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IRB Process FAQs

What's an Institutional Review Board (IRB)?

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.

What is the role of the IRB in general as it relates to scientific review?

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.

Do I have to submit my project for review?

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

Is it research?

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

Consider:

  • 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.

Two Possibilities:

  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.

Does the project involve "human subjects"?

"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)]

Consider:

  • 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.

Three possibilities:

  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.

How do I get IRB approval?

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.

What is CITI training and why is it mandatory?

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).

What level of review does my project need?

Just as research studies are not one-size-fits-all, neither are the IRB processes that coincide with them. Some studies are rather simple and relatively low risk. Other studies are more complicated and invasive. There are three levels of review—Exempt, Expedited, and Full Board—to meet the varying levels of risk human subjects may encounter as participants in a research study.

Exemption: [45 CFR 46.101(b)]

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.

Expedited Review: [45 CFR 45.110]

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.

Full Board Review: [45 CFR 46.111]

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.

Do program evaluations require IRB review?

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.

Common Elements
EvaluationResearch

Determines merit, worth, or value

Strives to be value-free

Assessment of how well a process, product, or program is working

Aims to produce new knowledge within a field (designed to develop or contribute to generalizable knowledge)

Focus on process, product, or program

Focus on population (human subjects)

Designed to improve a process, product, or program and may include:

-needs assessment

-process, outcome, or impact evaluation

-cost-benefit or cost-effectiveness analyses

Designed to be descriptive, relational, or causal

Designed to assess effectiveness of a process, product, or program

Designed to be generalized to a population beyond those participating in the study or contribute broadly to knowledge or theory in a field of study (designed to develop or contribute...)

Assessment of program or product as it would exist regardless of the evaluation

May include an experimental or non-standard intervention

Rarely subject to peer review

Frequently submitted for peer review

Activity will rarely alter the timing or frequency of standard procedures

Standard procedures or normal activities may be altered by an experimental intervention

Frequently, the entity in which the activity is taking place will also be the funding source; impact or outcome data may be provided to external sponsor to fulfill contractual obligations

May have external funding

Conducted within a setting of changing actors, priorities, resources, and timelines

Controlled setting (interaction or intervention) or natural setting (observation which may or may not include interaction or intervention)

Informed by:

Coffman, J. (2003). Ask the Expert: Michael Scriven on the Differences Between Evaluation and Social Science Research. The Evaluation Exchange, 9(4). Retrieved December 31, 2013 from http://www.hfrp.org/evaluation/the-evaluation-exchange/issue-archive/reflecting-on-the-past-and-future-of-evaluation/michael-scriven-on-the-differences-between-evaluation-and-social-science-research

How do I put together the application?

The application is available in IRBNet and should be read with the understanding that the IRB is charged with ensuring that human subjects are protected and informed. To this end, the application should clearly explain the purpose and procedures of the research and how the risks to the subjects have been considered and minimized. There must be adequate resources for informing subjects of what they will encounter and their rights as participants in the study. Subjects must be given the opportunity to make a conscious, well-informed decision about participating, and the confidence to withdraw if they desire.

Preparing a thoughtful, thorough, organized protocol will take time. Investigators and research team members must complete training prior to the study commencing. The IRB must evaluate the protocol, comments relayed to researchers, and perhaps revisions made all prior to the start of the research. Please give yourself adequate time to prepare the protocol and for the IRB to consider it.

Why does the IRB need a copy of my grant or contract?

Federal regulations require that the IRB compare the grant application or proposal to the study protocol to ensure that the research described in the proposal is entirely consistent with the study protocol submitted to the IRB.

If activities outlined in the funding application differ from those in the study protocol, these discrepancies should be explained in the funding section of the protocol and must be resolved before the IRB will issue approval.

Do I need to use a consent form?

Each protocol must identify an informed consent process. This process may or may not include a consent form. The consent process begins with the initial contact with potential human subjects and continues throughout the study. The purpose of informed consent is to ensure that individuals have the information they need to knowledgeably and voluntarily decide whether or not to participate in a study. Generally, consent starts with a conversation about the study and what subjects can expect as a participant. This conversation should include information about the risks and benefits of the study, how confidentiality will be handled, and who to contact to have questions answered.

The consent form is one way to document the consent process.

This conversation should continue throughout the study and participants should be given any new information that may affect their desire to remain a research subject. If a consent form was signed by a participant upon entering a study, it may be appropriate for him/her to sign a revised version that has been approved by the IRB.

Sometimes there are studies that do not require the use of a consent form. Usually, this arises when the consent form itself provides a link to data that would not otherwise exist, therefore, increasing risk for participants. Informed consent must still occur but a consent form is not used. Justification for using other methods such as verbal consent, information sheets, and cover letters should be included in the protocol.

For more information, please go to our Informed Consent page or contact RIO.

What do I do if I need to use deception or incomplete disclosure in my study?

Incomplete disclosure may be used as long as ALL of the following are true AND clearly explained in the protocol:

  1. Incomplete disclosure is truly necessary to accomplish the goals of the research,
  2. there are no undisclosed risks to subjects that are more than minimal, and
  3. there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.

Do I have to follow the approved protocol as written or can I improvise?

It is important for researchers to follow the approved protocol and to use the recruitment and consent materials approved by the IRB. If changes are necessary, they must be reviewed and approved by the IRB prior to being implemented.

Some unexpected things have happened (or haven't happened) while conducting my project. What do I do?

The PI must assess each adverse or unexpected event to determine if it must be reported immediately or if it can wait to be included in the next renewal. Any unanticipated problems with the study, adverse events to human subjects, and all deaths must be reported to the IRB within five business days.

Unanticipated problems with the study may be outside direct problems with human subjects. For example, losing a laptop that contains confidential information would qualify as an unanticipated problem that must be reported within five business days.

RIO provides a form for reporting problems in IRBNet. If you are unsure about the reporting requirements for an event, please contact our office for guidance. You may also find further guidance on this website.

How do I make changes to my protocol?

Changes must be reviewed and approved prior to implementation. Changes may be requested by submitting a modification through IRBNet.

Changes may not be implemented until the request for modification has been approved.

I still have work to do but my approved protocol will expire soon. What do I do?

Non-exempt protocols must undergo a continuing review at least once a year, though the IRB may elect for shorter periods such as every six months or quarterly. As a courtesy, the IRBNet sends a reminder approximately two months prior to the expiration date.  Unfortunately, federal regulations do not allow expired protocols to be renewed. Once a protocol expires, it must be closed and research with human subjects halted. For the study to continue, a new protocol must be submitted, reviewed, and approved.

I'm finished with my project. How do I close my protocol?

To close a project, complete the closure form in IRBNet prior to the expiration date.

You must keep pertinent records of the study for at least three years past the official closure date, maybe longer if a sponsor requires it.

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