IRB Quick Look
Federal Wide Assurance:FWA00011478
Q: Is UWO IRB review required for my project?
A: Please refer to SOP #1 and the supplementary decision trees in order to determine if your project will require IRB review. If you are uncertain, please contact the IRB at 424-3215 or email@example.com.
Q: What information is considered identifiable private information?
Q: Is IRB review required in order to conduct an analysis of existing data?
Q: What is the estimated time for IRB review turnaround at UW Oshkosh?
Average Review Time:
Exempt and Limited IRB Reviews: 1-2 weeks
Expedited Reviews: 2-3 weeks
Full Board Reviews: 4-8 weeks
The Full Board will review any research that is deemed more than minimal risk, involves deception, or vulnerable populations. The committee convenes approximately every 6 weeks during the academic school year.
Q: What is the record retention for IRB projects?
Q: Can my study be closed?
A: If you can answer yes to ALL of the following statements, then you may submit an IRB Closure Form:
- The research is permanently closed to enrollment
- All participants have completed all research-related interventions / interactions
- Collection of private identifiable information is complete
- Analysis of private identifiable information is complete
Q: Are there additional resources that I can access pertaining to the Revised Common Rule?
A: Yes, a list of helpful Q&A’s is available on OHRP’s website is being updated and expanded regularly. Access them here: www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html
Q: I missed the application deadline. Can I still submit my application or do I have to wait until next meeting deadline?
A: You can submit your application at any time. The IRB meeting deadlines on our IRB website are for the full board meetings, but only a small portion of the applications we receive need to be reviewed by the full committee. The majority are reviewed through exempt determination or expedited review process which is done on a continuous basis.
Q: Can you comment on the anonymity of Amazon MTurk? Although the researcher does not ask for any identifiable information and the online consent form may state the survey is anonymous, MTurk may collect IP address information.
A: MTurk is not anonymous: Amazon has clearly stated that the MTurk platform is not meant to support participant anonymity. We are seeing this tension play out across social media research, where all kinds of identifiers are being tracked and maintained by the host or company. But—often, these data are not available to the researcher. The researcher should not promise anonymity but rather confidentiality. Recently, researchers found a data security vulnerability in Amazon Mechanical Turk (mTurk) that can allow mTurk worker IDs to be connected to personally identifying information that mTurk workers post on their Amazon profile pages. For a thorough discussion of this topic, see the journal article titled “Mechanical Turk is Not Anonymous,” available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2228728. The IRB will expect that appropriate language be included in mTurk consent scripts to alert mTurk participants to this vulnerability and explain how participant confidentiality will be protected. For example, a consent form might say “Please be aware that any work performed on Amazon MTurk can potentially be linked to information about you on your Amazon public profile page, depending on the settings you have for your Amazon profile. We will not be accessing any personally identifying information about you that you may have put on your Amazon public. The IRB has an example mTurk Consent Template that may be used.
Q: Do student class assignments require IRB review?
Q: Leaving UW Oshkosh: What do you need to do prior to your departure?
- Contact your new institution’s IRB Office for instructions on how to seek approval for the studies and close any open studies at UW Oshkosh
- Close the studies at UW Oshkosh.
- Study closure is appropriate when the research is permanently closed to enrollment, all participants have completed research-related interventions, and collection of private identifiable information is completed. Note: Analysis of de-identified data and manuscript preparation can occur after the study is closed.
- Determine if the individual meets the criteria, per the PI Policy (See IRB SOP# 6: Principal Investigator Eligibility Policy)
- Submit a Modification Request Form to change the PI along with updated changes to consent forms, advertisements, etc for the IRB to review
- New PI must provide documentation of current human subjects research CITI training certificate
- Provide new PI with research data and records required for retention
- Contact your new institution’s IRB Office to find out their requirements. Work with the UW Oshkosh IRB Office for setting up appropriate agreements.
- Agreements may be necessary.
- If the new institution is willing to rely on UW Oshkosh’s IRB review, an RB Authorization Agreement may be established.
- Data use agreement or materials transfer agreement are required in some cases
Q: I will be collaborating with a colleague from another Institution for a project. Is IRB review required at both Institutions?
A: Please contact the IRB office to see if your role in the project constitutes human subjects research. If yes, then the IRB office can determine if an IRB Authorization Agreement for a single IRB review is possible or if review will be required at both institutions. This depends on the role of the UWO researcher on the project, level of risk, funding source, federal wide assurance agreements, and the other Institutions IRB policies.
Q: I will be collaborating on a human subjects research project with an individual that is not associated with UWO or another institution of higher education. What is the process for adding that individual to the project?
A: The non-affiliated individual will be considered volunteer research personnel and must complete volunteer paperwork with UWO Human Resources (link to HR “hiring a volunteer” page). Research personnel volunteers working on UWO projects may complete the online human subjects research training in CITI Program.
UW Oshkosh IRB Revised Common Rule
The Department of Health and Human Services announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight. Implementation of the Revised Common Rule has been delayed for an additional 6 months. The new effective date is January 21st, 2019.
