What Every Researcher Needs to Know

Investigator Responsibilities

  • Ultimate responsibility for all research activity resides with the Principal Investigator (PI)
  • Conduct the informed consent process without coercion or undue influence, while giving subjects sufficient time to consider participation in the research
  • Obtain consent with the currently approved and IRB-stamped version of the consent form
  • Document the consent process in the subject’s case history record prior to their participation in the research
  • Conduct the study according to the currently approved protocol, institutional policies, and all applicable regulations
  • Obtain approval from the IRB of any changes in the research prior to implementation except where necessary to eliminate apparent immediate hazards to human subjects. Such urgent changes must be reported to the IRB within five (5) working days.
  • Personally supervise or conduct the research and ensure appropriate delegation of tasks
  • Maintain complete and accurate study records and make them available for inspection
  • Notify the IRB Office of any external inspections of the research
  • Report unexpected adverse outcomes to the IRB within five (5) working days of knowledge of each occurrence
  • Assume responsibility for initial and continuing review of the research by the IRB

IRB Responsibilities

  • Review and have authority to approve, require modifications in or disapprove all research activities
  • Ensure all requirements for approval of research are satisfied in accordance with federal regulations
  • Report any serious or continuing non-compliance by investigators to the appropriate institutional officials, the Office for Human Research Protections, the Food and Drug Administration and any other appropriate regulatory agencies
  • Suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects
  • Determine that all criteria for IRB approval of research are met as stipulated in the federal regulations
  • Require that information given to subjects as part of informed consent is in accordance with federal regulations
  • Conduct continuing review of research at intervals appropriate to the degree of risk but not less than once per year, including the authority to observe or have a third party observe the consent process and research

Qualifications

Required Backgrounds

As a researcher you and your staff must be qualified by training and experience for research. It is important to understand that the responsibility for the welfare of participants resides on you, the researcher, even though participants may have given consent. You and your staff must have the necessary backgrounds to comply with application regulations such as:

  • Those concerning IRB review
  • Informed consent requirements
  • Reporting requirements
  • Maintenance of records
  • Retention of records
  • Supervision of research conduct
  • Apply relevant professional standards that are applicable to your research

You and your research staff should understand when activities are subject to IRB review.

Changes in Protocol

Researchers must report and seek prior approval for changes or modifications to their research study.

Changes should not be implemented without IRB approval unless they are needed in order to eliminate an immediate hazard.

Conflicts of Interest

Federal guidelines require the IRB to assure there are no conflicts of interest in research projects that could affect human subject participation and protection.

Researchers are required by IRB policy to disclose any potential conflicts involved in the conduct of their research with human subjects.

Conflict of Interest is not just when financial interests are involved, but rather any circumstance that could result in perception of undue influence or coercion would constitute a potential conflict of interest.

For example, if a researcher wishes to recruit a subject who is also a student, an employee, a colleague or a subordinate of the researcher, the potential for coercion exists.

Though the researcher may be very careful to avoid potentially coercive behavior, the very nature of the relationship with the subject can create the appearance of coercion.

For this reason, researchers should avoid using their own students or employees as subjects.

Researchers who do wish to include these groups as subjects must make special considerations due to this inherent conflict.


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