Research Integrity and Clinical Operations
Participant and Clinical Interactions (PCIR)
The Participant and Clinical Interactions Resources (PCIR) supports the research participant. Developing an environment that is both conducive to the conduct of clinical research for researchers and a welcome place for potential enrollees, UMMS and UMMHC have the following four goals:
- Create a consumer-focused education and outreach program that promotes community awareness and interest in UMass clinical research.
- Provide investigators with easily accessible services and facilities that ensure success across life cycle of clinical trials and studies.
- Ensure core competencies for research practice and GCP across UMMS and UMMHC.
- Provide electronic study management to aid in consistent documentation, evaluation of research performance metrics and facilitate cost recovery.
Conquering Diseases Volunteer Recruitment Core (VRC)
The success of our clinical research rests upon the willingness of individuals to contribute specimens and provide access to their personal clinical information. Many patients seek access to novel treatments unavailable outside of clinical trials. Many medical centers, including UMMS and UMMHC, are establishing clinical research volunteer databases to make their clinical trials more available to their patients and to address these concerns.
In addition to speeding up the translation of discoveries to therapeutics, the Conquering Diseases Volunteer Recruitment Core (VRC) and volunteer database will provide interested and qualified patients with better access to approved clinical trials. For some patients, participation provides an opportunity to give back or contribute to a larger cause: medical research. The creation of the VRC will provide community access to UMMS and UMMHC research programs.
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Clinical Research Ethics
Recent discoveries, including the description of the human genome, RNA-based gene regulatory mechanisms, novel modes of small molecule drug discovery, key advances in immunology and related potential therapeutics, as well as still nascent fields such as stem cell therapeutics and gene therapy have resulted in urgency for real-world applications to address treatment strategies for some of the most serious illnesses.
These advancements may lead to new territory in bioethics, an interdisciplinary field which brings together philosophers, physicians, scientists, nurses, lawyers, policy analysts and other professionals to meet these challenges. To respond thoughtfully and compassionately to this challenge, the UMCCTS has adopted three goals.
- Expand the ethics consultation service providing guidance and advice to research faculty, staff and the clinical community.
- Support design and conduct of innovative and vital ethics research, fostering scholarly pursuit of contemporary ethical challenges.
- Enhance and diversify current courses of instruction and seminars on responsible conduct of research (RCR) and provide access to all faculty and research staff.
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