Introduction to Human Subjects Research at the University of Michigan – Dearborn. Debra Schneider IRB Administrator (313)

Research Support at the University of Michigan Human Subjects research support is provided by a number of departments and methods. OVPR (Office of the Vice President for Research) DRDA (Division of Research Development Administration) HRPP (Human Research Protection Program Office) The UM IRB’s eResearch IRB Application Process

Functions of OVPR and DRDA Office of Vice President for Research oversees all aspects of research at the University of Michigan. Vice President for Research: Stephen Forrest Division of Research Development and Administration: Helps submit proposals Reviews Contracts Processes Grant Awards Makes sure that all sponsored research involving human subjects are submitted for IRB Review

HRPP: Human Research Protection Program Purpose: Protect the rights and welfare of human subjects participating in research at the university Promotes compliance with relevant legal requirements and ethical standards. Supports investigators in their research activities

9 University IRB’s IRB Med (5 IRBs) IRB Health Sciences & Behavioral Sciences (2 IRBs) Dearborn IRB Flint IRB

IRB Application Process PI submits application via eResearch PI completes PEERRS Human Subjects training eResearch application goes to IRB Reviewer If necessary, reviewer requires changes to protocol to ensure that adequate Human Subjects Protections are in place. When adequate protections are in place Reviewer approves the study. Reviewer may also determine that PI may not proceed with study.

Application review cycle 1 PI initiates IRB Application 2 IRB administrator checks application for clarity and completeness & forwards to reviewer or returns application to PI 3 PI makes changes and resubmits; application is forwarded to Reviewer 4 Reviewer checks application for adequate subject protections 5 Application returned to PI for changes or Approval is given. 6 Repeat steps until Approval is Given IRB Administrator processes Approval and notifies PI who can then begin study.

Responsibility of PI and Research Team Safeguarding the subjects takes precedence over the goals and requirements of any research. The PI and research team are expected to know about and comply with the ethical and legal requirements of the Belmont Report and the Common Rule.Belmont Report Common Rule

Need for IRB Review The need for IRB review of a project is determined by the United States Code of Federal Regulations. (45 CFR 46) which defines both “research” and “human subject” Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45CFR46.102(d) Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or indentifiable private information. 45CFR43.102(f) Important: If your project meets both of these tests it must be reviewed by the IRB

Responsibility of the IRB To make sure that all studies involving human subjects comply with the ethical and legal requirements of the Belmont Report and the Common Rule. Done by: ◦ Reviewing and approving research involving human subjects. ◦ Conducting continuing review/oversight (at least yearly) ◦ Assess informed consent documents ◦ Assess risk/benefits to subjects ◦ Protect vulnerable subjects.

Types of Review: Full Board Convened (Full Board) ◦ The IRB reviews studies that are more than minimal risk, involve vulnerable populations, or involve special circumstances: for example studies that ask about illegal activities. ◦ The Dearborn IRB meets once each semester. Additional meetings will be scheduled if an application requiring Full Board Review is submitted.

Types of Review: Expedited Reviews Expedited review can be done on studies that are minimal risk or less. Research on individual or group characteristics or behavior or research employing surveys, interviews, focus groups, etc. Studies that involve the following will not be considered for Expedited Review: ◦ Vulnerable populations: prisoners, children, pregnant women, impaired adults. ◦ Studies using deception ◦ Studies of illegal activities such as drug use ◦ Studies of private activities such as sexual behavior

Types of Review: Exempt Determination To qualify for an exempt determination a study must be less than minimal risk AND fall within one of 6 categories: 6 defined categories; including curriculum research, anonymous surveys/interviews, collecting non-sensitive data (data which is not damaging to the subject’s financial status, employability, or reputation), research involving the collection or study of existing data or publically available data sets. Studies that utilize the University of Michigan – Dearborn Psychology Subject Pool may not be given an exempt determination.

How to apply for IRB Review Go to Click on “Regulatory Management” Login using your uniqname and kerberos password. Click the “New Study” button on the left side of the screen.

Human Subjects Training & Support Resources All University of Michigan researchers must complete the relevant PEERRS Human Subjects module. Director of Research & Sponsored Programs is available to answer questions. IRB Administrator is available to answer basic questions.

UM Website Support Human Research Protection Program (HRPP) ◦ Office of Vice President for Research (OVPR) ◦ Federal Wide Assurance ◦ Office of Human Research Compliance Review ◦ Dearborn Office of Research & Sponsored Programs ◦

Other Useful Websites eResearch Regulatory Management ◦ Program for Education and Evaluation in Responsible Research & Scholarship (PEERRS) ◦ What OHRP finds IRBs do wrong most often ◦