Compliance Corner

IC tools help validate, discuss and document

Research site uses barcoding for informed consent

Large and state-of-the-art research organizations are proving that technological solutions can make every compliance effort more efficient and better documented. For example, barcoding moved from the grocery store to the hospital, and now it can be used to validate research participants and the informed consent process.

"By pushing documents to the Web, we've incorporated barcoding," says Laury Finn, CCRP, supervisor and research regulations specialist at the University of Texas M.D. (UTMD) Anderson Cancer Center in Houston, TX.

UTMD's online database with protocol documents includes informed consent forms. The informed consent process is well-organized to ensure compliance, based on the following three steps:

  • Validate/confirm: choose the correct subject and study; determine possible eligibility; retrieve bar-coded informed consent.1
  • Discuss/enroll: establish a checklist with points of discussion; make certain latest informed consent version is being used; and enroll subject on study.1
  • Document/report: use a template for dictation to complete documentation; use a checklist when proofreading consents; report that the subject is accurately enrolled on the study.1

Once the informed consent form is approved by the IRB and any other committee that reviews it, then it is activated and available electronically for use in recruiting study participants, Finn says.

"By putting the document on the website, which is a convenient location for research staff and faculty, then we can ensure the informed consent form they pull up is always the most current, IRB-approved version," Finn adds.

This is an important difference over the hard copy IC process in which a study's filing cabinet might contain several different versions of the informed consent form, and researchers could mistakenly grab the wrong version when enrolling a new participant, notes Maria Mercado-Cooper, supervisor of research regulatory systems at UTMD.

"Also, the electronic file contains different language versions of the informed consent form," she says. "If there's a Spanish translation that's been done, then they can grab that one."

"Research subjects who sign informed consent forms hand-sign a paper copy, and we send these to our medical records department, scan the document, store it, and put a barcode on it," she explains.

"It has not only barcoding information, but also the participant's medical information," Finn adds. "And it has the date when the participant signs the consent form, and one more barcode identifies the document as a research document and designates where the document will be stored."

Other information on the IC form is as follows:

— Protocol number

— Date IRB approved the form

— Participant information.

Clinical trial investigators and coordinators can retrieve the signed informed consent form with electronic access codes, validate their own information and the patient's information, Finn says.

"We make sure the employee's user access ID is current and check the subject's demographic information against the institutional database to make sure we have the right person," says Matt Lindblom, MS, manager of research regulatory systems at UTMD.

"We also have a list of eligibility criteria that must be adhered to, and we make available to all research faculty a blank eligibility checklist that they can use as a valuable tool for ensuring the subject is a good candidate for the study," Lindblom adds.

Another helpful compliance tool is a checklist of what to discuss with participants during the informed consent process.

"We give different departments guidance for talking with participants," Mercado-Cooper says.

These points of discussion include the following:

— purpose of the study

— treatment and schedule of the study

— voluntary choices

— risks and benefits and alternative treatment options

— privacy or HIPAA regulations

— any financial coverage

— study withdrawal or completion

— who to contact

— language assistance, if applicable

— optional procedures, if applicable.

The checklist should cover everything the participant needs to know about the study, Mercado-Cooper says.

After a participant is enrolled in the study, a progress note is dictated. Researchers can use an electronic voice system.

"Every office and institution is different," Finn says. "We have a voice-activated dictation system, and our records are dictated and automatically filed in the electronic health record."

Documentation includes these details:

— Is the patient eligible for enrollment?

— Was there an opportunity to discuss this with the doctor?

— Did the subject verbalize understanding of the study?

— Is the informed consent form signed and dated appropriately?

Signed copies of informed consent documents are kept in the medical record, study file, and sponsor file.

Other items pertain to the session number, the study accrual and treatment planning, the patient's height, weight, chemotherapy notations, and documentation that the patient participated in the discussion process and that the study chair and research staff also participated, Finn says.

Another useful compliance tool lists the total accrued registrations.

"It's a double-check that comes at the end of the entire process," Lindblom says.

For instance, in 2010, the number of active protocols open for accrual was 3,303, Mercado-Cooper says.

"We get about 40 protocol submission requests bimonthly, which is a huge amount of protocols that come through," she adds. "All of these tools are just to ensure that research regulations are in place and being followed in each of the departments."

Reference:

  1. Matza MJ, Finn L, Lindblom MZ, et al. Essential regulatory compliance tools and checklist for the documentation of the informed consent process. Poster presented at the 2010 PRIM&R Advancing Ethical Research Conference, held Dec. 6-8, 2010, in San Diego, CA.