1. The University’s Human Research Protection Program
Updated Oct. 4, 2019
University of Nevada, Reno recognizes that responsibility for human research protection is not the sole responsibility of a single office or of the IRB. Rather, this responsibility transcends departmental jurisdictions, and falls to multiple entities within the University and Affiliate institutions and the research community. University and Affiliate administrators, offices/departments, and committees whose roles/responsibilities directly or indirectly involve human subject research; and Principal Investigators, Faculty Advisors, student researchers, and members of the research team comprise the University’s Human Research Protection Program (HRPP).
Termed institutional components of the University’s HRPP, these entities must
- consider the rights and welfare of human subjects participating in research when developing and carrying out core functions supporting the research;
- meet their own compliance responsibilities; and
- ensure their core business processes and responsibilities are integrated into or align with the University’s HRPP.
Institutional Component: Vice President for Research and Innovation
Under the authority of the University President, the Vice President for Research and Innovation (VPRI) has sufficient standing, authority, and independence to ensure implementation and maintenance of the University’s HRPP. The VPRI is the Institutional Official (IO) on the University’s FWA.
The University Administrative Manual, Under the Sponsored Projects policy for Facilities and Administrative Rates (December 2012, codifies fiscal support for VPRI through the allocation of 60.25% of Facilities and Administrative Costs (i.e., indirect costs) to the VPRI division.
In her/his institutional role and capacity as IO, the VPRI or her/his designee (i.e., Assistant VP, Research Administration):
- has signatory authority for the University’s HRPP;
- ensures that resources are appropriately allocated and adequate facilities, equipment, and resources are available for implementation and maintenance of the University’s HRPP;
- recognizes Research Integrity (RI) as the institutional component with primary responsibility for implementation and maintenance of the University’s HRPP, including the IRB;
- ensures that adequate facilities, equipment, and resources are available to support the day-to-day management and operation of the RI and the IRB;
- ensures HRPP components cooperate with and support the RI and the IRB in the performance of each component’s assigned authorities;
- uses the proposed budget and annual report prepared by the RI Director to evaluate the adequacy of resources for and effectiveness of the RI and the IRB;
- ensures that adequate resources exist to support the training and education requirements for researchers and others involved in the University’s HRPP;
- ensures HRPP compliance through consultation with the RI Director, and interpretation and coordination of ethical principles, federal regulations and guidance, state and local laws, and University policy;
- ensures that the IRB functions independently and free from undue influence;
- has the authority to investigate and make recommendations for resolution or corrective action involving allegations of attempts to limit or influence IRB determinations, Chairs, or members; or RI staff;
- coordinates with the RI Director to ensure requirements are met for institutional reporting of serious or continuing non-compliance with the IRB, unanticipated problems involving risks to participants or others, suspensions or terminations of IRB approval, financial conflict of interests, and other emergent issues related to human subjects research as warranted;
- coordinates with the RI Director in the implementation of IRB Authorization and Investigator Agreements; and
- has the authority to limit or prohibit the involvement of University faculty, students, or staff in human subject research.*
*When circumstances suggest the involvement of Affiliate faculty, students, or staff should be limited or prohibited, the VPRI will notify the CEO or facility director of the Affiliate site.
The VPRI and the directors/administrators with the VPRI’s division meet monthly to discuss institutional changes and other topics of importance to the Division.
Institutional Component: Research Integrity
The University’s Research Integrity (RI) is located administratively within the Vice President for Research and Innovation. The RI is the institutional component charged with overseeing human subject research conducted by University and Affiliate faculty, students, and staff. As such, the RI is responsible for determining whether projects require exempt or IRB review or do not constitute human subject research, and managing the University’s IRBs. The RI’s other responsibilities include oversight of conflict of interest and research integrity.
RI should have open communication with researchers and research staff and be responsive to questions, concerns and suggestions. Communication may be engaged with emails in University Outlook, IRBNet software or direct telephone using the contact information on the website. Researchers or staff members may request a meeting with RI staff to discuss planned research, IRBNet submission questions or current regulations and policies. Anonymous concerns or questions may be sent to the RI staff using the Contact Us form on the website.
