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Per the federal regulations for the protection of 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(e)]

Consider:

• Is the project designed to produce generalizable knowledge? This describes investigations that are designed to draw general conclusions, to transfer or extrapolate results to a broader population or situation than those from which the information was initially derived, or to establish or enhance scientific evidence about a topic of interest.
• Will information be collected in a systematic way? This means the project is conducted using step-by-step procedures organized according to a set of interrelated ideas or principles.

Per the federal regulations for the protection of human subjects, “Human subject means a living individual about whom an investigator (whether professional or student) conducting research (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.” [45 CFR 46.102(e)]

Consider:

• Is the information about a living individual?
• Are data (information or biospecimens) obtained through intervention? This includes both physical procedures by which data are gathered (for example, venipuncture), and manipulations of the participant or the participant's environment that are performed for research purposes.
• Are data obtained through interaction? This includes verbal, written, virtual or electronic communication, or interpersonal contact between an investigator and a participant.
• Is private identifiable information being obtained or used? 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, or 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). If there is no participant interaction or intervention, private information must be individually identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) for the project to constitute research involving human subjects.

If the project satisfies the definitions of both "research" and "human subject," the project is considered human subjects research and IRB review and oversight is required.

If the project does not satisfy the definitions of both "research" and "human subject," the project may be excluded from human research protection oversight. Upon request, Research Integrity & Security or the University’s IRB will document by letter any not human subjects research determination.

See “Does my class project, program evaluation, or quality improvement project require IRB review?” section in the FAQ for more information on determining whether a project meets or does not meet the definition of human subjects research.

Researchers wishing to submit a human research determination request may follow the steps outlined in the instructions section of the quickstart guide to create an IRBNet account and a Part I Cover Sheet. Instead of a protocol, complete and attach a Human Research Determination Request form to the submission. Human subject training is not required to submit a human research determination request, nor does the listed Principal Investigator (PI) have to meet PI eligibility criteria (i.e. a student or individual in training may submit such a request). Sign-off by the listed PI is required. If the project is determined to constitute human subjects research, a complete submission will then be required.

Researchers should allow sufficient time to complete the required training and prepare a submission before the target start date of the research. The human research training and IRB submission process requires some investment of time and careful planning. There are multiple factors that may affect the timeframe to prepare for and obtain IRB approval.

As a general guide, from completion of training and preparation of an IRB submission to requested revisions and approval:

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

Although Research Integrity & Security will work with researchers to attempt to meet award deadlines imposed by funding sponsors on an as-needed basis, it is the responsibility of the researcher to prepare their submission proactively and follow-up on additional requests in a timely manner. Incomplete submissions will be sent back to the research team, which may impact the ability to meet internal and sponsor deadlines.

All submissions to the University’s IRB, with the exception of requests to determine whether a project meets the definition of human subjects research, must list an eligible Principal Investigator (PI). The PI assumes responsibility for the ethical and compliant conduct of the study and ensures that all research personnel follow the IRB-approved protocol.

View the qualifications and responsibilities to serve as PI on human research projects in IRB policy 35. Requirements and Responsibilities of Principal Investigators for Human Research Projects.

Students and individuals in training (including undergraduate and graduate students, post-docs and residents) are not allowed to serve as PI on human research projects and should work closely with a faculty advisor.

Human research training

All investigators engaged in human research activities (including principal investigators, co-investigators, student investigators, research coordinators and any other research personnel who plan to engage in human research activities) must complete the required training for human research. To determine who is considered to be engaged in human research, review the criteria outlined in the Human Research Protection Policy Manual definition for “Engaged in Human Subjects Research (Engagement in Research).”

Researchers should create an account on the CITI online training platform and follow the course navigation instructions offered in the training for human research section of the training information from Research Integrity & Security.

