COVID-19 and in-person human subjects research, March 18, 2020
Per the University of Chicago Provost's directive, all human subjects research involving direct contact with participants that does not directly benefit participants must be suspended immediately. Direct benefit, for the time being, means clinical therapies that are improving the mental/physical health of a research participant.
Research that can be conducted remotely, online, or by phone is strongly encouraged. Changes in IRB-approved research must be submitted to the IRB. Proposed changes may not be implemented prior to IRB review and approval unless the changes are necessary to eliminate apparent immediate hazards to the research subject.
No new human subject research will be approved at this time that involves direct in-person contact with research participants.
AURA IRB site will be unavailable from 8 pm March 8 to 6 am March 11
Over the next 3 weekends, AURA-IRB system will be undergoing maintenance to address performance issues. IT services is anticipating some improvements the first weekend and increased improvements as it progresses through each weekend. This maintenance process will be complete by March 25th. IT services will start this process March 8th, at 8PM and will continue until 6AM Monday March 11th. While the system is performing maintenance, the AURA IRB site will unavailable.
July 31, 2018
Continuing Review Process
The SSA/CHC IRB has adopted an altered-version of the burden-reducing provision in the Common Rule’s Interim Final Rule Delay Period: https://www.federalregister.gov/documents/2018/06/19/2018-13187/federal-policy-for-the-protection-of-human-subjects-six-month-delay-of-the-general-compliance-date.
Effective July 19, 2018, the SSA/CHC IRB will implement a revised continuing review policy to excuse the following protocol studies from future IRB annual reviews: Expedited-reviewed protocol studies that are:
1) limited to data analysis only with no future follow-up with research participants; and
2) not subject to U.S. Department of Justice or U.S. Food and Drug Administration sponsorship, oversight or previous jurisdiction; and
3) where the SSA/CHC IRB is not the IRB of record for an outside entity.
Studies currently approved by the IRB will be assessed at the next continuing review to determine whether they qualify for an exception to ongoing continuing review. When applicable, PIs are reminded to submit a continuing review to close a study. The policy and procedures manual has been updated to reflect this new policy but is not yet posted on the SSA website.
July 19, 2018
Delay to General Compliance Date for Revised Final Common Rule
June 1, 2018
General Data Protection Regulation (GDPR)
A new European Union (EU) data protection law, the General Data Protection Regulation (GDPR), takes effect on May 25, 2018. See https://www.eugdpr.org/. GDPR gives individuals more control over their personal data. It is designed in and for the European Union; however, given the nature of Internet collection of data and data sharing flows, the jurisdictional reach of the GDPR may affect research studies conducted outside of the EU.
The GDPR affects research if the research involves recruitment of individuals in the EU and/or collection of personal data about individuals who reside in EU countries. In addition, GDPR could indirectly apply to researchers if their university or organization has contractual relationships with research vendors or other third parties who are subject to the GDPR.
The GDPR defines identifiable personal data as information relating to an identified or identifiable person including direct and indirect identifiers. Indirect identifiers include identification number, location data, and online identifier (e.g., IP addresses, mobile device IDs), or to one or more factors specific to the physical physiological, genetic, mental, economic, cultural, or social identity.
Consent Information: The request for consent from EU residents must include be clear about the nature and extent to which the individual is consenting in an easy to understand and easily accessible form. The consent must include information on whether data will be transported outside of the EU, the right to have data removed or destroyed from a study, and consent to use the personal data for future research purposes and to certain areas of scientific research. Data subjects must be able to refuse or withdraw consent without detriment or negative consequences. It must be easy to withdraw consent. Data subjects must provide either written consent, recorded verbal consent, or checking an unchecked box in an online context. See the June 1, 2018 International Guidelines at http://www.ssa.uchicago.edu/institutional-review-board for more information, including the required elements of consent provided to EU residents.
April 20, 2018
NPRM That Proposes to Delay For an Additional 6 Months the General Compliance Date of the Revisions to the Common Rule Published in the Federal Register
On April 19, 2018, HHS released an Notice of Proposed Rulemaking (NPRM) proposing to delay the general compliance date for the revised Common Rule until January 21, 2019. A 30-day comment period will be open until May 21, 2018.
