The Research Compliance Program (RCP) is administered by the MedStar Health Office of Corporate Business Integrity, which supports and promotes ethical research practices throughout the entire MedStar Health system. The RCP serves the MedStar research community by coordinating system-wide research compliance policy and procedure development; providing comprehensive regulatory guidance to the research community; developing training and education; auditing and monitoring; and ensuring that MedStar investigators are compliant with federal, state, and local laws and regulations, as well as with MedStar policies. The RCP covers the following areas:
It is the policy of MedStar Health and its affiliated entities (“MedStar”) that interactions with industry should be conducted in a fashion that avoids or minimizes actual or perceived conflicts of interest and/or conflicts of commitment.
MedStar’s COI program utilizes a survey tool for reporting, COISmart. To complete the disclosures, an account must be created in the system for you. For more information on how to obtain an account, please reference the FAQs.
MedStar associates should be familiar with the following policies that govern the conflict-of-interest program at MedStar:
Business ethics and confidentiality
Conflicts of interest and interactions with industry
In addition to the Research COI Policy, MedStar has three procedures. These documents are also available on StarPort.
For public requests for information regarding significant financial interest for key senior research investigators related to research funded by the Public Health Service (PHS) or National Institutes of Health, utilize the following form.
The MHRI Quality Assurance Auditing Program reviews the conduct of studies on a routine and for cause basis. The program is responsible for the internal auditing of research involving human subjects to ensure compliance with federal regulations, state laws, institutional policies, and Good Clinical Practice guidelines.
Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording, and reporting research trials that involve the participation of human subjects.
The Quality Assurance Auditing Program is designed to be a collaborative, educational process to assist investigators with ensuring study conduct and documentation meet all applicable regulations and standards.
Studies can be selected for quality assurance auditing in a variety of ways:
- Routine selection by the research compliance team - generally based on identified risk factors present in the study
- For cause - identified by the IRB or others due to an identified concern about the conduct of the study
- By request- investigators can request a quality assurance audit themselves at any point during the study to ensure all applicable standards are met
Research or scientific misconduct means fabrication, falsification, or plagiarism in proposing, performing or reviewing research, or in reporting research results.
Federal agencies have published research integrity and/or misconduct regulations that define research misconduct and outline the process for investigating those allegations.
Allegations of research misconduct should be reported to MedStar Health’s Research Integrity Officer in the Office of Corporate Business Integrity (firstname.lastname@example.org or via the Research Compliance Director) or through the MedStar Integrity Hotline (877-811-3411).
The HIPAA privacy rule regulates the way covered entities, like MedStar Health, handle protected health information (PHI). Researchers working at MedStar Health or with MedStar Health data will need to comply with the Privacy Rule in their research.
In general, the Privacy Rule allows covered entities to use and disclose PHI for research if authorized to do so by the research participant. In addition, in certain circumstances, the Privacy Rule permits covered entities to use and disclose PHI without authorization for certain types of research activities.
Questions about conducting research with protected health information? Contact the Research Compliance Director.