December
2004
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IUPUI/Clarian
SOPs for Data Management and Security of Research Data Available for
Public Comment; Previous SOP Release Comment Period Closes on Dec
22
As reported in the SOP Communication #1, (http://www.iupui.edu~res-poly/human-sop/communication-1.htm)/, IUPUI/Clarian developed Standard Operating Procedures (SOPs) governing the policies and procedures for all human subjects research being conducted by researchers whose work is subject to review and approval by the IUPUI/Clarian Institutional Review Boards (IRBs).These SOPs will become the minimum required standards for conducting human subjects research and will be the framework against which all applications are evaluated and audited by the IRBs. The SOPs roll out plan calls for the SOPs to be released to the IUPUI/Clarian research community via this Web site. For a limited time, the SOPs will be open to the IUPUI/Clarian research community for review and comment. All comments must be received prior to the close of the comment date posted in the SOPs Table of Contents. Approved revisions to a SOP will be made in a timely manner and displayed on this Web site (http://www.iupui.edu/~respoly/human-sop/human-sop-menu.htm). Only comments that are appropriate, constructive and objective will be considered. Due to resource limitations, we can only accept comments transmitted electronically to the Research Compliance Administration mailbox at resrisk@iupui.edu. Comments received by other media (e.g., by telephone, fax, mail and to other e-mail addresses) will not be considered.Clarification Regarding Compliance Training for Researchers HIPAA Security Training The IUSM Office of Compliance Services is offering HIPAA Security Training on DVD which will be available to all of the Departments in January. The DVD only references the HIPAA Security Regulation, IUPUI, and IUSM policies; it does not include FDA 21 CFR Part 11 regulation. You will need to check with your Department to determine if they will accept the HIPAA Security training on the DVD as meeting their obligations under the HIPAA Security Rule. The Office of Compliance Services is also offering General HIPAA Security Training (these sessions do not include FDA 21 CFR Part 11) in March, 2005. Attendance at prior sessions has been unexpectedly overwhelming and therefore, in order to attend any one of these sessions listed below, registration is required at least 5 days before the date of the session you wish to attend. We cannot guarantee that the session you wish to attend will be open when you email or call. If we cannot accommodate your session choice, we will contact you directly. Registration
Information for HIPAA Security Only Please include in your email or phone message your full name, the spelling of your last name (if leaving a message by phone), department, division, campus phone number, campus email address and the date and time of the session you wish to attend. Because this email and phone number is used to register other training, it is very important that you state the name of the training session for which you are registering. Those who show up at any of these sessions but did not register at least 5 days before the date of the session will only be permitted in the training session if there are extra seats available. The HIPAA Security Training sessions are listed below. Again, these sessions do not include FDA 21 CFR Part 11. March 2, 2005
(Wed), 12:00 – 1:00 p.m., ROC Auditorium Attendance
Forms and Tracking for HIPAA Security Training Combined
HIPAA Security/21 CFR Part 11 Training Attendance at prior sessions has been unexpectedly overwhelming and therefore, in order to attend any one of these sessions listed below, registration is required at least 5 days before the date of the session you wish to attend. We cannot guarantee that the session you wish to attend will be open when you email or call. If we cannot accommodate your session choice, we will contact you directly. Registration
Information for HIPAA Security/21 CFR Part 11 January 11, 2004 (Tue), 5:00 – 6:00p.m., ROC Auditorium Additional training sessions for this combined training is being scheduled for February but could not be announced at this time pending room confirmations. Attendance Forms and Tracking for HIPAA Security Training/CFR Part 11 trainingThe IUSM Office of Compliance Services only provides access to the combined training for HIPAA Security/CFR Part 11 training. A copy of the attendance form obtained during a face to face training session conducted by a member of the IUSM Office of Compliance Services staff must be provided to your supervisor or Department or division HIPAA Liaison. It is the responsibility of each Department to assure their staff attends the Security Training prior to April 20, 2005. Again 21 CFR Part 11 training is not required but recommended. The combined training is provided to those interested in attending both. The IUSM Office of Compliance Services does not track training. Please contact your supervisor in your Department for more information on their training requirements. OHRP Guidance Results in Revised Follow-up Consent for Subject Withdrawing from a Study In a recent meeting, the IRB Executive Committee reviewed the standard statement “In the event that you withdraw from the study, we request you allow us to continue to follow your health and continue to collect clinical data from your medical records,” as stated in National Cancer Institute (NCI) informed consent template. A concern was identified that this statement does not allow subjects to completely withdraw from the study since information collection would continue after the subject’s participation was terminated. The Office for Human Research Protections (OHRP) was queried for their input regarding this practice. OHRP’s response noted that regulations require that subjects be permitted to withdraw from a study at any time, without penalty or loss of benefits. The above-referenced standard statement, calls for continued participation, without the option to fully withdraw, as a condition to participate in the study. OHRP and the IRB Executive Committee agreed that it would be appropriate to give subjects the option to consent or refuse to allow the investigator to continue to follow their health and collect clinical data from their medical records. As a result, the IRB now requires that in studies intending to continue to follow subjects’ health and collect clinical data from their medical records, investigators develop a separate informed consent or an addendum to the main consent to allow subjects to “opt-in” or “opt-out” of continuing data collection at the time they withdraw from the study. The committee recognized that there may be studies where it is necessary to continue to follow subjects even after their withdrawal for safety reasons (e.g., FDA may require such follow-up to learn about newly developing toxicities related to a study drug). Appropriate revisions will be made to the IUPUI/Clarian informed consent template (included in the IRB Instruction Packet) to comply with the new policy. Ongoing studies will be evaluated at the time of continuing review to determine the appropriateness of this requirement. |
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| Christmas
2004/New Year 2005 Holiday Closing Information for Research and Graduate
Education Research
Compliance Administration (IRB/IBC) Sponsored
Program Administration |
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Your News to the R&SP Communicator Deadline for
R&SP Communicator news article submission: R&SP Communicator
readers: Shannon Walden Coordinator of Educational Programs for Responsible Conduct in Research UN 618 620 Union Drive, Room 618 Indianapolis, IN 46202-5167 Phone - (317) 274-8285 Fax - (317) 274-8744 E-mail: sfwalden@iupui.edu |
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