Office of Human Research Ethics SOP 1501: Investigator Responsibilities

Title

Office of Human Research Ethics SOP 1501: Investigator Responsibilities

1. Purpose

Investigators are ultimately responsible for the conduct of research. Investigators may delegate tasks to appropriately trained and qualified members of their research team. However, investigators must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibilities.

2. Procedures

2.1 Investigators

The research team is made up of "investigators," differentiated as follows, along with their responsibilities in the conduct of research involving human participants.

At the University of North Carolina at Chapel Hill ("UNC-Chapel Hill" or "University") only faculty members with UNC-Chapel Hill-paid appointments may serve as the Principal Investigator (PI) or as the faculty sponsor on a research project involving human subjects.

Adjunct faculty and any investigator whose status is considered to be “in training” (e.g., students and medical residents) may not serve as a PI but may serve as a co-investigator or sub-investigator. PIs will ensure that research designed and conducted by trainees has sound research design and is appropriately supervised.

The IRB recognizes one PI for each study. The PI has ultimate responsibility for the research activities.

Studies that require expertise or skills beyond those held by the PI must either be modified or have expertise and skills supplemented by the inclusion of one or more additional qualified co/sub-investigators.

2.1.1 Trainee Investigators

Trainee investigators when listed as the Principal Investigator in the application are students, employees in postdoctoral training programs, or fellows who have the primary research responsibility for an application submitted to the IRB along with their Faculty Advisor These investigators may take a leading role in the research, but do not have ultimate administrative and fiscal responsibility for the project. Trainee investigators should be privy to all correspondence sent by the IRB that pertains to a project on which a Trainee investigator is listed.

2.1.2 Sub-Investigators

Any individual other than the PI who is involved in the conduct of a research study. Such involvement could include:

• Obtaining information about living individuals by intervening or interacting with them for research purposes;
• Obtaining identifiable private information about living individuals for research purposes;
• Obtaining the voluntary informed consent of individuals to be subjects in research; and
• Studying, interpreting, or analyzing identifiable private information or data for research purposes.

2.1.3 Research Team Members

Every member of the research team is responsible for protecting human subjects in accordance with the guidelines specified in SOP 101, reporting all noncompliance to the IRB, and for complying with all IRB findings, determinations and requirements. Team members must complete human subject research training as required by the University of North Carolina; and as applicable, the funding source or sponsor.

