PRESENTING A PROTOCOL AN IRB INFOSHORT FEBRUARY 2013

INITIAL REVIEW OF PROTOCOLS The primary reviewer provides A brief summary of the research plan, to remind other members of the Type of study Its specific aims A description of the intervention The risk level and the means to reduce risk Any other elements that are essential to understanding the study

INITIAL PROTOCOL REVIEW (2) The primary reviewer : Discusses * the review criteria detailed in the protocol review sheet ( sound research design, use of biologics, equitable subject selection, safeguards for vulnerable populations, adequate privacy and confidentiality, appropriate process informed consent, risks minimization, safety maximized, benefits and alternatives stated, economic considerations are equitable, injury plan is clear, and the informed consent document contains all the required elements) Focuses on * Problems or deficiencies in the application or consent form Identifies * Any issues requiring committee deliberation

ROLE OF THE SECONDARY REVIEWER Second person expected to closely review the materials Supplements the primary reviewer’s presentation * Identifies any additional issues that require committee attention * (Also completes the review sheet )

PRESENTERS: REMEMBER MEMBERS: REMINDER The entire application should have been read by all members. A detailed description of the study and its every feature should not be necessary

RENEWALS Key Point: Remember the study has already been fully reviewed and approved. The renewal review is to assess the progress of the study

WHAT DOES OHRP SAY? “IRBs should pay particular attention to the following four aspects of the research : - Risk assessment and monitoring; - Adequacy of the process for obtaining informed consent; - Investigator and institutional issues; and - Research progress.”

RENEWALS (2) Include in your presentation: A brief description of the study Study accrual to date Any unanticipated adverse events or problems in the past year Any new information that may affect the risk/benefit assessment If there are major amendments for committee review: Describe the change Assess whether the change will affect the risk/benefit assessment

AMENDMENTS Major amendments require full committee review Remember that the underlying protocol /consent form have already been approved Focus of the presentation should be on the changes represented by the amendment Assess whether any of the changes impact the risk:benefit assessment

REMEMBER If you have questions, contact the PI and/or the regulatory analyst before the meeting → And don’t forget to hand in your review sheet: these review sheets are kept with the protocol file and demonstrate consideration of the essential regulatory elements required for IRB approval of a protocol ←