survey measures, will code and analyze identifiable data.
  • RU Faculty member will help collect and measure air samples on a collaborative project looking at the quality of air/pollution in individuals’ homes. RU Faculty member will not be recruiting or consenting subjects but rather will collect samples, have access to data and will help with publications.
  • RU Faculty member will help a colleague at another institution recruit students to participate on study looking at eating habits and keeping food diaries. The RU faculty will help recruit/consent subjects. S/he will not administer the intervention but have access to de-identified data. S/he plans to publish separately.
  • RU Faculty member worked on a project while completing their PhD at another university. Part of the study included therapy sessions to treating alcoholism among children of alcoholics. Study is an ongoing, multi-year project which s/he is no longer involved with recruiting/consenting/administration of measures but has access to identifiable data. S/he wishes to help analysis data and publish with and separately from his/her colleagues.

*This is not an exhaustive list.

**Once an activity is determined to involve Rutgers as an institution being engaged in human subjects research, whether it be involved in some aspect of the research, then research is required to be reviewed by Rutgers IRB. More information about the different types of IRB review can be found in the Review Types Section.