- This Core conducts quality improvement/good clinical practice guideline audits to provide onsite guidance to PRCTRC researchers and determines state of compliance with regulations, institutional policies and Institutional Review Board requirements.
- Develops educational/assistance programs to help PRCTRC researchers develop regulatory review/submission documents and informed consent forms.
- Ensures that conflicts of interest are eliminated or managed appropriately, and develop a Data Safety Monitoring Board that will ensure compliance with the highest ethical standards ensuring hence that the protection of the human subjects enrolled in the trials are guaranteed.
- Ensure maximum protection for human research subjects, and assure that all PRCTRC research projects and activities are in compliance with federal policies and regulations.
- Ensure that all PRCTRC researchers are trained in the science and ethics of research human subjects in order to optimize study design, facilitate regulatory review, understand the informed consent process and uphold transparency in conflict of interests in clinical and translational research.
- Stimulate the generation of independent research projects, which evaluate barriers in the informed consent that mediate and influence Hispanic participation in research activities in Puerto Rico.
- Ensure the continuity and the ongoing process of the reciprocity among the three IRBs of the Consortium institutions.
RKS activities are expected to reduce regulatory obstacles for research through education and support services, ensure researcher compliance with changing regulations, and improve community participation in research while safeguarding the health of human subjects and protect animals in research. The RKS ultimate end is to ensure that PRCTRC investigators adhere to good scientific practices for increased scientific rigor.
- Provide personalized support and technical assistance to help researchers in the regulatory aspects of their pr
- Perform random audits to studies with the purpose to assist the investigators in maintain regulatory compliance, and promote the improvement of the data integrity and subject safety.
- Provide individual orientation for all investigators and staff in which the different services requested depending on the stage of the proposal
- Development of the informed consent document, help submitting IRB application form, help submitting to the Biosafety Committee, developing SOPs, guidance regarding the courses to protect human subjects in research and how to comply with federal and institutional requirements.
- Offer training opportunities in the regulatory aspects of research.
- Protocol Development Support: On all regulatory aspects of protocol development including informed consent document, risk/benefit analysis, instruction on vulnerable groups, etc.
- Regulatory review: Upon investigators request, protocols and consent forms are reviewed before being submitted to the IRB.
- IRB Reciprocity Implementation: Assist the PI in the submission process for reviewing and approval protocol, being the link between institution upon approval
- Institutional Compliance Support: Guidance is provided regarding the IRB process and documentation.
- Research Ethics Consultation Service: This service is provided in collaboration with Research Design and Biostatistics Core.
- Offer training in the regulatory aspects of research.
- Assistance in FDA application: Investigational New Device (IND) and device application.
Leader: Dr. Wanda Figueroa
- 23 Standard Operating Procedures (SOPs) were developed
- 17 SOPs were developed to be in compliance with the Institutional Biosafety Committee’s requirements
- 20 tools were designed to monitor regulatory and ethical research aspects
- Implementation of periodic audits for regulatory compliance; including assessment of regulatory binder, participant record, informed consent document, and informed consent process.
- 39 clinical and translational research studies were audited.
- Provided the Research Subject Advocate’s (RSA) support for minority investigators and clinical and translational research
- Dissemination of regulatory news and services through the PRCTRC newsletter.
- Evaluation of study proposals for the Pilot Project Program
- Support of the PRCTRC Volunteer Registry.
- From 2012 to 2018 a total of 20 IRB Reciprocity applications were approved.
- From 2014 to 2018 a total of 86 Data Safety Monitoring Plan Forms were approved.
- Provide administrative oversight to ensure maintenance of high ethical standards and regulatory compliance in clinical and translational research activities among PRCTRC.
- Oversee the review process for request PRCTRC services.
- Monitor the IRB reciprocity agreement among PRCTRC institutions.
- Provide orientation, support, and technical assistance in regulatory aspects among PRCTRC investigators.
Investigators requesting services from the PRCTRC must complete required trainings (click here) related to the regulatory aspects of research. Investigators must check with their home institution for the source and availability of these trainings.
The PRCTRC conducts required audits on all IRB approved studies to assure that investigators follow all the necessary steps to warrant the safety of subjects participating in research studies supported by the Consortium. Audits also warrant that studies are performed according to approved protocols by the Institutional Review Board (IRB).