2.2 Responsibilities

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

1. Develop and conduct research that is in accordance with the ethical principles in the Belmont Report;
2. Develop a research plan that is scientifically sound and minimizes risk to the subjects;
3. Incorporate into the research plan a plan to ensure the just, fair, and equitable recruitment and selection of subjects;
4. When some or all of the subjects are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons), include additional safeguards in the study to protect the rights and welfare of these subjects;
5. Ensure that the research plan includes adequate provisions for the monitoring of subjects and data to ensure the safety of subjects;
6. Ensure that there are adequate provisions to protect the privacy interests of subjects;
7. Ensure that there are adequate provisions to protect data confidentiality and interests of subjects, including an information security plan that considers the collection, storage, maintenance, analysis, and transmission of data and other identifiable information; Have sufficient resources necessary to protect human subjects, including:
   1. Access to a population that would allow recruitment of the required number of subjects.
   2. Sufficient time to conduct and complete the research.
   3. Adequate numbers of qualified staff.
   4. Adequate facilities.
   5. Necessary equipment.
   6. A plan to ensure proper supervision of the research including a plan for periods of absence or decreased availability.
   7. Availability of medical, psychological, or other support that subjects might require during or as a consequence of their participation in the research.
8. Assure that all procedures in a study are performed with the appropriate level of supervision and only by individuals who are licensed or otherwise qualified to perform such procedures  under the laws of North Carolina and the policies of UNC-Chapel Hill;
9. Assure that all study personnel are educated in the regulatory requirements regarding the conduct of research and the ethical principles upon which they are based;
10. Assure that all persons assisting with the research are adequately trained and informed about the protocol/research plan and their specific duties and functions;
11. Promptly report any changes in, addition to, or departure of investigators or research staff to the IRB for evaluation and approval (note that investigators and staff may not begin work on the research until IRB-approved);
12. Protect the rights, safety, and welfare of participants;
13. Ensure that when private health information is used, legally effective HIPAA authorization is obtained for each subject unless the Privacy Board or IRB has approved a waiver of the requirement;
14. Ensure that the language in the consent form is consistent with that in the protocol/research plan and, when applicable, in the HIPAA authorization;
15. Obtain and document informed consent and ensure that no human subject is involved in the research prior to obtaining consent or consent/permission from their legally authorized representative, unless a waiver of the requirement has been approved by the IRB;
16. Have a procedure to receive questions, complaints, or requests for additional information from subjects and respond appropriately;
17. Ensure that all information provided to the IRB is accurate and complete so that the IRB may fulfill its responsibilities to review the research and make the required determinations;
18. Ensure that all research involving human subjects receives IRB review and approval in writing or a determination of exemption before research begins;
19. Ensure that all research involving human subjects is reviewed by other experts and organizational components and committees as applicable to the research;
20. Ensure that potential conflicts of interest related to the research are reported pursuant to UNC-Chapel Hill policies and any resulting management plans are followed;
21. Comply with all IRB decisions, conditions, and requirements;
22. Ensure that studies receive timely continuing IRB review and approval;
23. Report unanticipated problems, deviations, complaints, non-compliance, suspensions, terminations, and any other reportable events to the IRB;
24. Notify the IRB if information becomes available that suggests a change to the potential risks or benefits of the research;
25. Obtain IRB review and approval before changes are made to the research unless a change is necessary eliminate apparent immediate hazards to the subject(s);
26. Seek HRPP or IRB assistance when in doubt about whether proposed research requires IRB review;
27. Retain records for the time period and in the manner required by applicable regulations, contractual agreements, and organizational policies.
28. Notify the IRB of a premature completion of a study.
29. Posting clinical trial consent form:  for each clinical trial conducted or supported by a Federal department or agency, one IRB-approved consent form used to enroll subjects must be posted on a publicly available Federal Web site, after the trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.

Additional investigator responsibilities, including specific responsibilities for investigators engaged in FDA-regulated research are described elsewhere in this document.

2.3 Investigator Records

Under these policies investigators must maintain, at a minimum but not limited to, the following research records under these policies. In addition, investigators must also comply with all record-keeping requirements from the sponsor, UNC-Chapel Hill IRB, and University of North Carolina Records Retention and Disposition Schedule.

2.3.1 Study Records

• Individual subject records
• Recruitment materials
• Documentation of consent process (who, what, when and how)
• Signed consent forms
• Unanticipated Problem & Reportable Event Reports
• Subject complaint reports
• Results of all procedures conducted on the subject, including final visit (if no final visit, reason why: e.g., removal from study, withdrawal from study, death)

2.3.2 Regulatory Records

• Most recent IRB-approved protocol/research plan
• Previous versions of protocol/research plan
• All correspondence (i.e., approvals, reporting forms and responses, etc.) to and from the IRB
• All correspondence with the sponsor and others regarding the study
• Continuing review progress reports
• Modification Requests
• Investigational product accountability records, when applicable
• Delegation of authority logs

2.3.3 Record Retention

Investigator records must be retained in accordance with regulatory, organizational and sponsor or grantor requirements, but no less than three years following the completion of the research. All records must be maintained securely with limited access. Disposal of investigator records must be done in such a manner that no identifying information can be linked to research data. Please note the UNC-Chapel Hill Records Management Policy may be more stringent than sponsor or federal requirements.

A records retention and disposition schedule is a document used to identify and manage the records that document the activities and history of an organization. It identifies and classifies the records created, received, and used by the organization and provides instructions on how long they need to be retained for legal, fiscal, and historical purposes.

