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Research compliance can help to ensure proper scientific, ethical and regulatory requirements are followed in research protocols and can promote research integrity through a standardized process.
Research compliance can address any or all of the following in an institution or hospital: Institutional Review Board and human subject protection, HIPAA, post approval monitoring, biohazard or radiation safety, billing, contracts, grants management, research overview, clinical trials conduct, personnel, award closeout and quality assurance.
Research Risks
The first step of research compliance is knowing which laws apply to your activity
The second step of research compliance is to figure out what that means
The Office of Research Integrity within the United States Department of Health and Human Services defines nine core areas in the responsible conduct of research:
1. Human subjects 2. Conflicts of interest and commitment 3. Mentor training and responsibility 4. Publication practices and responsible
authorship 5. Data management, acquisition, sharing &
ownership 6. Research involving animals 7. Research misconduct 8. Peer review 9. Collaborative Science
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Establish Basic Rules for the Conduct of Clinical Trials
Regulatory/HIPAA: OHRP, IRB, AHHRPP, NIH
Regulatory oversight for life of the study for both employed and non employed groups
Create a liaison to IRBs especially if you use commercial IRBs and establish guidelines for reporting
Assert research credentialing and training requirements for all staff
Establish criteria for claims review and reimbursement
Maintain enforcement with the rules by setting examples
Facilitating Compliance for Research Standardize SOP’s system wide
Provide mentoring to new clinical research coordinators
Network with sponsors/CRA’s about other areas in organization conducting research
Create consistent policies
Promote transparency to ensure credibility
Establish policies and procedures to make roles clear, responsibilities known and accountability validated
Perform compliance self monitoring of clinical research studies, both for-cause and not-for-cause
Systematic review of research-related documents to determine the Medicare billing status of both the study itself and the items and services provided to the research subjects that are outlined in the research documents over the course of the study
Review based on thorough research, supported by industry guidelines which meet the “generally accepted in the medical community” standard and are compliant with government regulations
Provides subjects with an accurate accounting of their financial liability before they enroll
Provides an accurate assessment of the true costs of the clinical trial with potential increased revenue
Protects your institution from violations of the False Claims Act and other regulations by showing due diligence
• HCPCS device code (if applicable) (Physician and outpatient)
• Q0 (Physician and outpatient)
• Charges or token charge (outpatient)
Services
• IDE Number
• ICD-9 Code V70.7 (Secondary diagnosis)
• Q0 or Q1 Modifier
– Physician Services
– Outpatient Services
• Condition Code 30 (outpatient only)
• NCT# 34
Routine Costs
Items or services that are typically provided absent a clinical trial (e.g., conventional care);
Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service, in particular, for the diagnosis or treatment of complications.
Bryan William Doreian, Ph.D., Case Western Reserve University
ORI found that the respondent engaged in RM by falsifying data related to studies funded by NIH, National Heart, Lung and Blood Institute, and NINDS.
His research must be supervised indefinitely, his employer must certify the accuracy of his experiments, he may not provide advisory services to PHS and his paper was retracted.
A procedure, treatment, or visit called for by the protocol is conducted outside of the required time frame and this has clinical consequence; poses risk of harm to subject or others and/or is thought to be impactful to the scientific integrity of the study.