Part 1 – Introduction, Purpose, and Ethical Principles
Which document outlines the policies and overarching rules for the Human Research Protection Program at the University of Michigan?
HRPP Operations Manual (OM).
What does HRPP stand for in the context of U-M’s research procedures?
Human Research Protection Program.
Name one of the core ethical principles guiding the U-M IRB's review of research.
Respect for persons, beneficence, or justice.
Who is responsible for reviewing and approving initial applications, amendments, and continuing reviews for IRB compliance?
The IRB Chair, members, and designated staff.
Who is ultimately responsible for ensuring compliance with regulations, laws, and policies for the conduct of research according to the U-M SOP?
The Principal Investigator (PI).
What precedence must safeguarding participants’ rights and welfare take over, according to the IRB mission?
Over the goals and requirements of any research endeavor overseen by the IRBs.
Name an organizational entity that supports the U-M IRBs.
University of Michigan Office of Research (OVPR) or Office for Research Compliance Review (ORCR).
What is a key responsibility of the HRPP concerning educational activities?
To assure the rights and welfare of human participants through educational and quality assurance activities.
What are the two main types of risk assessments conducted during IRB reviews?
Minimizing risk and Risk-Benefit analysis.
What eligibility requirement is specified for individuals wishing to perform research at the University of Michigan?
Individuals must be qualified and have a direct University of Michigan affiliation.
What is the primary mission of the IRBs at the University of Michigan?
To protect the rights and welfare of participants in human research studies by careful review and monitoring of research in accordance with applicable laws, regulations, and university policies.
What is the role of the IRB Chair during a board meeting?
To oversee the meeting, ensure quorum, and guide discussions and voting on research proposals.
Which document should researchers consult for guidance on ethical and procedural issues related to human subjects in research?
The HRPP Operations Manual (OM).
What is the importance of a quorum, and what must be included in a quorum for a convened IRB meeting?
A quorum ensures all discussions and decisions are made with sufficient representation. It must include at least one non-scientist member.
What must investigators obtain and document from research participants, as per the SOPs?
Informed consent.
What is the main objective of the SOP?
To ensure consistent and safe operation of the IRBs
What does SOP stand for?
Standard Operating Procedures