With consideration for the protection of human participants, RI has the authority and responsibility to
- provide guidance and direction to University and Affiliate faculty, students, and staff conducting or planning to conduct research involving human participants;
- require University and Affiliate, and independent investigators and IRB members to complete training according to institutional and federal requirements;
- determine the appropriate Review Type for each project/package submitted in IRBNet;
- determine when projects are exempt from IRB review requirements (i.e., make exempt determinations);
- manage review and approval processes for the University’s IRBs for non-exempt research including new projects, continuing reviews, and amendments to approved research;
- coordinate reviews by external IRBs, including development of IRB Authorization and Investigator Agreements when warranted;
- coordinate with SP to facilitate investigator access to grant monies for research with indefinite plans for the involvement of human participants;
- assess complaints and reported problems for “internal” resolution or for referral to the IRB;
- assess the quality of the University’s HRPP and make recommendations for improvement; and
- establish and update written procedures for compliant IRB review and management;
- ensure IRB policy and procedures are publically available;
- communicate changes in policies, researcher forms and review worksheets to IRB members and researchers; and
- communicate with representatives of other institutional components when human research protection requirements intersect with the component’s institutional authority or responsibility.
See the online Policy Manual for details about the responsibilities of the RI Director and Staff.
Institutional Component: The University IRB
The primary purpose of the University’s IRB is to protect the rights and welfare of human subjects involved in research activities in which University and Affiliate faculty, students, and staff are engaged (see the online Policy Manual Definitions).
As a secondary purpose, the IRB seeks to ensure that the University, and Affiliate and collaborating institutions and investigators are compliant with ethical standards (e.g., the Belmont Report); and applicable federal regulations and requirements, state and international laws, and University policies.
The University grants the IRB the authority necessary to function independently to ensure the consistent and unbiased application of the requirements for human research protection.
- The IRB functions independently of, but in coordination with other institutional components and regulatory committees. Approval by other institutional bodies cannot substitute for IRB approval.
- IRB disapprovals may not be superseded by other institutional authorities although studies that receive IRB approval may be deemed inappropriate for conduct at the University or Affiliate site by other institutional authorities.
The University IRB is authorized to
- determine a project does not constitute human subject research;
- grant exemptions from IRB review;
- review non-exempt projects by either Full Committee or Expedited Review and approve, disapprove, or require revisions to secure approval;
- assess risk of non-exempt research as minimal or greater than minimal;
- require, review, and approve recruitment materials, consent documents, and HIPAA authorization forms as appropriate for a research project;
- approve waivers of informed consent, documentation of consent, and HIPAA authorization (according to regulatory requirements);
- specify the length of the approval period (no longer than 12 months);
- evaluate and request changes to project procedures or Conflict of Interest management plans when an interest related to a research project may affect participants;
- monitor or observe the consent process and the conduct of human subject research to ensure that the rights and welfare of research participants are adequately protected;
- work with University and Affiliate administrators (e.g., department heads, deans, chairs, and program directors) in ensuring that non-exempt human subject research activities are conducted as approved by the IRB;
- suspend or terminate IRB approval for research that is not being conducted in accordance with the IRB’s requirements or is associated with unexpected serious harm to research participants;
- make determinations of serious or continuing noncompliance or unanticipated problems involving participants or others, and require corrective actions; and
- investigate reports of human subject research activities conducted by University or affiliate investigators without prior IRB approval and report findings to the VPRI.
See the online Policy Manual for responsibilities of IRB Chairs and members.
Institutional Component: Sponsored Projects
Review and Oversight of Requirements for Contracts Involving Human Subjects Research
The University Sponsored Projects (SP) reviews contracts and oversees relationships and agreements with external parties that fund research at the University. These parties include federal agencies, foundations, and for-profit corporations.
To ensure University contracts and funding agreement include the required language for human research protection, SP uses a checklist and the AAHRPP tip sheet 25: Provisions in Contracts and Funding Agreements to verify the requirements are met. SP and the RI work jointly to develop and update the checklist to ensure it complies with regulatory requirements and accreditation standards.
- The contract/funding agreement indicates who will provide and pay for medical care for research participants with a research-related injury.
- The information about medical care for research-related injuries is consistent between the contract/funding agreement and the IRB-approved version of consent documents.