Changes to Exempt Research
Classroom research cannot adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.
New Use of identifiable information may be exempt if IRB conducts a Limited IRB review to determine that the research includes appropriate provisions for protecting privacy and confidentiality. Research involving benign behavioral interventions on adults; will likely result in the majority of currently-expedited social-behavioral-eduacational research being exempt. Secondary research use of information protected by HIPAA; will allow exempt review of retrospective and prospective chart reviews. No continuing review for exempt or expedited research (unless justified by IRB for limited IRB/expedited review) or full board research limited to long-term follow-up only or data analysis only New Exempt Categories may be viewed on IRB Forms page.
Exempt studies will still be reviewed by IRB members and trained IRB staff to make the IRB exempt determination. Some activities previously reviewed under expedited categories have been moved to exempt status; e.g., EXEMPT CATEGORY 3, which includes research involving benign behavioral intervention in conjunction with the collection of data from an adult (not minor) through verbal or written responses or audio-recoding; + may include deception if prospectively authorized by the participant
- There are no changes to the current expedited categories. Expedited Categories may be found on the IRB Forms page.
Removal of Continuing Review
Revisions of 2018 were created to reduce the administrative burden on investigators and IRBs where the burden does not provide additional protection of human subjects. Under the 2018 requirements: No continuing review will be required for: 1) Exempt or expedited research (unless requested & justified by IRB during Limited IRB/Expedited Review) OR 2) Full board research limited to long-term clinical care follow-up only or data analysis only (including identifiable data)
- Researchers will receive an annual check-in email outlining their ongoing responsibilities to the IRB but no formal IRB review will be required for research meeting the above criteria.
- Any changes to the study will require an IRB Modification Request Form and approval from IRB before implementation.
- Existing protocols approved prior to July 19, 2018, will be grandfathered into the old rules until the time of annual continuing review. At the time of continuing review, the IRB will transition the protocol to the new requirements, unless applying the 2018 Requirements will not provide benefit to investigators or subjects. Transitioning will be done a case-by-case basis.
Informed Consent Changes
New Key Information at Beginning of Consent
- Consent must begin with a concise and focused presentation of key information (e.g. statement that the project is research and that participation is voluntary, a summary of the purpose, duration, procedures, risks, discomforts, benefits, appropriate alternatives, costs and payment).
- Should be written at an appropriate comprehension level to assist the participant in making a decision on why one may or may not choose to participate in the research.
New required elements of consent
Notice about possible future research use of information or biospecimens stripped of identifiers:
Notifying prospective subject that subjects’ information or biospecimens may be used for future research without additional consent; or will not be used for future research.
- Consent is not needed for data screening/prescreening.
- Must provide participants an opportunity to obtain a copy of the consent form, even for online studies.
- Post online the consent form for clinical trials supported by federal funding
Additional elements of consent (when applicable):
- Potential for commercial profit and sharing of profits with subjects.
- Whether clinically relevant research results will be disclosed to subjects and, if so, under what conditions.
- For research involving biospecimens, whether the research will involve whole genome or exome sequencing.
- Secondary research use of identifiable private information for which consent is not needed (See Exempt Category 4).
The key information section and new elements of informed consent are included in the new UWO Informed Consent Template on the IRB Forms page.
Revised Clinical Trial Definition
Clinical Trial: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”
NIH funded studies meeting the definition of a clinical trial will have additional requirements, including posting the consent document and training in good clinical practices.
Cooperative Research & Single IRB
Requirement for Single IRB Review: All U.S. institutions engaged in federally funded collaborative research for the portion of the research conducted in the U.S. Implementation Date: January 20, 2020; NIH funded research has a single IRB effective date of January 25, 2018
- When more than a single IRB review is required by law.
- Whenever any federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
CITI Program Training Updates
CITI Program will be updating all human research training modules effective on the implementation date (January 21, 2019).
- Current CITI training will be valid until it expires (3 years from date completed).
- When CITI refresher training is due, the revised human subjects course will automatically be assigned to researchers.
- Names of the courses will not be changing at this time.
- A specific course titled: Revised Common Rule Course is available to all faculty, staff, or students interested in learning more on the revisions to the human research regulations.
CITI Final Rule Overview Resources: https://about.citiprogram.org/en/final-rule-resources/
Resources on Common Rule Changes
- HRP Consulting Group: Appendix A: Applicability of the Common Rule, Changes to FWA.
- HRP Consulting Group: Appendix C: Management of pre-existing studies
- SACHIRP Attachment A: Recommendations on Compliance Dates and Transition Provisions
- SACHIRP Attachment C: Recommendations for Broad Consent Guidance
- HRP Consulting Group: Appendix B: Broad Consent.
- CITI Final Rule Overview Resources: https://about.citiprogram.org/en/final-rule-resources/
- A list of helpful Q&A’s is available on OHRP’s website: www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html
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