The MUH-CTRC Scientific Advisory Committee(SAC) has been recently reconstituted to reflect the breadth of active clinical research in the institution. The committee includes members of the Schools of Medicine, Nursing, Pharmacy, and the Graduate School of Public Health. The committee also includes representatives from the University of Pittsburgh Cancer Institute, and leaders of extramurally funded core facilities. The committee meets on the third Friday of each month in the Berkman Board Room, Room 727 in Montefiore Hospital.

Members of the MUH-CTRC Scientific Advisory Committee are able to earn Continuing Education Credits by participating in meetings and by serving as reviewer.

There are two types of CME credits- Category 1 and Category 2. Category 1 Credits are granted in what would be considered true educational experiences, such as attending a lecture. Category 2 Credits can be earned through other learning experiences, such as consultation with peers and medical experts, developing and reviewing quality assessment data, teaching health professionals, medical writing, etc.

The MUH-CTRC committee participants are able to earn Category 1 credits for participating in a SAC meeting. Participants can earn 2 credits for each time the committee meets. These are reported by the CTRC Administrative Secretary (Cathy Hensler) on a quarterly basis. In order for us to report these, we need the last 5 digits of your social security number. The reporting is based on meeting attendance, so it is important that committee members sign in at each meeting attended.

On the left hand side of the page is a Credit Transcripts Link. Once you go here, you’ll be asked to provide your social security number and your last name. There is also a drop down menu that says Select. Choose Add/Modify, and hit Submit Query. On the next page select Add Credits. The space will say that it is for “external credits”, but it is fine to keep your record here.

The document below provides the Scientific Advisory Committee members with a mapping to assist them in their reviews. It compares the sections listed in OSIRIS with the PHS 398 format.

The protocol, consent(s) and attachments on the Advisory Committee Web Site have been downloaded from the IRB OSIRIS application. If you are having difficulty accessing the documents, or require additonal information regarding the protocol you have been assigned to review, please contact Cathy Hensler who will be able to assist you at 412-648-6691 or muhctrc@upmc.edu.

• Gene transfer study (involving recombinant DNA)
  
• Emergency research with a waiver of informed consent
  
• Investigator-initiated trial for a drug that has no current FDA approval for any indication
  
• Implantation of a device with an IDE that has been designated by the IRB as a significant risk device
  
• Phase I trial which is the very first trial in humans (no clinical data exists)
  
• Study of a surgical intervention not in use at UPMC
  
• Clinical trial requiring the withdrawal of subjects' own prescribed medication
  
• Protocols involving decisionally-impaired subjects
  
• Protocols involving pregnant women, fetuses and neonates

If you are assigned a protocol for review and are not sure if a protocol should be considered "significant risk" please contact the Research Participant Advocate listed below.