This records retention and disposition schedule is a tool for UNC-Chapel Hill employees of to use when managing UNC-Chapel Hill records. The schedule lists records found in the administrative, academic, and health affairs units of the University and gives an assessment of their value by indicating if, and when, they should be destroyed or transferred to University Archives.

For records not included in the UNC-Chapel Hill General Records Retention and Disposition Schedule, refer to Federal retention requirements including but not limited to:

1. DHHS regulations require that, “records relating to research which is conducted shall be retained for at least 3 years after completion of the research.” [45 CFR 46.115(b)]
2. For FDA regulated research, including Investigational New Drug (IND) studies as outlined in 21 CFR § 312.57 and 21 CFR 312.62 ; and Expanded Use Access as outlined in 21 CFR 312.305(c)(4) and 21 CFR 312.62
3. For FDA regulated device (IDE) studies “investigators must maintain the required records for a period of two years after the date that the records are no longer required for purposes of supporting a premarket approval application, a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification submission, or a request for De Novo classification, whichever date is later.” 21 CFR 812.140(d)
   • For significant risk devices “the investigator must maintain accurate and complete records relating to the investigation under 21 CFR 812.140”
   • For non-significant risk devices studies “investigators must maintain the records of each subject’s case history and exposure to the device under §812.140(a)(3)(i)” FDA Policy on IDE Records

2.3.4 Public Records Request

Some of this documentation may be subject to public access under the North Carolina Public Records Act. The UNC-Chapel Hill Office of University Counsel should be consulted when a public records request is received prior to distributing any requested documentation. If any documentation requested meets the criteria for promptly reportable information as outlined in SOP 1401, please submit accordingly.

2.4 Recruitment Incentives

Payment arrangements among sponsors, organizations, investigators, and those referring research participants present a conflict of interest and may place participants at risk of coercion or undue influence or cause inequitable selection. Payment in exchange for referrals of prospective participants (“finder’s fees”) is not permitted. Similarly payments designed to accelerate recruitment that is tied to the rate or timing of enrollment (“bonus payments”) are also not permitted.

2.4.1 Compensation from Sponsors

To minimize inappropriate financial incentives in study sponsorship, project support in all University projects:

• Must be based on fair market value of services performed or actual cost;
• Must be expressly stated in a contract between the University and the research sponsor;
• May not be conditioned upon a particular research result or tied to successful research outcomes; and
• May not include payments or other incentives for achieving human subject enrollment target numbers or meeting target enrollment accrual timelines or identifying eligible human research subjects.

2.5 Investigator Concerns

Investigators who have concerns or suggestions regarding UNC-Chapel Hill’s HRPP or IRB(s) should convey them to the Institutional Official or other responsible parties (e.g., supervisor, college dean, departmental Chair), when appropriate. The Institutional Official or designee will consider the issue, and when deemed necessary, seek additional information and convene the parties involved to form a response for the investigator or make necessary procedural or policy modifications, as warranted. In addition, the Chair of the IRB or the OHRE Director will be available to address investigators’ questions, concerns and suggestions.

In addition to these SOPs, which are made available on the UNC-Chapel Hill website for investigators, investigators have access to Carolina Ethics Line, the anonymous reporting and inquiry hotline used by UNC-Chapel Hill.

Related Requirements

External Regulations and Consequences

• U.S. Food and Drug Administration - Policy on Investigational Device Exemption (IDE) Records
• 21 CFR 312.57 - Recordkeeping and Record Retention
• 21 CFR 312.62 - Investigator Recordkeeping and Record Retention
• 21 CFR 312.305(c)(4) - Requirements for All Expanded Access Uses: Safeguards
• 21 CFR 812.140 - Records

University Policies, Standards, and Procedures

• Records Management Policy

Contact Information

Policy Contact

Name: Kimberly Brownley
Title:  Associate Director of Policy and Initiative
Unit: Office of Human Research Ethics (OHRE)
Email: kim_brownley@med.unc.edu