By Melinda Young
An important and useful function of an IRB’s website is its ability to give researchers — as well as the public — access to a wide variety of forms, guidance, and tools.
When created well, an IRB’s website can be easy to navigate. It also should be updated with new and revised information regularly. Like crowdsourcing websites and with permission, an IRB’s website also can adopt and adapt tools that researchers and other IRBs have found useful.
One example is Northwestern University IRB’s webpage, which lists a variety of forms and templates, including informed consent short forms in 21 different languages. (The forms are available at: https://www.irb.northwestern.edu/templates-forms-sops/.)
Develop Short Form Consent
When a researcher encounters a non-English-speaking potential study participant, an informed consent short form, written in the person’s primary language, can provide essential information. Then, an interpreter can review the full consent form or the full form can be translated once the person decides to enroll in the study, says Lisa Linn, CIP, biomedical IRB manager at Northwestern University.
Short form consents provide some flexibility in the informed consent process. It is desirable to offer a short form for every language spoken and read by potential research participants. But IRBs might not have the resources to translate dozens of short-form consents, so a form of crowdsourcing is helpful.
“A couple of years ago, we reached out to the University of Minnesota and obtained some translated short forms with their certificates of translation for a couple of languages we run into quite often,” Linn says. “We made these available online for our research community.”
The IRB’s webpage library of short-form consents grew as new languages were added, including Gujarati, Lao, Hindi, Oromo, Somali, Khmer, Tagalog, and Korean.
“Through the years, as short form requests came in, researchers brought in short forms and certificates of translation for their studies, and they shared these with the research community,” she adds. “The library has grown, slowly, over time.”
The English short form consent is a single page. It gives potential participants an idea of what investigators will tell them as part of informed consent. For example, the form states: “Before you agree, the investigator must tell you about (i) the purposes, procedures, and duration of the research; (ii) any procedures which are experimental; (iii) any reasonably foreseeable risks, discomforts, and benefits of the research; (iv) any potentially beneficial alternative procedures or treatments; and (v) how confidentiality will be maintained.”
The short form also provides names and phone numbers of people to contact if they have questions about the study.
Other IRBs can use Northwestern’s short form consents, if needed, says Nathalia Henry Whitely, MS CIP, CHRC, executive director of the IRB office.
“If someone finds them on our website and reaches out to us for permission to use them, it would be ideal,” Whitely says. “It’s possible that other places have stumbled onto our website and borrowed and modified [tools], and that’s OK, too.”
Create a Media Relations Form
Another tool on the IRB’s website involves how researchers should interact with media. Called the Media Relations Form, the four-page document includes several pages of instructions on which media relations materials must be submitted to the IRB, including these explanations:
- “When the material pertains to a study that is still open at NU (data lock is not in place and medical records may still be accessed for research purposes); or,
- “When the activity involves a non-scripted interview of a study participant who is currently enrolled and actively participating in the research study. The participant should sign a revised consent form or an addendum to the consent. The consent document should be submitted with this form for IRB review.”
The form includes these five sections:
- study information;
- media relations material;
- financial conflict of interest information;
- requirements, the press release, subject activities in study;
“This form is for when studies are open and recruiting,” says Braden T. Van Buskirk, MSW, CIP, social and behavioral IRB manager. “The main focus is there wouldn’t be exaggerated claims or statements made either by a participant or a friend that might be misleading or overstating benefits,” Van Buskirk says.
Sometimes, investigators are invited to speak on TV or radio, or are interviewed by newspaper journalists about their studies. The Media Relations Form is relevant to those situations, Whitely says.
It is important for the IRB to use a Media Relations Form to prevent blurring the line between the research recruitment process and auxiliary media events in which investigators engage. “What we often hear is this was not an intended method of recruitment; it wasn’t their idea,” Whitely says. “Someone approached them.”
The IRB trained researchers to understand that if they use the media as part of their recruitment, they should let the IRB know. If the media event occurs after the study is closed, then the Media Relations Form and materials do not need to be submitted to the IRB.
If a current study subject is asked about participating in a media interview, the person should be told that engagement is voluntary. There could be an addendum to the informed consent about the interview, Linn notes.
“This situation comes up from time to time,” Whitely says. “It gives the research community a resource about media relations because the average clinical investigator doesn’t know the process of getting media approvals on campus.”
“We give them information on what to do, what to expect, who to call, and it works well,” she adds. “Having those materials out there has reduced random phone calls and emails to our office.”
In another section of the website, the IRB provides a list of study support resources and templates. (For more information, visit: https://www.irb.northwestern.edu/study-support-resources-and-templates/.)
“We created a document for the research community to use: The delegation of authority log,” says Piper Hawkins-Green, MS, CIP, IRB compliance manager.
This webpage includes tools for various activities, such as:
- Assent and parental permission enrollment log;
- Biomedical research delegation of authority;
- Consent form collection alternative;
- Social-behavioral research eligibility checklist;
- Device accountability log;
- Research record components;
- Participant identifier log;
- Protocol deviation log.
“These are basic tools to allow researchers and study teams to be successful,” Hawkins-Green says. “We identified a need from post-approval monitoring activities and self-assessment. We found that quite often — because we cover both biomedical and social-behavioral research — that some investigators were equipped to conduct research, but they didn’t have the support documents to ensure the regulatory portion.”
With the templates, investigators can plug in their own information and meet compliance expectations. “Whenever we perform a for-cause audit, we prefer investigators to use these [tools] throughout the life of a research study,” Hawkins-Green says.
The IRB also offers post-approval monitoring tools to assist with self-audits and self-monitoring. “Those are tools they can use to assess every component of their study, from initial approval to closure,” Hawkins-Green says. “We include questions on the regulatory piece, the IRB piece, a clinical trial checklist, and an FDA-specific inspection checklist that helps study teams prepare for FDA inspection.”
Investigators are instructed to assess their own research studies. “Especially with COVID, we can’t go out into the field to do post-approval monitoring,” Hawkins-Green says.
Investigators are encouraged to conduct self-assessments as part of post-approval monitoring activities. They can find checklists and other tools on the IRB’s website.
“They do complete [self-assessments]; we have an 85% completion rate,” Hawkins-Green says. “Because of COVID, some requested postponement because study teams are not on campus, so it would be difficult to complete full assessment activities.”