What are investigators’ responsibilities during the conduct of an approved research study?
Investigators play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by the IRB. Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that include:
- obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research, unless these requirements have been waived by the IRB (45 CFR 46.116; 45 CFR 46.117).
- complying with all ethical standards set forth in all relevant government policies and Macalester Colleg policies and procedures. Investigators are also expected to comply with any conditions the IRB has placed upon their research, to follow the research protocols in their IRB-approved submissions, and to notify the IRB of any changes to their protocol.
- obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)).
- ensuring that progress reports and requests for continuing review and approval are submitted to the IRB promptly. In certain circumstances, investigators also would be responsible for meeting the following additional regulatory requirements:
- providing to the IRB reports of any unanticipated problems or adverse events involving risks to subjects or others within one week of their occurrence (45 CFR 46.103(b)(5));
- providing to the IRB reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB (45 CFR 46.103(b)(5)). Reports should be provided to the IRB within one week of such an event or within one week of the IRB’s request for such a report.
- submitting a Study Closure Report to the IRB when an approved expedited or full review protocol has been concluded. Investigators should file the Study Closure Report when they will no longer obtain data through interaction or intervention with subjects, and/or obtain or use identifiable private information about subjects. Investigators should also submit a Study Closure Report if 1) the study was never initiated, and no enrollment took place; and 2) they will leave Macalester College without requesting a change in the primary investigator. A Study Closure Report is required by federal regulations for all expedited and full review studies approved by the IRB.
- Researcher Advisors must work with student investigators to submit a Study Closure Report.
- After study closure, investigators may not contact study subjects for further data collection without consulting with the IRB about re-opening the study by means of a continuing review or a new protocol submission.
- Under HHS regulations at 45 CFR 46.115(b), an investigator – or a student investigator’s Research Advisor – must retain certain records (e.g., informed consent documents signed by subjects) on behalf of the institution for a minimum of 3 years after completion of the research for those studies not requiring a HIPAA authorization and 6 years after completion of the research for those studies requiring a HIPAA authorization Consent forms for FDA-regulated studies should be retained in accordance with the sponsor agreement. Such records may be preserved in hardcopy, electronic or other media form and must be accessible for inspection. Retention of multiple copies of each record is not required. A scan of the entire consent form can be made and the original hardcopy destroyed. These records must be kept in appropriate storage, restricting access to anyone except those individuals identified in the approved study application.
- Once the 3 years (or longer depending on the decision of the principal investigator or other requirements) has passed, the signed consent forms must be effectively destroyed by shredding or burning. This is the final step and must be carried out to complete the retention process.
- Recorded information (visual or audio) may often be deleted after these have been transcribed so that only the transcribed information is stored. Such transcriptions must be stored in a way that will ensure the confidentiality of participants as per the understanding developed in the study’s informed consent process.