The IRB ProcessThe IRB Process

Tony Medure, M.A., CIP, RACTony Medure, M.A., CIP, RAC

Vanderbilt Human Research Vanderbilt Human Research Protection ProgramProtection Program

OutlineOutline

►Overview of the IRBOverview of the IRB►Type of Research and ReviewsType of Research and Reviews

Behavioral vs. BiomedicalBehavioral vs. Biomedical Non-human subject and Non-researchNon-human subject and Non-research Exempt vs. Expedited vs. StandardExempt vs. Expedited vs. Standard

►Where to BeginWhere to Begin►The Journey of a Research ProposalThe Journey of a Research Proposal

Institutional Review BoardsInstitutional Review Boards

► In response to many research and ethical In response to many research and ethical controversies, Congress passed the National controversies, Congress passed the National Research Act in 1974.Research Act in 1974. Established the “National Commission for Established the “National Commission for

Protection of Human Subjects of Biomedical and Protection of Human Subjects of Biomedical and Behavioral Research.”Behavioral Research.”

The Belmont Report was released in 1979 as a The Belmont Report was released in 1979 as a result of the Commission’s meeting.result of the Commission’s meeting.

The Code of Federal Regulations (45 CFR 46) was The Code of Federal Regulations (45 CFR 46) was developed from the three basic principles of the developed from the three basic principles of the Belmont Report.Belmont Report.

Institutional Review BoardsInstitutional Review Boards

► The mission of an IRB is to ensure the The mission of an IRB is to ensure the protection, safety, and welfare of human protection, safety, and welfare of human subjects.subjects.

► Overseen by the Office of Human Research Overseen by the Office of Human Research Protections (OHRP), which is under the Protections (OHRP), which is under the Department of Health and Human Services Department of Health and Human Services (DHHS).(DHHS).

► OHRP is separate from the Food and Drug OHRP is separate from the Food and Drug Administration (FDA), which has its own set of Administration (FDA), which has its own set of regulations.regulations.

► Each IRB Committee is composed of Each IRB Committee is composed of scientists, non-scientists, and community scientists, non-scientists, and community members.members.

IRB OversightIRB Oversight

► Non-human Subject and Non-researchNon-human Subject and Non-research► Human Subjects ResearchHuman Subjects Research

Clinical InvestigationsClinical Investigations Diagnostic or Therapeutic ProceduresDiagnostic or Therapeutic Procedures New Interventions or TreatmentsNew Interventions or Treatments

► Data and Specimen RepositoriesData and Specimen Repositories► Humanitarian Use DevicesHumanitarian Use Devices► Emergency Use of Investigational DrugsEmergency Use of Investigational Drugs► Case StudiesCase Studies► Internet ResearchInternet Research► Pilot StudiesPilot Studies

IRB ReviewsIRB Reviews

►Behavioral vs. BiomedicalBehavioral vs. Biomedical

►Exempt vs. Expedited vs. StandardExempt vs. Expedited vs. Standard

►Non-human Subject and Non-researchNon-human Subject and Non-research

IRB Reviews by the NumbersIRB Reviews by the Numbers

► In 2008, the IRB received a total of 8409 In 2008, the IRB received a total of 8409 submissions.submissions. Of those submissions, 1413 were new studies.Of those submissions, 1413 were new studies. Amendments – 3349, Continuing Reviews - 2262, Amendments – 3349, Continuing Reviews - 2262,

Adverse Events - 753, and Protocol Deviations – 415.Adverse Events - 753, and Protocol Deviations – 415.

► In 2009, the IRB received a total of 8974 In 2009, the IRB received a total of 8974 submissions.submissions. Of those, 1578 were new studies.Of those, 1578 were new studies. Amendments – 3814, Continuing Reviews – 2353, Amendments – 3814, Continuing Reviews – 2353,

Adverse Events – 838, and Protocol Deviations – 391.Adverse Events – 838, and Protocol Deviations – 391.

So where do I start?So where do I start?

Investigator TrainingInvestigator Training

► Be sure to complete the required human Be sure to complete the required human subjects training subjects training beforebefore submitting to the submitting to the IRB. Any key study personnel (KSP) must IRB. Any key study personnel (KSP) must also complete training.also complete training. CITI Program – CITI Program – http://www.citiprogram.org

► Continuing IRB Education/Training.Continuing IRB Education/Training. Must complete at least one hour annually.Must complete at least one hour annually. One additional CITI module, VHRPP workshops One additional CITI module, VHRPP workshops

(e.g., News You Can Use, IRB Essentials, etc.), or (e.g., News You Can Use, IRB Essentials, etc.), or another session focused on human subjects another session focused on human subjects protections.protections.