University researchers must complete one of the following courses (as appropriate for their research discipline) to satisfy human research training requirements:

• Social-Behavioral-Educational (SBE) Comprehensive course
• Biomedical (Biomed) Comprehensive course

Plan to dedicate at least 4-6 hours to this training, and note that it does not have to be completed in one sitting. 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 applications. The comprehensive courses are valid for 4 (four) years.

Note that Responsible Conduct of Research (RCR) training, Conflict of Interest (COI) training, and Good Clinical Practice (GCP) training do not meet IRB requirements for human research training, although these may be helpful supplements when preparing an IRB submission.

Affiliate researchers (e.g., VA Sierra Nevada Health Care System, Renown Health) must comply with the human research training requirements set forth by their institutions.

External collaborators must meet the human research training requirements of their respective institutions. Collaborators who are not affiliated with an external institution or whose institution does not mandate human research training must complete the coursework required for University researchers. External researchers may take the University-required courses free of charge by affiliating with the �Ƽ��Ӱ�ԭ�� on the CITI platform.

HIPAA training

HIPAA training is required for research projects that involve accessing or collecting protected health information (PHI). University researchers using PHI must provide evidence of CITI training in one of the following CITI courses:

• HIPAA for Education and Research
• HIPAA Basics for Healthcare Professionals

The HIPAA courses are valid for 1 (one) year.

The University’s IRB uses an online electronic system, , for submission management and IRB review. All human research projects must be submitted through IRBNet.

Step-by-step guides for using IRBNet, including initial registration of a user account and navigation through the submission process, are available on the University’s IRBNet access and training page.

Instructions for new submissions

1. Complete human research training (and HIPAA training, if applicable). All investigators must have completed the required trainings and have valid (non-expired) completion certificates as a condition for IRB review. Note that CITI certificates do not need to be uploaded if completed through the University.
2. Register an account in IRBNet. If you have not already done so, register an account in IRBNet and affiliate with UNR to gain access to the forms and templates library. There, researchers can access the templates for a protocol form. Templates are also available as applicable for consent forms or consent information sheets, research plans with certain populations, and more. Templates have instructions to help write your application.
3. Create an IRBNet project. To create a new project, access your IRBNet account and click on “Create New Project”. You will be asked to fill out some basic information, such as project title and name of the Principal Investigator. Once the project is created, it can be accessed by clicking on “My Projects”.
4. Create the Part I, Cover Sheet. The Part I, Cover Sheet is an electronic smart form created directly within IRBNet. To complete this form, click on “My Projects” and select the relevant project title. From there, click on the “Designer” section and select the grey “Start a Wizard” button to create a �Ƽ��Ӱ�ԭ�� – Part I, Cover Sheet. Next, select “Create a new wizard from scratch”.
   
   This form is required for all new submissions and covers information such as research team members, funding, study location, and more. Do not download it; IRBNet will save it when finished and automatically include it in the submission.
   
   After completing the Cover Sheet smart form, please open a PDF version by clicking on “View this Document” and review the “Instructions to Researchers” section at the bottom of the document. The instructions contain a listing of researcher forms that must be completed and attached to the submission package based on the study details provided in the Cover Sheet.
5. Complete the protocol application. Depending on the nature of the project, complete and attach to the submission one of the following protocol application forms, found in the IRBNet forms and templates library.
   
   Documents are uploaded via the grey “Attach New Document” button in the “Designer” section.
   
