Policies and Procedures
The following policies and standard operating procedures (SOPs) ensure compliance with regulatory standards and outline responsibilities for researchers, IRB members, and the Human Research Protection Program (HRPP). Each document is available as a downloadable PDF that opens in a new tab.
- Investigator Manual: A comprehensive guide detailing researcher responsibilities throughout the IRB submission and study management process.
- HRP-013- SOP - LARs, Children, and Guardians: This policy establishes how to determine which individuals meet the following DHHS and FDA definitions of Legal Authorized Representatives (LAR), children, and guardian. Investigators are to follow this policy when obtaining permission for adults unable to consent or children to take part in research.
- HRP-090- SOP - Informed Consent Process for Research: This policy establishes the process to obtain informed consent from subjects, which includes the Legally Authorized Representative (LAR) of adults unable to consent, or the parents or guardians of children.
- HRP-091 - SOP - Written Documentation of Consent: This policy establishes the process to document the informed consent process in writing.
- HRP-025 - SOP - Investigations: This policy establishes the process to conduct investigations by either the IO/OO or designee, when IRB staff members and chair cannot answer a question required by HRP-024- SOP- New Information.
- HRP-026 - SOP - Susp or Term Issued Outside of Conv IRB: This policy establishes the process for someone other than the convened IRB to institute a Suspension of IRB Approval or a Termination of IRB Approval.
- HRP-030 - SOP - Designated Reviewers: This policy establishes the process for an IRB chair to designate IRB members who can conduct Non-Committee Reviews.
- HRP-032 - SOP - Non-Committee Review Conduct: This policy establishes the process for a Designated Reviewer to conduct a Non-Committee Review or a Limited IRB Review.
- HRP-041 - SOP - IRB Meeting Conduct: This policy establishes the process to conduct convened meetings.
- HRP-044 - SOP - Not Otherwise Approvable Research: This policy establishes the process for the organization to review research that is not otherwise approvable, but because the research is not subject to regulatory approval no government agency will conduct a review of this research to determine whether it can be approved.
- HRP-050 - SOP - Conflicting Interests of IRB Members: This policy establishes the process to identify and manage Conflicting Interest of IRB members.
- HRP-051 - SOP – Consultation: This policy establishes the process for the IRB to obtain consultants.
- HRP-054 - SOP - Institutional Conflicts of Interests: This policy establishes the process to identify institutional financial interests that may cause an institutional conflict of interests.
- HRP-063 - SOP - Expiration of IRB Approval: This policy establishes the process for a Designated Reviewer to determine whether current subjects may continue in expired research.
- HRP-064 - SOP - NIH GDS Institutional Certification: This policy establishes the process to certify approval for investigator submission of large-scale human genomic data to an NIH-designated data repository. The HRPP Director and the IRB Designee verify for the IO/OO that all data meet criteria for submission to the data repository.
- HRPP Plan: Provides an overview of the VU HRPP’s mission, roles, and responsibilities in supporting the conduct of ethical and compliant research.
- HRP-001 - SOP - Definitions: This policy establishes the definitions followed by the human research protection program. This is a non-exhaustive list and regulatory agencies should be referenced for complete definitions where applicable.
- HRP-012 - SOP - Observation of Consent Process : This procedure establishes the process to observe the consent process.
- HRP-020 - SOP - Incoming Items: This procedure establishes the process to triage information submitted to the IRB.
- HRP-021 - SOP - Pre-Review: This procedure establishes the process to pre-review a request for approval (approval of new research, approval to rely on an external IRB, continuing review of research, or modification to previously approved research) or a determination whether an activity is exempt Human Research or is not Human Research.
- HRP-024 - SOP - New Information: This procedure establishes the process to manage information reported to the IRB to ensure that information that represents Non-Compliance, Unanticipated Problems Involving Risks to Subjects or Others, Suspensions of IRB Approval, and Terminations of IRB Approval are managed to protect the rights and welfare of subjects.
