Responsibilities of the Investigator

Print-Ready Responsibilities of the Investigator

1. The Investigator shall obtain the prior approval of the HMS/HSDM Committee on Human Studies (CHS) before implementing any protocol changes, unless a change is necessary to eliminate apparent immediate hazards to the research participants. If, because of the aforementioned, prior approval was not able to be obtained, the CHS must be informed, in writing, and with specificity, of the deviation from the approved protocol at the first available opportunity and, in no event, later than two (2) business days after discovery. Failure to obtain prior approval of a change in the protocol will jeopardize your ability to use the data collected during the lapsed period and may result in further disciplinary action.

2. The Investigator is solely responsible for seeking and obtaining re-approval of her/his research before the expiration date listed on the previous page if s/he wishes to continue the research beyond the stated approval period. Failure to do so will result in a lapse in approval. If your approval lapses you may not gather any additional data in connection with your research and your sponsor may need to be notified.

3. Unless an Investigator has specifically asked for, and been granted, a waiver from the requirements of informed consent and/or the documentation of same, an exact duplicate of the CHS approved and stamped consent form, attached with the Report on Action or Determination Letter (if applicable), shall be the only form used to enroll participants. At no time may a participant be enrolled with an expired consent form or one that has been revised, without prior approval of the CHS. In addition, if an amendment to the consent form has been approved, the newly amended consent form is the only form that may be used, going forward, to enroll new participants.

4. Investigators must submit to the CHS adverse events, unanticipated problems with the study/study participants, non-compliance with the approved protocol, suspensions or terminations of research, complaints about the research (from study participants or others), protocol deviations and violations, within 48 hours, or as soon as learning of the event. Data safety monitoring reports (as applicable) must be submitted when obtained by the Investigator. These event reports must be sent sponsors and appropriate federal agencies as applicable and as required by those entities.

5. The Principal Investigator is responsible for maintaining an accurate file of all documents relevant to the IRB review. The PI’s records should be a mirror image of the IRB’s records, meaning that all documents (including signed copies) submitted by the researcher to the CHS Office, as well as all correspondence between the CHS office and the researcher should be kept on file. More specifically, the researcher’s study file should at least include:

• The original protocol or grant and all amended versions (with a version date and/or number)
• CHS Documentation:
  • Copies of all signed and dated forms submitted to the IRB (including, but not limited to the CHS Initial Application, Continuing Review Applications, Amendment Requests, Personnel Rosters, Unanticipated or Adverse Event Reporting Forms, Non-compliance Report Forms, or other supplemental forms)
  • All approved study materials, including IRB validated copies, if applicable (e.g., consent forms, recruitment materials, data collection instruments or forms)
  • Any foreign language materials (if applicable)
  • Original Approval Letters and/or notification of IRB decisions
  • All correspondence with the CHS office
• All study materials and relevant correspondence not with the CHS (e.g. correspondence with the sponsor, Annual progress reports to the sponsor, Data Safety Monitoring Board Reports, Copies of any inspection or audit reports, IRB or ethics committee reviews from other sites)
• Up-to-date Policies and Procedures Manual (SOP, MOP)

A Regulatory Binder Tool with print-ready binder tabs is available to help Principal Investigators achieve and maintain regulatory compliance and adhere to high standards of record keeping for research protocols involving human subjects - regardless of the size or scope of the project. Each binder section outlines the regulatory documentation requirements, general guidance for organization and record keeping, and, when applicable, references to federal regulations and Good Clinical Practice guidelines.

6. In accordance with the Faculty of Medicine policy on retention of research records, Investigators should keep all records pertaining to clinical studies for a minimum of seven years after the study is complete. The CHS recommends this retention policy for all studies, regardless of risk or type of CHS review. At a minimum standard set by DHHS (45 CFR § 46.115(b) and the FDA (21 CFR § 56.115(b), Investigators must keep complete study records for three years. Records must be kept in a secure location that allows for maintaining participant confidentiality. The study records must be available for inspection by the CHS, DHHS, FDA, or the funding source, as applicable, and if requested.

In conducting review, the CHS Chair or the Chair’s designee gives due consideration to ensuring the following:

Risks to participants are minimized: (i) by using procedures which are consistent with sound research design, and which do not unnecessarily expose participants to risk, and (ii) whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.

Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result from the research.

Selection of participants is equitable. In making this assessment, the CHS takes into account the purposes of the research and the setting in which the research will be conducted, and is cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, persons with cognitive impairments, or with economic or educational disadvantages.

Informed consent will be sought from each prospective participant or the participant's legally authorized representative, in accordance with, and to the extent required by §46.116.

Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

When appropriate, the research plan makes adequate provision for monitoring the data collected, to ensure the safety of participants.

When appropriate, there are adequate provisions to protect the privacy of participants, and to maintain the confidentiality of data.

When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, persons with cognitive impairments or with economic or educational disadvantages, additional safeguards have been included in the study to protect the rights and welfare of these participants.

Updated: 19-Dec-2011