aim analytics panel: irb
TRANSCRIPT
IRB OVERVIEWAIM ANALYTICS
CINDY SHINDLEDECKERIRB-HSBS DIRECTORNOVEMBER 7, 2016
Essential questions What is the IRB? When is IRB review required?
Regulatory Definitions “Not Regulated” Research Activities
FERPA and Research with Student Records
What is the IRB? The Institutional Review Boards at UM
are responsible for protecting the rights and welfare of human subjects participating in research by ensuring that the research is conducted: In accordance with ethical principles In compliance with federal regulations (45
CFR 46), state law, institutional policies We are also responsible for supporting
the research mission of the University.
What is the IRB? UM Ann Arbor has two IRB organizations:
IRBMED covers: Research conducted by faculty/staff of the
Medical School or UMHS involving patients, facilities, records of the
UMHS or research activities regulated by the FDA
Research on medical educational involving our med students reviewed by IRBMED
IRB-HSBS covers all other units on the Ann Arbor campus
When is IRB review required? IRB review is required for projects that
meet the regulatory definition of research with human subjects: Is the activity “research”?
a systematic investigation designed to contribute to generalizable knowledge
Are there human subjects involved? a living individual about whom an
investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information
“Not Regulated” Research Activities
Not research Program evaluation/QA/QI
Intended to assess and improve practice internally rather than for dissemination outside the institution
Research, but no human subjects to protect Analysis of coded/deidentified/publicly
available datasets IRB review is not required but eResearch
includes a brief “application” for those seeking a formal determination
Exempt Research Exempt research meets the definition of human
subjects research but falls within on or more specific categories of exemption defined with the federal regulations or institutional policy
Presumption of no more than minimal risk Requires a formal application and determination
by the IRB, but once issued the research activity is not monitored by the IRB Amendments not required unless change exceeds
the definition of the exemption IRB does not review consent docs, recruitment
materials, etc. BUT…
Study team is still obligated to understand and abide by ethical principles of responsible research conduct
Exempt #1 “Established or commonly accepted educational setting”
- Any place where instruction would take place “Normal educational practices” - Activities that typically
occur in a classroom or other educational setting Effectiveness of instructional strategies, classroom
management, school activities Curriculum development and evaluation Assessment of attitudes about learning Test development
Researchers using student education records must meet FERPA requirements and must include information about data to be used must be included in application
Studies that focus on personal characteristics of students or teachers (rather than the educational activity of interest) would most likely not qualify
Exempt #2 Surveys, interviews (includes focus groups),
educational testing, or observation of public behavior Public behavior is generally open to view by any
member of the community and/or which would not involve any special permission to observe, such as at a park, in a mall, or movie theater. A classroom is not considered public.
Limitations for use with minors (under 18s) – only educational tests or observation where investigator does interact with kids
Two conditions: Data collected is not sensitive (criminal/civil
liability, financial standing, employability or reputation), OR
Data collected is anonymous
Exempt #4 Collection or study of existing data, documents,
records, or specimens, if these are publicly available or subjects cannot be identified
Primarily applies to projects where identifiable private information is accessed and viewed but is not recorded Example – Student data including personal identifiers
is screened but data elements recorded for research analysis do not include identifiers.
Exempt Application and Review Application
A brief eResearch application that is focused on the information necessary to determine eligibility for exemption Description of the research, including description of
student data required (specific sources/data elements) Data collection tools (surveys/interviews) Informed consent if you will be asking permission to
use student data Study team members must complete PEERRS Human
Subjects Research (institutional requirement) Review
Conducted by qualified IRB staff Turnaround typically less than one week
Expedited Review Research activities that do not qualify for exemption often
will qualify for an expedited review process meaning review by a single IRB member rather than the full committee
Expedited research must pose no more than minimal risk to subjects and meets one or more of 9 federal categories of expedited research Category 5 - Research involving materials (data,
documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes.
Category 6 - Collection of data from voice, video, digital, or image recordings made for research purposes.
Category 7 -Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Expedited Application and Review One of two application types in eResearch:
Standard – for research involving an interaction/intervention with participants Must include informed consent documents,
recruitment materials, survey/interviews Secondary Use – for research involving
secondary data analysis and no direct interaction with participants
Section 24 – include description of specific data sets/data elements to be analyzed as part of research
Application is pre-reviewed by IRB staff and then by a single board member
Turnaround typically 2-4 weeks
Full Committee Review Required for projects that may pose more than
minimal risk to participants, involve sensitive topics or complex research designs
Reviewed by one of the full IRB committees Submitted via Standard or Secondary Use
eResearch application Applications must be submitted several weeks in
advance of a scheduled meeting for assignment to a meeting agenda
2 meetings per month Fewer than 5% of applications reviewed by IRB-
HSBS go to full committee
Release of Student Data and the IRB
The IRBs do not have jurisdiction over compliance with FERPA or the release of student data. These are the responsibility of institutional data stewards.
IRB approval or determination of exemption does not mean that the data steward approves the release of data.
The IRB will advise researchers about the requirements of FERPA and will ask to see documentation that institutional requirements for release of data are met.
FERPA and Research Written agreement (MOU) between institution
(data steward) and researcher is required even for U-M researchers using U-M student data
Elements of agreement Purpose, scope and duration of the study and the info to
be disclosed PII used only for the authorized purpose of the study Does not permit disclosure of PII outside of the research
team PII destroyed at the end of the study and time period of
destruction The institution has developed a standard MOU for
Learning Analytics projects Requests for access to student records may be sent
Contact Information IRB-HSBS Staff:
Cindy Shindledecker, [email protected], 734-615-9466
Deb Schild, staff reviewer for institutional and education research [email protected], 734-615-9462
IRB-HSBS [email protected], 734-936-0933
Resources IRB-HSBS Website
http://research-compliance.umich.edu/irb-health-sciences-and-behavioral-sciences-hsbs
eResearch Regulatory Management (IRB application): http://eresearch.umich.edu
HRPP Guidance re FERPAhttp://research-compliance.umich.edu/sites/default/files/umhrppguidance_ed.pdf