Investigator Responsibilities

Shortcuts eIRB Compliance Training (must log in to access) Investigator Qualifications & Training Ethical Responsibilities Cooperation Record Keeping Integrity Adequate Resources to Conduct the Research Investigator Reporting Responsibilities Conflicts of Interest Student Investigators Collaborative Projects   Campus Institutional Review Board 483 McReynolds University of Missouri Columbia, MO 65211 573 882-9585 phone 573 884-0663 fax umcresearchcirb@missouri.edu

Investigator Qualifications & Training

Key personnel are defined as "all individuals responsible for the design and conduct of the research study." There are common responsibilities incumbent to any investigator or key personnel engaging human participants in research studies. A qualified investigator or key personnel provides the best opportunity for maximizing the assurance for the protection of humans participating in research.

The Campus IRB mandates that all investigators and key personnel, under its jurisdiction, conducting research with humans must meet the requisite responsibilities to assure the safety and welfare of the participants. Investigators shall possess the qualifications and expertise to appreciate the complexities in the research and be able to ethically carry out the proposed activities.

• Key Personnel Responsibilities (PDF, 64K)
• Live Training Schedule

Ethical Responsibilities

Investigators must conduct research activities in compliance with the principles of the Belmont Report. The investigator must comply with the following, which is not limited to:

1. Submit all information regarding the proposal to the Campus IRB to facilitate an accurate and well informed IRB review process.
2. Secure Campus IRB approval prior to conducting any human subject research activities.
3. Assure that all human subject research activities being conducted have received prospective review by the Campus IRB.
4. Assure that all modifications of approved human subject research activities have been prospectively reviewed by the Campus IRB.
5. When serving as an Advisor, complete the Advisor Approval Form after reviewing the student or staff member's proposal. Assure that the applicant, and application complies with all requirements set forth by the Campus IRB.
6. Maintain appropriate oversight of the research protocols, research staff, selection and recruitment methods, research study conduct, and appropriately delegate research responsibilities to individuals qualified and capable of completing the task.
7. Timely submit the requisite Continuing Review Report 45 days prior to the expiration date or the report will not be reviewed.
8. Assure that Informed Consent is provided to all subjects in compliance with Campus IRB policies and procedures.
    
   • Informed Consent Policy
   • Informed Consent Template
9. Protect and maintain the confidentiality of the participating subject or their data during the conduction and after the conclusion of the research.
10. Recruit participants in a fair and equitable manner, weighing the potential benefits of the research to the participants against their vulnerability and the foreseeable risks. :
     
    • Recruitment Methods Policy
11. Assure that the research proposes the least risky alternatives, with detailed processes for promptly detecting potential harm; and mitigating potential injuries when research involves greater than minimal risk to participants.

Cooperation

1. The research team shall cooperate with the oversight activities of the Campus IRB in order to be able to exercise the privilege to conduct research at the University of Missouri-Columbia.
2. Federal regulations require the Campus IRB to have access to all researcher's records for (3) years following closure of the research. The research team shall cooperate with the Campus IRB, its approved representatives, or the Campus IRB Audit or Quality Assurance Team during onsite inspections to confirm IRB compliance; investigate human subject research allegations or complaints.

• Record Keeping Policy (PDF, 80K)
• Quality Assurance Policy (PDF, 64K)

Record Keeping

1. Retain all research records (including but not limited to audio and video tapes, documents, and instruments) for a period of three years after the completion of the research or termination of the project.

• Record Keeping Policy (PDF, 80K)

Integrity

1. Avoid acts that subvert the integrity of the Campus IRB approval process by submitting false information to the board; intentionally withholding information that may impact the decision making process of the Campus IRB; or submitting an application for approval after the project has already been completed.

