April
2004
| Human Subjects | |||
| Research
Compliance Administration (RCA) Institutes Online Adverse Event Reporting
System The online reporting form mimics the paper form that is currently being used. The submitter is presented with the same questions that are included on the paper form. The system “audits” the form to ensure that the adverse event meets the IRB’s reporting requirements before the report can be submitted. If someone other than the principal investigator (e.g. research coordinator) submits the adverse event, an e-mail notification is sent to the principal investigator to ensure that he/she is aware of and accepts responsibility for the adverse event submission. Currently, no supporting documentation (e.g., MedWatch Reports) can be submitted electronically. The submitter will be instructed to forward those supporting documents to the RCA office identifying to which adverse event they apply. Currently, only studies that were submitted to the IUPUI RCA office can be accessed; however, we hope to add Methodist studies at a later date. Additionally, you must possess an IU password and login to access the system. When you do access the system, you will only be able to access those studies for which you are identified as the principal investigator or contact person as listed on previous IRB submissions. If additional delegates need to have access to the system, please contact RCA. At this time, only new adverse events that are submitted electronically will be in the system. As such, even if paper adverse events have been submitted in the past, those events have not been added to the electronic system so all electronic numbering will begin with the number one. Please be aware that in the near future the use of the reporting system to report adverse events to the IRB will be mandatory for all investigators. If you have constructive comments or questions, please forward them to resrisk@iupui.edu. The URL to access this system is: http://webdb.iu.edu/iupuirsp/ae3422.htm.IRB Instruction Packet Revisions Listed below are the major changes to the 04.04 version of the IRB Instruction Packet and IRB forms: IRB Packet
IRB Forms
IRB Institutes New Telephone Line for Subject Questions or Concerns Usually, subjects are directed to contact the patient representative at a specific hospital or another appropriate representative within the institution to whom questions such as these may be addressed. Recently, due to issues with respect to the assistance provided by individuals who have answered the patient representative lines at the various hospitals, the IRB requested that subjects be provided with a single telephone number to be used such that they may speak with an IRB representative in these situations. As a result, Research Compliance Administration has instituted both a local and toll-free telephone line that may be used by subjects for this purpose. The IRB application packet has been updated with these new telephone numbers. With regard to new IRB submissions, the informed consent statements should now contain these new telephone numbers. For existing studies, investigators may submit a minor amendment if they wish to change the telephone numbers listed in their informed consent statements; however, this will not be a required change. IUPUI/Clarian
Standard Operating Procedure for Human Subjects Identification, Selection,
and Recruitment Finalized
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.Required Signature Lines in the Informed Consent Statement Previously, the informed consent template required (at the very least) that signatures be obtained from the “subject” and the “witness.” However, there has been some confusion as to what the term “witness” signified and it has been since clarified that what the IRB wants investigators to obtain on the informed consent statement is the signature of the “person obtaining informed consent.” The IRB noted that when the “person obtaining informed consent” signs the consent statement, this attests that the consent process was properly administered, not that the subject’s signature was witnessed. For FDA-regulated studies, the signature from the “person obtaining informed consent” is not required, but the FDA does require the presence of a “witness” signature only when there is concern that the subject is incapable of understanding the informed consent statement. However, for IUPUI/Clarian studies, regardless of sponsor, the investigator should at the very least obtain a signature from the “subject” and the “person obtaining informed consent.” As a side note, individuals who sign as the “person obtaining informed consent” should be listed as either the principal investigator or a co-investigator on the Summary Safeguard Statement. Additionally, the IRB has indicated that if the consent process was conducted via telephone (as is appropriate in some cases); it is acceptable to have the person administering the consent sign the consent form prior to mailing it to the potential subject.Listing the Number of Subjects in IRB Study Documentation In some cases, investigators state the total number of subjects to be enrolled in