Investigator Manual: 3. Researcher Roles and Responsibilities

Every research study requires a Principal Investigator (PI). This person takes full responsibility for the study’s conduct. Northeastern has a policy on who may serve as a PI in addition to guidance for non-faculty members serving in this role.

A PI is responsible for the overall conduct of a study. Some of these responsibilities include, but are not limited to, the following:

• Conducting the study in compliance with relevant regulations (e.g., 45 CFR 46/the Common Rule, FDA, other federal agencies, state law) as ethical principles described in the Belmont Report.
• Completing required human subjects research training.
• Providing adequate training to and oversight of study personnel.
• In the case of certain types of clinical trial research, ensuring the protocol complies with applicable Good Clinical Practice requirements.
• Obtaining legally effective informed consent, when required.
• Obtaining permission for the use and disclosure of protected health information in compliance with the HIPAA Privacy Rule, as applicable.
• Comparing Ensuring study materials are consistent with any contracts or grants. Submitting follow-up applications as required for approved or exempt studies, including changes, continuing reviews, and reportable events.
• Submitting a closure report when a study is completed.
• Complying with all institutional requirements related to human subjects research, including conflict of interest.
• Assuring participant privacy and confidentiality according to institutional and regulatory requirements including HIPAA and FERPA (as applicable).

Yes, principal investigators on IRB protocols can be changed at any time. In addition to submitting a modification form and revised protocol application form, other documents may require revisions; i.e., any document that identifies the PI will need to be changed. For example, consent and assent documents and verbal scripts, recruitment material, etc.

Northeastern University requires all individuals engaged in human research that fall under the purview of its IRBs to be listed as part of the research team. Individuals are considered members of the research team if they:

• design research;
• direct research or serve as the principal investigator for the study;
• enroll research subjects (including obtaining subjects’ informed consent or screening potential subjects);
• make decisions related to eligibility to participate in research;
• conduct study procedures;
• analyze or report research data;
• analyze or report adverse events.

The Principal Investigator and student researcher (if student-driven research) are to be listed on the protocol application form. All other members are to be listed on the Research Team Form. One form should be completed for each protocol. This form is to be updated as individuals are added or removed from the protocol and submitted to the DHR.

While the PI bears overall responsibility for the conduct of a study, study team responsibilities include, but are not limited to:

• Completing required human subjects research training.
• Complying with all institutional requirements related to human subject research, including conflict of interest.
• Adhering to federal regulations, state and local laws, institutional policies, and procedures surrounding the safety and protection of human participants.
• Assuring participant privacy and confidentiality according to institutional and regulatory requirements including HIPAA and FERPA, when applicable.

Undergraduate class assignments and/or Capstone graduation projects generally do not require IRB review and oversight because the goal is to teach methods and prepare the student for future research. They do not fall under the federal definitions of human subject research as they are not intended to or likely to contribute to generalizable knowledge. Rather, the activities are resources of teaching which facilitate learning of concepts and the opportunity to practice various procedures.

Faculty overseeing student research projects are expected to understand the philosophy, ethics, and practice of protecting human subjects in research; and to adhere to these principles during the conduct and supervision of classroom research projects. Faculty will be responsible for:

3. Ensuring that assigned projects involving humans can be classified as a course-related student project under the criteria provided.
4. Ensuring that all student research projects are conducted by federal regulations and principles regarding the protection of human subjects in research.
5. Ensuring that the students are adequately trained and that their planned research activities are designed with appropriate and adequate safeguards in place to ensure that the activities are within the scope of ethical conduct.

Capstone projects intended to contribute to generalizable knowledge should explicitly justify why an exception is warranted when seeking a review.

Under the direction of the Office of the Vice Provost for Research, Northeastern University requires completion of training on the protection of human subjects and the ethical principles of research for all human subject research, regardless of whether or not investigators have received funding to support their project.

All members of the research team involved in the design, conduct, or reporting of the research must complete training. Members of the research team who have not completed human research protection training may not take part in aspects of the research that involve human subjects until they complete the required training.

Northeastern University has an account with CITI. All NU affiliates can take this course at no charge. Approval for training is valid for 3 years and investigators are to ensure their certificate is active any time they are engaged in human subject research. If an investigator has completed training elsewhere, they may provide documentation so long as the training has taken place in the past 3 years. If the training was completed through CITI, an individual can log in to their CITI account and add their Northeastern affiliation. Please refer to the DHR for instructions on accessing the CITI training.

The Institutional Review Board [IRB] must ensure that financial or other business interests do not compromise the protection of human subjects in research. If an investigator on the study team has an actual, potential, or perceived conflict of interest, this information must be disclosed to the IRB, which may require disclosure to potential participants.

Depending on the nature of the conflict, a management plan may need to be  developed. Management plans are written documents or statements that enhance transparency and create separation between an employee’s activities and their university work to avoid the appearance of impropriety in university decision-making or research. The document describes how conflicts will be managed, monitored, or avoided.

The Common Rule and Food and Drug Administration (FDA) do not regard research on oneself as different from research involving other human subjects. Before commencing any research activities involving self-experimentation (e.g., blood draws, equipment testing), a protocol application is to be submitted and approved by the NU IRB. The IRB will review the application to ensure the activities do not raise any ethical concerns and that adequate protections are in place.

The Common Rule and FDA regulations also require that informed consent be obtained from all research participants unless certain conditions are met. The IRB recommends researchers provide a document that will serve as the basis for documentation of informed consent for participation in human subject research when the experimentation involves the researcher.