   Note that the protocol application form is used to outline the full study plan and is required for almost all new submissions except human research determinations. The protocol should clearly explain the purpose and procedures of the research, and how risks to participants have been considered and minimized.
   1. Protocol – Biomedical
   2. Protocol – Social Behavioral Educational Research and Record Research
6. Attach consent documents. If applicable, attach the consent form or consent information sheet that will be used to inform potential participants about the study. Commonly used templates available in the IRBNet library include the following (note that secondary analysis of data such as medical records or educational records may not require a consent process in some cases):
   1. Consent Form Template for Social Behavioral or Educational Research
   2. Consent Form Template for Biomedical Research
   3. Consent Information Script or Sheet Template
   4. Parent Permission Form Template
   5. Photo/Video Release Form for Research Template
7. Attach recruitment materials. If applicable, attach all recruitment materials (e.g., emails, flyers, social media posts, scripts for verbal communications, etc.) that will be used to invite potential participants to consider enrolling in the study. Note that recruitment materials should contain the minimum required content per IRB Policy 302. Recruitment Materials and Combined Recruitment/Consent Materials.
8. Attach data collection instruments. If applicable, attach all instruments (e.g., surveys, interview guides, etc.) that will be used to collect study data. For protocols involving secondary data, provide a list of the variables to be recorded and analyzed for the study.
9. Include other forms and study documents. Depending on the nature of the study, investigators may be required to complete and attach a variety of additional forms (e.g., Population: Children Form, Research: International Form, HIPAA Waiver Request Form, etc.) and other study documents such as permission letters from study sites, screening instruments used to determine eligibility, etc. Investigators should review the “Instructions to Researchers” section of their completed Part I, Cover Sheet for information regarding which forms are required for their study.
10. Complete the electronic signature and submission. All submissions must be shared with and signed by the Principal Investigator. Once the package is complete, the Principal Investigator should click on “Sign this Package” to attest that they have reviewed and approved the submission and all attached study materials in accordance with all institutional requirements. Depending on the nature of the study, the following electronic signatures may also be required, as follows. Once the package has been signed, click “Submit this Package” to complete the electronic submission process.
    1. Projects conducted by the �Ƽ��Ӱ�ԭ�� School of Medicine faculty, students, or staff, or that involve UNR Med data, must be shared with and signed by the Office of Clinical Research.
    2. Projects conducted by or at Renown Health, or that involve Renown Health data, must be shared with and signed by the Renown Clinical Research Department.
    3. Projects conducted by or at the VA, or that involve VA data, must be shared with and signed by the Reno VA research staff.
11. Screening and review. Once a package has been submitted, Research Integrity & Security staff will screen the submission for completeness and determine the required level of review. If it is determined that the submission is incomplete, the package may be unlocked and a request made for additional information or forms. It is the responsibility of the researcher to address these requests in a timely manner, then mark the package “Lock – Revisions Complete” to notify staff that the project is ready for review.
    
    Furthermore, an “Information Required” determination may be made and a Requested Revisions letter sent with requests for clarification or directed changes to study materials. In this instance, the investigator should follow the instructions in the Requested Revisions letter and create a new package within the existing project by clicking on “Create a New Package”. Note that this is not the same as creating a new project. In the new package, the investigator should upload a letter responding to the requested revisions and any documents that needed to be added or changed. The Principal Investigator should then sign the new package and click “Submit this Package”.
    
    Once a package is complete, it will be assigned for review at the exempt, expedited, or full board level. View a breakdown of the levels of IRB review required for different project types.

It is the responsibility of the Principal Investigator to comply with all post-approval requirements throughout the life of the study. This includes adherence to the procedures outlined in the IRB-approved protocol and in any IRB-approved study materials; safety monitoring commensurate with the risks and complexity of the research; appropriate data handling and storage to safeguard participant privacy and confidentiality; and record keeping for at least three (3) years after the study has been closed.

As part of their post-approval responsibilities, the Principal Investigator should adhere to the following submission requirements:

Amendments (all studies)

All changes to IRB-approved protocols must be submitted and approved prior to implementation. Follow these steps to submit an amendment request:

• Create a new “Amendment/Modification” package within the existing IRBNet project.
• Complete and attach an Amendment Request Form, available in the IRBNet library.
• Attach revised copies of all study documents (e.g., protocol, consent, data collection, etc.) impacted by the proposed changes. For each revised study document, submit two copies: one with tracked changes with the proposed changes redlined, and one clean (finalized) copy with the tracked changes accepted.
• If applicable (e.g., for personnel changes, funding status updates, etc.), revise the Part I, Cover Sheet by locating it under the “Designer” tab and clicking on the pencil button to “Update this Document”.
• Attach any other required documentation (e.g., new site permission letters, additional forms, etc). Ensure all team members’ human research (and HIPAA, if applicable) training certificates are up to date. Have the Principal Investigator sign the submission and then submit the package.

