General Consulting

General consulting covers the full scope of HRP’s services and is frequently provided on an “on-call” basis giving our clients maximum flexibility in how they utilize HRP while fully controlling their budget. On-Call Consulting may also be accessed for other purposes such as regulatory questions, development or review of policies and procedures and other materials, support with issues that may arise during the conduct of research (e.g., unanticipated problems, noncompliance, etc.), training, and other services.

Program Evaluation

Many organizations recognize the value in having an external entity conduct a comprehensive unbiased review of their research oversight programs and committees to evaluate compliance, structure, effectiveness, efficiency, processes, accreditation readiness, staffing, or any number of factors. Program evaluations help organizations identify and understand strengths, weaknesses, and areas of potential risk, and where to best focus their attention to improve or enhance their programs.

Whatever the purpose, HRP Consulting Group can conduct a comprehensive, customized program evaluation to help you achieve your goals.
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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.

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Customized Policies, Procedures, & Tools

HRP Consulting maintains a suite of template Standard Operating Procedures (SOPs), Forms, Checklists, and other tools and resources to support compliance with federal regulations, guidance, and accreditation standards (when desired).   Customization is critically important with one of the most common findings in inspections, audits, and accreditation reviews being the failure to adhere to one’s own written policies and procedures.   Using HRP’s templates as a point of reference or a base, our consultants can work with your organization to evaluate and enhance your existing materials or to develop new materials, always customized to your organization.

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

Research Administration/Operations

Conducting research properly can be complicated. How do you operationalize the necessary policies and procedures in the most efficient manner, while maintaining a high level of compliance to protect your research participants? HRP can help with the following:

• Research Contract Review/Negotiations (CTA, CDA/NDA, Master Agreements, etc.)
• Identifying appropriate staffing models for research coordinators/staff
• Assistance with Acuity Scoring to measure workload
• Assessment of current research organizational infrastructure
• Identify methods and processes to increase participant recruitment
• Identify gaps in research billing compliance

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.

Compliance Assessments, Audits

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.

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