- HRP-026 - SOP - Susp or Term Issued Outside of Conv IRB: This procedure establishes the process for someone other than the convened IRB to institute a Suspension of IRB Approval or a Termination of IRB Approval.
- HRP-031 - SOP - Non-Committee Review Preparation: This procedure establishes the process to prepare for a Non-Committee Review.
- HRP-040 - SOP - IRB Meeting Preparation: This procedure establishes the process to prepare for a convened IRB meeting.
- HRP-042 - SOP - IRB Meeting Attendance Monitoring: This procedure establishes the process to monitor quorum at convened IRB meetings.
- HRP-043 - SOP - IRB Meeting Minutes: This procedure establishes the process to record minutes for convened meetings.
- HRP-051 - SOP – Consultation: This procedure establishes the process for the IRB to obtain consultants.
- HRP-052 - SOP - Post-Review: This procedure establishes the process for communications after a protocol is reviewed.
- HRP-055 - SOP - Financial Conflicts of Interests: This procedure establishes the process to evaluate a report of an individual financial interest of an investigator or research staff Related to the Research or an institutional financial interest Related to the Research.
- HRP-060 - SOP - Annual Evaluations of the HRPP: This procedure establishes the process to conduct annual evaluations of the human research protection program.
- HRP-064 - SOP - NIH GDS Institutional Certification: This procedure establishes the process to certify approval for investigator submission of large-scale human genomic data to an NIH-designated data repository.
- HRP-065 - SOP - Response Plan for Emergencies-Disasters Impacting the HRPP: This SOP establishes the process for initiating a response to an emergency/disaster situation impacting the HRPP or HRPP operations. Challenges to HRPP operations or the conduct of Human Research may arise, for example, from extreme weather events, natural disasters, man-made disasters, and infectious disease outbreaks.
- HRP-070 - SOP - IRB Records: This procedure establishes the process to maintain IRB records.
- HRP-071 - SOP - Toolkit Management: This procedure establishes the process to create and update standard operating procedures and associated checklists and worksheets.
- HRP-072 - SOP - IRB Records Retention: This procedure establishes the process to retain IRB records.
- HRP-080 - SOP - IRB Formation and Registration: This procedure establishes the process to form a new IRB or update the OHRP IRB registration of an existing IRB.
- HRP-081 - SOP - IRB Removal: This procedure establishes the process to remove an IRB.
- HRP-082 - SOP - IRB Membership Addition: This procedure establishes the process to appoint and re-appoint an IRB member.
- HRP-083 - SOP - IRB Membership Removal: This procedure establishes the process to remove an IRB member.HRP-061 - SOP - Quarterly Evaluations of the HRPP: This procedure establishes the process to conduct quality improvement of the human research protection program.
- HRP-084 - SOP - IRB Meeting Scheduling and Notification: This procedure establishes the process to schedule and notify individuals of convened meetings.
VU HRPP Descriptions for Types Research
VU HRPP uses the following descriptions to distinguish between social, behavioral, educational, and health research and biomedical research, as well as what constitutes the use of VUMC resources. While these descriptions are not exhaustive, they are intended to assist researchers in determining whether the VU IRB or VUMC IRB will review the study.
Social, Behavioral, Educational Research Examples
- Quantitative and/or Qualitative Questionnaires
- Interviews
- Focus Groups
- Observations of Participants (public behaviors or in private settings)
- Secondary Analysis of Identifiable Information and/or Identifiable Biospecimens. *These studies may be exempt from federal regulations.
- Benign Behavioral Interventions
- Educational/Behavioral Interventions Collection of Data / Biospecimens through Noninvasive Procedures or Small Blood Collection. Examples of noninvasive procedures include use of VR headsets, EEG, MRI, TMS, eye trackers, and smart watches. Small blood collection is defined as collection of blood samples by finger stick, heel stick, ear stick, a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or b) from other adults and children [2], considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
- Research on Minimal Risk IDE Exempt Devices (FDA approved devices; FDA cleared devices (e.g. 510K device); noninvasive diagnostic devices that pose minimal risk, do not introduce energy into the body, and are not used as sole diagnostic tools without confirmation from established medical procedures.)
