What is the irb charged with

what is the irb charged with

IRB Process FAQs

An IRB is a committee that has been formally designated to review, approve, and monitor research involving humans as subjects. The intent of the IRB is to protect the rights and welfare of the research subjects.

The University of Nevada, Reno, has two IRBs, one to review biomedical research and the other to review social behavioral research. Each board must be comprised of at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The board must include at least one scientific member, one non-scientific member, and one member who is not otherwise associated with the University.

IRBs need to determine whether the regulatory criteria for approval are met. These determinations are ethical criteria and not scientific criteria. They are judgment calls. They require the IRB to make decisions about how low is low enough ("minimized"), what is "reasonable," what is "important," what is "equitable," when his influence "undue," etc. None of these judgment calls is a scientific decision.

The first part of scientific review needed by IRB's is the input from one of more individuals with scientific or scholarly expertise in the research who can determine the answers to these questions concerning the information submitted to the IRB:

  1. Is there a safer way to perform the research that would still accomplish the research aims?
  2. Are there procedures that would reduce subject risks without negatively affect the research?
  3. Does the protocol accurately describe the risks?
  4. Does the protocol accurately describe the benefits?
  5. Is the protocol likely to yield the knowledge proposed to result?

If the answers to the first two questions are "no" and the answers to the last three questions are "yes," then the investigator has provided the IRB with sufficient information to determine whether the regulatory criteria for approval are met. Otherwise, the individuals with scientific or scholarly expertise can fill in the gaps or guide the IRB on where to get additional information.

The second part of scientific review needed by IRB's is an explanation of the submitted information so that it is understandable to all IRB members, scientific and nonscientific. The individuals who provide scientific or scholarly expertise are often in the best role to provide this explanation. Once this process has provided the IRB with sufficient information and understanding, the IRB has what it needs to commence with an ethical review of the research and determine whether the protocol meets the regulatory criteria for approval. At this point, the opinions of the scientists are equally valid to the opinions of the nonscientist.

Projects must be submitted for review if they meet the federal definition of "research" AND if the project involves "human subjects."

"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)]

  • Is the project designed to produce generalizable knowledge? (see policy manual definitions page)
  • Will information be collected in a systematic way?
  • Systematic means the project is conducted using step-by-step procedures organized according to a set of interrelated ideas or principles.
  1. If the project does not satisfy the definition of research, the project may be excluded from human research protection oversight. The UNR OHRP will document by letter any exclusion determination by request.
  2. If the project does satisfy the definition of research, then a second question needs to be asked.

"Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information." [45 CFR 46.102(f)]

  • Is the information about a living individual?
  • The data is obtained either directly (e.g. survey, interview) or obtained indirectly (e.g. existing data, records).
  • Is data obtained through intervention?
  • 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.
  • Is data obtained through interaction?
  • Interaction includes communication or interpersonal contact between investigator and subject.
  • Is private identifiable information being obtained or used in the project?
  • 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 or school records).
  • 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.
  1. If the project does not satisfy the definitions of both "research" and "human subject," the project may be excluded from human research protection oversight. The UNR OHRP will document by letter any exclusion determination by request.
  2. If the project satisfies the definition of "research" but not "human

    subject," the project may be excluded from human research protection oversight. The UNR OHRP will document by letter any exclusion determination by request.

  3. If the project satisfies the definitions of both "research" and "human subject," the project is considered "human subjects research" and an application is required.

The first step to approval is understanding the roles and responsibilities of the researchers and the principles behind human subjects' protections. The researchers and their team members must complete basic training through CITI prior to an IRB's review of a protocol. Protocols submitted by researchers who have not (or whose team members have not) completed training will be placed on hold until completion can be verified.

CITI stands for "Collaborative Institutional Training Initiative." CITI offers online training that meets the federal standards and requirements associated with human subjects' protections. The University is required to ensure all research team members participating in a study that includes human subjects have been appropriately trained. Since the courses are online, researchers may access them at their convenience.

The initial training requirement must be satisfied through completion of one of two Basic Courses for the Protection of Human Research Subjects, either the Basic Course for Biomedical Research or the Basic Course for Social Behavioral Research. See the CITI website for instructions on registering and completing the course.

A passing score is 80%.

The University will honor completion of this training for five (5) years. Extension of certification expiration dates of previously completed training, for both initial and continuing education, was automatically extended to five years. The extension does not apply to training requirements for research conducted at the VA Sierra Nevada Health Care System (VASNHCS).

Under Federal regulations, certain categories of activity are considered research, but can be declared exempt from further review by the IRB. This determination is made by the IRB itself, not the researcher. To qualify for an exemption, the study may not pose more than minimal risk to human subjects and may not recruit participants from vulnerable populations such as prisoners, rely on audio/ videotaping or incomplete disclosure, or link data to subjects. Researchers must submit an application for exemption. There is no deadline for applications. Approved applications are valid for three years and cannot be renewed. However, they may be resubmitted for a subsequent three years should more time be required.

Studies that pose no more than minimal risk that don't qualify for an exemption, may be eligible for expedited review. Studies qualifying for expedited review must fall within a federally mandated list of seven categories. Please review the list carefully and note the applicable category(s) on your application. Expedited review means that the protocol does not have to be read and discussed by the full board at a scheduled meeting. The appropriate IRB chair or a designated board member may conduct the review outside of regularly scheduled meetings. Consequently, there is no deadline for expedited review of a new protocol.

Approvals are generally granted for a year (but may be less) and applications may be renewed through a continuing review process. However, time lapses between the expiration date and renewal may not occur. Continuing reviews should be submitted well in advance of the expiration date. Should a protocol expire prior to undergoing a continuing review, the protocol is closed; the recruitment and enrollment of human subjects as well as data collection on enrolled subjects must stop until a new protocol can be reviewed and approved.

Human subjects research that is not classified as exempt or expedited requires review by the full IRB at a convened meeting. Applications for full board review must meet a submission date to be included on the agenda for a scheduled meeting. All board members will receive a copy of the protocol though typically one member will be assigned as the primary reviewer. This reviewer will present the protocol details and concerns to the board.

Approvals are generally granted for a year (but may be less) and applications may be renewed through a continuing review process. However, time lapses between the expiration date and renewal may not occur. Continuing reviews should be submitted well in advance of the expiration date. Should a protocol expire prior to undergoing a continuing review, the protocol is closed; the recruitment and enrollment of human subjects as well as data collection on enrolled subjects must stop until a new protocol can be reviewed and approved.

Research studies involving human subjects require IRB review. Evaluative studies and activities do not. It is not always easy to distinguish between these two types of projects and projects frequently have elements of both. Therefore, the decision about whether IRB review is required should be made in concert with the IRB.

Research studies are defined by Federal Regulation as:

Systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Evaluative studies are defined as:

Systematic collection of information about the activities, characteristics and outcomes of programs to make judgments about the program (or processes, products, systems, organizations, personnel, or policies), improve effectiveness, and/or inform decisions about future program development.

Below are elements that are common to research and evaluation projects. This list is not intended to be comprehensive and not all elements are required in order for a project to be considered research or evaluation. Rather, this list of elements can be used to assist faculty in determining whether an activity involves research requiring IRB review.

Source: www.unr.edu

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