Timing is EverythingTiming is Everything

► Start your project NOW. It’s never too early Start your project NOW. It’s never too early to start planning.to start planning.

► Allow yourself more time than you think you Allow yourself more time than you think you need.need.

► IRB review may take longer than anticipated IRB review may take longer than anticipated depending on the complexity of your study.depending on the complexity of your study.

► Respond promptly to correspondence from Respond promptly to correspondence from the IRB Committee.the IRB Committee.

► If you plan to travel abroad, make sure you If you plan to travel abroad, make sure you have all the pieces in place before you have all the pieces in place before you leave. Please leave. Please do notdo not submit your project on submit your project on Monday and say you’re leaving on Friday.Monday and say you’re leaving on Friday.

Use the Resources Available to Use the Resources Available to YouYou

► Work with mentors or other experts in your Work with mentors or other experts in your area of study.area of study.

► Talk to colleagues that have submitted to the Talk to colleagues that have submitted to the IRB.IRB.

► Call the VHRPP to set up an appointment to Call the VHRPP to set up an appointment to speak with someone about your project.speak with someone about your project.

► Call or email me with any questions you have.Call or email me with any questions you have.► Talk to someone in the Biostatistics Talk to someone in the Biostatistics

department and attend one of the weekly department and attend one of the weekly clinics.clinics.

► Get help with literature searches from the Get help with literature searches from the libraries on campus.libraries on campus.

Putting Your Proposal Putting Your Proposal TogetherTogether

► A typical proposal/submission includes: an A typical proposal/submission includes: an application, a consent form, a protocol, and application, a consent form, a protocol, and additional supporting documents (e.g., additional supporting documents (e.g., questionnaires, advertisements, brochures, questionnaires, advertisements, brochures, interview guides, etc.).interview guides, etc.).

► All of the forms you may need are available All of the forms you may need are available on the VHRPP website.on the VHRPP website.

► Slide shows and step-by-step video tutorials Slide shows and step-by-step video tutorials are available on the VHRPP website.are available on the VHRPP website.

► Submit your study electronically through Submit your study electronically through DISCOVR-E.DISCOVR-E.

The Review ProcessThe Review Process► Once your study is sent to the IRB, it will go through the “pre-Once your study is sent to the IRB, it will go through the “pre-

review” process.review” process.► When your study is ready, it will be sent out for review (Exempt When your study is ready, it will be sent out for review (Exempt

or Expedited) or put on the next available agenda (Standard).or Expedited) or put on the next available agenda (Standard).► When the review is complete, you will receive a letter through When the review is complete, you will receive a letter through

DISCOVR-E from the IRB Committee with an update on the DISCOVR-E from the IRB Committee with an update on the status of your study (Approved, Approved Pending, or Deferred).status of your study (Approved, Approved Pending, or Deferred).

► If your study is approved, no other action is needed on your If your study is approved, no other action is needed on your part. If your study is approved pending or deferred, you need to part. If your study is approved pending or deferred, you need to make the requested changes and submit the changes to the IRB make the requested changes and submit the changes to the IRB for review.for review.

► After your study is approved, any changes you want to make After your study is approved, any changes you want to make must be submitted as an amendment to the study prior to must be submitted as an amendment to the study prior to implementation. Any changes to Exempt studies must be done implementation. Any changes to Exempt studies must be done within the first year.within the first year.

► Expedited and Standard studies must be reviewed at least once Expedited and Standard studies must be reviewed at least once annually (i.e., Continuing Review).annually (i.e., Continuing Review).

Points to ConsiderPoints to Consider

► Simple research is good research.Simple research is good research.► Be aware of working with vulnerable populations Be aware of working with vulnerable populations

(e.g., children, prisoners, etc.).(e.g., children, prisoners, etc.).► Consider working with your advisor/mentor on one Consider working with your advisor/mentor on one

of his/her studies.of his/her studies.► Allow ample time for International studies.Allow ample time for International studies.► Be sure to partner with a contact abroad to make Be sure to partner with a contact abroad to make

yourself familiar with the local research context. yourself familiar with the local research context. You will also need approval from a local IRB, Ethics You will also need approval from a local IRB, Ethics Board, Hospital Administration, or other governing Board, Hospital Administration, or other governing body associated with the site where you plan to body associated with the site where you plan to conduct your study. This can take a LONG time, so conduct your study. This can take a LONG time, so be proactive.be proactive.

Contact InformationContact Information

►322-2918 – VHRPP Front Office322-2918 – VHRPP Front Office►http://www.mc.vanderbilt.edu/irb/►322-2260 – direct line322-2260 – direct line►anthony.medure@vanderbilt.edu

Questions?Questions?