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All research involving human subjects that is conducted at or sponsored by the University of Illinois at Urbana-Champaign, whether funded or unfunded, and whether conducted by Illinois faculty or others, must comply with applicable policies for the protection of human subjects. Under a formal assurance made by the campus and approved by the federal Office for Human Research Protections (OHRP), and per federal regulations, the Institutional Review Board (IRB) is given broad authority and wide-ranging responsibilities for ensuring the ethical and legal conduct of human subject research at Illinois.

  • Obtaining appropriate consent is critical to data sharing and to reuse in future research. This guidance provides models and advice to consider when creating or revising informed consent language.

    Many major US funding agencies (for example NIH, NSF, etc.) now strongly encourage data sharing and reuse and may even require it as part of the grant award. Similarly, many academic publishers also encourage data sharing. In fact, articles have been retracted because of the author’s inability to provide the underlying data when a study’s validity has been questioned.

  • This guidance was created to introduce Data Transfer and Use Agreements (DTUAs) and help researchers understand the process on the Urbana-Champaign campus. This document contains basic information about DTUAs and an associated assessment form.

    A DTUA is used in “both directions” where ‘outgoing’ is when a UIUC Investigator wants to share data with an outside party and ‘incoming’ is when a UIUC Investigator wants to receive data from an outside party.

  • Consider Alternatives to the Morisky Medication Adherence Scale(MMAS-4 and MMAS-8)

    Lawyers representing the purported owner of the Morisky Medication Adherence Scale (both MMAS-4 and MMAS-8), and one of its authors, Dr. Donald Morisky, have threatened universities and researchers with copyright infringement and breach of contract lawsuits, and pushed for retraction of publications, when a researcher has used either MMAS-4 or MMAS-8 as part of academic research. The University of Illinois Office of University Counsel’s (OUC) current advice is not to sign any license, permission, or other document that MMAS Research, LLC, Dr. Morisky, or his associate Mr. Steven Trubow, might send to you in connection with the MMAS-4 or MMAS-8, and forward the document to Sponsored Programs Administration (SPA). If you are contacted directly by Dr. Morisky, Mr. Trubow, or one of their lawyers asserting that you may have violated a law or contract, please contact OUC. OUC also urges you to consider using (or, if protected by copyright, requesting permission to use) a publicly available alternative to the MMAS-4 or MMAS-8 as part of any research involving medication adherence. For example, researchers at peer universities are now using NIH-funded Self-Reported Medication Nonadherence measurement tools created by Corrine Voils, PhD, available here, as alternatives to MMAS-4 or MMAS-8.

     

    You may also want to consider using, or requesting permission to use, one or more of the following, instead of the MMAS-4 and MMAS-8: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4656225/table/Tab2/?report=objectonly.

  • When appropriate the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (45 CFR 46)

    Data monitoring is required for all IRB protocols, regardless of risk level, and must include methods for monitoring and ensuring the accuracy, security, and validity of the data.

    Safety monitoring includes the methods to ensure the safety of the subjects. The details and protections for this part of the plan should be calibrated to the likely harms associated with the research.

    “When appropriate” allows an IRB to determine when a safety plan may not be required; however, there are definitive times when such plans are required. Details of data safety monitoring plans and boards, components, and requirements are detailed in the drafted guidance.

  • This guidance, prepared by OPRS, provides in-depth information to University of Illinois at Urbana-Champaign investigators who may be uncertain if their study meets the definitions of human subjects research stated in the federal regulations (45 CFR 46.102).

  • Research in educational settings require special conditions be put in place to ensure the safety and welfare of student participants. Issues particular to students in grades K-12 include gaining access to school sites and obtaining parental consent and child assent for students under the age of majority at the study location (in most instances this will be 18 years of age but this can differ based on local and state regulations and interpretation).

  • The COPPA rule gives parents control over what information websites can collect from their children, as well as establishes additional protections and procedures that companies covered by the rule need to follow. Though the rule was designed to protect those under 13, it applies to operators of commercial websites and online services aimed at general audiences that collect, use, or disclose personal information from children, or on whose behalf such information is collected or maintained.

