Human Subjects Review (HSR)
CONDUCTING RESEARCH AT REGENT UNIVERSITY
There are many opportunities to conduct research as a student, staff member, or faculty member at Regent University. Research can occur at the undergraduate level through research papers, theses, essays, projects, etc. and similarly at the graduate level, but with one unique addition: doctoral dissertations and projects. While all research is important and can significantly benefit the student, faculty member, the university, and the academic community at large, not all research is subject to the same academic standards and oversight. Research involving human subjects requires more oversight than research that does not. By “human subject” we mean a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual (e.g., surveys or interviews), or (2) identifiable private information.
The purpose of this website is to help you determine if your research requires evaluation by the Human Subjects Review (HSR) process. The HSR process is primarily relevant to two specific types of research: (1) dissertations, and (2) academic publications or presentations. The role of the HSR process is to ensure that all research projects protect the worth, dignity, rights, health, welfare, and privacy of all persons who choose to be willing participants in research involving human subjects in a loving manner. Regent University is committed to ethical, sensitive, and responsible conduct in the research of human subjects. Researchers must respect personal dignity and autonomy, secure voluntary consent from fully informed subjects, and protect persons by minimizing potential risks or harm of subjects. Depending on the type of research and the way it is funded, the research involving human subjects may require compliance with federal (45 CFR 46) and/or state (Virginia Code 32.1-162.16) regulations.
The resources on this website will help you determine if your research requires submission of an HSR application to be reviewed by an HSR representative in your school. In particular, the HSR Decision Tool takes you step-by-step through the process, allowing you to determine if your research requires review. Please read the Process Overview and then navigate through the HSR Decision Tool to determine if your research requires review.
Research projects that are (1) part of normal, typical coursework, and (2) not intended for dissemination (e.g., publication) are generally not required to undergo human subjects review even if human subjects are involved. Additionally, surveys or other data collection efforts for the purpose of program or institutional improvement (e.g., Student Evaluations of Teaching) and are not intended for dissemination are generally not required to undergo review. Regardless, research must follow ethical guidelines for the protection of human subjects. To that end, all researchers employing human subjects must complete the CITI (Collaborative Institutional Training Initiative; see Training). This training and other guidelines (see Forms & Resources) include information on the development of appropriate introductory letters and utilization of other informed consent language. Human subjects data collected in non-HSR research may not be used in future publications or presentations. There will be no ex post facto approval of such activities to legitimize turning these studies into approved human research.
If you want to find out if your research must undergo the HSR process, use the HSR Decision Tool below.
HSR ELIGIBLE RESEARCH
Research projects that involve (1) the use of human subjects, and (2) include results that are intended to be externally disseminated (e.g., via publication, presentation, grant application, etc.) are subject to the HSR process. There are three different levels of review: (1) Exempt, (2) Expedited, and (3) Full.
- Exempt Review: Lowest risk studies, typically anonymous surveys that do not include highly sensitive information.
- Expedited Review: No more than minimal risk studies. These studies include studies such as data collected through non-invasive means, collection of video or voice, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Full Review: These are more than minimal risk studies that require multiple reviewers. These include studies with vulnerable populations (such as children or prisoners) and sensitive questions as well as any study with potential physical risk. These studies also utilize government funding and will require evaluation by an external Institutional Review Board. For Full reviews, contact your school’s HSR representative (see Contact Information).
Exempt and Expedited Reviews require the submission of applications (see Forms & Resources~Human Subjects Review Application). Once submitted, the application will be reviewed by an HSR representative appointed by the dean of your school (see Contact Information).
To determine if your research requires an HSR Exempt or Expedited review, use the HSR Decision Tool below.
Below are some questions and responses that will help you understand the Humans Subjects Review process.
Before we continue, it would be helpful to agree on definitions. When we speak of a “human subject” we mean “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (see Code of Federal Regulations 45 CFR 46.102(f)).
Research can be defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (see Code of Federal Regulations at 45 CFR 46.102(d)).
Anonymous research is research that can never be traced back to a participant (e.g., a number on a questionnaire), not even by the researcher. Confidential research is research in which names and information are only known to researcher, and not revealed to anyone else.
Use the HSR Decision Tool below.
Complete a Human Subjects Review Application form and submit it electronically to your school’s Human Subjects Review representative (see Contact Information). Be sure to include all relevant information (grant proposals, consent forms, questionnaires, test instruments, advertisements, debriefing statements, contact letters, etc.); more details are provided in the Exempt and Expedited HSR application forms located under Forms & Resources. If you are a student working under the guidance of a faculty member (e.g., sponsored research, thesis, or dissertation), you must secure the approval of your faculty advisor before submitting your application for review.
The depth of the review process is dependent upon the type of research that you are proposing. HSR applications are classified as exempt, expedited, or full review. The HSR application has a checklist to help you determine in which category your application belongs, although the HSR contact within your school will review your submission and make the final determination of the application type.
