INVESTIGATOR OBLIGATIONS

According to the Code of Federal Regulations, you, as Principal Investigator (PI) are responsible for ensuring that the research study is conducted according to the protocol and in compliance with applicable regulations, for assuring that human subjects are protected, and for controlling any investigational product being used during the study. By signing on to be a PI for a human research study, you agree to:

1. Protect the rights, safety, and welfare of the human research subjects, in accordance with the Belmont Report and other guidances on protection of human subjects.
2. Conduct the study in compliance with the CGIRB-approved study protocol and applicable regulations and guidelines governing the conduct of clinical studies, including state and local laws and CGIRB policies and procedures. This includes understanding and application of the definitions of legally authorized representative (LAR) and guardian in your state.
3. Delegate significant study-related duties only to qualified personnel and directly oversee these personnel to ensure that they are performing their duties in compliance with applicable standards and in the best interest of the human subjects.
4. Use only the subject information and consent form (SICF) and HIPAA authorization language approved by CGIRB. Any change to the consent/authorization document must be reviewed and approved by the CGIRB Board prior to use.
5. Protect the privacy of the study subjects and maintain the confidentiality of the personal health information and study data. In determining if the level of privacy is sufficient, you should consider the degree of privacy of any information being collected and whether a reasonable person would consider the release of the information without permission to be an invasion of privacy. You should consider whether the provisions to maintain confidentiality are reasonable in relation to the degree of privacy of the information.
6. Obtain the legally effective informed consent of the subject or the subject's legally authorized representative prior to participation in the research.
   1. Ensure the circumstances of the consent process provide the prospective subject or the legally authorized representative sufficient opportunity to review the consent document and to consider whether to participate.
   2. Ensure the circumstances of the consent process minimize the possibility of coercion or undue influence.
   3. Ensure the individuals communicating information to the subject or the legally authorized representative during the consent process will provide that information in language that is understandable to the subject or the LAR.
   4. Assess whether the subject or LAR comprehends the content of the informed consent document.
   5. Obtain assent from children or adult subjects unable to provide consent, when applicable.
   6. Provide non-English speaking subjects with a CGIRB-approved translation of the subject information and consent document in the subject's primary language.
   7. Ensure an impartial witness is included in the consent process when subjects or LARs are unable to read or are visually impaired.
7. Provide CGIRB with copies of all study-related materials that will be provided to subjects.
8. Supervise the administration of the investigational product (IP) to the research subjects, as applicable, and maintain full accountability of the IP.
9. Obtain CGIRB approval for any amendments to the protocol prior to implementation of the changes.
10. Promptly report to CGIRB all changes made to the research without CGIRB approval to eliminate an apparent immediate hazard to subjects.
11. Promptly report to CGIRB all unanticipated problems involving risk to subjects or others.
12. Submit and obtain CGIRB approval for all advertisements and other subject recruitment or retention materials for CGIRB approval prior to use.
13. Provide the Continuing Review Status Report and the Investigator Site Closure Request and Final Study Status Report to CGIRB in the timeframe required by CGIRB.
14. Maintain and retain study-related documentation in accordance with applicable regulatory requirements.