• Key Personnel Responsibilities (PDF, 64K)
• Noncompliance with Campus IRB Policies and Procedures (PDF, 90K)

Adequate Resources to Conduct the Research

The investigator is responsible for assuring there are proper resources to conduct the research. The project must be supported by, but not limited to, the following:

1. The investigator must have access to the population that will allow recruitment of the required number of participants.
2. The investigator must have sufficient time to conduct and complete the research within the research period.
3. The investigator must have adequate numbers of qualified staff.
4. The investigator must have adequate facilities.
5. The investigator must have available medical or psychological resources that participants might require as a consequence of the research.
6. The investigator must have adequate resources in terms of a process to ensure that all persons assisting with the research were adequately informed about the protocol and their research related duties and functions.

Investigator Reporting Responsibilities

The investigator is responsible for reporting certain activities to the Campus IRB to assure the safety and welfare of research participants. The investigator shall inform the IRB if any of the following, but not limited to, any of the activities occur within (5) days:

You must immediately report within (5) days to the Campus IRB any of the following:

1. Unanticipated problems or adverse events causing harm to subject participants;
2. Issues of noncompliance;
3. Any issue that arises that could impact the adequate protection of human subjects involved in research. (example: The subject becomes incarcerated during the research project).

NOTE: Any research involving “death” must be reported within 24 hours.

The investigator shall report any of the following to the Campus IRB as soon as you become aware:

1. Deviations, Amendments or alterations to approved research project activities;
2. Any conflicts of interest;
3. Complaints made in reference to research activities;
4. Requests to extend project term periods;
5. Funding source changes;
6. Any suspension or closure of approved projects;
7. Any issue that could impact the adequate protection of human subjects involved in research.

• Reporting Policy (PDF, 80K)
• Unanticipated Problem and Adverse Event Policy (PDF, 112K)
• Key Personnel Responsibilities (PDF, 64K)

Conflicts of Interest

Identification and management of a conflict of interest is an important step in the IRB process. The Campus IRB requires the investigator to comply with institutional "disclosure methods" that may potentially affect human subjects to facilitate preserving the integrity of the IRB processes.

The investigator must disclose a conflict of interest in the following situations, but not limited to:

1. Disclosure to the government (if applicable)
   1. Inform the appropriate regulatory authority
2. Disclosure to the Institution (Mandatory)
   1. Mandatory for those receiving federal funds
   2. Must contact the Conflict of Interest Committee in the Office of Research (573) 882-9500.
3. Disclosure to the Campus IRB (Mandatory)
   1. This is a routine portion of the proposal submission process
   2. Disclosure "after" Campus IRB approval requires notice to the Conflict of Interest Committee.
   3. The Campus IRB may restrict IRB activities pending a disposition from the Conflicts of Interest Committee.
   4. The Campus IRB will coordinate its review efforts with that of the Conflicts of Interest Committee.
4. Disclosure to the Subject
   1. Subjects should be aware of any conflicts so that they can make an informed decision of whether to participate in the research.
   2. The Campus IRB engages in proactive education of key personnel and research teams
   3. The Campus IRB promotes a culture of compliance that promotes self-identification and resolution before there are problems.
   4. If a conflict of interest arises after a project has been approved, the researcher should contact the IRB for directives.

• Office of Research Conflict of Interest Disclosure Form (Word, 64K)
• Conflict of Interest Policy (PDF, 32K)

Student Investigators

Students may conduct research on the University of Missouri-Columbia campus so long as they are supervised by an advisor faculty member. The Advisor will be required to provide written certification that the submitted application has been reviewed, and that the student is in good standing to conduct research.

• Key Personnel Responsibilities (PDF, 64K)
• Login to eIRB (Opens in a new window)

Collaborative Projects

The Campus IRB is receptive to a research community founded upon collaboration among investigators or at multiple sites, and appreciates the growing need to gain knowledge of the compliance requirements within the various venues. The Campus IRB will assure that at least one site can be designated as the primary institution, which will be responsible for documenting IRB assurances from the other institutions.

The Campus IRB is responsible for ensuring that MU investigators conducting research at other facilities (or external researchers conducting research at MU) are appropriately trained to perform those activities in compliance with the policies and procedures governing the IRB research community.

• Research Involving Collaborative Institutions (PDF, 50K)
• DHHS Collaborative Research Regulations