Determining the Appropriate IRB Application for Your Research August 10, 2015

Federal Definitions Human Subject – a living individual about whom an investigator (whether professional or student) conducting research: obtains information or biospecimens through intervention or interaction with an individual and uses, studies, or analyzes the information or biospecimen; obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens; or identifies a subject as either a recipient of a test article or as a control. A subject might be either a healthy individual or a patient. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used. When medical device research involves in vitro diagnostics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects.

Federal Definitions Research – a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. FDA defines research as any experiment that involves a test article where the results of such experiment areintended to be submitted to or help for inspection by the FDA. 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.

Local Definitions Vanderbilt HRPP – a human research protection program (HRPP) designed to ensure the protection of humans participating in research studies. IRB Committee – a committee of scientists and non-scientists charged with reviewing the risk/benefit ratio of proposed research. Analyst – a person who works on one of four teams that support the IRB Committees by conducting pre-reviews of research studies and making sure everything is in order for a study before it is reviewed.

Application Pathways Through DISCOVR-e Standard or Expedited (includes repositories and registries) Exempt Umbrella Review Comparative Effectiveness Research Non-Human Subject Determination Quality Improvement/Non-Research Determination Request Review by Another IRB Coordinating Center ONLY

Non-Human/Non-Research Determination Request When & Why Your project meets the non-human and/or the non-research definition shown on the federal definitions page and you need documentation from the IRB to give to your sponsor, funder, or granting agency. Note: This may not be appropriate if the proposal is funded by a federal grant that involves human subjects for which you are the PI or the direct recipient of the grant. Please choose the “Umbrella Review” button.

Exemption Request Must meet definition of minimal risk shown previously on the federal definitions slide. Falls into one or more of the 6 exemption categories. At Vanderbilt, exempt status can only be determined by the IRB. Exemption from Subpart A of the Federal Regulations does not mean a study is exempt from human subjects protections or Vanderbilt HRPP policies and procedures.

Exemption Request Overview of 6 Exempt Categories Research conducted in established or commonly accepted educational settings, involving normal educational practices. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (exceptions). If data recorded identifiable, the IRB conducts a limited review. Research involving benign behavioral interventions (exceptions). If data recorded identifiable, the IRB conducts a limited review. Secondary research involving the collection or study of data, documents, records, pathological specimens, or diagnostic specimens (exceptions). Research and demonstration projects, which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine public service agencies. Taste and food quality evaluation and consumer acceptance studies.

Exemption Request When & Why Your research meets at least one of the six categories shown on the preceding slide. An exempt determination must be made by someone other than PI. Vanderbilt has designated the IRB as the party responsible for making exempt determinations.

Specimen/Data Repository When & Why Repositories may be proposed, built, and maintained by individuals (e.g., Investigators), groups, programs, departments, or institutes. A single Investigator or a group of Investigators may wish to pool research specimens/data from multiple research studies into a single specimen bank or database that could be accessed by the group and others for further use. When data contained in a database will be accessed for multiple projects or by multiple Investigators, a repository should be established.

Coordinating Centers A Coordinating Center (CC) may consist of a group of individual researchers or a single Investigator responsible for oversight of more than one performance site engaged in research. Additionally, a CC maintains sufficient mechanisms for the protection of research participants with regard to its activities and responsibilities.

Biomedical/Health Sciences and Behavioral/Social Sciences Biomedical/Health Sciences – Studies designed primarily to increase the scientific base of information about normal or abnormal physiology and development, and studies primarily intended to evaluate the safety, efficacy, and usefulness of drugs, biologics, devices, medical products, procedures or interventions. Behavioral/Social Sciences – Studies designed to contribute to behavioral, educational, and social science research. Includes quantitative and qualitative investigations of individual and group characteristics.

Clinical Trial Can be Biomedical or Behavioral: 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.

Biomedical/Health Sciences and Behavioral/Social Sciences Most frequently used applications. Both Standard and Expedited applications available. Type of research will determine the level of review required. Standard - full committee (10 person panel); or Expedited - sub-committee (1 designated committee member). Keep in mind “Expedited” review indicates a sub-committee review not necessarily a faster review or less comprehensive review (criteria for approval found in 45 CFR§46.111 must still be met) and must be minimal risk to qualify. Expedited applications incorporate the review categories.

Biomedical/Health Sciences When & Why Use when research involves human subjects in a research project involving greater than minimal risk (e.g., new drug or indication, a device that has not been cleared, etc.) or minimal risk research that fits in one of the expedited review categories.

Behavioral/Social Sciences When & Why Use when research involves human subjects in a research project that involves greater than minimal risk, a complex intervention that includes a vulnerable population, or minimal risk research that fits in one of the expedited review categories.

Human Subject Radiation Committee (HSRC) and/or Radioactive Drug Research Committee (RDRC) HSRC – For review and approval of research studies involving human participants and radiation exposure for research purposes only RDRC – For review of the use of any substance defined as a drug under the Federal Food, Drug and Cosmetic Act that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. Included are any non-radioactive reagent kit or nuclide generator that is intended to be used in the preparation of a radioactive drug and "radioactive biological products."

HSRC and/or RDRC Applications When & Why Your project includes radiation ionizing procedures for research purposes submit a HSRC application concurrently with the IRB application Your project includes the administration of a radioactive drug as described in the previous slide submit a RDRC application concurrently with the IRB application

Other Types of Submissions Continuing Review Adverse Event Report Amendment Request Non-compliance with the Protocol The title of form represents the type of submission it should be used for; however, if additional guidance is needed after reviewing the specific form and/or accompanying instructions, please contact a protocol analyst for further assistance.

Resources Available VHRPP Staff - Protocol Analysts Use for specific IRB questions related to a specific ongoing project or a proposed new project. Compliance Analysts Use for education and assistance on topics related specifically to IRB related policies/procedures, as well as compliance and documentation issues. Other Resources Use for issues related to a specific component of the research that falls within the purview of an established department, such as: Office of Contracts Management Clinical Trials Billing Compliance within the Department of Finance Center for Technology Transfer Medical Center Conflicts of Interest Committee

Contact Information HRPP General Line – 322-2918 Website: www.vumc.org/irb