Tutorial Chapter 7: What are the investigator’s responsibilities?

While the regulations for research involving human subjects are established by the Federal government, the University is responsible for their implementation through the development of internal policies and procedures.

However, primary responsibility for incorporating and adhering to the regulations and policies rests with the principal investigator. In carrying out any research work with human subjects, it is the responsibility of the principal investigator to:

  • Know, understand and adhere to the ethical principles and applicable Federal, State, local and institutional regulations, relating to research activities with human subjects
  • Consider and incorporate these principles and regulations and the welfare of potential subjects in all aspects of the design and execution of research projects
  • Fully complete the Application for Activities Including Human Subjects, including all necessary documentation and associated information (for example, IRB approvals from cooperating institutions, interview schedules and questionnaires, consent and permission forms)
  • Submit the Application for Review to the UCAIHS at the appropriate point in the research development process. Timing may be particularly important if external support is being sought for the project since most federal and many other sponsors require IRB approval as a condition of award. Sponsors may delay or withdraw an award if approval is not available at the appropriate time. The UCAIHS, therefore, strongly recommends that all researchers applying for external support submit an Application for Review to the UCAIHS within 60 days after submission of the proposal for funding.
  • Respond to any requests for revisions, additional information, or clarification as part of the approval process. Investigators should be aware that technical revisions may be reviewed by a sub-committee of the UCAIHS, but that substantive revisions must be reviewed by the UCAIHS as a whole at a convened meeting. Thus the submission of substantive revisions should be made with submission deadlines and meeting dates in mind. (A discussion of substantive vs. technical issues is included in the chapter entitled, What Decisions May the UCAIHS make.)
  • Receive full approval from the UCAIHS before initiating any research activities with human subjects and do only such work with human subjects as has been approved by the UCAIHS.
  • Train and supervise research staff in all aspects of the ethics and individual responsibilities of research involving human subjects and ensure that key personnel complete and pass this tutorial.
  • Fully inform potential subjects of the purpose and nature of the research work in which they are being asked to participate (what will be involved in participation, that under all circumstances participation is fully voluntary, and that participants are entitled to protection of their privacy) and ensure appropriate consent for all subjects.
  • Submit changes in the project to the UCAIHS for review and approval prior to their initiation.
  • If the project has not received Exempt Status, complete and submit an annual Continuing Review Progress Report before the end of the current approval period
  • Notify the IRB immediately of any adverse outcomes or effects involving human subjects and of the steps taken to remedy such outcomes or effects.

Chapter Review

Question 1

Principal investigators must adhere to governing Federal, state, local and institutional regulations that relate to research activities involving human subjects.

Question 2

The welfare of potential research subjects must be of prime importance throughout the research process.

Question 3

The principal investigator's responsibilities to the UCAIHS end once the Application for Review of Activities Including Human Subjects has been submitted to the UCAIHS.

Question 4

Principal investigators must obtain full approval from the UCAIHS before initiating any research activities involving human subjects.

Question 5

Principal investigators are responsible for notifying the UCAIHS immediately of any adverse outcomes or effects involving human subjects.

Next Chapter: What are the categories of application?

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Glossary
  • References