University of Louisville Human Subjects Protection Program Office                                                             UofL Home

"Accredited since 6/17/2005"

For HSPPO News and Announcements <click here> Links Committee Rosters Customer Service Survey Questions, Concerns, Or Complaints Applying to the IRB Biomedical Forms Social/Behavioral/Educational Forms Fees '07 Biomedical Meeting Dates '08 Biomedical Meeting Dates '07 SBE Meeting Dates '08 SBE Meeting Dates Training Human Subjects Training HIPAA Training Researcher Education Opportunities   Training Opportunities Hospital Research Offices Norton Healthcare Research Office Jewish Hospital Research Office University Hospital Research Office Investigator Guidance Materials FWA Internet Resources Investigator Guide FDA Medwatch Information Guidance for Conducting Scientific or Scholarly Merit Review of Research International Compilation of Human Subject Research Protections Now Available IRB Materials HSPPO Mission Statement IRB Member Handbook IRB SOP's Human Subjects Protection Program Research Related Policies Authority of the UofL IRB KY Correction P&P-Research & Survey Projects IRB Report of Findings Policy Unanticipated Problems Involving Risks to Subjects or Others Suspension or Termination of Previously Approved Research Electronic Transmission of IRB Approvals Case Report Policy Paying Human Subjects Policy Policy and Procedures for Responding to Violations of UofL Research Policies Action For Failure To Obtain Required Subject Authorization For The Use Or Disclosure Of Protected Health Information Non-compliance Involving Human Subjects Research Contact the HSPPO by emailing the Service Account. Click Here		BRAAN2 PLEASE READ THIS BEFORE LOGGING ON TO BRAAN2!! Use of the Consent Form Builders has been temporarily suspended while the current bugs/issues are being resolved. Until further notice, please attach your consent forms to the Misc. Attachments page of the IRB protocol, under the section "Approval Attachments". Before submitting your protocol, please delete any consent form builders you have started working on. At this time BRAAN2 is not compatible with Internet Explorer 7.0! The only compatible web browsers at his time are: For PC users - Netscape 7.0; Internet Explorer 6.0; and Firefox 1.0. For Mac users - MAC OS 10.4: Netscape 7.1; Safari 2.0. MAC OS 10.3: Netscape 7.1; Safari 1.2. MAC OS 9.2: Netscape 7.1 All new studies must be submitted in BRAAN2. Studies that were approved via the paper method will remain in paper for now, actions on these studies (i.e, amendments, continuing reviews, adverse events, etc.) should be submitted in paper. BRAAN2 LINKS BRAAN2 System (https://braanprod.louisville.edu/) BRAAN2 Website (http://louisville.edu/research/braan2) External SAEs do not need to be reported to the IRB unless they are UPIRTSO.  Risks associated with the external AEs do not need to be added to the consent forms unless required by the Sponsor as a recommendation from a DSMB or the FDA. If the PI needs to submit these they need to include a coversheet that can be stamped and returned.  These will not be reviewed. This coversheet should have the level of detail that is required by the sponsor. Human Subjects Protection Program Office The HSPPO serves as the administrative office for UofL's two Institutional Review Boards. The Institutional Review Boards, or IRBs, are the committees that conduct oversight for all research involving human subjects at University of Louisville, UofL Hospital, Norton Healthcare, Inc. and Jewish Hospital Healthcare Services, Inc. These committees are federally mandated to ensure that research is conducted in accordance with the federal regulations, and that the rights of human subjects are protected for all ongoing investigations. Federal regulations require that all research involving human subjects or analysis of data gathered from human subjects, regardless of funding status, be reviewed by the IRB prior to the implementation of any research activity. Training Opportunities If you have taken the basic CITI training, you may complete one of the training options found in the training opportunities link. Send a copy of your CME or CE certificate to the Office of Research Integrity for validation and credit. Scientific/Scholarly Merit Review Form Clarification: When submitting a scientific/scholarly merit form, please ensure that all the sections are completed with explanations under each category. If the review is ceded to an external reviewer, the review must be provided by an objective reviewer, (NIH, AHA, ADA, NCI, FDA, etc.). The documentation of the review from the external reviewer must be retained in the departmental chair's office. The review will be conducted by one or more departmental or unit peers of the researchers who are both impartial and competent to assess the scientific or scholarly merits of the university research. This form (per University of Louisville Policy), must be signed by the departmental chair or division chief. Any submissions missing these items, will be returned to the Investigator as an incomplete submission. Meeting Dates & Results Biomedical Meeting of Thursday, February 7 , 2008 Biomedical Meeting of Thursday, February 21, 2008 Next Submission Deadline: Wednesday, February 13(noon) for the February 28 meeting Social/Behavioral/Educational Meeting of Wednesday, February 6, 2008 Next Submission Deadline: Tuesday, February 20(for the March 5 meeting) Before any new study or continuation request may be submitted, Human Subjects Protection training and HIPAA training must be taken by investigators and key personnel.

University of Louisville

Institutional Review Board

Human Subjects Protection Program Office

501 E Broadway

MedCenter One, Suite 200

Louisville, KY 40202

Phone (502)852-5188 Fax (502)852-2164

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