PACCM Scientific Review Process
What is the purpose of the PACCM departmental scientific review?
The purpose of the scientific review is to ensure that research proposals reflect an acceptable level of scientific rigor and merit prior to ethical review. Through the scientific review process we ensure that the study is well-designed, has a valid research hypothesis, objectives, appropriate balance between the potential risks and benefits, and has adequate resources so that we do not expose research subjects to unnecessary harms. The scientific review process also offers the Division of PACCM an opportunity to improve the quality of pulmonary research and to facilitate mentoring of junior researchers, identification of synergies among related lines of investigation, and knowledge of current research that can support plans for Division growth.
Which research studies need scientific review?
All pulmonary-based human subject research is required to undergo scientific review prior to submission for IRB review, with the exception of (1) research qualifying for “exempt” review status; and (2) research reviewed by a peer scientific review committee as a condition of research funding (e.g., NIH/NSF sponsored research).
Who perform the PACCM departmental scientific review?
The designated individuals responsible for oversight of the scientific review process for PACCM are:
- Alison Morris, MD
- Joseph M. Pilewski, MD
- Nydia Chien, MSN (Administrative Designee)
If Dr. Morris or Dr. Pilewski is a member of the study team or does not have the expertise to review a study, another individual will be assigned to conduct the review.
What paperwork is required for the PACCM departmental scientific review?
Research studies submitted to Pitt IRB – PittPRO system: No additional paperwork is required. As soon as the PI submits the study for review, an e-mail notification is sent to Drs. Morris, Pilewski and Nydia to conduct the review and issue scientific approval.
Research studies submitted to UPMC OSPARS (e.g. Industry initiated research studies): The PI or the study team is required to provide as much information as possible to facilitate the scientific review. Incomplete information may slow down the review and approval process.
**Submit the scientific request to Dr. Alison Morris (morrisa@upmc.edu) or Dr. Pilewski (pilewskijm@upmc.edu), and attach the following required documents in the e-mail request:
- PACCM scientific/risk review draft approval letter (template available upon request)
- Sponsor Protocol
- Sponsor Model Consent Form
- Investigator’s Brochure
- Other documents if applicable