When designing research activities, it is important to consider whether you need to obtain university Institutional Review Board approval to conduct your research PRIOR to collecting data. This decision chart will help you determine if the activity is considered research by The Common Rule definition (45 CFR 46). If you determine using this chart that you must pursue IRB approval, please see the VCSU Institutional Review Board website or OneStop solution center for more information. Class projects are course-related activities designed specifically for educational or teaching purposes, where data are collected from and about people as part of a class exercise or assignment that is not intended for use outside of the classroom. Capstone projects usually are not research, but they should be evaluated against the definition of research in the decision chart. Projects to be presented at the VCSU Student Scholar Symposium or similar programs usually are not research but they should be assessed against the definition of research in the decision chart.

Definitions Definition of Research on Human Subjects: Any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge based on data obtained from human subjects. This includes both original studies and replications of existing studies performed by faculty, students, or others. Research involving human subjects can consist of a full range of activities described in this section and include activities that make use of such things as: Private information, such as personal, educational, or medical information, which can be readily identified with individuals, even if the information was not specifically collected for the study in question. Psychological or social research, or research on cell lines or DNA samples that can be associated with individuals fall into this category. Private information that 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). 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. The IRB has the sole authority to determine whether or not a research project constitutes the involvement of human subjects. Biospecimen (human): samples of any cellular constituents or liquid secretions of the human body. The molecular makeup of biospecimens reflects the physiologic or pathologic condition of the person from whom they derive; and provides sensitive and specific insight into the biologic state of the donor. This includes residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research. It is important to note that specifically excluded from this definition are activities whose primary focus is on benefiting the individual(s) involved in the procedure. (See item e., below.) Activities Included as Research Physical, chemical, electrical or psychological stimulation of responses with the human body as well as interview, observation of behavior, administration of tests or other techniques of measurement, examination, or evaluation of individual humans. Observation of the performance of activities; or of physical or psychological reactions of individual humans or groups of human beings to stimuli which are either controlled by the investigator or are present in a normal non-manipulated environment. Observation or evaluation of the products of individual performance of tasks or reactions to stimuli in which human beings are directly involved through their active conduct or through giving consent to have procedures performed upon them. Activities Specifically Excluded: These activities are distinguished from research as understood under the auspices of the IRB and include activities that may be classified as beneficial services. Activities under "Excluded" do not need IRB approval. These activities include: Teaching/training of individuals. Performance of diagnostic evaluation of individuals which will directly benefit the individual, or the relation of an individual to whom the human participant has agreed to assist, or the mass screening of disease. Performance of therapeutic procedures for the direct benefit of the individual participating or for the relation of an individual participating as in the interviewing relative to counseling services. Clinical Training and Research: Clinical training covers those procedures and activities that are used to teach students to engage in professional activities with human beings other than the teacher or student involved in the procedure. Clinical training is excluded from the scope of this policy. Research training is intended to train the student in the methodology and the procedures for conducting research involving human subjects and is involved in the scope of this policy. There may be cases where the original procedure is performed as Clinical training or as Diagnosis or as Therapy and at some later date the case record, or product of such service, would be the subject of study. In this case, it is the subsequent use of records or products that will constitute research involving human subjects and is subject to this policy. If Research training utilizes research designs, methodology, procedures, and/or techniques that are frequently used and does not violate minimal risk or confidentiality, then the original design must be approved by the IRB with periodic review every five years. Categories of Human Research: It is expected that any research involving human subjects will be reported to the IRB Chair. Even if it is determined that a research activity is exempted from review, the researcher pursuing this activity must obtain permission from the IRB approving the work under the exempt classification. Research funded by external agencies requiring review, e.g., DDHS. Such research will be reviewed by the IRB in accordance with the appropriate agency guidelines. Research not funded by agencies requiring review but employing human subjects in a manner not explicitly exempted. Such research shall be subject to either an expedited or a full review by the IRB and must conform to the principles outlined in this document. Explicitly exempted research are projects of no or low risk. These guidelines are principally based upon those established by the U.S. Department of Health and Human Services (HHS). Specifically exempt from full IRB review are: Research on normal educational practices that are conducted in schools. (Examples of normal educational practices include research or comparison of instructional strategies and techniques, curricula, and classroom management methods.) Research which involves the use of educational tests (cognitive, diagnostic, aptitude, achievement) if the investigator will record the information so obtained in a manner that makes identification of the subjects impossible. Research involving survey or interview procedures where the subjects are legally competent, and where the investigator identifies himself/herself, and states that he/she is conducting a research survey interview. Research involving the observation (including observation by participants) of public behavior in places where there is a recognized expectation of privacy, except where both of the following conditions exist: Observations are recorded in such a manner that the human subjects can be identified directly or through identifiers linked to the subjects, and the observations recorded about the subjects, if they became known outside of the research, could reasonably place the subjects at risk of criminal or civil liability, be damaging to their social standing, or be damaging to the subjects' financial standing, employability or reputation. Participant Information Statement, Informed Consent Form, and Informed Consent: In many research activities an informed consent must be obtained by the investigator from each of the participants; or, in the case of those not able to give consent (e.g., children, mentally handicapped), consent must be obtained from their guardians or legal representatives.