Continuing reviews and progress reports (non-exempt studies)

All non-exempt projects have an expiration date or a progress report due date, as indicated in the Approval Letter, and must be renewed before that date passes for human research activities to continue. Follow these steps to submit a continuing review or progress report:

• Create a new “Continuing Review/Progress Report” package within the existing IRBNet project.
• Complete and attach the Continuing Review/Progress Report Form, available in the IRBNet library.
• Attach any other required documentation (e.g., safety reports for greater than minimal risk projects).
• Ensure all team members’ human research (and HIPAA, if applicable) training certificates are up to date.
• Have the Principal Investigator sign the submission and then submit the package.

Note that continuing review/progress report submissions may not be combined with amendment submissions. All amendments other than personnel removal must be submitted independently of the continuing review or progress report package.

Reportable events (all studies)

Report any protocol deviations, participant complaints, or unanticipated problems which may increase risks to human participants within five days. 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. Follow these steps to submit a reportable event notification:

• Create a new package within the existing IRBNet project using one of the following submission types: Protocol Deviation/Violation, Unanticipated Problem (UP), or Other Reportable Event.
• Complete and attach one of the following forms available in the IRBNet library, as applicable: Reportable Event Form – Protocol Deviations, or Reportable Event Form – Unanticipated Problems.
• Attach any other relevant documentation.
• Have the Principal Investigator sign the submission and then submit the package.

Audits (all studies)

Comply with any audits conducted by Research Integrity & Security; and implement in a timely manner any changes required by Research Integrity & Security or the IRB as a result of audit findings.

For studies reviewed by an external IRB:

Work with Research Integrity & Security to determine when review by an external IRB is appropriate and what documentation is needed to secure approval. Once a study is approved by the external IRB and the University’s IRB, the local Principal Investigator must notify the University’s IRB of: the IRB of Record's determinations of serious or continuing noncompliance, unanticipated problems, and suspension or termination of the IRB approval or investigator's involvement in the research; and study closures. Follow these steps to submit external IRB determinations:

• Create a new package within the existing IRBNet project using one of the following submission types: "Other" for external determinations of serious or continuing noncompliance, unanticipated problems, and suspension or termination of the IRB approval or investigator's involvement; "Closure/Final Report" for notifications of study closures.
• Attach documentation of the IRB of Record's determination, any relevant correspondence with the external IRB, and the University’s IRB Closure Request Form if applicable.
• Have the Principal Investigator sign the submission and then submit the package.

An IRB is a federally mandated 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. [45 CFR 46]

The �Ƽ��Ӱ�ԭ�� 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 are tasked with determining whether the regulatory criteria for approval are met for human subjects research. The criteria for IRB approval include determining whether (1) risks to participants are minimized by using procedures consistent with sound research design and that do not unnecessarily expose participants to risk, and (2) risks to participants are reasonable in relation to anticipated benefits to participants, if any, and the importance of the knowledge that may reasonably be expected to result. [45 CFR 46.111(a)(1) and (2)]

These regulatory requirements provide the framework for the IRB’s scientific and ethical review. Scientific review conducted by the IRB does not serve as a peer review intended to maximize the scientific quality of a study. Instead, such review is primarily aimed at promoting the ethical treatment of research participants by ensuring an appropriate balance of risks and benefits. IRB determinations about how low of a risk is low enough ("minimized"), what is "reasonable," and what is "important" are judgment calls that involve, but are not limited to, an assessment of the scholarly merits of the proposed research. Thus, scientific review and ethical review are overlapping processes.

