The new face of informed consent

Krell Clinical developed VECTER in reaction to current informed consent forms (ICFs) that are often so difficult for study participants to understand. VECTER is an informed consent document that assists potential participants in arriving at an informed decision. VECTERs are written in the simplest possible language that conveys required information. VECTERs combine readable content and proven design elements to create a single, cohesive, eye-pleasing informed consent document that engages readers and promotes fuller understanding of the clinical research.

What makes a VECTER informed consent document better?

VECTERs are carefully written so that the reading level is at 8th grade or below. And, VECTERs are tested and proven to deliver better reader comprehension by potential study participants than traditional ICFs. VECTERs have been verified to increase comprehension in a joint industry-sponsored research study. Results of that study can be shared by contacting Krell Clinical for a teleconference and online presentation.

VECTERs are designed by professional graphic designers who make the pages attractive and interesting enough to encourage study participants to read the informed consent document thoroughly.

VECTERs protect patient rights

Most ICFs are written at too high a reading level. A 2006 study confirmed that 90% of ICFs are written at an 11th grade level or higher. However, 50% of US adults cannot read any higher than an 8th grade level. So, it’s easy to see why traditional ICFs make it nearly impossible for study participants to understand their rights and responsibilities as well as details about the study. VECTERs are written and designed to protect patients' rights and safety by ensuring the IC document can be understood.

VECTERs create realistic expectations

By organizing content in a reader-friendly format and clearly communicating study requirements and schedules, VECTER informed consent documents enable potential participants to fully grasp their role in the study.

VECTERs cultivate trust

By limiting the use of medical and legal jargon, a VECTER informed consent document fosters a feeling in potential participants that both the study and the investigator can be trusted.

VECTERs conform to your workflow

VECTERs don’t require the purchase of any new technology or any change in your review process. VECTERs are delivered to you via email in Microsoft Word format so all reviewers can read, review, comment, with or without track changes, and even revise the document as they usually would.

VECTERs meet and exceed industry guidelines

The International Conference on Harmonisation (ICH) has clearly defined informed consent:

"A process by which a subject voluntarily confirms his or her willingness to participate in a specific clinical trial after having been informed of all aspects of the clinical trial that are relevant to the subject’s decision to participate."

Any irrelevant information that is presented in an ICF undermines both the regulatory compliance and legal standing of the document. That’s why VECTERs stay on point, delivering only required information in easy-to-understand language.

VECTERs meet and exceed the requirements and recommendations of the Food and Drug Administration (FDA), Health and Human Services (HHS), National Institutes of Health (NIH), and International Conference on Harmonisation (ICH) guidelines, as well as the requirements of local and central Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs).