Institutional Review Board And how it affects you.

 To ensure the institution is in compliance with the HHS Protection of Human Subjects (Federal Regulation 45 CFR part 46).  To be eligible for a Federalwide Assurance (FWA), a commitment that we will comply with this regulation.  To be eligible for grant money.

 A review committee established to help protect the rights and welfare of human research subjects.  Research is a systematic investigation designed to contribute to generalizable knowledge.  Human subjects are those about whom an investigator obtains data, or from whom identifiable private information is obtained.

Approve / disapprove research Modify research Hold continuing reviews Observe / verify changes Suspend / terminate approval Observe the consent process and research procedure Require collaborating outside agencies to have an FWA

Five members minimum Both sexes must be included Varied Professions: 1 non-science, 1 science, 1 not affiliated with the institution. Additionally, the board must be culturally diverse, be sensitive to community issues, and have members that understand the research being done.

 Juliana Serafin, Chair  Brad Deel  Debra Mullins  Stephen Cook  Dean Reardon  Jennifer Pack  Lynn Gunnoe *  Diana Long * Nonvoting Members:  Marea Dodd, Assistant to the Board and Recordkeeper  Dennis Flaherty, ad hoc * Denotes an outside representative who is not affiliated with UC

 The IRB meets quarterly to complete full reviews:  August  November  February  May Check with Marea Dodd for specific dates.  The IRB may hold additional, Special Meetings, based on need.

Application for initial reviewApplication for Annual Renewal/Progress ReportAmendments or modificationsReports as indicated by the IRBClosure ReportReports to other agencies may also be required.

Forms and instructions are on the UC website (Faculty and Staff) The primary investigator for research involving human subjects must submit an IRB application. The investigators must have the appropriate NIH training or their application will not be reviewed.

Investigators must have current Training in Protecting Human Research Participants or applications will not be reviewed. Training is found at: phrp.nihtraining.com PI is responsible for submitting a copy of their current certificate with EACH application. Training is good for 3 years from the date of certification. Plan to renew your training before it expires, to avoid delays with your project. PI Certification Expires before project is complete, the project is suspended until: The PI renews training certification, or An application for change in PI to another PI who has training certification, is approved.

NOTE: Our process has changed for issuing application numbers. You will NOT be issued an application numbers, until the project has been approved. Submit (Choose a Method) Signed & Scanned Electronic to: OR Signed Paper Copy to: Marea Dodd, SOP-304 Save Electronic Copy of All Completed Forms Complete Forms(All appropriate) Choose Forms(All appropriate) Review InstructionsForms

Full Committee ReviewExpedited ReviewExempt ReviewAnnual Review

IRB will go over the application at a formal meeting. Modifications may be requested by the IRB before approval is given There must be a quorum present for the IRB to vote and each member will vote to approve or disapprove the project.

Risk Level Minimal Falls into one of nine specific categories (Refer to Instructions for detail): Noninvasive Sample Collection Blood Samples Studies with approved drugs/devices Data that has already been collected or will be collected for non- research purposes Review Two IRB Members are chosen to review.

Risk Level No Risk Minimal Risk Falls into one of six categories: Educational Research Educational Tests Educational Research involving public officials or candidates for office De-identified existing records Research conducted by heads of government department Taste and Food Quality Evaluations Review IRB selects one IRB Member to review

Prisoners Surveying or Interviewing Children Observations of public behavior when investigator participates

CAMC’s IRB actions will be accepted in lieu of UC’s IRB Other Institutions involved in a study must have a FWA and obtain approval from UC’s IRB

Select Application Type: Save a Copy of All Completed Forms: Print Copy & Obtain All Required Signatures: Submit Signed Application: See You will need this for the next two steps. You will also want a copy for your records. Primary Investigator Other Investigator School/Division Chair Electronically to: (Scan entire application and attachments as one inclusive OR Mail Hard Copy to: Marea Dodd, SOP-304, Charleston Campus

If there are changes to the project, such as, PI, PI’s NIH Certification Expires, or Circumstances or situations arise that were not previously know. You MUST notify the IRB. You may NOT begin your project, until you receive written approval from the IRB. Once approved, it is good for one year from date of approval. If you wish to continue beyond one year, you must seek approval through the Renewal Process.

A project must stop at the end of the approved year; unless you have applied for and received approval. Apply at least 60 days before the expiration of your approval. NIH Training Certification must remain current.

At Project Termination Project Completed Funding Ended PI Left University At end of Approved Year Unless completing a Renewal Application

Four Weeks Exempt Six Weeks Expedited Eight Weeks Full Review Submit 60 days prior to expiration of the approved year. Annual Renewal / Progress Report No approval required, due upon the completion or termination of project or suspension of approved year; unless, applying for renewal. Closure

For Additional Assistance, Please Contact: Dr. Juliana Serafin, IRB Chair OR Ms. Marea Dodd, IRB Asst./Recorder Charleston Campus, CTB-716 Charleston Campus, SOP