Tutorial Chapter 18: What should investigators do during the application process and the course of their projects?

The regulations for research involving human subjects are established by the Federal government in conjunction with state and local requirements. The University is responsible for their implementation by developing internal policies and procedures.

Primary responsibility for incorporating and adhering to the regulations and policies, however, rests with the principal investigator and the research staff. In carrying out any research work with human subjects, the principal investigator is responsible for:

  • Knowing, understanding, and adhering to the ethical principles and current Federal, state, local and institutional regulations, relating to research activities involving human subjects
  • Considering and incorporating these principles and regulations and the welfare of potential subjects in all aspects of designing and carrying out the research
  • Fully completing the Application for Activities Including Human Subjects, and providing all necessary documentation and associated information, including when appropriate, IRB approvals from cooperating institutions and the application for waiver of HIPAA authorization.
  • Submitting the completed application 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)
  • Responding to any requests from the UCAIHS for revision or additional information and clarification as part of the approval process
  • Receiving full approval from the institutional IRB before initiating any research activities with human subjects and completing only such work with human subjects as approved by the IRB
  • Training and supervising research staff in all aspects of the ethics and individual responsibilities of research involving human subjects
  • Informing potential subjects fully of the purpose and nature of the research work in which they are being asked to participate
  • Assuring the voluntary nature of participation and that of the data obtained
  • Informing subjects of the extent to which their privacy will be protected
  • Submitting modifications to the project to the UCAIHS for review and approval before implementing them
  • Completing and submitting an annual Continuing Review Progress Report before the end of the current approval period if the project is not deemed exempt
  • Notifying the IRB immediately of any adverse outcomes or effects involving human subjects and the steps being taken to remedy such outcomes or effects.

Chapter Review

Question 1

Principal investigators and their research staff have primary responsibility for incorporating and adhering to all the regulations and policies governing human subjects research.

Question 2

In addition to ethical principles, principal investigators and their research staff have to adhere to (select all that apply):

  • Federal regulations
  • state regulations
  • local regulations
  • none of the above

Question 3

Once their projects have been approved by the UCAIHS, principal investigators and their staff are free to continue with their projects and change them if necessary.

Question 4

When working with potential subjects, principal investigators and their research teams are required to (select all that apply):

  • inform potential subjects of the purpose and nature of the research work
  • explain that participation is voluntary
  • inform potential subjects of the extent to which they are entitled to protection of their privacy and that of the data obtained
  • all of the above

Question 5

Adverse events and unexpected outcomes are part of research and no action is required when and if they occur.

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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?
  • Take the Certification Exam!
  • Glossary
  • References