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 ←