IRB launches new interactive website
IRBs and researchers can contribute ideas
The Children’s Hospital of Philadelphia (CHOP) IRB launched its massive new website in July, full of information to help investigators — and other IRBs — in every step of protocol and policy development.
The website began taking shape five years ago as part of CHOP’s intranet, says Mark Schreiner, MD, executive vice-chair of the Committee for the Protection of Human Subjects at CHOP and physician reviewer for IRB Advisor. "We added to it a page at a time, with forms and templates for our own users," he says.
The IRB members and staff found that they were writing the same explanations over and over again on questions such as waivers of consent, HIPAA, and waivers of documentation of consent. "Instead of writing long explanations, we would write a Web page to provide the information," Schreiner says. When undergoing recertification for the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the AAHRPP site visitors expressed a wish for access to the information outside the institution.
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"We didn’t think the information was proprietary," he says. "We spent the last six months reorganizing the site, supplementing it, and transferring it to make it accessible."
Using the site
The home page (https://irb.research.chop.edu) features an overview of CHOP’s Committees for the Protection of Human Subjects and its structure.
The How to Use This Website drop-down box at the bottom of the home page takes users to an explanation of the site and where to find the Help! section, frequently asked questions (FAQs), forms and templates, policies and procedures, and more.
The site features a detailed section on how to choose and use any of the protocol templates. It also includes links to other resources for writing protocols, including CHOP’s own tips and key features for well-written protocols.
"One of the problems we found with many investigator-initiated protocols was they didn’t contain enough information to conclude the research was scientifically sound," Schreiner says. "So we decided to provide information on protocol writing. A lot of the information links to key references and consensus guidelines. If investigators could give the IRB a complete protocol, we can approve their research very quickly. A lot of times the information is in the investigator’s head but they don’t have it in the protocol."
A lot of noncompliance issues arise from incomplete protocols that are ambiguous. Ineligible subjects often get enrolled because the inclusion criteria were not apparent to the study team, Schreiner says. "Writing a good protocol is the first step to staying out of trouble," he says. "We’re trying to provide information and explanations of what we require. A lot of investigators don’t understand what IRBs need for approval."
CHOP also hopes to give other IRBs ideas for forms and policy development, Schreiner says. "We have a section on consent form templates and short forms," he says. "Our short forms are in 14 languages. Other institutions modify the forms and just use their institution’s name in place of ours."
Regulations and Resources section includes external links to the regulations from the FDA, Office of Human Research Protections (OHRP), and other regulatory bodies. It also contains links to guidance and ethics websites such as the Belmont Report and the Declaration of Helsinki.
"The references link directly back to regulations and guidance documents, and literature links go to PubMed to see the abstract for the reference," he says. "This way, if the regulations change, the URL will remain the same, as opposed to uploading PDF files of the regulations. "
The Policies and Procedures section gives links to PDF files of the IRB’s standard operating procedures (SOPs), which were revised during the IRB’s AAHRPP accreditation and recent reaccreditation process. Having the SOPs on the website can help other IRBs when preparing for AAHRPP accreditation, Schreiner says.
"When we started preparing for AAHRPP reaccreditation, it really helped us to look at the policies and procedures of other sites," he says. "I think it’s very helpful for institutions that are getting ready for AAHRPP to see what others have done to get accreditation. We didn’t think it should be so proprietary."
The CHOP website goes beyond other IRB sites by focusing on topics other than regulatory issues. For example, Schreiner says, there is a section on investigator responsibilities, which the Food and Drug Administration (FDA) covers but OHRP doesn’t. "PIs have to understand that they are responsible for the research and can’t just delegate to study nurses and staff," Schreiner says. "A lot of investigators wind up in trouble due to noncompliance because they assumed everything was going OK without having an active part in running the study. Study coordinators often will look at the information a lot more than the PIs."
Looking for Help
The Help! section is described as the first place investigators, IRB members, and study coordinators should look for guidance in the protocol development and approval process. Sections include:
• Principal Investigator Responsibilities
• Preparation for Study Submission
• What Must be Reviewed by the IRB
• Criteria for IRB Approval
• During and After the Study Approval Process
• HIPAA and Research
Each section has a drop-down box that will take users to a full Web page on each topic. Pages contain links to other sections of the website that contain the relevant information.
"There are about 700 internal hyperlinks," Schreiner says. "If it’s the word consent,’ clicking on it will take you to the consent information page. Clicking on unanticipated problems’ anywhere will take you to the unanticipated problems page. It’s a very interactive experience."
The FAQ section addresses assent of children, document retention, exempt research, expedited review, full board review, review requirements, minimizing risk, unanticipated problems, and other topics.
The CHOP IRB plans to expand the FAQs as more ideas are received from researchers. "Those are the areas where there’s confusion," Schreiner says. "People often don’t know what they don’t know, and don’t know what questions to ask and where to look. Investigators now take training courses that cover the research regulations and ethics issues, but many have had no formal training in conducting clinical research."
Finding new ideas
The CHOP IRB continues to work to improve the website and add information. The How to Use This Website page also includes instructions for users to send in any suggestions for topics or other website content. "We are hoping that, like Wikipedia, there will be crowdsourcing and others will contribute ideas," Schreiner says. "Our hope is that people may have some good information on topics that we’re not covering, and by making it open they might want to expand on articles or contribute new ones."
"We did all this work and wanted to share it, hoping that others might collaborate — maybe we got things that are a little wrong and it would be great to work on it," he continues. "Some pages are shorter than they could be, but it takes a tremendous amount of effort to put it together, and we hope to get input from the wider community."
