What Every Researcher Needs to Know

Principal Investigator Responsibilities

Researchers are ultimately responsible for the conduct of their research. Though research responsibility may be delegated to research staff, researchers must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibility.

The University of Minnesota is responsible for oversight of its research and for ensuring that faculty and staff are in compliance with University, sponsor, and state and federal regulations. The University provides several resources and offices to assist individual researchers in their management of research and sponsored projects.

University Roles and Regulations

Researcher Responsibilities Summary Document

Research Coordinators and AAHRPP Powerpoint Presentation, December 2009

Conduct

Researchers play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by the IRB. Along with meeting the specific requirements of a particular research study, researchers are responsible for ongoing requirements in the conduct of approved research that include:

• ensuring that selection of study participants is equitable in relation to anticipated risks and benefits and that recruitment methods are appropriate
  • Recruitment & Subject Contact
• obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research, unless these requirements have been waived by the IRB
  • 45 CFR 46.116; 45 CFR 46.117
• obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects
  • 45 CFR 46.103(b)(4)
• ensuring that progress reports and requests for continuing review and approval are submitted to the IRB in accordance with the policies, procedures, and actions of the IRB
  • 45 CFR 46.103(b)(4), 45 CFR 46.109(e), 45 CFR 46.115(a)(1)
• providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others
  • 45 CFR 46.103(b)(5);
• providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB
  • 45 CFR 46.103(b)(5)
• keeping certain records as required by the federal regulations for at least three years after completion of the study
  • 45 CFR 46.115(b)

What's Included

Special Requirements for Drugs and Devices

FDA regulations governing research on investigational test articles delineate additional responsibilities of researchers. More information regarding these requirements can be found at

• 21 CFR 312.53, 60, 61 and 62 and 21 CFR 812.43, 100 and 140

Obtaining and documenting informed consent?

Researchers are responsible for obtaining and documenting the informed consent of research subjects or their legally authorized representatives, unless the IRB approves a waiver of informed consent, or a waiver of documentation of informed consent, respectively (45 CFR 46.116, 45 CFR 46.117). Researchers must give a copy of the informed consent document to each research subject (or the subject’s legally authorized representative), and keep the signed original or a copy of it for their records (45 CFR 46.117(a); 45 CFR 46.115(b)). When the documentation requirement is waived, the IRB may require researchers to provide subjects with a written statement regarding the research (45 CFR 46.117(c)). 

If deception is part of the experimental design, the study must include a debriefing procedure which will be followed upon completion of the study or upon withdrawal of a subject. As part of the debriefing, subjects must be told the purpose of the study, the reason for the deception and given an opportunity to withdraw their data from the project if they wish.

Revising an IRB-approved research study

If researchers wish to modify an ongoing IRB-approved research study, they must submit a request to the IRB and receive IRB approval before implementing the proposed modification. Federal regulations allow for expedited review and approval of requests for minor changes in previously approved studies (45 CFR 46.110(b)(2)).  If the change is designed to eliminate an apparent immediate hazard to subjects, prior IRB approval may be waived (45 CFR 46.103(b)(4)), however these situations are rare. In such cases, researchers should report those changes promptly to the IRB.

Obtaining continuing review of research

Researchers are responsible for fulfilling requirements associated with continuing review in time for the IRB to carry out review prior to the expiration date of the current IRB approval. Continuing review of research and approval of research studies is required so long as the research study is ongoing, that is, until research-related interactions and interventions with human subjects or the obtaining and analysis of identifiable private information described in the IRB-approved research plan have been completed. Researchers are responsible for submitting sufficient materials and information for the IRB to meet its regulatory obligations, and should follow the institutional policies and procedures for continuing IRB review of research that are required by HHS regulations at 45 CFR 46.103(b)(4)

When IRB approval expires?

If IRB approval of a specific study expires before continuing review and approval occur, researchers must stop all research activities involving human subjects related to that study (45 CFR 46.103(b)), except where they judge that it is in the best interests of already enrolled subjects to continue to participate. When researchers make this judgment, they must promptly notify the IRB (45 CFR 46.103(b)(5)). When the IRB reviews the researcher’s decision, it may decide whether it is in the best interests of already enrolled subjects to continue to participate in the research by considering the best interests of subjects either one at a time or as a group. If an IRB determines that it is not in the best interests of already enrolled subjects to continue to participate, researchers must stop all human subjects research activities, including intervening or interacting with subjects, or obtaining or analyzing identifiable private information about human subjects (45 CFR 46.103(b)). Researchers may resume the human subjects research activity once continuing review and approval by the IRB has occurred.

Post-completion

If all research-related interventions or interactions with human subjects have been completed, and all data collection and analysis of identifiable private information described in the IRB-approved research plan have been finished, then the human subjects research study has been completed. When a human subjects research study has been completed, the researchers no longer are required to obtain continuing review and approval of that study by the IRB and the IRB should be notified of the study’s completion.
Once a study has been completed, researchers may keep the data they collected, including identifiable private data, if consistent with the IRB-approved research plan. Researchers should continue to honor any confidentiality protections of the data.  Researchers also should honor any other commitments that were agreed to as part of the approved research, for example, providing information about the study results to research subjects, or honoring commitments for compensation to research subjects for research participation.

Advising

Independent class projects, senior theses, undergraduate research projects, master's projects, and similar exercises must be independently submitted to the IRB by the student-researcher. However, when students conduct research as part of a course of study, a faculty member ultimately is responsible for the protection of the subjects, even if the student is the primary researcher and actually directs the project. Advisors shoulder the responsibility for students engaged in independent research, and instructors are responsible for research that is conducted as part of a course. 
During the design of a project, advisors and faculty members should instruct students on the ethical conduct of research and help them prepare applications for IRB approval. In particular, students should:

• understand the elements of informed consent, 
• develop a readable consent form following the template found on the IRB’s Web site at http://www.research.umn.edu/irb/guidance/consent.html  
• plan appropriate recruitment strategies for identifying subjects, 
• establish and maintain strict guidelines for protecting anonymity and confidentiality, and 
• allow sufficient time for IRB review and completion of the project.

As assurance that the University's guidelines will be followed, the advisor or instructor is required to sign the student's application for IRB approval. After IRB approval, faculty members should take an active role in ensuring that projects are conducted in accordance with the IRB's requirements. Meeting periodically with students to review their progress is one way to meet this responsibility.