Date Updated
Thursday, October 17, 2013
Descripton

Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 111
AAHRPP Elements: I.1. D., I.1.E., III.2.A.


PROCEDURE


The following procedure provides the process for keeping IRB members, UIC OPRS staff, investigators, and research staff updated as to new developments, requirements, and policies and procedures related to human subjects research protection.

  1. Resources for Disseminating New Information.
    1. Initial and Continuing Investigator Education. All UIC Investigators and key research personnel are required to meet the initial training requirements in human subjects protections before their involvement in the research. HIPAA research training is required for investigators and key research personnel who are involved in research utilizing PHI. All UIC investigators and key research personnel involved in human subjects research must also complete a minimum of two hours of continuing education in human subjects protection every two years. As new regulations and policies are implemented, the OPRS updates the training sessions available to investigators.

      OPRS provides options in training for initial and continuing education in both Biomedical and Social and Behavioral research:

      1. Offerings through the OPRS website include the CITI Basic Course and CITI Refresher Course, Good Clinical Practice, Obtaining Effective Informed Consent, among others. Some courses are offered in Spanish.
      2. Live initial courses in HIPAA and Investigator 101 are presented by an OPRS Assistant Director at convenient campus locations or in OPRS.
      3. Continuing education live sessions include Town Hall lectures (The Decisionally Impaired in Research), presentations (Conflicts of Interest and Human Subjects Research), and various campus seminars sponsored by OPRS and academic departments (How Not to Make Hard Medical Decisions and Ethical Decisions and Care at the End of Life). UIC employees and students are also welcome.
      4. OPRS also offers webinars for continuing education, such as the FDA Adverse Event Compliance in Drug and Biologic Clinical Trials Know What to Report, When and How.
    2. IRB Continuing Education. At the beginning of the applicable IRB meetings, IRB members are provided updates on policies, procedures, forms or reviewer checklists by an individual knowledgeable in the subject matter followed by a question and answer session. The OPRS Newsletter and any related materials may be placed on the agenda of applicable Board meetings as part of continuing education. IRB members discuss the applicable OPRS Newsletter article at the beginning of the respective IRB meeting. Articles from external sources may be also used as supplements. Each IRB member receives a copy of the OPRS Newsletter and any related materials prior to the meeting in the information packet.
    3. Email/listserve. Between OPRS Newsletter cycles, information and updates are disseminated by email to applicable listserves, including JBVAMC investigators, with either the source document attached or a hyperlink provided.
    4. Peer review and Trade Publications. From time to time, articles appearing in peer review or trade publications are highlighted by OPRS staff and distributed by a designated individual to OPRS Staff, investigators, IRB members and/or research staff through mass e-mail and/or hard copies.
    5. Brown Bag Lunches. These one-hour sessions are provided on request to UIC faculty investigators and research personnel and affiliated community members and may involve any type of human subjects protection question, training need, or explanation of new requirements at the request of UIC OPRS staff, the department, the UIC faculty investigator, or the affiliated community member. Sessions are open to all individuals within a department and to the affiliated community member personnel and may be performed on-site or at the UIC OPRS offices. OPRS also accepts for credit departmental presentations or lectures if approved by the OPRS Director. The OPRS web site has departmental request forms, as well as individual request forms.
  2. OPRS Staff Meetings. These sessions introduce OPRS Staff to new UIC OPRS policy and procedure, regulatory developments, as well as reinforce important compliance matters. Topics are presented by an individual experienced in the subject matter in an interactive format where OPRS Staff discuss the practical implications of the updates after they are presented.
  3. UIC OPRS Responsibilities.
  4. UIC OPRS maintains the policies and procedures related to the UIC IRB/s that review VA Research.
  5. UIC OPRS maintains and updates its website with all UIC HSPP policies and procedures, links to Veteran’s Administration policies and procedures, and Federal and state guidances and regulations.
  6. The addition of new or updated policies, procedures, guidances or forms is communicated by announcements on the OPRS website and newsletter.
  7. Publication and distribution to UIC community of a bi-monthly OPRS Newsletter.
  8. After notification by either the investigator or the program source (CITI, attendance sheets) OPRS sends the investigator a certificate by email or post, and also enters the information into RiSC.