Program Enhancement

Organizations frequently self-identify areas for improvement, or become aware of a need because of an audit, inspection, or accreditation review, but need recommendations or assistance to address the issues at hand.  Leveraging the extensive experience and expertise of our HRP consultants and network of research professionals, we can help you identify and implement the best solution for your organization.

Accreditation Assistance

With experience and insight in bridging the gap between existing program structure and accreditation standards, HRP Consulting Group has always been viewed as a leader in helping organizations achieve and maintain accreditation. We’ve worked with organizations large and small; from pharmaceutical companies to independent IRBs, universities/colleges, academic medical centers, hospitals, corporations, non-profits and government agencies such as NIH.

Accreditation services include all or any combination of the following:

• Evaluation of your program and gap analysis.
• Assistance with interpretation and application of accreditation standards and elements.
• Development of customized SOP’s, forms, checklists and other supporting documents.
• Building your application and response packages.
• Responding to feedback provided by the accrediting organization.
• Site Visit preparation.

Committee Start-up & Support

HRP Consulting can provide guidance or hands-on assistance with the development, implementation, and ongoing support of research oversight committees, including IRB, IACUC, Conflict of Interest (COI) Review, and others.  The successful implementation of such committees is more complex than most appreciate at first glance, HRP can help with the following and more:

• Member composition and documentation
• Federal registrations, when applicable
• Standard Operating Procedures, forms, checklists, and resources
• Electronic system implementation
• Chair, member, staff, and investigator training
• Temporary staff
• On-call guidance and support

Training & Education

HRP consultants and our network of research professionals have extensive hands-on experience with both the oversight and conduct of research in a wide variety of settings including academia, health care, government agencies, foundations, independent IRBs, and more.  HRP can leverage its experience to support your internal training needs, including initial and ongoing training of leaders and staff with key responsibilities for research, committee chairs and members, and investigators and their staff.   HRP will work with you to identify the best solution for your education and training needs from brief topic sessions during committee meetings to full day programs.

HRP Consulting is frequently asked to assist organizations by providing an independent assessment of investigator, committee, or program compliance with regulatory or accreditation standards.  Whether routine QA or for-cause, comprehensive or targeted, or an evaluation of inspection or accreditation readiness, HRP is prepared to help.

IRB Reliance

IRB reliance is an important element of a successful IRB operation. Single IRB review is required for most federally funded multisite studies. In addition, FDA has recently issued draft guidance indicating that a similar requirement for FDA-regulated research is on the horizon. HRP Consulting can provide resources and support to your organization for a variety of reliance-related issues, including, but not limited to:

• Evaluating and updating your existing reliance-related SOPs
• Assisting with joining and implementing the SMART IRB agreement
• Facilitating the process of executing reliance agreements and documenting reliance arrangements
• Identifying requirements of serving as the Reviewing IRB for external sites
• Assistance in implementing best practices for ceding IRB review to an external IRB
• Explaining the functions of different reliance platforms, including SMART IRB’s Online Reliance System (“ORS”) and IRB Reliance Exchange (“IREx”)
• Providing educational resources that will allow research teams to manage Single IRB issues
• Providing guidance on how to satisfy AAHRPP’s Standard I-9 for Single IRB Review

Interactions with Federal Agencies

Any program can find itself struggling with a regulatory interpretation or needing to report or respond to a federal agency.  The best administrators realize that proactively addressing questions, managing mandated reporting responsibilities, and providing complete and on-target responses to findings or observations from federal agencies will minimize organizational risk and ensure that the credibility of their program remains intact.

With our extensive experience in the field, including experience within FDA, OHRP, and other agencies, our consultants and associates understand agency processes and expectations and can help your organization with anything from asking a question anonymously to responding to agency concerns and findings.

Research AI & Training

Research involving artificial intelligence (AI), machine learning (ML), and other emerging technologies is expanding rapidly across disciplines. These innovations drive new opportunities for discovery, but they also create unique ethical, regulatory, and human subjects protections challenges.

We partner with institutions to design, implement, and optimize oversight frameworks that align with ethical principles, regulatory requirements, and best practices for AI/ML research; while also building internal expertise through targeted training and continuing education.

Let HRP Consulting Group’s greatest assets become yours. Contact us today to find out how we can support your staffing requirements.