13. Investigator Responsibilities

13 Investigator Responsibilities

13.1 Investigators

13.2 Protocol Development

13.3 Changes to Approved Research

13.4 Continuing Review after Protocol Approval

13.5 Required Reports to the CUHS

13.5.1 Unanticipated Problems

13.5.2 Complaints, Non-compliance, and Protocol Deviations

13.5.3 Progress Reports

13.6 Investigator-Required Record Keeping

13.7 Conflict of Interest – Investigators

13.8 Training / Continuing Education of Investigator and Research Team

13.9 Subject Recruitment

13.10 Payment to Subjects

13.11 Investigator Concerns

13 Investigator Responsibilities 

Investigators are ultimately responsible for the conduct of research. While Investigators may delegate research responsibility, they must maintain oversight and retain ultimate responsibility for research conducted under their auspices. 

In order to satisfy the requirements of this policy, investigators who conduct research involving human subjects 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 subjects; 

• have sufficient resources necessary to protect human subjects, including: supervision, a sufficient number of appropriately trained staff, and appropriate support services. 

• protect the rights and welfare of prospective subjects; 

• have plans to monitor the data collected for the safety of research subjects, 

• have a procedure to receive complaints or requests for additional information from subjects and respond appropriately, 

• ensure that pertinent laws, regulations, and institutional procedures and guidelines are observed by all participating faculty, students and research staff; 

• ensure that all research involving human subjects receives CUHS review or appropriate determination of exemption before commencement of the research; 

• comply with all CUHS decisions, conditions, and requirements; 

• obtain and document informed consent as required by the CUHS; 

• ensure that protocols receive timely continuing CUHS review and approval; 

• report unexpected problems or serious harm to subjects to the CUHS; 

• obtain CUHS review and approval in writing before changes are made to approved protocols or consent forms; 

• seek CUHS assistance when in doubt about whether proposed research requires CUHS review. 

13.1 Investigators 

Principal Investigators 

At the University-Area institutions faculty members may serve as Principal Investigator or as faculty sponsor on a research project involving human subjects if their School allows them to serve as Principal Investigator on applications for sponsored funding to be administered through the University. 

Adjunct faculty of the University, including lecturers (unless School policy specifically allows them to serve as Principal Investigator), and any other investigator whose status is considered to be “in training” (e.g., students and postdoctoral fellows) may not serve as a Principal Investigator, but may serve as a co-investigator. 

The CUHS ordinarily 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 his or her skills, or the Principal Investigator must include on the protocol one or more additional qualified co-investigator(s). 

Student Investigators 

Students may not serve as Principal Investigators on research studies involving human subjects. They must have a faculty sponsor who fulfills the Principal Investigator eligibility criteria and who will serve as Principal Investigator and faculty advisor on the study. 

Research Team 

The Research Team is comprised of the PI and other individuals 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. 

13.2 Protocol Development 

When developing a protocol, the investigator or a member of the research team may contact the CUHS Office for a determination as to whether the proposed project constitutes human subjects research, and if so, what level of review is required. Contact with CUHS Office may be by phone, letter, or email and must include a brief description of the proposed research. The CUHS Office will respond to the investigator or member of the research team by phone, letter, or email. 

Using the CUHS protocol application, the investigator must carefully develop a Description of Study (investigator/local research plan) and consent form(s), making sure that consent form information is in agreement with the research plan. See Section 7.4.3

The investigator must submit the CUHS application and all attachments to appropriate institutional regulatory committee offices (e.g., Radiation Safety Committee, etc.) for review and approval. 

If research is externally sponsored, the CUHS will receive a copy of the application for funding; if CUHS notes a significant variation between the DHHS application and the CUHS protocol, the investigator must identify and justify the discordance. 

13.3 Changes to Approved Research 

Investigators must seek CUHS approval before making changes in approved research during the period for which CUHS approval has been given, unless the change is necessary to eliminate an immediate hazard to the subject (in which case the CUHS must then be notified at once). 

Minor changes (i.e., changes that do not involve increased risk or discomfort) may be authorized by the CUHS Chair or his/her designee. A letter specifying the changes requested and a revised consent form (if applicable) should be sent directly to CUHS Office. The CUHS Office must reply in writing to indicate approval. 

Note: CUHS approved amendments to ongoing research do NOT extend the original approval expiration date. 

13.4 Continuing Review after Protocol Approval 

Ongoing research studies must be reviewed by the CUHS at least annually, or more often if the CUHS finds that the degree of risk to subjects warrants more frequent review. This renewal must take place prior to the end of the approval period noted in the Report of Committee Action; otherwise, subject participation, including recruitment and enrollment, must be suspended, unless doing so would pose a risk of harm to subjects. 

It is the investigator’s responsibility to submit a timely continuing review application. See Section 7.4.4 for a description of the information that must be included. As a courtesy, the CUHS Office will send Renewal Notices to the investigator at 75, 45, and 15 days prior to the expiration of each approved protocol. The investigator should allow sufficient time for development and review of renewal submissions. Note: The "approval date" and the "approval expiration date" are listed on all CUHS certifications. 

The convened Committee must use the Reviewer Checklist to determine whether research meets the regulatory criteria for approval when undergoing continuing review. 

Continuing review must occur as long as: 

• Research remains active for long-term follow-up of subjects, even when the 

research is permanently closed to the enrollment of new subjects and all subjects have completed all research-related interventions. 

• The remaining research activities include collection or analysis of private identifiable information. 

