As an investigator conducting research involving human subjects, you have many important responsibilities. Here’s a list of the ‘Top 10’ things you are responsible for as a researcher. Following the list is the Catawaba Valley Medical Center Policy & Procedures that guide human subjects research. Be sure to read Section VII thoroughly to learn of your specific responsibilities related to conducting research at CVMC.The information in Sections V.D.-I. and VIII should also be reviewed.

Investigator Responsibilities

1. Protecting the rights and welfare of human research subjects;
2. Being knowledgeable about the requirements of the HHS regulations (US Department for Health & Human Services), applicable state law, and CVMC policy and procedures for the protection of human subjects (completion of PHRP is required);
3. Conducting their research according to the IRB-approved protocol and complying with all IRB determinations;
4. Obtaining and documenting the informed consent of each subject (or legally authorized representative) unless the IRB has waived this requirement;
5. Ensuring that each potential subject understands the nature of the research and participation;
6. Providing a copy of the IRB-approved informed consent document to each subject (or legal representative) at the time of the consent, unless the IRB has waived this requirement;
7. Promptly reporting proposed changes in previously approved human subject research activities to the IRB. Changes may not be implemented without IRB approval, except where necessary to eliminate apparent immediate hazards to the subjects;
8. Reporting progress of approved research to the IRB as often as, and in the manner, prescribed by the IRB (including the completion of the research);
9. Promptly reporting to the IRB any unanticipated problems involving risks to subjects or others or any serious or continuing non-compliance with the HHS regulations or determination of the IRB;
10. Keeping certain records as required by the HHS regulations for at least three years after completion of the study (e. g. all signed consent documents).

Download the Top 10 List of Investigator Responsibilities here

Download CVMC Policy RI-20 here