Academic Standing Committees

IRB for the Protection of Human Subjects

The Institutional Review Board (IRB) is responsible for ensuring that the university complies with federal regulations regarding research with human subjects and for safeguarding the rights and welfare of subjects at risk in research activities conducted through the university.

For those faculty, students and staff who gather information from humans for their research and professional activities, work with the IRB is expected and is a sign of a successful, scholarly campus community.

The IRB reviews and approves research activities that involve human subjects at CNU as well as research activities conducted by agents of the university at off-campus locations.

For detailed information about IRB policies, please review the IRB Guidelines and Standard Operating Procedures.

CNU adheres to the REVISED COMMON RULE (2018 Requirements) for all IRB submissions. The CNU IRB strongly encourages researchers to complete the CITI training on the revised common rule to become acquainted with the new federal regulations before submitting an IRB proposal.

For all projects, when investigators are faculty members, care must be taken to ensure that participation is not made a condition of student participants’ course performance. However, extra credit may be given for participation, as long as equitable alternative assignments are provided.

The IRB wants to ensure that human subjects are protected in the course of normal research procedures. Given the COVID-19 Pandemic, PIs conducting in-person research should conduct a safety audit of their procedures and protocols to ensure that all CNU, CDC and VDH policies (e.g., Campus Visitor Policy, T4) and guidelines for preventing virus transmission are being followed. If your protocol requires modification in order to protect against potential virus exposure and transmission, please submit a modification to the IRB explaining those modifications. If it is not possible to comply with the CNU, CDC and VDH policies and guidance even if modifications are made, the research should be temporarily suspended until that time that it can be resumed safely. PIs continuing in-person research should provide all prospective participants with the COVID-19 risk information sheet downloadable from the IRB website as part of the informed consent process. All applications for in-person research activities submitted during the ongoing pandemic will receive heightened scrutiny to ensure that pandemic related safety precautions are built in to the procedures being proposed. The IRB thanks you for taking the time to consider the effects of your research on the human participant volunteers and the risk that participation may pose to them.

What Qualifies as Research?

Research is a broad term that refers to any "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities." (45 CFR 46.102). Under this definition, research includes, among others, such data-gathering activities as surveys, focus groups, interviews and observation.

Questions about CNU's Institutional Review Board for the Protection of Human Subjects should be directed to the Committee Chair, Dr. Alice E. Veksler, at (757) 594-7461 or IRB@cnu.edu.

Changes to the “Common Rule” has led to the implementation of a Single IRB (sIRB) mandate. This mandate requires a single IRB review for projects that involve multiple institutions and will apply to all federally-funded research. All sites within the US participating in federally funded cooperative research* must comply with the sIRB mandate. Some exceptions are permitted and include cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native Tribe) or research for which any Federal department of agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate.

For those cooperative research projects in which Christopher Newport will not be the lead institution, please follow the necessary steps outlined in the CNU IRB Submission Instructions. In short, you should create a new package in IRBNet and upload a letter of intent indicating that you plan to cede review to a designated other IRB, complete the Reliance Agreement and, upload the IRB approval letter from the designated IRB once approval is obtained. The Reliance Agreement should be completed well in advance of any deadlines. Finally, if a letter of support from CNU’s IRB indicating our eventual reliance on the chosen sIRB, please indicate this in your letter of intent and ensure that such requests are made at least 10 business days prior to the submission deadline for the designated IRB. Your letter of intent should provide the name of the CNU PI, names of all collaborating PIs, the lead site and name of PI at that site, name of the sIRB (if already selected), name of the funding agency, title of the study/grant, grant deadline, and a brief description of the study.

Christopher Newport will generally not serve as the IRB of record at this time. In the event you wish your cooperative project to use CNU’s IRB as the review board of record, please contact the Vice Provost for Research, Graduate Studies, and Assessment and the Chair of IRB at irb@cnu.edu.

