Page 19 - Research Compliance Welcome Package (1.4.19)
P. 19
ISSUE
10 JANUARY 2019
In this issue: Revised Common Rule P. 2 Responding to Audit Reports P. 2 Spotlight P. 3 Ask the Auditor P. 3 Trend Watch P. 3 Responsible Authorship P. 3
New Research Compliance Tip Sheets
Take a few minutes to read brief overviews of important topics from our Tip Sheets located in iRIS and on our page of BSWConnect:
• Privacy in Research
• Research Conflict of Interests
(COI) Management
• Coming Soon: EU General Data
Protection Regulation
Responsible Principal Investigators
The commitment to serve in the role of Principal Investigator (PI) for a research project is a significant one. In general, PIs are responsible for protecting the rights, safety, and welfare of subjects; ensuring the integrity of research data; and controlling any test articles under investigation. Because most PIs must juggle many, sometimes competing responsibilities (such as a physician/PI who also has patient care duties), it is important to remember that sufficient time must be dedicated to the appropriate supervision of research.
During inspections of clinical research, such as those routinely conducted by the FDA, auditors will interview staff and review documentation to determine if evidence exists to reflect PIs are fulfilling their commitment to “personally conduct or supervise the described investigation”1. Although PIs can delegate tasks to qualified staff (e.g., research coordinators), this does not absolve them from having ultimate responsibility for the conduct of the research. To demonstrate this personal involvement, it is important to document routine meetings and other communications between the PI and staff who have been appropriately delegated tasks.
Occasionally, a PI may experience a planned or unexpected absence. This can lead to significant issues relative to trial oversight. For example, in the case of unanticipated problems or adverse events, immediate evaluation and reporting (under PI signature) to the IRB or sponsor may be required. For a more prolonged absence, issues may also arise regarding timely review of subject eligibility, assessment of out-of-range lab results, availability for sponsor monitor visits, et cetera. It is therefore important to discuss any PI absences with the IRB Office, in advance or as soon as possible, in order to determine an acceptable plan for oversight depending on the circumstances.
PIs must remember when signing investigator agreements, an FDA Form 1572/Statement of Investigator, submissions to the IRB, and other documents requiring the commitment to fulfill PI responsibilities, they are ultimately responsible for regulatory violations from failure to adequately supervise their research. PIs should work with their research coordinators or other personnel to whom they have delegated responsibilities to establish processes for keeping them apprised of what is happening in the research they have committed to oversee.
1 21 CFR 312.53(c)(1)(vi)(c)
In The News
• Chief Medical Officer of Memo- rial Sloan Kettering Cancer Center resigns after failure to disclose industry relationships
• New findings of research misconduct made against:
~ Former scientist at Cedars- Sinai Medical Center
~ Former Ph.D. student at University of Colorado, Denver
~ Former professor at University of Kansas Medical Center
Regulatory Changes
• Revised Common Rule with general compliance date of January 21, 2019
• FDA issues draft guidance regarding civil monetary penalties relating to the ClinicalTrials.gov data bank
• NIH issues a policy regarding new research misconduct reporting responsibilities
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