The NPRM to delay for an additional 6 months (July 19, 2018 until January 21, 2019) the general compliance date of the revisions to the Common Rule was published in today's Office of the Federal Register. To read/access the April 2018 NPRM visit: https://www.federalregister.gov/documents/2018/04/20/2018-08231/federal-policy-for-the-protection-of-human-subjects-proposed-six-month-delay-of-the-general
Comments on the NPRM must be received no later than 11:59 p.m. Eastern Standard Time on May 21, 2018. To submit comments during the open comment period or browse posted comments, https://www.regulations.gov/document?D=HHS-OPHS-2018-0007-0001
February 12, 2018 IRB News:
Final Rule delayed until July 19, 2018
The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule).
The Interim Final Rule delays the effective date and general compliance date of the revised Common Rule to July 19, 2018.
Any revised provision that conflicts with the pre-2018 Rule will not be implemented in AURA-IRB for SSA or Chapin Hall human subjects research projects until July 19, 2018.
January 11, 2018 NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research:
Effective January 25, 2018, the National Institutes of Health (NIH) will require the use of a single IRB (sIRB) of record for the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site (multi-institutional research) in the United States.
The goal of this policy is to enhance and streamline the IRB review process in the context of multi-institutional research so that research can proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections.
NIH grant applications and contract proposals with due dates on or after January 25, 2018 will be expected to include a plan for the use of a single IRB.
September 21, 2017 IRB NEWS:
New NIH policy for issuing Certificates of Confidentiality
Please be aware of the new NIH policy for issuing Certificates of Confidentiality. As of October 1, 2017, a Certificate of Confidentiality (CoC) will be issued automatically to NIH-funded research projects that collect or use identifiable, sensitive information; however, researchers or institutions will not receive an actual CoC.
A CoC protects the privacy of subjects from forced disclosure by limiting the disclosure of identifiable, sensitive information. Researchers who have a CoC may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individual research participants.
Compliance with the requirements of this new NIH policy will become a term and condition of an NIH award. All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this NIH policy is issued a CoC through this policy. For more information, please visit the Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html
For studies in which informed consent is sought, NIH expect researchers to inform research participants of the protections and the limits to protections provided by a CoC issued by NIH’s policy.
Disclosure to any other person not connected with a NIH-funded research project of the names of research participants or research data that contains identifiable, sensitive information about the individuals that was collected or compiled for research purposes is permitted only when:
- Required by other Federal, State, or local laws (e.g., state laws requiring the reporting of communicable diseases to state and local health departments);
- Necessary for the medical treatment of the individual to whom the research data pertains and made with the consent of such individuals;
- Made with the consent of the individuals to whom the research data pertain;
- Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research
NIH will continue to consider requests for CoCs for specific projects that are not NIH funded in accordance with its current NIH policy.
April 27, 2017 IRB NEWS:
Required training for researchers
As a reminder to all members of a research team who will be obtaining informed consent from research participants, interacting with research participants to collect data, and/or analyzing non-anonymous data, the SSA/IRB requires study personnel to have completed Human Subjects Protection Training through CITI online training at http://www.citiprogram.org/.
Required course modules in the protection of human subjects research prior to IRB review
- "Social Service Administration and Chapin Hall– Basic Course"
- "Social Service Administration and Chapin Hall Modules–Refresher Course" (Every two years)
The CITI program will notify researchers before their training certification expires. Notices are sent to the researcher's email address on file with CITI beginning 60 days prior to expiration of the last completed stage. After the initial notification, reminders will be sent 30 days and seven days prior to expiration of the last completed stage, and then one day and seven days after expiration of the last completed stage.
Research Assistants who are not affiliated with the University of Chicago or Chapin Hall Center for Children who do not have a CNET ID can take NIH training at: https://phrp.nihtraining.com/users/login.php
IRB policy on translation of research materials
As of November 2016, the SSA/CHC IRB requires a "single back-translation" which means a second, independent translator checks the work of the primary translator. One translator translates the document, and a second, independent translator translates it back into English to check if appropriate meaning is conveyed. When using a single-back translation, the researchers are required to upload in Section 16.0 of the AURA-IRB application the SSA/CHC IRB Certification of Translation Form. The Form can be accessed by clicking this PDF link.
Data Use Agreements
We would like to remind folks that if you are going to do a research study in which you will be analyzing data obtained from a 3rd party, and the data provider is asking you to enter into a data use agreement (DUA), the DUA must be reviewed by University Research Administration (URA). It doesn't matter whether the study has external funding or not – if you are being asked to sign a DUA to obtain access to a dataset, the DUA must be submitted to URA for review. DUAs should be forwarded to the appropriate departmental administrator for routing, and must be routed to URA through the AURA grants system.