  • The IRB is charged with minimizing the risk of harm and maximizing the benefits to human research subjects. One potential risk to consider is the risk caused by radiation exposure to an embryo/fetus if a pregnant person is included in a research protocol. Pregnant persons are excluded from almost all research protocols involving radiation exposure as to minimize risk. However, questions have been raised about the manner for determining pregnancy status for a person with child-bearing potential, as well as the need for these people to share equally in the benefits of research.

  • International human research refers to research conducted outside the United States using participants from the local community. Such research involving UIUC investigators remains subject to the review and approval authority of the UIUC IRB and the obligations under the registration of the UIUC Federal Wide Assurance with OHRP. This Policy & Procedure applies to all on-going and future human participant research projects conducted by UIUC faculty, staff, or students or by anyone conducting a research activity supported by UIUC.

  • Researchers are charged to protect the privacy of research participants and confidentiality of their data per federal regulations and must abide by the State of Illinois Abused and Neglected Child Reporting Act, 325 ILCS 5/1. In addition to these federal and state laws, the University of Illinois has adopted a Protection of Minors Policy that requires university personnel to report any suspected abuse or neglect to the University of Illinois Police Department. The University Police also has information regarding Interacting with Minors that may apply to human subject research., e.g., a single investigator should avoid being alone with a minor in an enclosed space. This guidance is meant to help researchers recognize events and circumstances that must be reported to authorities for protection of minors.

  • The DMI staff can build random samples for survey research projects using complex criteria for Urbana Campus faculty or students. More information about the services offered by DMI and a link to the DMI Online Request Form is: http://dmi.illinois.edu/datarequests.htm#dataretrieval. For questions regarding services provided by DMI, contact Amy Edwards. 

  • These guidelines are intended to provide information about employees’ conduct when working or engaging with minors so that the university may maintain high standards of professional and moral behavior.

  • Research funded or supported by the Department of Defense (DoD) must be reviewed by the IRB under an additional set of federal regulations [32CFR219]. The DoD follows the DHHS and FDA regulations on human subjects research, but also applies DoD regulations for protection of human subjects at 32 CFR 219 and DoD Instruction 3216.02 "Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research."

  • OPRS and the IRBs follow the Policy and Procedure Manual when reviewing new and ongoing research. The Policy and Procedure Manual is available for review by the research community.

  • Box is now available for storing Protected Health Information. Individuals who would like to use Box to store PHI, may only do so in a provided Box Health Data Folder. A request for a Box Health Data Folder can be submitted here. Researchers are responsible for following set policies and guidance listed at the previous webpage.

  • Regulations require IRBs and PIs to retain research data while the resesearch is being conducted and after the research is completed. As a result, researchers must comply with the longest applicable standard according to current state and institutional policies. 

  • The Biomedical Imaging Center (BIC) at the Beckman Institute is a state-of-the-art biomedical imaging facility that researchers on campus can utilize.

  • A registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov is a service of the U.S. National Institutes of Health and provides information about a trial's purpose, who may participate, locations, and phone numbers for more details.

  • The Family Educational Rights and Privacy Act (FERPA) is a Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education.

  • The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by HHS. OHRP has published a variety of policy and regulatory guidance materials to assist the research community in conducting ethical research that is in compliance with the HHS regulations.

  • The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule protects personal health information and gives patients a variety of rights. The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes.

  • The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA regulations are published as part of chapter 21 of the CFR, and FDA's human subject protection regulations are in parts 50, 56, 312 and 812.

    For FAQs drafted by FDA please click here.

  • The U.S. Department of Health and Human Services (HHS) issues and enforces rules pertaining to the protection of human subjects in research. All regulations issued by federal agencies under the statutory authority established by Congress are published in the Code of Federal Regulations (CFR). Regulations pertaining to the protection of humans subjects can be found in Title 45 Part 46 (45 CFR 46) and is divided into four subparts: A, B, C, and D.