the study at this site as a range (i.e., “5-10 subjects”) because it is not known precisely how many will eventually be enrolled at this site. While the IRB recognizes that it is not always possible to predict the total number of enrollees that will be enrolled at this site, it notes that upon the time of continuing review, it can become difficult to assess the status of the study when, for example, it is reported that 7 have been enrolled (following the example of “5-10 subjects”). In this case, the IRB often asks the investigator to provide additional information about the status of the study since it is difficult to ascertain whether study endpoints have been met or whether it is anticipated that additional subjects will be enrolled. For these reasons, the IRB has requested that study documentation identify the total number of subjects to be enrolled in the study as a single number. For example, instead of stating “5-10 subjects,” investigators should denote the predicted enrollment as “10.” In either case, investigators are not penalized for completing their enrollment at 5 or 7, for example, because the IRB is primarily concerned with the maximum number to be enrolled. Additionally, regardless of whether study enrollment is listed as a range or as a single number, an amendment would still have to be filed if the investigator proposed to increase the potential enrollees to 15. It should be noted that amendments do not need to be filed to modify the enrollment notation to meet this new policy on existing studies; however, for new submissions, investigators are requested to list a single number to denote the number of subjects to be enrolled. |
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| Proposals & Awards | |||
| New
Option for NIH Modular Grant Applications The form includes questions relating to your project that are intended to draw out costing issues which may require prior approval, cost sharing, or university commitments. The form also provides a space to enter information needed for the indirect cost calculation. Check with your department or school to see if the use of the alternative Budget Information Sheet for NIH Modular Applications is acceptable. Projects involving multiple schools or departments may require a detailed budget. Additional Information about Modular Grants is available on the NIH web site and in the PHS 398 Application Instruction Packet. |
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| What's New | |||
| Take
the Web Site Redesign Survey for the Office of the Vice President for
Research Even if you are not in the habit of visiting the OVPR website, your responses to several of the questions are important to the project team. Please take a moment to complete the survey (link below). If you have any questions or comments pertaining to the survey, please feel free to contact Sherry Fisher, project team lead, at 812.856.0504. Thank you. What’s New at R&SP? Michelle comes to R&SP from Contract and Grant Administration (C&G) where she works on the Red Team handling NIH grants and contracts. Michelle will be working in R&SP on Mondays, Wednesdays, and Thursdays and in C&G on Tuesdays and Fridays. She will join R&SP full time after she completes her Masters in Information Science at the end of this semester. Angie previously held the position of Grant Assistant in Sponsored Program Administration. Jody was formerly the Assistant Director in Research Compliance Administration. Please join us in welcoming Michelle and congratulating Angie and Jody on their promotions! To view the complete R&SP organization chart, see: http://www.iupui.edu/~resgrad/org-chart/spon-org.htm. |
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| Events | |||
| Apr
23 HIPAA and Medicare Update for Clinical Researchers Cost: None CMEs: 1.5 Presenters: Heather Gipson, Compliance Analyst; Leslie Pfeffer, Compliance Training Specialist, and Pam DeWeese, Clinical Trials Program Director Content: Functional requirements and minimum expectations; How these laws have impacted research and operations at IUPUI; What does the future hold?; How to incorporate these requirements into your IRB submissions, recruitment, budget development, electronic data, and billing.  The Crossroads Chapter of SoCRA presents: “Electronic Data Capture, A Study Coordinator’s View -Lilly’s Use of InForm” Wednesday
May 5, 2004 Parking is available for a fee in both the parking garage across (south) from the Cancer Center in the Vermont Street Parking Garage and in the lot at the corner of Michigan and Barnhill Drive. 5:30 Check-in Attendance is free and open to SoCRA and non-SoCRA members. This program has
been awarded 1.0 Continuing Education Unit (CEU). If you plan to attend and would like a CEU certificate, please contact Ahran Lee at alee4@clarian.org. |
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| 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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Send COMMENTS,
QUESTIONS to: |
Research
and Sponsored Programs
UN 618 General - 317 274-8285 Research Compliance - 317 274-8289 Sponsored Program Development - 317 278-0249 |
