Best Practices Spotlight

Informed consent process pays close attention to details, habits

Checklists and logs help

When a research institution is trying to stay compliant and keep track of the voluminous paperwork filed during the clinical trial process, it helps to use logs and checklists that capture each small detail.

CRI Worldwide of Clementine, NJ, has developed a best practice in which logs and checklists help clinical trial staff with study checks and balances.

For instance, the research organization receives many revised informed consent documents, says Terry Smolenski, CCRC, director of regulatory affairs at CRI Worldwide.

"We keep track of those by a log I created," Smolenski says. The log notes why there is a change in the informed consent since it was IRB approved, and it details when study coordinators received the revised document, she says.

The most typical reasons an informed consent document might be revised involve a change or update to the study's risks and when an investigator's brochure is updated, Smolenski notes.

"Changes to the consent document are all done through the sponsor," she adds. "If there's an amendment to the protocol, it's done through the sponsor, and so they send it out to the site level."

Before the institution receives an amended change to the consent form, the investigator will have gone to the sponsor and IRB with the proposed change.

By documenting precisely when informed consent document changes were logged in and by whom, the institution stays in compliance with all regulations and rules.

"So before the sponsor audits [the study site], we can look and see exactly what day [the revised consent] was given to the coordinator," Smolenski says.

It's important that investigators and study coordinators do not overlook the latest informed consent revisions, so the institution also has what it calls a "consent-in."

"This is where we go into the consent bin and update documents in there to make sure the most recent was in there," Smolenski says. "We fill out a form and put on a cover sheet that says the protocol number and which changes were made to the consent document."

They further alert staff to the change by using red paper.

"It tells them what's changed in the consent form, so if a coordinator is busy or if somebody picks it up, they'll know exactly what was changed in it," Smolenski says. "We also put tabs on the consent bins so the most recent approval date is there so the staff can look at that and make sure they're using the right one."

Regulatory affairs professionals give study coordinators the changed and approved informed consent document as quickly as possible so they can use it when giving informed consent to new participants and for giving revised informed consent to existing participants, Smolenski says.

The institution's best practices go back even further in the process.

For example, there are quality assurance analysts at the sites. Their job is to monitor the consent process and oversee everything done at the sites to make sure it's all in compliance, Smolenski says.

"They do spot checks on the CRF [clinical research form], and they notify the quality analyst at that site and let them know by e-mail when there's a new consent document," Smolenski says.

This way the quality analyst can make certain the revised document is being used and can make certain study coordinators are re-consenting all participants, using the revised document, she adds.

For another best practice, regulatory affairs professionals refer to checklists when assessing the initial informed consent form.

"When we get the initial consent, we have checklists to go through," Smolenski says. "We go through the consent process and make sure all elements are there and are required by the regulations and HIPAA [Health Insurance Portability and Accountability Act]."

If investigators find some elements missing, they need to return to the sponsor and IRB and let them know about any upcoming changes, Smolenski says.

"It's amazing the things you will catch," she says. "Ultimately you're responsible if you're not using a good consent document."

Smolenski researched what should be on a consent form and perused the regulations on informed consent before creating the checklists.

The checklists include these types of items:

  • The informed consent document tells volunteers that their participation is voluntary;
  • It tells volunteers that if there is any new information it will be given to them as investigators learn of these;
  • The informed consent document should clearly state that the study involves research, explain the study's purpose, and describe the procedures that will be done;
  • It should describe anticipated risks and discomfort to the subjects and outline the duration of their participation;
  • It should give the approximate number of people who will be involved in the research and describe any benefits the participants will receive;
  • The document should provide a name and contact information for someone the participant can reach in the event of research-related injuries;
  • There needs to be a disclosure of alternate procedures or treatments to participation in the study;
  • Documents should have a description of HIPAA with an end date listed for how long the information might be used, or if there is no end date, then there should be a statement describing how the study is open-ended;
  • Also, there should be a statement about the confidentiality of records;
  • And there needs to be a statement about how if a participant refuses to participate in the study it will result in no penalty or loss of benefits;
  • Finally, there typically is a statement relating to the risk to fetuses and embryos.

"Usually, if I see something is missing from the informed consent document, I'll bring it to investigators' attention, and I'll give them sample language to use," Smolenski says.

The checklist is followed after the study receives IRB approval and all of the IRB's suggestions for change have been incorporated into the informed consent document, she says.

"Once we have everything in place, the informed consent copy is sent to the study coordinator, and it goes into our consent bin at the site," Smolenski says. "So if one of our doctors sees a potential subject, and the doctor feels the person might be appropriate for the study, then he might go to the consent bin and copy the consent form and read it to the patient."