Ride the Wave: On April 15th, eProtocol™ will be launched for Human Research Protocol submissions and IRB review
Eddie would go! You can too--watch this ORC Latest News webpage to learn more about eProtocol™ as we begin the countdown to launch.
Bookmark this link because it is updated daily and is your primary source of information about the launch of eProtocol™.
Contact any member of the Human Studies Program (HSP) listed below to
- Ask questions about the use of eProtocol™
- Request one-on-one help on entering your protocol into eProtocol™
- Arrange a workshop or seminar on eProtocol™ for your department or group
- Donna (808) 956-5007 Donnakob@hawaii.edu
- Janine (808) 956-5007 firstname.lastname@example.org
- Kristin (808) 956-8480 email@example.com
- Jacob (808) 956-7659 firstname.lastname@example.org
- Denise (808) 956-8287 email@example.com
To ease the transition from the current paper system for IRB submissions to the eProtocol™ system, the HSP of the Office of Research Compliance (ORC) offers the services listed below. Please call one of the people in HSP listed above between 8:00 am and 4:30 pm to make arrangements for any of these services:
- HSP provides information about using eProtocol on the ORC home page under “Latest News”
- HSP provides on-line answers to Frequently Asked Questions (FAQs) and an on-line means for you to ask HSP your own questions
- HSP provides on-line video clips to help you learn how to access and use eProtocol™
- HSP offers you a means on-line to provide HSP with feedback about your experience with eProtocol™ and with suggestions
- HSP will provide a live webinar accessible to all UH campuses and will record it and then post it on the ORC website for your continued reference and for those unable to participate in the original broadcast
- To get the word out about eProtocol™, HSP is contacting key administrators, departments, and also is reaching out personally to researchers who currently have IRB protocols
- HSP is staging the launch of eProtocol: those submitting protocols that they suspect will be exempt should use eProtocol beginning April 15, 2016. Those submitting protocols expected to require full review or expedited review have the option of submitting the paper forms or using eProtocol™ until July 1, 2016 after which all protocols must be submitted through eProtocol™
- HSP provides a link to Key Solutions™, the UH vendor for eProtocol™
Some Benefits of using eProtocol™
- A paperless system
- Basic information does not have to be reentered into eProtocol™ for subsequent applications
- eProtocol™ is personalized (creates "Smart Forms" instantaneously on line)—it “knows” what questions to ask for the particular type of application you are completing
- eProtocol™ checks for errors or omissions:
- automatically self corrects typographical errors
- will not advance to next page until all required information has been entered correctly
- displays in red font any errors or information that must be entered before it will advance to the next screen (f the next screen does not appear after clicking the "next" button, then scroll to the top of the page to view error or omission message)
What to Expect
- You will be using the eProtocol™ system to complete and submit an application for researching people. Based on the degree of potential risk to the health and welfare of the people being researched, the protocol for the human study will be classified as exempt from full committee (IRB) review or will require full committee review. Protocols are classified as exempt if they present little risk to study participants (e.g., the data is preexisting, participants are not identifiable personally, the data comes from responses on questionnaires or from noninvasive observations). Protocols with greater risk to participants will require full committee review. Protocols also can be submitted for expedited review. In addition to entering the type of submission (exempt, full-review, or expedited), the eProtocol™ system will require other information such as the contact information of the Principal Investigator (PI), the title of the research being conducted, the purpose, rationale and justification of the study, consent or assent forms if required, and other information critical for a fair and speedy review of the application by the IRB. Set aside at least 30-minutes to complete an application for the first time. If you are unable to complete the application in the time you have allotted, you can save the information you already have entered, exit the system, and enter the remaining information into the system at a later time.
- A "Help" link is located at the top right corner of each page of the on-line application for additional instructions on completing the application if needed.
- If using Windows™, use Internet Explorer™ (IE) or Firefox™ as your browser.
- If using Apple™ or Linux™, use Safari™ or Firefox™ as your browser.
- Your browser must be configured to allow pop-ups while using eProtocol™. See instructions in your browser for allowing pop-ups.
- Other browsers may work, but cannot be guaranteed to work reliably.
Federal requirements for research involving human research participants, animal subjects, and recombinant molecules have increased dramatically over time. As a requirement by the federal government, researchers must submit to institutional committees protocols that describe the research they wish to do and the means by which the research participants, research personnel, animal subjects, and the Public will be protected from potential harm. Research protocols involving human participants are submitted to Institutional Review Boards (IRBs) of which the University of Hawaii (UH) has three. Research protocols involving vertebrate animals are submitted to the Institutional Animal Care and Use Committee (IACUC), and research protocols involving recombinant molecules and certain microbiological agents and toxins are submitted to the Institutional Biosafety Committee (IBC). At UH, the Office of Research Compliance (ORC) administers these committees.
As research has increased at UH, greater efficiencies are required through use of software that lessens the burden on researchers and committee reviewers. For greater interoperability, the long range goal of Dr. Vassilis Syrmos, UH Vice President for Research & Innovation, is to consider use of the Kuali™ software system for submitting research protocols to each compliance committee (IRB, IACUC, IBC) for review. The Kuali™ system currently is used by the Office of Research Services (ORS) to manage grant submissions and awards. Having a single software solution should enable easier exchange of information between ORC and ORS and provide users with a common interface.
Until the transition to an entirely Kuali™ based system is complete,
- Topaz™ will continue to be used for IACUC submissions,
- Key Solutions eProtocol™ will be rolled out April 15, 2016 for IRB submissions, and
- Paper forms will continue to be used for IBC submissions.
The eProtocol™ IRB software has been customized during the last 12 months, to operate within the UH environment and also to fulfill the specialized needs of UH researchers and of IRB committee members who review the protocols for compliance with federal, state, and university regulations. Key Solutions eProtocol™ is being rolled out now so that researchers and reviewers can benefit immediately from the functionality that the eProtocol™ software provides during development of an equivalent IRB Kuali™ module at UH. In addition, a transition period will better inform Kuali™ programmers about the specifications and requirements that will be necessary to achieve with the Kuali™ system.
Animation courtesy of amazing-animations.com at http://www.amazing-animations.com/animated-computers2.php, last accessed April 5, 2016.