VCSU has an obligation to ensure that investigators, IRB members, and staff maintain continuing knowledge of, and comply with, the relevant ethical principles, federal regulations, applicable guidance, state and local laws and institutional policies for the protection of human subjects. To fulfill this obligation, VCSU researchers and IRB members are required to complete and provide documentation of online training regarding informed consent and human subjects research protections. Training must be updated every 3 years.  VCSU has approved two online training choices. Documentation of completion of training must be submitted to the IRB Chair who will track completion. Option 1:  Human Research Protection Training This training is conducted through US Department of Health and Human Services Office for Human Research Protections.  Lessons 1 and 2 are required. Option 2:  Introduction to Informed Consent This training is one module conducted through the Global Health Training Centre.  

The Review Process Basic Expectations: It is expected that research design will satisfy the following two criteria: Risk: Research procedures should be designed so as to ensure that subjects are not exposed to physical, psychological, or social risks significantly in excess of that normally encountered in daily life. Any possible risks imposed must be weighed against the scientific importance and the potential benefits of the research. Specifically, risks of harm to human subjects must be (1) of no greater probability or magnitude than those encountered in daily life or during performance in routine physical or psychological examination or tests; or (2) reasonable in relation to expected benefits of the research and minimized by the use of the safest procedures. The review process is dependent on the amount of risk involved in regard to the human subjects. Confidentiality: Research procedures shall not disclose confidential information, including names and/or salient identifying characteristics, to other than the investigator(s) and their research staff. Further adequate provisions must be made to protect the confidentiality of information that is to be retained over an extended period. Exemptions from IRB Consideration: For projects associated with university courses, if the identity of a research subject is sufficiently protected and the subject is at minimal risk, an exception may be granted. All submissions for exempt status will receive special attention by the Chair if a protected population is included in the study. Expedited Review: An expedited review is a review by a subcommittee of the IRB consisting of the chair of the IRB and two other members of the IRB for research that involves no more than minimal risk, protected populations, or to review minor revisions in previously approved research, or review revisions for proposals that were approved but require revision. The subcommittee meets as needed to perform expedited reviews. An initial discussion of a project proposal with the IRB chair will determine whether an expedited or full review is necessary. Limited Review: Verifies conditions for certain exemptions are met. HHS maintains a list of these criteria allowing certain research to undergo the Expedited review mechanism, unless the reviewer determines that the study involves more than minimal risk. If so, the rationale must be documented. Full Review: A full review is a review of a project proposal by the entire IRB. This will be conducted for research that involves greater than minimal risk, or when the research is of a psychological nature. Documentation: Results of reviews will be documented under the supervision of the IRB Chair. Records will be retained according to VCSU records management schedule. Researchers and supervising advisors, if appropriate, will be notified according to established VCSU timelines. The IRB reserves the right to seek clarification or additional materials from the researcher. Absence of required documentation upon initial submission may delay the review. Monitoring of Ongoing Research The IRB shall maintain ongoing review of nonexempt human research with respect to subjects' rights. Monitoring procedures shall be arranged at the time of the review on a case-by-case basis. No continuing review is required for research eligible for expedited or limited review or for studies that have completed interventions and only involve analyzing data or accessing follow-up clinical data. IRB can override this and require continuing review, but this must be documented.

Forms Human Subjects Approval Request (HSAR I) - All IRB approval requests must be submitted using this online form.  Human Subjects Approval Request (HSAR II) - Must also be submitted for approval requests if you are asked to do so or if your study will involve minors or protected populations, deception, or higher than minimal risk, and does not qualify for an exemption under 45 CFR 46. Samples and Resources - The following are required for Expedited and Full Reviews, or if requested by the IRB. If subjects are over 18 and do not belong to any protected population, complete a Debriefing Form and an Informed Consent Form.  If subjects are under 18 years old, complete a Debriefing Form and a Parental Consent Form. If the study is taking place in an institution such as a school or disciplinary facility, complete the Administrative Permission Consent Form. This may not be necessary if the institution has its own IRB process. Administrative Permission Consent form Debriefing form Informed Consent Parent Consent form Participant Consent form Sample forms Youth Assent form – Example of an assent form, which are similar to consent forms used to inform children about participating in the study. See https://irb.research.chop.edu/assent for more information.