As part of the IRB review process, IRB members and/or consultants with appropriate expertise in the field of research under review will ponder questions such as:

1. Is there a safer way to perform the research that would still accomplish the research aims?
2. Are there procedures that would reduce participant risks without negatively affecting 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 intended knowledge or benefits?

Entities other than the IRB (e.g., funding agencies, hospital systems, and departments/schools) often conduct their own scientific review of research proposals. Such review of scholarly merit helps support the IRB’s mission by ensuring that human research protocols are properly designed and likely to yield scientific value. In the case of greater than minimal risk projects, the IRB requires that a Responsible Official (e.g., dean, chair, or other departmental authority) verify that the design for the proposed research is scientifically valid as a condition for IRB review.

Research studies involving human subjects require IRB review. Evaluative studies and training activities do not. It is not always easy to distinguish between these 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 Research Integrity & Security staff.

IRB policy 507. New Projects that May or May Not Be Human Research provides further guidance on what kind of projects constitute human subjects research. A human research determination request can be made to the IRB as described in the question above.

All human research protocols that involve collection of data through interaction or intervention with human participants must identify an informed consent process. Examples of protocols that require informed consent include survey studies, interview and focus group research, as well as clinical studies designed to test medical interventions.

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 the research. The consent process begins with the initial contact with potential participants and continues throughout the study. It generally starts with a conversation about the study and what individuals 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 process usually involves, but is not limited to, a written consent form.

Documentation of the consent process and the participant’s agreement to enroll in the study is typically achieved through a signed consent form. Legally valid consent can be obtained via paper-based consent forms using an ink signature, or electronically using a legally recognized electronic signature (e.g., DocuSign). In some cases (e.g., studies that pose minimal risk, are not federally funded, and involve a single study session), documentation of consent is not required. In such instances, the consent process may involve a paper-based information sheet with no signature lines, an online information page with electronic acknowledgment by the participant (e.g., click “Yes” if you agree to proceed to the survey), or a verbal presentation of the consent information.

In limited circumstances such as secondary research when certain conditions are met, projects involving human subjects may not require a consent process (meaning that there is no obligation to either document consent, or to inform the individuals whose data are analyzed for research purposes). For example, records research does not require consent if the information is recorded in a de-identified format and the investigator does not contact or re-identify the individuals.

Given the complexities surrounding the consent process and documentation requirements (including waivers thereof), investigators are encouraged to review policies 325-346 of the Human Research Protection Policy Manual and reach out to Research Integrity & Security staff for guidance on which consent process(es) and template(s) to consider for their study.

Just as research studies are not one-size-fits-all, neither are the IRB processes that coincide with them. Some studies are 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 and complexity human subjects may encounter as participants in a research study. Only Research Integrity & Security or the IRB have the authority to make a determination about a project's level of review.

Exempt Review:

Under Federal regulations [45 CFR 46.104], certain categories of activity are considered research, but may be eligible for exemption from the federal regulations. This determination is made by the IRB or Research Integrity & Security, not the researcher. Institutional policies for the protection of human subjects still apply.

Studies qualifying for exempt review must fall within . 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 a human research protocol prior to beginning research activities. Exempt studies are reviewed by an IRB member or Research Integrity & Security staff outside the convened meeting schedule, and therefore do not have to be submitted by a certain date. 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.

Expedited Review:

Under Federal regulations [45 CFR 46.110], studies that pose no more than minimal risk and that do not qualify for an exemption may be eligible for expedited review. Studies qualifying for expedited review must fall within a . 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. 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 administratively closed; the recruitment and enrollment of human participants, as well as data collection on enrolled participants, must stop until a new protocol can be reviewed and approved.

Full Board Review:

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.

If it is determined that a submission is incomplete, an “Information Required” determination may be made and a Requested Revisions letter sent with requests for clarification or directed changes to study materials. An IRBNet package will not be unlocked once such a determination has been made.

