Adelma Rivera Cruz, BSN, RN, CCRC is the Research Subject Advocate of the RCMI-Clinical Research Center. Her main responsibility is to assure that all steps are taken throughout any clinical research activity to protect the participating subjects and to ensure that their safety is given the highest priority. Also it is her responsibility to assure that all investigators/collaborators and CRC personnel are managing patient health information according to the Health Information Portability and Accountability Act.

The Research Subject Advocate responsibilities also includes:

• Serve as an unbiased observer during the Informed Consent process when requested by either the subject/volunteer or investigator.
• Assure that the investigators are performing their studies in accordance with the IRB approved protocol and safety monitoring plan.
• Oversee the reporting of unexpected and serious adverse events to the IRB, other local committees and Federal Agencies.
• Assure that the investigators are following the safety monitoring plans, when required by NIH.
• Assess protocols to ensure patient safety
• Ensure that all research studies conducted in the CRC are keeping regulatory documents and approvals updated.
• Continually assess that patient health information is kept confidential and secure as establish in the CRC standard operating procedures.

Contact information:
For more information about research subject advocate, please contact Adelma Rivera Cruz, BSN, RN, CCRC at:
Phone: (787) 759-0306 ext. 230
Fax: (787) 759-0305
e-mail: arivera@rcm.upr.edu