The SSA/CHC IRB will request that a copy of any DUAs that are connected with a human subjects research study to be uploaded to the IRB protocol study to ensure that the data security plan in the IRB protocol study is consistent with the terms of any study-related DUAs.
If you have any questions about URA's review process for DUAs, please contact Kimberly Lee. Kim's email address is firstname.lastname@example.org and her phone number is 773.834.4833.
November 9, 2016:
The SSA and Chapin Hall IRB has adopted a Policies and Standard Operating Procedures Manual that outlines the policies, regulations and procedures governing research with human subjects (research participants). This manual is also a reference point for researchers and members of the research community seeking information about SSA and Chapin Hall IRB’s processes and policies. It was last updated November 9, 2016 and is available online at here.
November 7, 2016:
Any new protocol submission started in AURA-IRB will use the revised submission form.
“Notice of Proposed Rulemaking (NPRM) for Revisions to the Common Rule (45 CFR 46 = Protection of Human Subjects)”
September 29, 2015
The Department of Health and Human Services (DHHS) Announces Proposal to Improve Rules Protecting Human Research Subjects
The U.S. Department of Health and Human Services along with fifteen other Federal Departments and Agencies have announced proposed revisions to the regulations for protection of human subjects in research.
On September 8, 2015, a Notice of Proposed Rulemaking (NPRM) was published in the Federal Register to revise the Common Rule.
The NPRM seeks comment on proposed changes. You may submit a comment until December 7, 2015, regarding the NPRM electronically, by mail, or by hand or courier.
IRB SUBMISSION AND MEETING DATES 2015-2016
IRB submission dates are now available through August 2016. There has been a change in submission deadlines. New protocols requiring full committee review must be submitted THREE (3) weeks in advance of the IRB meeting date. Amendments requiring full review must also be submitted THREE (3) weeks in advance of an IRB meeting date.
Amendments to full committee protocols are generally reviewed at the same level, full committee. New protocols and amendment applications must be complete to be guaranteed review at the meeting. Late submissions of new protocols and amendments will be accepted for the next meeting date.
Continuing reviews requiring full committee review must be submitted TWO (2) weeks in advance of the IRB meeting date. These include studies that were reviewed by the full committee at its previous IRB review and are open to subject enrollment or where subjects have not completed all research-related interventions. If you are uncertain if submission deadline applies to your continuing review submission, please contact the IRB office at 773-834-0402 or email@example.com .
NOTE: There are no submission deadlines for protocols that are given expedited review. These protocols are sent to the reviewers weekly. For more information, please contact the IRB office.
Navigating the AURA-IRB Electronic System
Thursday, September 17, 2015 1:00 - 3:00 pm
Edelstone Center, Room 106, 6030 Ellis Avenue, Chicago, IL
Attend this hands on training session and learn how to navigate AURA IRB like a pro enabling you to submit your Initial Submissions, Amendments, Continuing Reviews, and Unanticipated problems with ease in record time! You will use the AURA IRB training environment to review all IRB Submission types and workflow. Gain know-how while navigating the system, locating approval letters, responding to IRB comments, and much more! Training resources and important contact information for assistance with AURA IRB will also be provided. Sign up today and be prepared for your next submission to the IRB!
Register through the Training @UChicago website or the University Research Administration by phone: 773.702.8669.
Note: If you have access to a laptop computer, please bring it to class as you can follow along as we walk through the AURA IRB System.
Persons with disabilities who need an accommodation in order to participate in this event should contact the University Research Administration for assistance.
University Policy on Payments to Research Participants:
The University's policy on payments to research participants is created by the Office of Financial Services. Please access the full policy here.
- Payments to Human Subjects over $100 per occurrence must be paid directly to the individual via University check. Gift cards, gift certificates, or in-kind payments over $100 per occurrence are not permitted as remuneration for participation in a research study. Refer to the University Check section within the Paying Human Subjects procedures and guidelines.
- Human Subject payments $100 and under per occurrence can be processed via University check or other methods including petty cash, gift cards, or in-kind payments. Refer to the Cash Payment section within the Paying Human Subjects procedures and guidelines.