This article features answers to Frequently Asked Questions about the Institutional Review Board process as it relates to human subjects research.   1. What is an IRB? The acronym IRB refers to an Institutional Review Board. Institutions receiving any kind of federal funding for research, must establish an Institutional Review Board to establish human research policies and review all research involving human participants. 2. What federal policies govern human subjects research?  Human subjects research is governed by United States Department of Health and Human Services policy 45 CFR 46. 3. When must research proposals involving human subjects be submitted to the IRB?  Research proposals involving human subjects must be submitted for review and receive approval before the research begins. Graduate student action research that involves protected/vulnerable populations or proposals identified as a risk through the pre-screening process. 4. What documentation is required for an IRB submission? A signed Administrator Consent form for each research site Completed HSAR-I Completed HSAR-II for all studies involving minors or other protected populations. Copies of appropriate informed consent forms (templates available under "Resources & Forms") Copies of all survey instruments Debriefing Form  (templates available under "Resources & Forms") *Absence of any of these documents upon initial submission may delay the review. **The IRB reserves the right to seek clarification or additional materials from the researcher.  All IRB Proposals should be submitted to kerry.gregoryk@vcsu.edu 5. What are the review categories? Exempt from IRB Consideration: For projects associated with university courses, if the identity of a research subject is sufficiently protected and the subject is at minimal risk, an exception may be granted. All submissions for exempt status will receive special attention by the Chair if a protected population is included in the study. Expedited Review: An expedited review is a review by a subcommittee of the IRB consisting of the chair of the IRB and two other members of the IRB for research that involves no more than minimal risk, protected populations, or to review minor revisions in previously approved research, or review revisions for proposals that were approved with contingencies. This review is conducted electronically and is typically completed within seven to ten working days. An initial discussion of a project proposal with the IRB chair will determine whether an expedited or full review is necessary. Full Review: A full review is a review of a project proposal by the entire IRB. This will be conducted for research that involves greater than minimal risk, or when the research is of a psychological nature. 6. How long does IRB review typically take? Exempt reviews are typically completed within 1-3 business days. Expedited reviews are distributed with a goal of completion within 7-10 business days, though reviews may take longer in periods such as semester breaks or over the summer session. Full board reviews are contingent upon the ability to schedule a meeting of all board members and thus may take a considerable time to schedule. 7. What are the possible committee decisions. Approved: Researcher can begin his/her project. Revise and Resubmit: More information is needed or revisions are needed before proposal is reconsidered. Not Approved: Research should not be started.  8. Are there additional reporting requirements for researchers after obtaining initial Approval? Yes, pursuant to federal requirements, researchers must report the research status to the IRB Chair, at least once every 12 months until the project is complete. 9. Why is there a population minimum of 15? Can smaller populations be used? The smallest population in which random sampling can be used and retain a 95% level of certainty on research results is 15. Populations smaller than 15 tend to pose challenges for research analysis, including reductions in validity, reliability, and statistical significance.  10. I am not collecting any identifying information; do I need to file for IRB approval? Yes. Proposals will be evaluated as Exempt, Expedited, or Full Board review based upon the criteria outlined on this site.

Submission Process The use of human subjects in research requires approval from the IRB before the research procedures are implemented and data are collected. The IRB requires that internal reviews be conducted by the academic department/School before contacting the IRB. Materials for review are then submitted to the IRB chair via the Human Subjects Approval for Research I form The IRB chair shall then advise the Department Chair/Dean and project investigators within ten working days whether the project is exempt or requires an expedited or full review. If necessary, the IRB chair will call a meeting of the full committee within ten working days (i.e., excluding weekends) of receipt of the materials. Review results will be given to investigators within an additional ten days of the meeting. Researchers are required to submit documentation of completed training in Responsible Conduct of Research according to NDUS policy 410.0.  All completed IRB proposals should include the following: Completed IRB Human Subjects Approval Request I form (HSAR I). Completed IRB Human Subjects Approval Request II form (HSAR II) as required. The following forms and statements must accompany the proposal as required by the project parameters: An Informed Consent Form(s) Signed letter of permission from an authorized institutional representative, if research is to be conducted in an institution such as a school, hospital, etc. Debriefing Statement All forms and statements above are required for Expedited and Full Reviews VCSU Graduate Students Graduate students must complete the following before applying to the IRB: Proposal Approval form and a two chapter proposal approved by their advisor. If subjects are over 18 and do not belong to any protected population, complete a debriefing form and an Informed Consent form. If the study is taking place in an institution such as a school or disciplinary facility fill out the Administrator's consent form. This is not necessary if the institution has its own IRB process. If the students are under 18 years old, complete a Debriefing form and a Parental Consent form. All forms except the Proposal Approval Form are found on the IRB site under Resources and Forms. Graduate Students should submit their IRB paperwork and proposals to their advisor for approval. The advisor will forward the IRB package to Misty Lindgren in the Graduate School office. All other IRB Proposals should be submitted to kerry.gregoryk@vcsu.edu via the Human Subjects Approval for Research I form.