May
2004
| Human Subjects |
| IUPUI/Clarian
SOP for Exempt and Expedited New Study Approval Process Available for
Public Comment 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. IRB 2004 Deadline and Meeting Schedule Revised When the IRB deadline and meeting schedule was published earlier this year, some meetings and deadlines were moved during the months of September, October, November, and December due to the 2004 Thanksgiving and Christmas holidays. This resulted in some of the IRB-04 and IRB-05 deadlines occurring on the same day and the meetings to occur only a day apart during these months. As a result, there were essentially only 2 biomedical deadlines during these months rather than the characteristic three. A request was made to consider “adjusting” the schedule to allow investigators more flexibility and options for IRB submissions. Although the RCA is not able to accommodate every request, they were able to adjust some of the deadline and meeting dates. Please see the revised deadline schedule in the IRB Instruction Packet (http://www.iupui.edu/~resgrad/irbpacket/irbpacket12-03.htm#Section5). Meeting and deadline dates are posted on the Research and Sponsored Programs (R&SP) Web site “Description of IRBs / Deadlines and Meeting Dates” page at http://www.iupui.edu/~resgrad/spon/irb-descrip.htm. Adverse Event Reporting Policies Clarified by IRB Executive Committee Recently, the Research Compliance Administration (RCA) was questioned regarding whether adverse events from external sites should continue to be reported to the IRB if study enrollment has ceased and all subjects are currently on follow-up at IUPUI/Clarian. The IRB Executive Committee determined that as long as the study is open with the IUPUI/Clarian IRB, adverse events should continue to be reported per the existing reporting requirements. Their concern was that an adverse event may be related to the research intervention and may be relevant to subjects on follow-up. Additionally, the IRB Executive Committee was asked to reconsider the IRB policy for reporting off-site deaths, especially those that are deemed to be unrelated to the drugs used in the study. The issue was that for some studies, such events are only shared with the investigator in aggregate in semi-annual reports, thus making it difficult to report them in a timely manner (within 10 working days per IUPUI/Clarian policy). The committee was concerned that deaths cannot actually be characterized as “unrelated” until the end of the study. However, the committee agreed that investigators should not be required to complete adverse event forms for deaths that have been reported to them in aggregate. It was recognized that only Data Safety Monitoring Boards (DSMB) in fact have access to and the ability to effectively assess such adverse event reporting trends; however, the local IRB must also review such events. The IRB Executive Committee agreed that for those studies where there is some level of external oversight, such as a DSMB, deaths that occur at external sites can be reported in aggregate at the time of continuing review. Such deaths do not need to be reported via individual adverse event reports. Co-Investigator Signatures Required On New IRB Study Submissions Recently the IUPUI/Clarian IRBs were informed that several co-investigators listed on the summary safeguard statement did not have knowledge of their participation in the study. This issue was discussed by the IRB Executive Committee in the past and resulted in the committee’s decision to add a certifying statement to the Documentation of Review and Approval (DRA) page for principal investigators to certify that all co-investigators have knowledge of and have agreed to participate in the study. The committee granted that requiring acknowledgement from the co-investigators created potential roadblocks to approvals when there are multiple co-investigators. The committee decided that because co-investigators listed on the summary safeguard statement do not always have knowledge of their participation in the study, even with a certification being provided by the principal investigator via the DRA page, some sort of co-investigator acknowledgment is necessary. Although the Electronic Research Administration (ERA) system currently under development will address this issue, the committee determined that an interim solution is necessary. For all new IRB applications submitted to a July IRB meeting and all subsequent meetings, written acknowledgement will be required of all co-investigators. Acknowledgement can be in the form of an e-mail or letter from co-investigators and included with the application or the co-investigator(s) signature(s) on the summary safeguard statement. Signatures, acknowledgement letters, and/or e-mails must be submitted to the IRB before final approval can be granted. Additionally, whenever a co-investigator is added to a study (i.e., via an amendment), this certification must be included. New Continuing Review Form and Informed Consent Wording for HUD IRBs, per Food and Drug Administration (FDA) regulations, are required to review and approve the use of a HUD at their institution. A full board review is required for the initial review, while the continuing review may be reviewed via the expedited review procedures unless the IRB determines that a full board review should be performed. Individuals using HUDs have found it difficult to respond to the various questions on the continuing review form since they are not normally conducting “research.” The IRB Executive Committee recently approved the use of a continuing review form specifically for HUD studies. This form will be sent to HUD investigators at the appropriate continuing review time. In addition, the IRB requests that specific wording be included in any informed consent that is provided to patients consenting to the use of a HUD. The wording is as follows:
FDA Revises MedWatch Adverse Event Reporting Forms To view instructions for completing the MedWatch Form 3500 go to: http://www.fda.gov/medwatch/report/consumer/instruct.htm. To download
forms, go to: |
| Proposal Development |
| IU
Registers for Indiana Solicitation Opportunities Program A link has been placed on the IU Research Gateway Proposal Development and Funding page as State of Indiana Solicitations at http://www.ai.org/cgi-bin/idoa/cgi-bin/bidad.pl. It is important to note that mail announcements will no longer be sent out to potential bidders. Therefore, you are encouraged to visit this link periodically to ensure timely receipt of important state opportunities. All questions and concerns regarding this announcement should be addressed to Etta Ward, Director of Sponsored Program Development, at 317.278.8427 or by email at emward@iupui.edu. |
| Submit
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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