How to Determine the Appropriate IRB Application for Your Research Denise Roe, MSM, CCRP, CIP, RAC Dena Johnson, BS, CCRP, CIP March 14, 2008

Learning Objectives  Identify the applications available Why When How  Identify the resources available IRB PIT Crew Research Support Services Other Resources

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

Non-Human/Non-Research Determination Request Human Subject – A living individual about whom an Investigator (whether professional or student) conducting research obtains either data (of any kind) through intervention or interaction with the individual or identifiable private information (of any kind) even in the absence of intervention or interaction or an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. Research – Any systematic investigation (including research development, testing and evaluation) designed to develop or contribute to generalizable knowledge. Do I Really Need IRB Approval?

Non-Human/Non-Research Determination Request  When & Why If your project meets the non-human and/or the non-research definition and you need documentation from the IRB for your sponsor that this is the case  What Submit through DISCOVR-E or paper IRB form #1122 Reviewed by Protocol Analyst Approximately 7 business days

Umbrella Request Umbrella Review: The review of a grant where the research study or studies are not yet fully developed.

Umbrella Request  When & Why Need IRB acknowledgement of a grant 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 Submit through the DISCOVR-E portal or paper IRB Form #1106 Reviewed by Chair or designee Approximately 7 to 10 business days

Exemption Request  Must meet definition of minimal risk  Fall into one or more of the 6 exemption categories  At VU Exempt status can only be determined by the IRB  Exemption from Subpart A does not mean exempt from human subjects protections.

Exemption Request  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.  6 Categories Overview 6 Categories Overview 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 If research meets at least one of six categories Does not require full committee review, but determination must be made by someone other than PI. VU has designated the IRB as the party responsible for making exempt determinations  What Submit through the DISCOVR-E portal or paper IRB Form #1102 Reviewed by PA level II or higher Approximately 7 to 10 business days

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 the data contained in a database will be accessed for multiple projects or by multiple Investigators, a repository should be established.  What Submit through the DISCOVR-E portal or paper IRB Form #1103 Reviewed by Full Committee or Expedited review, whichever is applicable Approximately 10 – 12 business days for first Committee Action Letter

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 an enrolling site) OHRP Guidance indicates that an IRB should assure human subject protections are in place when the institution operates a coordinating centerOHRP Guidance  What Submit through the DISCOVR-E portal or paper IRB Form #1125 Reviewed by Full Committee or Expedited review, whichever is applicable Approximately 10 – 12 business days for first Committee Action Letter

Health Sciences or Behavioral Social Science Main Application  Health Science – Studies designated 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 Science – Studies designed to contribute to behavioral, educational, and social science research. Both quantitative and qualitative evaluations address issues of confidentiality, coercion, distress, and effects on social status.

Health Sciences or Behavioral Social Science Main Application  Most frequently used application  Type of research will determine level of review required (Standard = full committee or Expedited = sub-committee)  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§ still must be met)45 CFR§46.111

Health Sciences or Behavioral Social Science Main Application Expedited Review Category Comments  Established Federal Review Categories Established Federal Review Categories  Must be Minimal Risk to qualify  Behavioral Social Science Application incorporates expedited review categories  Health Science paper application does allow the Investigator to choose an expedited category; however, electronic submission through DISCOVR-E will guide the Investigator through a much shortened expedited application. Best advice is use DISCOVR-Eelectronic submission

Health Sciences or Behavioral Social Science Main Application  When & Why Use when research involves human subjects in a research project that involves greater than minimal risk or minimal risk research that fits in one of the expedited review categories and the proposed research does not fit into one of the aforementioned applications  What Submit through the DISCOVR-E portal or paper IRB Form #1100 (health science) or #1124 (behavioral social science) Reviewed by Full Committee or Expedited review, whichever is applicable Approximately 10 – 14 business days for first Committee Action Letter

Human Subject Radiation Committee (HSRC) and/or Radioactive Drug Research Committee (RDRC) Applications  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 If the project includes radiation ionizing procedures for research purposes submit a HSRC application concurrently with the IRB application If the project includes the administration of a radioactive drug as described in the previous slide submit a RDRC application concurrently with the IRB application Of note: the most typical IRB Application used in conjunction with an HSRC or RDRC application is the “main” application.  What Submit through the DISCOVR-E portal or paper IRB Form #1107 (HSRC) or #1108 (RDRC) Reviewed by Full Committee or Expedited review, whichever is applicable Approximately 10 – 14 business days for first Committee Action Letter if expedited and 15 – 20 business days if full committee as both of these committees only meet once a month

Supplemental Forms  CRC Supplemental Form  Coordinating Center Supplemental Form  Specimen/Data Repository Supplemental Form  HIPPA Compliance Forms Data Use Agreement, if applicable  Waiver of Consent Authorization Form  Vulnerable Population Forms  Conflict of Interest Forms

Supplemental Forms  When & Why Supplemental forms are to be completed and submitted in conjunction with the IRB application. Typically the IRB Application selected will guide the preparer on which supplemental forms are required.  What Specific supplemental forms are downloaded, completed, and submitted in whichever format the Investigator has chosen either electronically through DISCOVR-E or paper submission via IRB main office.

Other Types of Submission Forms  Continuing Review  Umbrella Continuing Review  Adverse Event Report  Amendment Request  Administrative Amendment Request  Protocol Deviation Report

Other Types of Submission Forms  In general title of form is self-explanatory  If further guidance needed review specific form and/or instructions for applicability  Contact a Protocol Analyst for further guidance

Resources Available  IRB Protocol Analyst Staff Excellent resource for specific IRB questions related either to a specific ongoing project or a proposed new project  IRB Performance Improvement Team (PIT crew) Excellent resource for additional education/assistance on topics related specifically to IRB related issues/processes  Research Support Services Excellent resource for broader issues related to the conduct of research  Other Resources Excellent resource 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 Other leaders of successful research programs within Vanderbilt

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