KGH Advisors LLC provides a wide-range of services to assist its clients in managing their legal obligations related to human subjects research, as well as in the context of other discrete specialty areas. KGH Advisors is always willing to discuss an individual client's specific needs.
Specific areas of expertise include:
- Tissue and data banks created for research use, including secondary research on stored specimens and information.
- HIPAA's requirements for the use and disclosure of health information in human subjects research.
- The use of genetic and other sensitive information in research.
- The management of investigator and institutional conflicts of interest in research.
- Research misconduct proceedings.
- Non-compliance investigations and reporting to government agencies.
- FDA oversight of clinical trials and human tissues.
- Billing for research-related items and services.
- Development of research compliance and human research protection programs.
- Accreditation of human research protection programs.
- Clinical trial agreement contracting.
- Human embryonic stem cell research.
- Organ donation.
- Assisted reproductive technologies.
Examples of available services include:
- Advising on the interpretation of federal and state laws, regulations and guidance, including proposed changes in the law that may impact future practice.
- Assisting researchers in drafting protocols for regulatory compliance.
- Providing advice and guidance to IRBs and other ethical oversight boards on specific issues that arise in the context of protocol review and oversight.
- Investigating allegations of non-compliance with applicable regulations or IRB requirements and assisting in reporting to federal and state agencies when required.
- Facilitating the inquiry and investigation of allegations of research misconduct.
- Developing applicable policies and assisting in their implementation.
- Assessing human protection programs and identifying potential compliance gaps; recommending process improvements.
- Assisting organizations applying for AAHRPP accreditation.
- Training and educating internal staff on relevant requirements.
- Serving as "on-call" and/or interim in-house counsel during vacations, maternity leaves and other times of transition.
- Serving as project manager for organizations undertaking larger projects that demand coordination and oversight by an individual with knowledge of both the content and the organizational politics required to accomplish the stated end goals.
- Assisting in legislative efforts (analyzing proposed legislative changes, drafting organizational responses to requests for comment,assisting in the preparation of testimony before governmental hearings, drafting proposed legislative language to be shared with policymakers).