Researchers should follow the instructions in the published Requested Revisions letter to create a new package within the existing project by clicking on “Create a New Package”. Note that this is not the same as creating a new project. In the new package, upload a letter responding to the requested revisions, and revise and upload all documents requiring revision or incorporating needed changes. Research activities described in the incomplete submission may not begin until a response has been received and final approval issued.

Yes. Different human research studies are eligible for different levels of IRB review. An exempt determination for exempt-eligible research is equivalent to IRB approval for research reviewed via expedited or full board review procedures.

Research activities that do not require an assessment of the IRB criteria for approval may undergo administrative review by Research Integrity & Security staff. If the submission is complete and there are no concerns, the submission is acknowledged. This means the research activities described in the submission may proceed.

Research activities eligible for administrative review include, but are not limited, to, changes in study personnel; some changes to study sites; annual progress reports where continuing review was not requested at initial review; study closures; and determinations of not human subject research.

Create a secured folder – tangible or electronic – or similar resource for organizing the study documentation. The Principal Investigator is responsible for keeping complete records that can be easily produced, referenced, and audited. The approved protocol application should be kept in chronological order. The same applies to consent and recruitment materials, adverse event reports, modification requests, etc. Screening, enrollment, consent, and withdrawal information, as applicable, should be kept as well as CVs, training certifications, financial disclosure information, etc. Keeping complete, organized records will likely simplify other IRB processes that may be required throughout the life of the study, including in the event of an audit.

It is important for researchers to follow the approved protocol and to use the recruitment, consent, and other study materials approved by the IRB. If changes are necessary, they must be reviewed and approved by the IRB, or acknowledged by Research Integrity & Security, prior to being implemented. Some minor amendments may be made without formal approval for exempt research; however, the researchers should still consult with Research Integrity & Security prior to implementing any changes.

Generally, changes must be reviewed and approved by the IRB, or acknowledged by Research Integrity & Security, prior to implementation. Changes may be requested by submitting an amendment request form through IRBNet in a new package. If new researchers or study team members are being added, revise the Part I, Cover Sheet and ensure all research team members have completed human subject training. If study materials such as the protocol, consent forms, recruitment materials, or data collection instruments are being modified, submit both tracked change and clean (finalized) versions.

The Principal Investigator must assess each adverse event or unexpected occurrence to determine if it must be reported immediately or if it can wait to be included in the next renewal. Research problems must meet the three criteria of unexpectedness, relatedness to the study, and increased risk to be immediately reportable to the IRB. Problems with the study may be outside direct problems with human participants. For example, losing a laptop that contains confidential information would qualify as an unanticipated problem that must be reported promptly.

All protocol deviations, unanticipated problems involving risk to participants or others, and the incarceration of a research participant, must be reported to the IRB within five (5) business days.

Research Integrity & Security provides a form for reporting problems in IRBNet as a new package. If you are unsure about the reporting requirements for an event, please contact our office for guidance. You may also find further guidance in policies 700-750 of the Human Research Protection Policy Manual.

Non-exempt protocols must undergo a continuing review or progress report check at least once a year, though the IRB may elect for shorter periods such as every six months or quarterly. Instructions to complete this process can be found in the “post-approval responsibilities” section of this page. Exempt protocols do not expire, although Research Integrity & Security may periodically verify that the study is ongoing.

As a courtesy, IRBNet sends multiple reminders starting approximately two months prior to the expiration date. If human research activities are ongoing (e.g. if there are still interactions, interventions, or follow-ups with participants, or identifiable study data continues to be analyzed), it is the responsibility of the Principal Investigator to ensure the project is renewed before the expiration date or progress report due date passes. Once a protocol expires, it will be administratively closed and research activities with human subjects must stop until a continuing review is approved by the IRB or a progress report is acknowledged by Research Integrity & Security.

To close a project, upload a Closure Request Form in a new package within the existing project in IRBNet, have the Principal Investigator sign the submission, and then submit the package. If the project was funded, make sure to notify Sponsored Projects about the study closure.

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