All questions should be directed to the Vice Provost for Research, Graduate Studies, and Assessment or the Chair of IRB at irb@cnu.edu.

*Cooperative Research is defined as the same research protocol being conducted at one or more domestic sites and that each site is under the control of a local participating investigator. This typically involves a lead site that receives the grant or contract directly from a federal agency and then establishes a sub-award or subcontract to each participating site. The research could be a clinical trial, an observation study, or a basic clinical research study.

As an important step toward streamlining protocol submission and review processes, CNU has now adopted the use of IRBNet, which brings the CNU community a robust set of electronic tools supporting the management, submission, review and oversight of our human subjects research protocols. Some of IRBNet’s many features include electronic document management, web-based protocol sharing and collaboration, automatic notifications, electronic submissions and reviews, integrated training and credential management, and important audit capabilities including electronic revision histories, electronic signatures and event tracking.

CNU has carefully chosen IRBNet not only for the important capabilities that it provides, but also because IRBNet is secure, web-based and extremely intuitive and easy to use. You may access IRBNet from virtually any computer using a web browser by visiting www.irbnet.org.

Before you can submit a new protocol, renew a protocol or submit modifications to existing projects, you must first create an account online. Detailed instructions are available on the IRBNet page (which include PowerPoints with photos, downloadable PDFs, and instructional videos).

Instructional Resources: http://www.irbnetresources.org/tresources/training.html
Institutional login: cnu
Password: training
(We suggest using Chrome as your browser. Please make sure both the login and password are lowercase.)

If you have issues creating an account, you can contact IRBAdmin@cnu.edu or IRB@cnu.edu with questions.

For full instructions and login information, please read the CNU IRB Submission Instructions.

The US Department of Health and Human Services (HHS) and Office of Human Research Protections (OHRP) strongly recommend that investigators "act in accordance with the requirements of the HHS regulations for the protection of human subjects," particularly at institutions holding an OHRP-approved Federalwide Assurance, as we do at CNU.

Thus, consistent with HHS Office of Research Integrity expectations regarding the Responsible Conduct of Research, the university has determined that all investigators who do research with human subjects (faculty, staff and students) complete training in protecting human research participants once every three (3) years. Upload your certification to the IRBNet system and retain your certification number for your records.

You will find training options at the Collaborative Institutional Training Initiative (CITI). Registration is required.

For Collaborative Institutional Training Initiative training, investigators should select the course most appropriate for their type of research and their role. The suggested course is the "Social and Behavioral Research - Basic/Refresher" course however the IRB will also accept completion of any of the following as evidence of successful investigator education:

  • Biomedical Research-Basic/Refresher
  • IRB Chair
  • IRB Committee (RCR)
  • IRB Members Basic/Refresher
  • Social and Behavioral Research-Basic/Refresher (suggested course)
  • Students - Class Projects

If your research project requires additional training beyond that which is required for basic social science work (e.g., blood-borne pathogen training), please make sure that you and all members of your research team complete and upload ALL of the training needed for the given project. The IRB, at their discretion, may withhold approval on a project until evidence of all necessary training is provided.

Please ensure all members of the study team have completed required ethics training prior to submitting your project proposal to the IRB.

CNU now adheres to the REVISED COMMON RULE (2018 Requirements) for all IRB Submissions. The CNU IRB strongly encourages researchers to complete the CITI training on the revised common rule to become acquainted with the new federal regulations before submitting an IRB proposal. This training is recommended but not required.

All forms (such as the project proposal form, continuing review form, project modification form, etc.) are now located in the "Forms and Templates" tab on IRBNet. You will need to create a free account in IRBNet to access these forms and submit your project for IRB review.

Project Classification Decision Charts

Projects deemed to be exempt based on these decision charts still require IRB review and approval. Only projects deemed not human subjects research can proceed without IRB review. Additionally, CNU requires adherence to all HHS regulations regardless of whether or not the research is funded. Please see the official guidance or consult with the IRB chair if you have questions about whether your project needs to be submitted to the IRB.

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