13.5 Required Reports to the CUHS 

13.5.1 Unanticipated Problems 

Prompt reporting to the CUHS Office is required for the problems described in Section 7.8. 

13.5.2 Complaints, Non-compliance, and Protocol Deviations 

Investigators must promptly report to the CUHS all non-compliance by research staff, protocol deviations, and complaints and concerns from subjects, except those manifestly lacking in substance. 

13.5.3 Progress Reports 

Investigators must report the progress of the research to the CUHS in the manner and frequency prescribed by the CUHS, but no less than once a year. 

When an approved research project is completed, the investigator should promptly notify the CUHS via email or letter. 

13.6 Investigator-Required Record Keeping 

Investigators are responsible for retaining copies of all CUHS-approved documents for a minimum of three years following the completion of the study. 

Where written informed consent is indicated, copies of all signed consent forms must be stored securely by the investigator for a minimum of three years following the completion of the research. 

13.7 Conflict of Interest – Investigators 

All investigators must follow the appropriate School and University Conflict of Interest Policies when conducting research funded by the National Science Foundation or the Public Health Service. Investigators must identify for resolution under those policies’ specific procedures any potential conflict of interest associated with a study, including but not limited to their personal investment in or other financial relationship with a company that might profit from the study. 

Regardless of the source of funding for the research, as part of the application process for CUHS approval, all investigators must disclose any potential or 

actual financial conflict of interest they may have as a result of the sponsorship for that study, or as a result of rights in intellectual property based directly on results of the study. 

If the investigator is permitted to proceed with the study following consultation and/or review concerning potential conflict of interest, the research consent form provided to subjects should include an appropriate description of any relationship that involves, or creates the appearance of, a conflict of interest. 

If, during the course of an approved study, a conflict of interest arises for an investigator or any member of the research team with respect to the study, the individual is required to notify the CUHS Office promptly of the conflict. The CUHS Officers will review the conflict as a modification to the protocol. 

13.8 Training / Continuing Education of Investigator and Research Team 

As stated above, one component of a comprehensive human research protection program is an education program for all individuals involved with research subjects. Harvard University is committed to providing training and continuing education for investigators and members of their research team related to ethical concerns and regulatory and institutional requirements for the protection of human subjects. 

Initial Education 

Investigators must complete appropriate training in human research ethics before submitting their first application to the CUHS, or begin training and commit to completing it before the initiation of their study. CUHS may make approval of an application contingent upon receipt of proof of completion of the appropriate training. 

Investigators who complete the online training course, Harvard Ethics Training in Human Research (HETHR), will automatically receive their certification; an investigator who elects to meet the initial education requirement by completing the CITI Course in the Protection of Human Subjects in Research (www.citiprogram.org) or similar training, must submit proof of completion to the CUHS. HETHR, CITI, or NIH training are required for NIH funded studies. CUHS will consider the sufficiency of other training, as disclosed in the application, Q. 3 (b), in light of the nature of the proposed study. 

Faculty Sponsor Obligations, Human Subjects Research Ethics Training 

Faculty sponsors who review and approve applications for students to submit to the CUHS must familiarize themselves with the STATEMENT OF POLICIES AND PROCEDURES GOVERNING THE USE OF HUMAN SUBJECTS IN RESEARCH AT HARVARD UNIVERSITY as voted by the President and Fellows 

of Harvard College, September 22, 2003, Appendix A, and ensure also that the student applicant is familiar with it. Where the research poses greater than minimal risk, the faculty sponsor must have experience carrying out research with a comparable level of risk, and the student must complete HETHR online training. 

Investigators who are also members of the CUHS or part of the CUHS administration will complete the training requirements for CUHS members and staff described in this policy under 5.6. 

Additional Resources 

1. Human research protection information will be made available on the CUHS Office website on an ongoing basis to ensure that the University research community is apprised of current regulatory and policy requirements and training opportunities. 

2. Federal Office for Human Research Protections: links to guidance and other relevant information on the OHRP website will be maintained on the CUHS Office website. 

13.9 Subject Recruitment 

CUHS approval is required for all recruiting procedures and materials. Recruitment materials must be consistent with the approved CUHS protocol, accurate, and not coercive. Investigators are responsible for recruiting research subjects in a manner that is fair, ethical, and equitable. 

13.10 Payment to Subjects 

Payment to research subjects may be an incentive for participation or a way to reimburse a subject for travel and other expenses incurred due to participation. However, payment for participation is not considered a research benefit. Regardless of the form of remuneration, investigators must take care to avoid coercion of subjects. In general payments should be proportional to the degree of risk, inconvenience, or discomfort associated with participation. 

The CUHS must review both the amount of payment and the proposed method of disbursement to ensure that neither entails problems of coercion or undue influence. 

The consent form must describe the terms of payment and the conditions under which subjects would receive partial payment or no payment (e.g., if they withdraw from the study before their participation is completed). 

Where monies for payment are administered through the University, the University Tax Office may require certain identifying information to issue payments for participation in research studies and to issue IRS 1099 forms where appropriate; in such cases, the consent form must inform subjects that 

they will be asked to provide that identifying information in order to be eligible for payment. 

13.11 Investigator Concerns 

Investigators who have concerns or suggestions regarding University-Area human research protection programs should convey them to the CUHS staff or chair, Institutional Official, or other appropriate school officials (e.g., school dean, departmental chair, center director). The Institutional Official will research any issue presented to him or her, and may convene the parties involved to respond to the investigator or to make procedural or policy modifications, as warranted.