Determining the Appropriate IRB Application for Your Research June 7, 2011

Federal Definitions  Human Subject – 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.  Research – a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.  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.

Applications Available  Non-Human/Non-Research Determination Request  Umbrella Request  Exemption Request  Specimen/Data Repository Application  Coordinating Center Application  Biomedical/Health Sciences Applications  Behavioral/Social Sciences Applications  HSRC and/or RDRC Applications  Supplemental Forms  Additional Submission Forms

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 form 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. Consider using the Application for Coordinating Center Activities (Form #1125).  What  Completed Form #1122  Submitted through the DISCOVR-E portal  Reviewed by Analyst

Umbrella Request  When & Why  Your project needs IRB acknowledgement of the intent of research for funding purposes; however, the individual study or studies have not yet been fully developed. Note: An umbrella approval does not grant approval for research on human participants; it is simply an acknowledgement of the intent of the grant application, but does not constitute an approval of the grant.  What  Completed Form #1106  Submitted through the DISCOVR-E portal  Reviewed by Committee Chair or a designee

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)  Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior with elected officials or federal statutes requiring confidentiality  Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if publicly available or recorded with no links  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  What  Completed Form #1102  Submitted through the DISCOVR-E portal  Reviewed by Analyst II or higher

Specimen/Data Repository Application  Specimens/data to be collected prospectively or retrospectively (previously stored), for undefined future research purposes that will be shared, used again, or stored for research purposes should be banked in a “research repository.”

Specimen/Data Repository Application  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.  What  Completed Form #1103  Submitted through the DISCOVR-E portal  Reviewed Full Committee or Expedited, whichever is most applicable based on the study

Coordinating Center Application  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.

Coordinating Center Application  When & Why  When the Investigator’s responsibility in the research is strictly limited to the Coordinating Center function (not enrolling at Vanderbilt).  OHRP Guidance indicates that an IRB should assure human subject protections are in place when the institution operates a coordinating center.  What  Completed Form #1125  Submitted through the DISCOVR-E portal  Reviewed Full Committee or Expedited, whichever is most applicable based on the study

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.

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§ 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 identified in Form #1133.  What  Completed Form #1100 or #1133  Submitted through the DISCOVR-E portal  Reviewed by Full Committee or Expedited review, whichever is applicable to the study submitted

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 identified in Form #1119.  What  Completed Form #1124 or #1119  Submitted through the DISCOVR-E portal  Reviewed by Full Committee or Expedited review, whichever is applicable to the study submitted

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  What  Completed Form #1107 or #1108 and Form #1100  Submitted through the DISCOVR-E portal  Reviewed by Full Committee for the study and Full Committee or Expedited review for HSRC/RDRC

Supplemental Forms  Coded Data Agreement (Form #1142)  Coordinating Center Supplemental Form (Form #1132)  Specimen/Data Repository Supplemental Form (Form #1136)  Data Use Agreement (Form #1109)  Complaint Report (Form #1114)  Waiver of Consent and/or Authorization to Access PHI (Form #1112)  Vulnerable Population Forms  Children (#1117), Prisoners (#1115), Pregnant Women (#1116), and Cognitively Impaired (#1118)  Conflict of Interest Opinion Request (Form #1120)  Investigator Held IND Supplemental Form (Form #1135)  Supplemental Form for Devices (Form #1134)  Specimen/Data Repository Supplemental Form (Form #1136)  Phase I and Phase I/II Supplemental Form (Form #1143)  Research Procedure Supplemental Form (Form #1140)

Supplemental Forms  When & Why  Supplemental forms, as well as any additional study documents, are to be completed and submitted in conjunction with the corresponding IRB application. Based on answers to questions within the IRB applications, the Investigator will be guided to which supplemental forms are required with the submission.  What  Supplemental forms related to the study are to be downloaded, completed, and submitted electronically through the DISCOVR-E portal.

Other Types of Submissions  Continuing Review  Umbrella Continuing Review  Adverse Event Report  Amendment Request  Administrative 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.  Process Improvement Team - PIT crew  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 Grants & Contracts Management  Clinical Trials Billing Compliance within the Department of Finance  Tech Transfer  Medical Center Conflicts of Interest Committee

Contact Information  IRB Front Office –  