  • The act requires informed consent documentation for College of Medicine research to be provided in a language that is understandable to the research subject/participant.

  • The act provides that information derived from genetic testing is confidential. It limits the use of genetic information by insurers and employers and provides an exception to the confidentiality of genetic information with respect to criminal proceedings.

  • While any person may make a report if they have reasonable cause to believe that a child or elder was abused or neglected, Illinois Public Act Code mandates that personnel of higher education institutions who suspect child or elder abuse or neglect report this to the Illinois Department of Children and Family Services (DCFS) or the Illinois Department on Aging, as appropriate.

  • The general statement of policy outlines the University of Illinois at Urbana-Champaign's basic responsibility to ensure the protection of human subjects and is applicable to all research involving human subjects.

  • On an annual basis, the University will perform a review of the human research protections program. The OPRS staff will conduct audits of ongoing research when directed by the IRB for reasons such as complaints or allegations of non-compliance. 

  • Research activities that are designed as part of a course requirement for purposes of learning experience only and are NOT designed to develop or contribute to generalizable knowledge MAY not require IRB review and approval. 

  • Recruitment of students from courses taught by the investigator may raise special ethical concerns. The primary issue with gathering data from one's own course is the potential for perceived coercion. 

  • There are ethical guidelines that govern all research involving student subjects. Campus policy governs the use of students in research and are intended to assist researchers in understanding and applying those campus policies. 

  • In an effort to reduce survey and research fatigue, the University of Illinois has a Policy Governing Electronic Surveys and Questionnaires. This policy designates Student Affairs to be responsible for reviewing and approving any campus-wide surveys that target students. 

    Student Affairs Research Approval (SARA) is needed for the following:

    • A researcher does not have an appointment at the University of Illinois Urbana-Champaign.
    • A researcher is requesting a sample of students through the University’s Division for Management of Information (DMI)s: www.dmi.illinois.edu/datarequests.htm. If approved, DMI will work with a researcher to develop a sample aligned with approved inclusion/exclusion criteria.
    • A researcher is looking to recruit students from any Student Affairs units at Illinois. This includes requests for distribution to via unit newsletters, social media, flyers, and requests for additional collaboration regarding student studies.

    For researchers who are requesting distribution only through academic units, individual faculty, or units outside of Student Affairs, SARA approval is no longer needed.  

    For more information, please follow this link to view the policy and locate the submission form: Student Affairs Research Approval

  • University students and employees may volunteer or be recruited as potential subjects; however, additional safeguards are required for these subjects.

  • The Office of Business and Financial Services provides guidance and procedures for making payments to human subjects for their participation in a research project or program. 

    Compensating Human Participants FAQs

  • Health and Human Services (HHS) requires additional financial disclosure and training for anyone involved in the design, conduct and analysis of PHS-funded research, including PIs, co-PIs, academic professional research staff, postdoctoral research associates, and graduate research assistants.

  • Campus Administrative Manual: The policy describes the role of the Institutional Review Boards and the responsibilities of the investigators engaged in university-sponsored research activities involving human subjects, human tissues, or medical records of human subjects.

  • Campus Administrative Manual: This policy establishes the role and responsibilities of a Principal Investigator; the categories of appointments for those individuals who are eligible to serve as a Principal Investigator; and an approval procedure to allow those individuals who are not included in the default categories to serve as Principal Investigators.

  • University Office of Human Resources and University Ethics Office: This policy outlines general requirements and safeguards the University has adopted with the intention to better protect minor children when they are on University premises participating in University programs and activities designed to include minors, or when they are in the care of University staff.

  • Office of the Vice President for Academic Affairs: The external activities of University employees can lead to conflicts of commitment or interest with regard to one's university responsibilities. This policy provides a general framework against which the propriety and advisability of non-university activities can be measured and monitored.

  • Full disk encryption (FDE) helps prevent unauthorized access to data stored on a device if that device is lost or stolen. As of January 1, 2013 all University owned laptops must be encrypted with FDE, per the laptop standard.