IRB, COI, and Research Misconduct services since 2008
Research Compliance Counselor provides higher education and hospital leaders with easy access to 25 years of experience to address today’s complicated compliance requirements. RCC services have helped current clients navigate IRB reliance and collaborative research coordination, IRB/COI staff loss and coverage, electronic submission system planning and project management and SOP review and development to maintain their operations through the Revised Common Rule implementation and recent disruptions caused by the pandemic.
It can be hard to promptly address compliance issues when you feel like you do not have enough related experience or time to become your own research compliance expert. In some situations, you may be the only individual at your institution responsible for making sure that “we’re covered.” You do not need a full regulatory colonoscopy to provide yet another list of previously known to-dos right now. You need someone’s expert counsel to work with you to help decide what needs to get done and then to do the work on your behalf.
Get in touch with me to set up a consultation or use the contact form at the bottom of this page to enquire whether my services are right for you.
Contact
➤ Location
Remote and In-Person Services throughout U.S.
☎ CONTACT
Info@RCCounselor.com
(440) 241-3609
Services
Institutional review boards (IRBs)
Submission form review and development
Electronic submission system transition project management
SOP and guidance review and development
Creation of external reliance review process (i.e., sIRB)
Special topics consultation - research HIPAA, HUDs, vulnerable populations, LARs, reliance/collaborative research agreements
interim professional staffing
IRB/HRPP or COI Director/Coordinator temporary staffing
Job description development and candidate interview/screening
Mentoring/training existing staff or new hires to meet institutional needs
Research misconduct and noncompliance
Independent initial assessment of allegations
RIO services, including inquiry and investigation report consultation
Human subject research noncompliance reviews, including federal agency reporting
COI noncompliance corrective action plans, investigator oversight/mentoring
ORI annual reports
conflict of interest (COI) disclosure and management
Disclosure and management process review and development
Support and training of local review committee/official
Submission form review and development
Independent institutional conflict of interest consult
SOP/investigator guidance review and development
Connect COI to IRB, IACUC, etc.…
Questions?
Use the form below to contact RCC. Please include a general topic area, such as external IRB reliance. You may also email or call me directly to make an appointment.