Consent form specialists assist investigators and board members

IC template also ensures compliance

Experts say IRBs spend much of their time discussing informed consent issues and nuances, and yet this is the area cited most often in recent regulatory letters sent to research institutions.

The Office for Human Research Protections (OHRP) of Rockville, MD, for example, has noted instances of risk and alternatives to a study’s intervention being omitted or inadequately described in OHRP’s recent letters of determination. These findings were sent to some of the largest research institutions in the country.

So if even large institutions can run into noncompliance trouble, what types of practices might prevent an OHRP finding?

One possibility is to have experienced IRB staff, called consent form specialists, help investigators and IRB members with all informed consent issues.

Johns Hopkins University School of Medicine in Baltimore has three consent form specialists who each work with two IRBs, and a consent form manager. The institution has used this model for more than a decade, and it’s worked well — helping to keep the institution compliant with informed consent regulatory requirements, says Judith Carrithers, JD, MPA, assistant dean for human research protection and the director of the human research protection program at Johns Hopkins University School of Medicine.

“If a specialist notices there are risks in the protocol that are different from those in the consent form, then they advise the board of these differences,” Carrithers says.

“Our IRB chairs would say having the specialists was the single best change we ever made,” she adds. “They are very helpful in smoothing the process out.”

Consent form specialists also help investigators reformat their consent form language and use simpler words, trying to reduce the reading level to an average of around eighth grade, she notes.

The three consent specialists rotate to working with different IRBs every six months so they become accustomed to working with all of the boards, says Victoria Hadhazy, MA, CIP, consent form manager in the human research protection program at Johns Hopkins University School of Medicine.

“We attend board meetings, which last two to four hours, depending on the agenda, and we are there to ask and answer questions,” Hadhazy says.

After IRB meetings, consent specialists spend up to two hours doing post-meeting work and additional documentation, she says.

“Our schedule is heavy and we’re all good at time management,” she says.

Hadhazy and the consent form specialists have significant research experience, including expertise in writing informed consent forms.

“We have two consent form specialists with master-level degrees, and a third with a European law degree,” Hadhazy says. “We all work in the exact same way with a private drive on our computers where all consent forms are kept.”

The specialists work interchangeably and determine by file name who has worked on a particular consent document, she adds.

Consent form specialists help the IRBs focus when discussing consent issues, and they bring disparities to their attention, Carrithers says.

“They confirm whether all of the required elements of informed consent are included,” she adds.

The consent form specialists provide a structural review, ensuring the online application and consent form are consistent, Hadhazy says.

“We look at the document and put in our standard wording where needed and try to bring down the reading level,” she explains. “We sometimes move text around to make sure the most serious risks are the first ones listed, leaving the more minor risks at the bottom of the section.”

The specialists also check the protocol to make sure that alternatives to the study intervention mentioned in the protocol are also mentioned in the consent form. The IRBs’ scientific experts also check to make sure alternatives are listed, she adds.

“For every new application, we complete an elements review,” Hadhazy says. “It’s actually part of the electronic application now, and the consent form specialist fills it out for each consent form.”

The consent form specialists list which essential elements and which additional elements are included in the consent form, and they point out if there’s an additional element that is protocol-specific that should be listed but is not, she notes.

“Our consent form template, which investigators follow, is in a question-and-answer format, so when they are drafting their consent form all elements are available in that template,” Hadhazy says.

The template is generally revised annually, and it has proven very helpful to researchers and the IRBs, Carrithers says.

The IRB office also provides investigators with a checklist that will help them prepare the consent form. The checklist refers directly to the eight required informed consent elements under 45 CFR 46.116 and the seven additional elements. It asks whether 18 items pertaining to the regulations are included on the consent form and whether an additional nine items related to additional elements of information be included when appropriate.

Here are some sample items from the informed consent checklist:

• a statement that the study involves research;

• a description of the reasonably foreseeable risks or discomforts to the participant;

• a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;

• a statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled;

• a statement that the particular treatment or procedure may involve risks to the participant which are currently unforeseeable;

• anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent;

• and a statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant.