11 Investigator Responsibilities
The following procedures describe the investigator responsibilities in the conduct of research involving human participants.
Principal investigators are ultimately responsible for the conduct of research. Principal investigators may delegate research responsibility. However, investigators must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibility.
At Brown University only faculty or staff members with University-paid appointments and graduate students (with an advisor’s collaboration) may serve as the Principal Investigator on a research project involving human participants. Specific and unusual circumstances may arise where the Principal Investigator may have an unpaid University courtesy appointment.
The IRB recognizes one Principal Investigator (PI) for each study. The PI has ultimate responsibility for the research activities.
Protocols that require skills beyond those held by the Principal Investigator must be modified to meet the investigator's skills or have one or more additional qualified faculty as co-investigator(s).
Undergraduate students may not serve as Principal Investigators. They must have a faculty sponsor who fulfills the PI eligibility criteria and who will serve as PI and faculty advisor on the study.
[Note: It is unusual that an undergraduate project would meet the definition of “research” as defined earlier in this document for the purposes of human research projects, since for most undergraduate projects the primary intent of the data collection is to obtain a passing grade rather than to obtain data to “develop or contribute to generalizable knowledge”.]
The RPO website contains the information needed to make the determination as to whether a project meets the human research definition of “research” and, therefore, requires IRB review. The faculty adviser, in conjunction with the student, will make the final determination regarding applicability.
The research team consists of the PI and other individuals, also known as key personnel, who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the protocol.
In order to satisfy the requirements of this policy, investigators who conduct research involving human participants must:
- develop and conduct research that is in accordance with the ethical principles in the Belmont Report;
- develop a research plan that is scientifically sound and minimizes risk to the participants;
- have sufficient resources necessary to protect human participants, including:
- access to a population that would allow recruitment of the required number of participants
- sufficient time to conduct and complete the research
- adequate numbers of qualified staff
- adequate facilities
- a process to ensure that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions
- availability of medical or psychological resources that participants might require as a consequence of the research
- protect the rights and welfare of prospective participants;
- have plans to monitor the data collected for the safety of research participants;
- have a procedure to receive complaints or requests for additional information from participants and respond appropriately;
- ensure that pertinent laws, regulations, and institution procedures and guidelines are observed by participating investigators and research staff;
- obtain and document informed consent as required by the IRB ensuring that no participant is involved in the research prior to obtaining their consent, as required by the approved protocol;
- ensure that all research involving human participants receives IRB review and approval in writing before commencement of the research;
- comply with all IRB decisions, conditions, and requirements;
- ensure that protocols receive timely continuing IRB review and approval;
- report unexpected or serious adverse event problems that require prompt reporting to the IRB (see Section 7);
- obtain IRB review and approval in writing before changes are made to approved protocols or consent forms; and
- seek IRB assistance when in doubt about whether proposed research requires IRB review;
A critical component of a comprehensive human research protection program (HRPP) is an education course for all individuals engaged in research with human participants. Brown University is committed to providing training and education for investigators and members of their research team related to ethical concerns, and regulatory and institutional requirements for the protection of human participants.
For purposes of this section and sub-sections, “research team, research personnel, and key personnel” includes: principal investigators, co-investigators, faculty advisors for student investigators, research assistants, and any research team member who has contact with human research participants and/or their research data and identifiers.
All Principal Investigators (PIs) and members of their research team (also known as “key personnel”) must review the following core training documents which are included in the initial CITI training described in Section 11.4.2:
a) The “Brown University HRPP Policy and Procedures Manual,” and
b) The “Belmont Report: Ethical Principles and Guidelines for the Protection of Human Participants of Research.”
The PI and all applicable research personnel must complete the “Brown University CITI Program in the Protection of Human Research Participants.” If a PI/research team member has received a comparable certification in the protection of human research participants within the previous three (3) years, he/she may submit that certification to the HRPP, along with completion of the Brown University CITI course (Group 4) which includes only the core documents described in Section 11.4.1.
The HRPP will review the certification of the PI and their advisor (if applicable) to ensure that it is comparable to the Brown University training and satisfies training requirements for the relevant study population. Based on this evaluation, the HRPP may require the PI or their advisor (if applicable) to complete additional modules. The PI is responsible for his/her study team’s certifications.
New research protocols, amendments, and applications for continuing review will not be approved or exemption granted by the IRB if the PI or their advisor (if applicable) does not hold a current certification of training. Final approval of any submission will not be granted until the PI and/or advisor (if applicable) has completed the initial education requirement (or the continuing education requirement once the initial education requirement has been satisfied).
All investigators and relevant research personnel must meet Brown University’s continuing education requirement every three (3) years after certification of initial education if they are still involved in human research.
Acceptable training includes review of appropriate refresher modules on the CITI web-based training site. Anyone certified through CITI will be sent automatic reminders from the CITI system when certification renewal is due. Those who met the initial education requirement with the submission of a comparable certification from a non-Brown institution may complete a Brown refresher course after three (3) years, or submit documentation of a comparable refresher course completion from another institution.
Human research protection information will be made available on the HRPP website on an ongoing basis to ensure that the University research community is apprised of current regulatory and policy requirements and training opportunities.