Human Subject Protection Services

CTTG provides an experienced resource for complying with human subject protection requirements.

Informed Consent: CTTG’s attorneys are experienced in reviewing and drafting consent agreements and negotiating modifications proposed by sponsors, Institutional Review Boards (IRBs), and clinical sites. We keep abreast of important developments in federal and state law, research on informed consent with various populations and for specific types of research, and guidance provided by the Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA).

IRB Policies and Procedures: CTTG attorneys have assisted IRBs develop and implement new policies and procedures. We keep apprised of human research protection issues on the federal and state level that affect IRBs and sponsors working with both local and Central IRBs. We welcome the opportunity to provide pro bono services to hospital based IRBs needing assistance on specific projects.

HIPAA: CTTG’s attorneys are experienced in helping companies and clinical sites understand and comply with the HIPAA requirements and the application of those requirements in clinical research.

We handle long-term assignments as well as short-term projects that require quick turn around.