Investigator Responsibilities - Responsible Conduct of Research
The Role of the Principal Investigator in an Academic Medical Center is a challenging and rewarding opportunity in which the Individual registered as the PI assumes increased responsibilities and assignments. It is important for the Investigator to identify the type of research project and understand the Federal, State, and Institutional Policies that must be adhered to when initiating a new project. The Principal Investigator may be engaging in
Basic Laboratory Based Research
Clinical Research (Including Medical Interventional Research or Social and Behavioral Research)
Clinical and Translational Research - Bench to Bedside Research Activities
The Office for the Vice President of Research and Graduate Studies at Temple University is responsible for the establishment and maintenance of University research policies. The OVPR has established research guidelines titled “Allocation of Responsibilities.” The Principal Investigator is responsible complying with these policies and for communicating with their Department Chairpersons and Dean of the School when conducting a new research project.
The Principal Investigator is also responsible to comply with the following administrative responsibilities when implementing or coordinating a new project.
Sponsored Projects Administration which includes
Fiscal Management of the Project
Effort Reporting
Disclosure of Conflict of Interest or Financial Interest
Human Subject Protections
Protection of animal subjects
Use of Recombinant DNA
Compliance with Environmental Health and Radiation Safety Regulations
Compliance with laboratory safety requirements
Compliance with Hospital Policy Requirements for the conduct of Clinical Research in the Health System.
Patents and Inventions
The University consists of different oversight and support offices to facilitiate investigators. These Offices includes Regulatory Affairs Offices, Research Compliance and Safety, Research Support and Financial Services Office, Data Statistical and Information Technology Services, Core Research Facilities, and Technology Transfer Office.
Human Research - Principal Investigator Responsibilities
An Investigator engaging in Human Subject Research assumes the responsibilities for implementation and conduct of the trial and must take into consideration:
Ethical Principles
Scientific Relevant Research
Protection of Human Subjects
Regulatory Compliance
The Protection of Human Subjects is the primary consideration when initiating a new project in which human volunteers will be involved. The fundamental principles of Principal Investigator compliance when conducting a Clinical Trial include:
Medical Management of Trial Participants to ensure safety and welfare of the participant during the trial. This includes:
Satisfy recruitment goal and ensure eligible subjects are enrolled into the clinical trial according to the inclusion/exclusion criteria
Implementing procedures and follows up visits in compliance with the research protocol or if necessary withdraw from protocol to medical treat the subject.
Provide Qualified Staffing - Ensure Self and Staff are Qualified and Trained to conduct the Protocol
Ensure Adequate Facilities and Equipment - are available to support trial requirements. This space includes Administrative and Clinical Facilities.
Adherence to the Research Protocol – Conduct the study in compliance with the IRB approved research protocol and implement proper study procedures.
Ensure Informed Consent is properly obtainedand documented from each participant prior to study procedures being initiated.
Institutional Review Board Communication - Consistently communicate with the IRB to receive approval and update the IRB throughout the trial including any changes to the approved research.
Safety Recording and Reporting - Accurately reports Safety Events (AE’s and SAE’s) Notify the IRB and Sponsor (If applicable) of all relevant safety information
Investigational Drug, Vaccine or Device - maintain control and accountability of the product so that the materials are used only according to the protocol
Subject Data- Manage and maintain subject data and resolve any data queries for accuracy.
Regulatory Documentation - Retain regulatory documentation in a central file to demonstrate compliance with Institutional and Federal Requirements
Additional Institutional Compliance Policies though OVPR
Conflict of Interest / Financial Interest
The Office of The Vice President for Research and Graduate Studies upholds Temple University’s established Policy about Conflict of Interest for Faculty and Employees conducting research activities at the University. The University Policies are:
This manual provides a useful guide in section II Pre-Study Activities Chapter 8.1? titled Reporting Requirements for Conflict of Interest.
Integrity Policy
Temple University Policy on Misconduct in Research and Creative work can be located at http://policies.temple.edu/getdoc.asp?policy_no=02.54.01. The Integrity Officer for Temple University’s is currently the Vice President for Research and Graduate Studies. If there is a possible violation, the charge should be brought to the Vice President for Research and Graduate Studies Attention. For more information on reporting Integrity concerns please visit the Vice President for Research and Graduate Studies Web-site at http://www.research.temple.edu/ovpr/integrity.html.
Institutional Guidelines on Data and Material Retention
The Institutional Guidelines on Data and Material Retention are provided by OVPR and is located at http://www.research.temple.edu/ovpr/date_retention.html. Original data and materials derived from University Research are the sole property of the University. They may be required in the event of a misconduct allegation, particularly in connection with research conducted under Federal or other external sponsorship. In addition, original data and materials may be required in the event of a challenge to the validity of a patent based on them.
Health Insurance Portability and Accountability Act (HIPAA)
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