- Epidemiological Studies
- Behavioral Clinical Trials
Biomedical Research Examples
- FDA-Regulated Studies (Drugs, Medical Devices, Software as a Medical Device). An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: a) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or c) intended to affect the structure or any function of the body of man or other animals, or d) software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device
- Invasive Sampling or Large Blood Collection. This includes tissue sampling, and blood collection that does not meet the small blood collection criteria listed above in the Social, Behavioral, Educational Research section
- Clinical Trials of Investigational Drugs and Investigational Devices
- Devices Sending Energy into the Human Body, such as CT Scans, X-Rays, MRI with contrast, muscle stimulating devices. Magnetism is not considered a form of energy
- Research Using Medical Equipment Designed for Clinical Treatment
- Creation of Biospecimen Repositories
VUMC Clinical Resources or VUMC Faculty Advisors
If your research study leverages of any of the following in the research, the study should be submitted to the VUMC IRB for review.
- VUMC patients and patient identifiable medical records or protected health information (PHI)
- VUMC systems (e.g. eStar, StarPanel, eSmart, Research Derivative, Scheduling systems, etc.)
- VUMC clinical facilities (e.g. OR, ED, Specialty Clinics, Imaging Facilities, CRC, etc.)
- VUMC advisors in the case of student-led studies
*All VUMC research must be reviewed by VUMC IRB. For exempt and non-federally funded research, the VU and VUMC portions of the project can be reviewed by each respective IRB. For federally funded research subject to regulations, the study will be reviewed by VUMC. Please contact irb@vanderbilt.edu or an HRPP team member to discuss study-specific details, such as how to define when a someone is "engaged" in research.
Definitions
-
Assent
A minor’s active agreement to voluntarily participate in research. Age of majority varies by country.
-
Belmont Report
Issued by the National Commission for the Protection of Human Subjects in 1978, this report outlines important ethical principles applied in human research.
-
Clinical Trial
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
-
Consent (also known as Informed Consent)
o An adult’s active agreement to voluntary participation in research. Adequate, comprehensible information must be presented to a potential research participant in order for them to make an informed decision to consent.
-
Exempt
Categories outlined in the federal regulations for minimal risk research that are exempt from federal regulatory oversight and requirements. Research qualifying for exemption must still be submitted to and reviewed by the VU HRPP. VU HRPP will only review exempt categories 1-6.
-
Expedited
A review procedure for certain types of minimal risk research that may be conducted by the IRB Chair or Chair Designated Reviewer, without the need for a convened IRB meeting.
-
Human Subjects Research (also known as Human Research)
A systematic investigation for the purposes of contributing to generalizable knowledge, and involving interactions and/or interventions with living human participants or their private, identifiable data and/or biospecimens.
-
Systematic Investigation
A structured plan that involves research development, testing, and evaluation (i.e., data collection and/or data analysis that isprospective and/or retrospective). Examples of methods that are used for systematic investigations: surveys, interviews, focus groups, participant observations, analysis of existing and prospectively collected data, or cognitive/behavioral experiments. Examples of activities that are not considered systematic investigations according to federal regulations: oral histories, journalistic activities, public health surveillance activities conducted by a public health authority, or phenomenological activities.
-
Generalizable Knowledge
The intent is to draw general conclusions. For example, findings that might inform policy or contribute to the field beyond a single program (e.g. via publication, presentation, dissertation). By contrast, activities that are not generalizable include internal quality assurance and program improvement projects, classroom exercises solely to fulfill course requirements, and public health surveillance activities solely for timely situational awareness.
-
Private Information
Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record, an educational record).
