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For Investigators - Human Subject Research
Standard Operating Procedures (SOPs) • Forms
Many of the standard operating procedures (SOPs) adopted by the Office of Research Compliance/Research Service are geared specifically for investigators and research staff. They give valuable information on topics such as how to submit protocols for approval, tips on conducting studies, how to obtain and document informed consent, and how to perform VAMHCS-specific administrative tasks such as setting up research study clinics, CPRS research notes, Research Subject Clinical Warnings, etc.
SOPs are binding upon investigators and staff. Investigators or staff who do not follow Research Service or IRB SOPs are at risk of being found non-compliant if an audit or complaint is launched. It is the responsibility of investigators to be familiar with campus SOPs and to ensure that their research staff also act in compliance with campus SOPs.
"Guidelines" (differentiated by a "G" suffix in the policy number) are non-binding. Investigators and staff may choose to follow guidelines as written or may wish to adapt the guidelines to specific situations.
The broad categories of investigator and staff responsibilities include:
- Obtaining proper approval of research protocols and amendments by the University of Maryland Baltimore IRB (through "BRAAN") and the VAMHCS R&D Committee;
- Conducting the informed consent process properly;
- Performing NO research-related activity until proper approval and consent have been obtained;
- Conducting the study according to the approved protocol and other procedures stated in the IRB/R&D submissions;
- Putting enrollment notes and study notes in the CPRS medical record;
- Putting a "Research Subject Clinical Warning" onto CPRS at the time of enrollment;
- Bringing copies of signed informed consent forms to the Research Service Office to be scanned into CPRS;
- Keeping regulatory and study documents in an organized and complete system;
- Notifying the VAMHCS Office of Research Compliance when an external study monitor arrives for a monitoring visit;
- Maintaining the privacy and security of the source data collected on subjects (as described in the BRAAN submission and the HIPAA authorization or waiver);
- Notifying the Research Service when a study is closed and performing proper closeout activities.
All of these responsibilities are discussed in Research Service SOPs and Guidelines listed below.
In addition to the SOPs and forms listed below, the Research Compliance Office will periodically send "Hot Topics" bulletins to investigators and research staff. These bulletins will alert investigators and staff of new developments within the human research program as well as reminders of important, long-standing information. The bulletins will be archived in the Hot Topics section for continual reference.
VAMHCS Research Service SOPS and forms that are of particular interest to investigators and staff are listed below. In addition, you should become familiar with the UMB IRB's Policies and Procedures*.
Please note that forms listed below are to be printed and manually completed.
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