Human Participant Research Principal Investigator Responsibilities

Principal Investigator Responsibilities

The Principal Investigator (PI) is responsible for the ethical conduct of the research and the professional conduct of the participating research teams. The PI, who must be a full-time CSC faculty or professional staff member, ensures that the appropriate materials and forms are submitted for IRB review prior to initiation of the research. In addition to the nine key obligations presented in the above section, the PI also ensures the following:

1. the study is properly designed, scientifically sound, and yields valid results;
2. participants meet selection and eligibility requirements;
3. the study is approved by the IRB and conducted according to the approved protocols;
4. informed consent is appropriately obtained, and documentation is maintained for three years following the conclusion of the study;
5. any unanticipated problems involving risks to participants or others are reported to the IRB Chair within 72 hours of any member of the investigation team becoming aware of the event;
6. the rights and welfare of participants are monitored throughout the research;
7. all members of the research team are qualified and trained in research methods and human participant protections;
8. the IRB Chair is notified, in writing, when data collection is complete;
9. research projects continuing beyond the year’s approval period will be resubmitted for continuing review when approval expires; and
10. records for research will be appropriate archived. If the PI leaves the employ of the College, these records (involving research methodology, informed consent, data collection and interpretation, and a copy of the resulting publication) are required to be deposited with the IRB Chair.

When research involving human participants is conducted by undergraduate or graduate students as part of a course assignment or thesis project, the instructor of the class or the student’s major professor shall serve as the PI, and the PI will assume responsibility for ensuring that the research is reviewed and conducted in accord with Chadron State College’s IRB policies and professional ethics.

The National Institute of Health now requires all investigators in research engaging human particpants to complete educational training on the protection of human research participants. To comply with federal requirements and standard 'best practice' in the field, this training is required for all individuals identified as "key personnel" in the proposal and who are involved with the human participants portion of the project. Online training on ethical issues involving human subject research is available from the Office of Human Subjects Research at the National Institutes for Health (http://phrp/nihtraining.com/users/login.php). This one-hour tutorial will generate a certificate of completion of the training. A copy of the certificate for all investigators is required with submission of materials for IRB review. The only exception to this will be for surveys conducted to improve program service as a part of the CSC assessment process that fully comply with the ‘administratively-reviewed exempt certification’ category below.

All faculty and staff who will be conducting research using humans or animals as research participants must complete the following:

1. Prior to the commencement of the research, submit appropriate forms for IRB review;
2. Prior to the commencement of the research, complete any modifications required by the IRB for approval;
3. Prior to the commencement of the research, receive written IRB approval;
4. Throughout the research project, comply with all institutional and federal research policies and approved procedures;
5. Upon completion of the research or as required, file reports and updates as appropriate; and
6. Following completion of the research, maintain documents of research, including informed consent permissions, data, etc., for at least three (3) years in confidential and secure locations.

Cooperative Research: Research involving collaborative institutions require that both institutions assume responsibility for safeguarding the rights and welfare of human participants. Thus, both Chadron State College and the cooperating institution must independently evaluate the research plan to determine that both federal and institutional policies are being followed.

1. If the project has been reviewed and approved by a qualified IRB (or Human Subjects Review Committee) at another institution, the researcher should submit a copy of the application and the other institution’s IRB’s finding to the Chadron State College IRB, along with the appropriate CSC application. CSC’s IRB Chair will complete a review of compliance with CSC’s policies.
2. If the project is a part of an established national on-going study, the local administrator of the project should send a letter to the IRB chair affirming that the project is being regularly reviewed by a qualified IRB at another institution.
3. Even if the project has not received IRB review elsewhere, CSC’s IRB must review the project prior to initiation.

All research involving human participants is required to have at least an annual progress evaluation. If the research involves extreme risk to participants, the IRB may require more frequent evaluations. The Principal Investigator is responsible for submitting required reviews and updates to the IRB.

Confidentiality: If a researcher discovers, through the process of conducting his/her research, that the participant poses a risk to self or others, evidence of child abuse, or the presence of infectious diseases required for report to local health authorities, the Principal Investigator is required to report these findings immediately to the IRB Chair and to the local police.