Compliance

Getting and Keeping Your

Ducks in a Row

“Compliance” covers the broad and expanding area of rules and regulations that apply to research. Whether your organization is large or small, a performer or sponsor of research, for-profit or non-profit you are subject to federal, state, local, and institutional rules, regulations and policies. C3Authority can guide you get through this compliance maze and assist you with development of policies and processes to help assure your ongoing compliance.

How We Can Help You

Policy Assessment, Review, Development

  • Research involving human subjects, animals, human pluripotent stem cells, other bio-safety issues
  • Data Sharing and Management, NIH Public Access policy, FOIA, HIPAA
  • Ethical conduct of research, training programs
  • Projects subject to Export Controls, limitations on participation of foreign nationals
  • Intellectual Property, Bayh-Dole, sharing of tangible research results
  • Allowable costs, cost-sharing, effort certification
  • Assistance with applications for external certification, e.g., AAHRPP, ALAAC

Pre-proposal submission review of compliance with sponsor solicitation requirements

  • Multidimensional assessment and evaluation of compliance issues and requirements prior to proposal submission
  • Assistance with development of Data Sharing and Data Management Plans, IP Plans for inclusion in proposals
  • Assistance with description of training and research responsbibity programs for inclusion in proposals
  • Assistance with Conflict of Interest review of sponsor requirements and applicable laws and regulations; assessment of situation and related risks,
  • implications for project, practical recommendations and strategies for management and compliance

During and Post Award Review and Troubleshooting

  • Assistance with response to Sponsor inquiries
  • Assistance with response to agency audits
  • Mutually satisfactory resolution of project –related disputes
  • Recommendations for monitoring compliance with award terms and institutional policies and suggestions for corrective action if necessary
  • Assessment of and solutions for compliance-related subcontracting requirements and issues

Processes, Procedures, Training

  • Evaluation of institutional compliance systems, processes, procedures, and personnel requirements compared to best practices
  • Assistance in development of COI policies including: disclosure, monitoring, identification, mitigation, management and corrective solutions, and reporting
  • Assistance in compliance policy and strategy development, assessment of institutional risk tolerance, suggestions for best practices to mitigate against risks of noncompliance
  • Updates and information on current and changing contract and grant laws, rules, guidelines, and regulations
  • Assistance in developing a compliance “Unit”, systems, procedures, and personnel requirements
  • Assistance with institutional coordination of compliance functions
  • Training – interpretation and application of policies, federal terms and regulations, related policies and procedures

404 Text