The Office of Quality Compliance conducts three types of reviews: Self-Assessment, Research Climate Assessment, and For-Cause Review.
A Self-Assessment Review can be requested by a study investigator or researcher. They are used to provide recommendations on-site about how to improve study activities involving human participants.
A Research Climate Assessment is a nuanced approach to obtaining information about a study from study team members and/or researchers. This type of assessment is requested through the Human Research Protection Program.
A For-Cause Review is a triggered investigation of any research study involving human subjects that has been identified through the ORIC.
Although brief summaries are included below, the complete details describing each of the OQC review processes and procedures is provided as independent SOPs, here.
Self-Assessment Review SELF-ASSESSMENT CHECKLIST PREVIEW
A “Self-Assessment Review” is a voluntary review, conducted at the request of a study principal investigator or researcher, to obtain data and recommendations regarding how to improve study activities involving human participants. The information obtained during the review will describe how well the study is meeting federal, industry-sponsored, and University regulations and policies. An investigator or researcher can request a self-assessment through the IRB’s online application system, ERICA. After requesting a Self-Assessment, the study team will complete a Self-Assessment Checklist. The checklist contains questions on regulatory and study documentation, and will be used to facilitate review by the OQC. A link to the checklist is provided in the section header.
Research Climate Assessment
A “Research Climate Assessment” (RCA) is a nuanced, qualitative approach to obtaining information about a study from study team members and/or researchers. The purpose of a RCA is to augment the quantitative information from compliance reviews and/or formal audits conducted by compliance-related units. RCAs are conducted through individual interviews with members of the study teams. Each interview, which will be tailored for each study, last approximately 15 minutes. The data collected during an RCA will be aggregate so that the anonymity and confidentiality of study team respondents can be maintained, and will be used to (a) determine how well a study team is working together and (b) propose resources to support the work of the study team.
RCAs can be identified and requested through various University research and compliance offices, including:
- The Director of the Human Research Protections Program (HRPP)
- The Director of the Office of Research Integrity & Compliance (ORIC)
- The Research Integrity Officer (RIO)
A “For-Cause Review” is an investigation of a research study that has been identified by the Office of Research Integrity & Compliance or other University compliance entity. Reasons for triggering an investigation include:
- Whistleblower Complaint
- Research Subject Complaint
- Employee Complaint
- IRB request due to new information that has the potential to negatively impact the rights and welfare of research participants
Participating in these reviews is not voluntary. The purpose of a For Cause Review is to investigate complaints and concerns about the conduct of study activities and/or potential misconduct. Reviews are designed to provide a full review of a study's activities as well as monitoring the quality and effectiveness of protocol management.
If concerns about a study's activities and/or potential misconduct have been reported, the OQC will contact the PI/lead researcher to inform them of the review.