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Researchers new to conducting research in humans should allow sufficient time to complete training and prepare a submission in relation to the target start date. The human research training and IRB review process require some investment of time and careful planning, and there are multiple factors which may come into play that affect the time frame to prepare for and obtain IRB approval.

As a general guide, from preparation of submission to IRB approval:

• Allow 4-6 weeks for basic, minimal risk research in populations which are not considered vulnerable
• Allow a minimum of 10 weeks for more involved longitudinal or complex studies, thesis research, research in the public school setting involving children, international research, and clinical research

All research personnel who meet the criteria of interacting directly with human research participants or their identifiable data require training, including:

• Principal investigators
• Faculty advisors
• Co-investigators
• Research coordinators
• Research collaborators at other sites
• Consultants and thesis committee members, if they meet the criteria above

Resources

• Course requirements
• Ethical foundation for preparing submissions and conducting research with humans

It is most effective to complete training in advance of preparing a first IRB application. For those who have completed training more than one year ago, it is beneficial to review the training materials again as a resource for developing human research and IRB applications.

Research Integrity & Security uses an online, enterprise electronic system, IRBNet, for submission management and IRB review for the life of a project.

Visit the University IRBNet information portal to register, complete a submission, and for instructions on other system processes.

For guidance on preparing the protocol content of new submissions, read our policy manual, submission requirements section.

Biomedical research collaboration with community faculty – special instructions

Students and community physicians who wish to collaborate on biomedical research have additional procedural requirements to follow to pursue such research.

Find more information for your area:

PI qualifications

View the qualifications to serve as principal investigator on protocols.

1. An IRB submission is received in IRBNet
2. Research Integrity & Security staff assign a primary staff coordinator to handle the review
3. The staff coordinator screens the submission within two days of receipt for
   1. level of review (administrative, expedited, or full board), and
   2. to determine whether review may proceed or if items must be addressed prior to review
4. For Research Integrity & Security administrative level review of submissions, review is completed within eight business days by the staff coordinator
5. If expedited or full board level of review is required, the staff coordinator assigns the submission for review by an IRB member
   1. For expedited review, the reviewer completes a review within 10 business days
   2. For full board review, the reviewer completes a review by the assigned meeting date for protocol review
6. The staff coordinator notifies the researchers through IRBNet of the review outcome
7. Researchers respond to the review if revisions are requested
8. The staff coordinator or IRB member completes the review of revisions
9. The staff coordinator notifies the researchers through IRBNet of the outcome

View a breakdown of the levels of IRB review required for different project types.

Exclusive use of IRBNet for submission of new and continuing applications (exempt, expedited and full review) will be required effective October 1, 2013. As in the ‘paper world’ your signature (now electronic assurance) will be required before your department faculty can submit studies to the IRB.

Here is some guidance to help you understand how to review and sign IRB submissions in IRBNet.

I. Register with IRBNet

Sign on to www.irbnet.org and register with IRBNet as soon as possible. Follow the directions for new user registration. To complete the registration process, you will need to authenticate your registration via your e-mail account.

II. Review your faculty’s IRB submissions

1. When one of your department/unit’s researchers require needs you to ‘review/sign’ the IRBNet submission, you will get an e-mail that the submission has been shared with you. That will be your signal to log on to the system (www.irbnet.org). Once you log on, you will be in your Study Manager, where you will see all the studies that have been shared with you and that are proposed, or are actively, going on in your department.
2. To review a study, click on the applicable title, and you will see the general details of the study. To see the specific documents associated with that study, click on Study Designer. There you will see all the documents (under ‘your study documents’) that will be submitted to the IRB once you review them, and electronically execute your assurance approving the study to go for IRB review.

III. Electronically Execute Assurance for IRB submissions

As before in the paper world, your electronic signature certifies that you have reviewed the application and all supporting documents pertaining to this research protocol and that you attest to the scientific merit of this study and the competency of the investigator(s) to conduct this project.

If you review an application and see problems, you can click ‘send mail’ (left side of screen) to the Principal Investigator or any member of the study team and alert him/her to the issue. Once resolved, and you are satisfied that the protocol meets your criteria for endorsement, simply click ‘sign study’ and follow the simple directions that follow. Note: PI and Chair signatures are required before the study is submitted to the IRB. Co-investigator e-signatures are required before the study receives final approval from the IRB.

IV. Study Manager

In your Study Manager, you can sort by status (at the arrows next to the word), and anything you see that says ‘work in progress’ needs your review. Once the status of a study is changed to ‘pending review’ or any other status it means the Researcher has already submitted to the IRB.

For studies receiving full board or expedited review, as indicated in the IRB review letter:

• Submit renewal requests for continuing projects for review and approval prior to the expiration date.
  • IRBNet continuing review instructions can be found in the IRBNet forms library
  • Full board continuing review submission content information
  • Expedited continuing review submission content information
• Submit proposed changes for review and approval prior to initiation.
  • IRBNet modification instructions can be found in the IRBNet forms library
  • Modification submission content
    When changes are implemented to eliminate apparent immediate hazards to participants without first obtaining IRB approval, such exceptions must be reported to the IRB promptly upon identification.
• Submit proposed changes to personnel and study sites for review and acknowledgement
• Report any unanticipated problems which may increase risks to human subjects or unanticipated adverse events to the IRB within five days.

For use of external IRB on all projects and requests, regardless of level of review:

• Request permission to use external IRB for purposes of monitoring and following federal regulations
• Ensure agreement between both IRBs is in place
• Provide a copy of the external approval letter and consent form
• Maintain an accurate and complete protocol file
• Submit a closure request after project completion to the IRB, following the closure process

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 ÍƼöÐÓ°ÉÔ­´´, has one IRB that reviews both biomedical research and social behavioral research. The 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)]

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.

“Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

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.

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).

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.

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, may not recruit participants from vulnerable populations such as prisoners or in some instances, children, and may not rely on incomplete disclosure. Researchers must submit an application for exemption prior to beginning research activities. There is no deadline for applications, and exemption determinations do not have an expiration date. Investigators who are considering changes to exempt research should submit an amendment request or consult with senior Research Integrity & Security staff to ensure their study remains eligible for an exemption.

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 . 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.

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 .

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.

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 contact Research Integrity & Security.

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.

Create a binder—tangible or electronic—or similar resource for organizing the protocol. The PI is responsible for keeping complete records that can be easily produced and referenced. The approved protocol application should be kept in chronological order with the most currently approved at the forefront. The same applies to consent and recruitment materials, adverse event reports, modification requests, etc. Screening, enrollment, and withdrawal information, if applicable, should be kept in the binder as well as CVs, training certifications, financial disclosure information, etc.

Keeping complete, organized records will likely simplify other OHRP processes that you may be required to go through throughout the life of the study. For example, current versions of protocol materials are required attachments to renewal requests; current, complete versions are required for quality improvement or compliance reviews; enrollment information is requested during renewals, modifications, and closures.

For assistance with understanding or creating a binder, please contact our office.

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.

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.

Research Integrity & Security 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.

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.

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.

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.