1. Research Compliance and Institutional Review Boards
Priscilla Adler, MBA
Director Regulatory Affairs
MedStar Health Resaerch Institute

2. Priscilla Adler, MBA Disclosure:
I have no relevant financial relationships
The opinions offered in this presentation are mine and do not reflect those of any other individual, institution or company.

3. Objectives Identify key areas of research compliance concerns
Identify key regulatory requirements for research
Define common pitfalls
Develop best practices

4. Research Regulatory Environment
HHS
OIG
PHS
OLAW
NIH
OBA
FDA
USDA
CDC
ORI
OHRP
OMB
DOJ
CMS

5. Definitions Definition of Compliance:
It is the process of understanding and meeting the expectations of those who grant us money, pay for our services, and regulate our industry.
Definition of Ethics: Doing the right thing, even when no one is watching.

6. Major Human Subjects Research Compliance Concerns
Safety
OHRP and FDA human research protection, clinicaltrials.gov registration and results reporting
Integrity
conflicts of interest
Privacy/HIPAA
protecting participant health information
Financial
clinical trial billing

7. Conflicts of Interest NIH Policy Highlights
Must disclose all interests of self, spouse, and dependents that may affect research
Significant financial interest is valued at >$5,000 or receiving compensation in any form that exceeds $5,000 within a year from a sponsor of research
Must disclose travel paid directly to the Investigator or reimbursed directly to the investigator by industry.
Certain financial conflicts of interest must be made available to the public
FDA Regulations –
$25,000 to $50,000

8. Human Research Protections
Overseen by the Office of Human Research Protections (OHRP) at the Department of Health and Human Services (DHHS) through authority of 45 CFR Part 46
FDA has its own IRB regulations for drug studies (21 CFR Part 56), but are largely harmonious with the OHRP regulations
FDA inspects IRBs and Researchers for compliance
IRB inspection occurs on a regular basis and includes, but is not limited to, minutes, quorum, and adherence to regulatory requirements for studies involving vulnerable populations

10. Human Research Protections – the IRB
No human research can be conducted without the prior approval of a registered Institutional Review Board
All requirements and directives of the IRB must be complied with to ensure continued study approval
The informed consent form must accurately reflect the protocol, the risks, and the financial responsibilities of the study
Must review the study contract when writing the informed consent to make sure that the informed consent information is correct

11. Key Factors
Study meets requirements for scientific merit with clear and concise study objectives, hypotheses, endpoints and study procedures.
Demonstrates adequate safety monitoring plan detailing methods and necessary precautions for protecting participants (safety and confidentiality).
Well-written informed consent at the appropriate reading level.
Consistency throughout

12. Additional Elements of an IRB Submission
HIPAA Authorization or Waiver
Conflict of Interest disclosure/management plan
Evidence of mandatory humans subjects research training
Submission to clinicaltrials.gov if the study is an applicable clinical trial.

13. Common Errors Incorrect or missing forms/information
Required consent template language is either altered or missing
Inadequate or missing data safety monitoring plan
Institutional requirements have not been met
Poor grammar, punctuation, and/or spelling.

15. Best Practices Meet all institutional requirements
Use correct application form(s)
Be precise in your language
Pay attention to grammar and spelling
Obtain the necessary institutional approval(s)
Provide a complete protocol and all required documents with your submission

16. Best Practices (cont’d)
Ask the IRB staff to pre-review your submission
Have someone independent of the research proof-read your documents
Submit all appendices, recruitment materials and consent documents

17. Conclusions Ask questions Follow directions Complete each form
Answer each question on the form(s)
Use lay language for the Informed Consent
QA your work

18. Questions?
Contact Information:
MedStar Health Research Institute
6525 Belcrest Road, Suite 700
Hyattsville, MD