- Informed Consents – The informed consent document provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, duration, potential risks and benefits, alternatives to participation, key contacts). The informed consent process consist of explaining the study to the prospective participant, the Principal Investigator or the authorized person conducting the process, with ongoing explanations that will help the participant decide whether or not to sign the document. The Institutional Review Board (IRB) must approve (stamp and date) all consent documents to be used. Approval must also be obtained from the IRB for each modification/change made in the consent form at any time after a study has initial IRB approval; changes in study protocol must be submitted and approved by the IRB prior to implementation of these changes. The version of the consent document being used should match exactly with the version given final IRB approval in the regulatory binder.
- Participant Record – All documents that substantiate data collected and/or are relevant to a subject’s participation in a clinical investigation constitute a research record. Proper record keeping is fundamental to the validity and reliability of data collected during research. One of the most common findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. It is the Principal Investigator’s responsibility to oversee the general organization and design of study records, both paper and/or electronic, to ensure that the study results are built on the foundation of credible and valid data.
- Regulatory Binder – The Regulatory Binder contains all study-specific information and regulatory documentation. The Principal Investigator is ultimately responsible for maintenance of the regulatory files, although this task can be delegated to other member of the research team. Organizing these essential documents allows research team members to reference information and also allows easy access to essential documents by trial monitor, auditors, IRB representatives, or regulatory authorities (e.g. OHRP, FDA, etc.) for review/audit purposes. The storage location needs to be secure, whether study documents are stored in a binder or electronically.
For more information regarding the construction or maintenance of the regulatory binder, please access the following links:
Research Resources when you submit an online application form:
- Biographical Sketch SOP
- Data Safety Monitoring Plan (DSMP) Form (if applicable)
- Personnel and Signature Log
- PRCTRC Confidentiality Agreement *Required to receive PRCTRC services (English/Spanish version)
Institutional Review Board (IRB) Reciprocity:
- IRB Reciprocity SOP
- IRB Reciprocity Application Form
- IRB Reciprocity Abbreviated SOP for Studies with IRB Approval
- IRB Reciprocity Abbreviated SOP for Studies without IRB Approval
- Adverse Event SOP
- PRCTRC Approval Process SOP
- PRCTRC Approval Process Table
- Audit at the PRCTRC SOP
- Financial Conflict of Interest SOP
- Data Safety Monitoring Plan SOP
- Expired IRB SOP
- Informed Consent Process SOP
- Personnel and Signature Log SOP
- Registration of Clinical Trials in ClinicalTrial.gov SOP
- Study Initiation Meeting SOP (Attachment A and B)
- Training Certifications for Investigators, Study Staff and PRCTRC Staff SOP
Audit Tools and Log Templates:
- Regulatory Binder Section
- Screening Log
- Enrollment Log
- Institutional Review Board (IRB) Submission Tracking Log
- Institutional Biosafety Committee (IBC) Submission Tracking Log
- Institutional Animal Care and Use Committee (IACUC) Submission Tracking Log
- Adverse Event (AE) Tracking Log
- Monitoring Log
- Personnel and Signature Log
- Students’ Log
- Standard Operational Procedure SOP Checklist for the Institutional Biosafety Committee*
*Required document when you submit an application to the IBC
- Biohazard Risk Group Definitions SOP
- Biological Spills SOP
- Biomedical Waste Disposal Procedures SOP
- Blood Collection and Delivery SOP
- Chemical Waste Disposal Procedures
- Colposcopy and Punch Biopsy SOP
- First Aid Procedures in Case of Accident SOP
- Handling and Transporting Tissue Samples Liquid Nitrogen (LN2) SOP
- Infant Saliva Collection Method by Salimetrix SOP
- Loop Electrosurgical Excision Procedures (LEEP) SOP
- Off Site Phlebotomy in Research Subjects
- Packing and Shipping of Ambient, Refrigerated Frozen and Combined Biological Samples SOP
- Saliva Collection Methods SOP
- Transport of Biological Specimens By university-owned vehicle
- Transportation of Biological Specimens SOP
- Universal Precautions for Handling Blood, Body Fluids and Tissues in Research Laboratories SOP
- Vulvoscopy and Punch Biopsy SOP
For additional Standard Operating Procedures (SOPs) related to Biosafety, please go to the TRCL and CRF webpages.
- Financial Conflict Interest NIH Tutorial
- UPR Disclosure of Investigators’ Significant Financial Interest (FORM 1.A)
- UPR Disclosure of Investigators’ Significant Financial Interest (FORM 1.B)
- UPR Financial Conflict of Interest Annual Disclosure (FORM 2.A)
- UPR Financial Conflict of Interest Disclosure Attachment (FORM 2.B)
- Investigational Device Exemption Application (IDE)
- Investigational New Drug Application (INDs)
- Office for Human Research Protections (OHRP)
- PHS 398 Biosketch Format