PA Supreme Court Decision Impacting Consent - Additional Guidance for Clinical Research from OCR and IRB
Since the July 21, 2017 email to the Penn Research Community regarding the Pennsylvania Supreme Court decision impacting consent, including informed consent in research, OCR and the IRB have received numerous requests for more detailed guidance. The purpose of the documents linked below are to provide more detailed implementation guidance to the research community regarding obtaining informed consent in clinical research at the Perelman School of Medicine.
- Guidance Document around Consenting Clinical Research Subjects in Interventional Trials from the IRB and OCR
- Additional Guidance in the form of an FAQ document based on research use cases
Message to NIH grant applicants/awardees, contractors, researchers and research administrators:
If you are conducting NIH funded research that involves human subjects, or considering applying to NIH for support of such research, we want to call your attention to important changes that may affect you. Click to go to the original announcement of the NIHs new Clinical Trial Requirements for NIH Grantees and Contractors. Your attention to detail will be critical to ensuring successful funding of your clinical trial awards.
Note about GCP Training: The Office of Clinical Research (OCR) offers an Onboarding curriculum that provides comprehensive GCP training. Researchers who have already completed GCP training still have the option of accessing the GCP training tracks we offer:
- ACRP Good Clinical Practice Training
- Experienced for Principal Investigators
- Experienced for Clinical Research Coordinators
Blinded Studies and MPM documents now posted on OCR website
If you are working on a research study that has test results in PennChart that need to be blinded from the patient (the patient is not to see the results), you are now able to suppress the results from being sent automatically to the patient from PennChart to their myPennMedicine account, thus aiding in maintaining the blind.
2016 IRB Continuing Review Form – Feedback Survey
On March 1, 2016 the IRB released the pilot version of the new submission form for Continuing
Review. The Continuing Review submission form became required as of June 1, 2016. In July
2016 the HSERA continuing review application was revised to remove redundant questions in
support of using the new form.
Memo: Click for full announcement
2017 Clinical Research Annual Recognition Event
The 2017 C.A.R.E Award starts March 20th. For more details: Click Here
New Penn Medicine Policy for Clinical Research- philanthropic funding in advancing clinical research efforts
This policy is in effect immediately and will be administered by Penn Medicine's Institutional Review Board (IRB) in consultation with the offices of Development and General Counsel.
As a leading health care institution, we remain committed to the equitable selection of research subjects and the need to mitigate any perceived or real conflicts of interest associated with the inclusion of subjects into research conducted here. The IRB and Development teams, have developed a short training module for researchers, medical professionals, and development staff detailing this policy and the important roles you all play in ensuring our collective efforts don't compromise the integrity of the scientific process.
We encourage you to share this new donor policy module link with any of your colleagues directly involved in the planning and implementation of clinical research efforts at Penn Medicine. Please contact either of us if you have any questions about the policy. Thank you for your time and attention to this important matter.
Tracy A. Ziolek
Director, Human Research Protections Program
Paul B. Mischler
Deputy Chief Advancement Officer & Chief Operating Officer
Penn Medicine Development and Alumni Relations
The Office of Clinical Research and PennChart Research recorded a “demo” of the functionalities for PennChart/ EPIC Research that will go live at PAH and CCH on October 22, 2016 and HUP, PPMC and HCHS on March 4, 2017 . This Research Demo of PennChart is not for training purposes and cannot be used as credit towards PennChart Training.
Sponsors of INDs, IDEs, or Comparable International Regulatory Filings
As of July 2016, all Perelman School of Medicine (PSOM) Sponsors of INDs, IDEs, or Comparable International Regulatory Filings are required to complete Sponsor Registration. In addition, Sponsors are required to complete Sponsor training. Sponsors outside of PSOM are encouraged to complete Sponsor Registration and Sponsor training as well. For more information, please click here to view Sponsor SOP 006.
Please register as a Sponsor here: http://tinyurl.com/z7frse6
Documentation from OCR confirming Sponsor Training Completion should be uploaded by the PI team to HS-ERA. IRB approval may be delayed in the absence of training documentation.
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