When the Human Subjects Review representative receives your application, he or she will examine your proposal to validate the type of application you submitted (Exempt, Expedited, or Full review). After completing the review process, the HSR representative will reply with a letter of approval, request for further information or revisions, or a letter of rejection. The review considers the proposed purpose, procedures, and subject populations to be used and determines if the benefits of the activity outweigh the risks to subjects. Issues considered in this analysis include ensuring that risks to the subjects are reasonable in relation to anticipated benefits, selection of subjects is equitable, informed consent is properly sought and documented, adequate preparation is taken to protect the privacy and confidentiality of subjects, and adequate provisions are made for the ongoing monitoring of the subjects’ welfare.
The estimated review timeframes are one week for exempt reviews, two weeks for expedited reviews, and one month for full reviews.
You will receive a letter from the HSR representative responding to your application, and you are required to wait for approval before beginning any research.
You must notify the HSR representative if you wish to change your research. You can make minor and administrative changes by submitting a written summary describing the proposed changes. Substantial changes in the focus, procedures, or subject population of the research may require submission of a new or revised application.
Approval is good for one year. If you will be collecting data after the one-year anniversary of your approval, you will be required to submit a renewal request using the HSR Application to secure an additional twelve-month extension. You may repeat this process for as many years as necessary just as long as you don’t substantially alter your original research request.
Government-funded human subjects research requires the employment of an Institutional Review Board (IRB). Regent University does not currently have an IRB that oversees federally-funded research, but there are ways to leverage resources from other institutions to assist in the review process. For more information, please contact the HSR representative for your school (see Contact Information).
Yes, the HSR website (see Training) has information about online training. All doctoral students completing a dissertation or final project need to complete the online training.
Click on the link to the HSR Decision Tool. This tool will help you decide which HSR application (if any) you are required to submit.
The following individuals must complete CITI training prior to conducting human subjects research:
- Faculty researchers
- Faculty overseeing student human subject research projects
- Student researchers
- Research assistants or related staff
The training course should take you 5-6 hours to complete.
To begin taking CITI courses, follow these steps:
- Go to the CITI Program website, https://about.citiprogram.org/en/homepage/
- In the upper right corner, select “Register”
- In “Select Your Organization Affiliation,” type in Regent University
- Check “I agree to Terms of Service”
- Check “I affirm that I am an affiliate of Regent University”
- Click “Continue to Create your CITI Program username/password
- Follow the remaining steps to register
- Choose the appropriate course. You need to complete one of the following courses (choose the course most appropriate):
- Social-Behavioral-Educational-Nursing Programs
- Social-Behavioral-Educational-Nursing Programs
Use the table below to determine which course you should take based on your discipline:
|School||CITI Training Course|
|College of Arts & Sciences||Social-Behavioral-Educational-Nursing Programs|
|College of Healthcare Sciences||Social-Behavioral-Educational-Nursing Programs|
|Robertson School of Government||Social-Behavioral-Educational-Nursing Programs|
|School of Business & Leadership||Social-Behavioral-Educational-Nursing Programs|
|School of Communication & the Arts||Communication|
|School of Divinity||Social-Behavioral-Educational-Nursing Programs|
|School of Education||Social-Behavioral-Educational-Nursing Programs|
|School of Law||Social-Behavioral-Educational-Nursing Programs|
|School of Nursing||Social-Behavioral-Educational-Nursing Programs|
|School of Psychology & Counseling||See SPC HSR website for details|
- Upon completion of required modules for your course, download a pdf certificate of completion and be sure to keep it for future documentation purposes for any course needs.
- Also, keep this certificate and submit it to Regent’s HSR representative(s) (or other appropriate Regent institutions) with your HSR application to conduct your research.
Your CITI certification lasts 3 years. When your certificate expires, you must take the refresher for your course to renew certification.
Please submit completed HSR forms electronically to your school’s Human Subjects Review contact.
- Human Subjects Review Application
- Sample Informed Consent Language (for survey research not requiring written consent)
- Written Consent Template (for research requiring written consent)
RESOURCES FOR FULL HSR PROCESS
The resources below provide additional information that may be helpful to your understanding of HSR requirements, processes and federal regulations for research requiring an external Institutional Research Board.
The primary contact for HSR process is the HSR representative in your school.
The contact for each school is listed below; please direct questions and submit your application to the appropriate resource. If you need additional assistance, please contact your dean.
|College of Arts & Sciences||Dan Koev, Ph.D.||firstname.lastname@example.org||757.352.4659|
|College of Healthcare Sciences||Ruth Cody, DNPemail@example.com||757.352.4529|
|Robertson School of Government||Gary Roberts, Ph.D.||firstname.lastname@example.org||757.352.4962|
|School of Business & Leadership||Emilyn Cabanda, Ph.D.||email@example.com||757.352.4357|
|School of Communication & the Arts||William Brown, Ph.D.||firstname.lastname@example.org||757.352.4216|
|School of Divinity||Lyle Story, Ph.D.||email@example.com||757.352.4402|
|School of Education||Jason D. Baker, Ph.D.||firstname.lastname@example.org||757.352.4447|
|School of Law||Eric Degroff, J.D.||email@example.com||757.352.4326|
|School of Psychology & Counseling||Fernando Garzon, Psy.D.||firstname.lastname@example.org||757.352.4341|