- When the sponsor conducts site monitoring visits or monitoring activities remotely, the contract/funding agreement requires the sponsor to promptly report to the investigator or the IRB any findings that could affect the safety of participants or influence the conduct of the study. For the purposes of this reporting, the University IRB defines “promptly” as no more than 30 business days after completion of the monitoring.
- When the sponsor is responsible for monitoring the data to ensure the safety of participants, the contract/funding agreement addresses the provisions and the time frames by which the sponsor will monitor the data and provide the data and safety monitoring reports to the investigator or the IRB. At a minimum and with consideration for participant risk, sponsors should monitor data for safety at least annually with more frequent monitoring required for research posing greater than minimal risk. Data and safety monitoring reports suggesting risk of harm to participants should be provided to the University within 10 days; routine reports may be submitted within 30 business days of completion of the monitoring.
- Before initiating research, the organization has a contract/funding agreement with the sponsor that includes plans for disseminating findings from the research and the roles that investigators and sponsor will play in the publication or disclosure of results.
- When participant safety could be directly affected by study results after the study has ended, the contract/funding agreement requires the sponsor to notify the researcher or the organization of the results in order to consider informing participants, describes the steps followed, and specifies a time frame during which the sponsor will communicate such findings. This requirement may not apply to all research studies.
Requirement for Privacy Certificate for Department of Justice Funding
Federal regulations at 28 CFR 22.23 specify that a Privacy Certificate is a condition of approval for grant applications or contract proposals submitted to agencies within the justice department for research or statistical projects components that involve the collection of information identifiable to a private person (see the online Policy Manual Definitions). SP is responsible for ensuring University investigators obtain any required Privacy Certificates.
Tracking Training Requirements for Sponsored Research
SP provides the RI with quarterly reports identifying agency-specify training needs (e.g., for research funded under the Public Health Service, National Science Foundation).
Coordination Related to IRB Approval for Funded Research
SP will not release funds for sponsored projects that involve human subjects without confirmation of IRB approval for new projects or continuing reviews; or notification that the research will not involve human subjects until IRB approval is obtained (see next section).
Coordination for Funded Research with Indefinite Plans for the Involvement of Human Subjects
Federal regulations recognize that certain types of applications for grants, cooperative agreements, or contracts may be submitted to departments or agencies with the knowledge that human subjects may or will be involved within the period of support, but definite plans for the involvement of human subjects may not be set forth in the grant application or proposal. Regulations at 45 CFR 46.118 describe the types of activities that do not require IRB review and approval before the award may be made.
The University recognizes that funds may be awarded to the University but preliminary or preparatory activities that are funded under the grant or contact must be completed before the investigator can finalize plans for the involvement of human participants.
RI and SP worked together to develop a policy for funded research with indefinite plans for the involvement of human participants. RI staff work with investigators to obtain specific information about the research plans and provide SP with correspondence stating that no activities involving human subjects will be conducted before IRB approval is obtained. SP either works with the sponsor to secure the award or establishes an account allowing the investigator to access the funds up to a specified date.
Coordination Related to Human Subject Research Involving Data Sharing
University and Affiliate investigators may conduct human research that involves sharing data/specimens with an external institution, either as the Provider or the Recipient. When the data/specimens include Protected Personally Identifiable Information or Protected Health Information (see the online Policy Manual Definitions) a Data Use or Materials Transfer Agreement is required. SP or the VPRI will assist University investigators in preparing and executing required research agreements. Affiliate investigators coordinate with RI staff when research requires data use or materials transfer agreements between the Affiliate site and an external entity.
Institutional Component: Responsible Officials
Responsible Officials include University and Affiliate deans, chairs, and other departmental authorities including whose faculty, students, or staff are conducting or planning to conduct non-exempt research involving human participants. In addition to general oversight of the researcher under her/his scope of responsibility, Responsible Officials review new projects submitted in IRBNet and via electronic signature confirm specific requirements are met. For details, see the online Policy Manual for responsibilities for responsible official.
Institutional Component: General Counsel
The General Counsel for the University and the UNR Med General Counsel’s Office assist the RI through interpretation and application of Nevada State laws, laws in other jurisdictions (e.g., other states or countries), federal regulations and guidance, and institutional policy when applicable to the protection of human participants.