-
Identifiable private info/biospecimens
Private information/biospecimens for which the identity of the individual is or may readily be ascertained by the investigator or associated with the information, either directly or indirectly (e.g., triangulation of certain information to identify an individual or obtaining coded data/biospecimens with a code link). For example, in some locations the intersection of someone's age and zip code might identify an individual.
-
Coded data/biospecimens
When identifiers are separated from the research data/biospecimens, and linked with a code. If anyone on the research team has access to the code link, then the data/biospecimens are considered to be identifiable.
-
Federalwide Assurance (FWA)
An assurance is a written commitment to protect human research subjects and comply with the requirements of the Common Rule.
-
Full Board Review (also known as Convened IRB)
Human research reviewed at a convened Institutional Review Board (IRB) meeting.
-
Institutional Review Board (IRB)
A formal research ethics review committee responsible for protecting the rights and welfare of human research participants in human subjects research.
-
Institutional Authorization Agreement (IAA) (also known as Reliance Agreement)
An agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating institution relying on the ethical review.
-
Individual Investigator Authorization Agreement (IIA)
A formal contract between Vanderbilt University, a Federalwide Assured (FWA) organization, and an individual investigator who is not affiliated with an FWA organization or institutional research collaborator who is not acting as an agent of an FWA assured organization.
-
Institutional Official/Organizational Official (IO/OO)
A term utilized by DHHS. The Institutional Official (IO) is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance. The IO is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. The IO represents the institution named in the Federalwide Assurance (FWA). The IO is the Title.
-
International Research
Research involving data and/or study populations located outside of the United States.
-
Minimal Risk
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
-
Multi-Site Research
A study in which two or more institutions coordinate, with each institution completing all research activities outlined in a specific protocol.
-
Principal Investigator (PI)
The individual responsible for the compliant and ethical conduct of a human research study. Refer to the HRP-103 – Investigator Manual for information regarding who is eligible to serve as a PI at VU.
-
Reportable New Information (RNI)
New information about a study that a researcher must report about to the IRB.
-
Single IRB (sIRB)
A study in which two or more institutions (participating sites, also known as pSites) coordinate to complete the research activities, but all institutions rely on a single institution’s/organization’s IRB for ethical review. The reviewing IRB may or may not be affiliated with any of the pSites.
-
Voluntary
Willingness to making an informed decision to participate without being coerced or unduly influenced.
Regulations
Research involving human subjects must comply with federal, state, and institutional regulations designed to protect participants' rights, privacy, and welfare. Below are key regulatory frameworks relevant to IRB submissions and human research protections:
- 45 CFR 46 (2018 Common Rule): Federal policy outlining protections for human research participants, including informed consent and IRB review requirements.
- 21 CFR 50 (FDA): U.S. Food and Drug Administration regulations governing the protection of human subjects in clinical research.
- FERPA (Family Educational Rights and Privacy Act):A federal law that protects the privacy of students’ personally identifiable information in their education record. More information about FERPA at VU can be found on the University Registrar’s website and in the VU Privacy Policy.
- PPRA (Protection of Pupil Rights Amendment): U.S. regulation ensuring parental control over certain student-related surveys and data collection.
- COPPA (Children’s Online Privacy Protection Act): Federal law protecting the online privacy of children under the age of 13.
- GDPR (General Data Protection Regulation): A European Union (EU) data privacy regulation that safeguards the privacy and security of personal information for individuals within the EU.
- Personal Information Protection Law of the People’s Republic of China (PIPL): Effective November 2021, China’s Personal Information Protection Law (PIPL) sets strict regulations on the collection, storage, use, and transfer of personal information of Chinese citizens.
- NIH Genomic Data Sharing (GDS) Policy: This policy pertains to all NIH-funded research that produces large-scale genomic data from humans or non-humans, including the use of this data in future research.
Adhering to these regulations ensures ethical and legal compliance throughout the research process.