The Offices are available to consult with the RI Director related to
- compliance with state and federal laws related to the conduct of human subject research conducted by University (including UNR Med) students, faculty, and staff;
- legal documents including but not limited to contracts, memorandums of understanding when these have implications for the University’s HRPP;
- litigation, contracts, business and health care law, tort law, employment law, dispute resolution, student rights, and public/private partnerships that may affect the University’s HRPP;
- resolution of conflicts between federal and other laws applicable to the protection of human subjects.
If a University researcher receives a Summons and Complaint, subpoena, or request for public records related to human subject research approved by the University IRB, the investigator may contact one of the Offices directly, or may prefer to involve the RI Director.
Institutional Component: Environmental Health and Safety
The University’s Environmental Health and Safety (EH&S) is charged with ensuring a safe and healthy environment for the entire University community which includes human subjects research. This charge is exercised through EH&S and its committees for overseeing biosafety and radiation safety.
EH&S staff are available to advise investigators using hazardous wastes in human subjects research to ensure the materials are handled safely and all employees are trained to minimize the risks imposed by the hazards.
Institutional Biosafety Committee
The University’s Institutional Biosafety Committee is responsible for developing policies and procedures that reduce risks to the University of Nevada, Reno community associated with biological agents in accordance with guidelines established by the National Institutes of Health, OSHA, and appropriate state and local authorities. This charge extends to human subject research involving biological agents.
Biological agents include the following:
- blood and blood products;
- other bodily fluids (e.g., saliva);
- human or non-human primate tissues;
- cells or cell culture; and
- recombinant DNA, including transgenic plants/animals when these involve human or primate DNA, or are used in combination with human subjects research.
When University or Affiliate investigators are conducting research involving biological agents at sites under the direct control of the University (e.g., UNR Med laboratories or clinics), a complete and signed Memorandum of Understanding and Agreement from the University’s IBC is required before the IRB will approve the research.
When University or Affiliate investigators are conducting research involving biological agents at an Affiliate or other external site, the research is subject to review and approval either by the University’s or the external site’s biosafety committee. The RI Director will work with a representative of the external site and the investigator to define authorities and responsibilities for review, approval, and oversight for the University and the external site as it relates to the use of biological agents.
Radiation Safety Committee
The University’s Radiation Safety Committee is responsible for establishing policies and procedures to ensure control of procurement, use and disposal of radioactive materials, in accordance with federal and state mandated legal requirements.
Research involving the exposure of human participants to radiation or radioactive materials when the participants would not otherwise have been exposed must be approved by a radiation safety committee, before the IRB will approve the research.
When University or Affiliate investigators are conducting research involving radioactive materials at sites under the direct control of the University (e.g., UNR Med laboratories or clinics) they must submit a radiation use application to the University’s Radiation Safety Committee and attach a copy of the committee’s approval when submitting the project for IRB review.
When University or Affiliate investigators are conducting research involving radioactive materials at an Affiliate or other external site, the research is subject to review and approval either by the University’s or the external site’s radiation safety committee. The RI Director will work with a representative of the external site and the investigator to define authorities and responsibilities for review, approval, and oversight for the University and the external site as it relates to the use of radioactive materials.
Institutional Component: Conflict of Interest Committee
The University has and follows written policies and procedures to identify, manage, and minimize or eliminate financial conflict of interests (COI). The organizational structure of the University places responsibility for COI under SP.
To facilitate identification of COI, RI applications and exemption researcher forms include a space for the Investigator to indicate a conflict of interest may exist and identify the researcher with the conflict. When the investigator identifies a possible COI, the RI Director determines if there is a COI Management Plan for the research and will either review the plan or refer the plan for IRB review. In the absence of a COI Management Plan, the RI Director will contact the person with the possible conflict to obtain more information.
If the IRB determines the Management Plan does not adequately protect human participants, the IRB notes the changes necessary for IRB approval. The changes may be satisfied through revisions to IRB application or consent documents. If the changes require an amendment to the Management Plan, the RI Director will inform the COI Official/COI Committee of the IRB’s concerns. The IRB will not approve any human subject research until it determines that the COI is sufficiently minimized or managed, or eliminated.