Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 15 July 2014 | By Alexander Gaffney, RAC,
A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator's views on informed consent.
As FDA explains in the draft guidance, Informed Consent Information Sheet, when most people think about the process of obtaining consent, they think of it as obtaining written consent from the subject to participate in a medical study. But FDA says this understanding—while technically correct—is not complete.
"Informed consent involves providing a potential subject with adequate information to allow for an informed decision about participation in the clinical investigation, facilitating the potential subject’s comprehension of the information, providing adequate opportunity for the potential subject to ask questions and to consider whether to participate, obtaining the potential subject’s voluntary agreement to participate, and continuing to provide information as the clinical investigation progresses or as the subject or situation requires," FDA explained in its guidance.
In other words, it's not just about obtaining a signature on a piece of paper, but should instead be about allowing a subject to consider the opportunities and risks inherent in participating in a trial, and whether participation is appropriate for that particular subject.
Even after the informed consent document is signed, the consent process may still continue, FDA added. "Depending on the clinical investigation, additional information may need to be given to the subject, and the subject may need additional opportunities to ask questions and receive answers throughout the clinical investigation."
The guidance itself is fairly straightforward, and contains concepts that should mostly be familiar—if not basic—to professionals who have extensive experience conducting clinical trials.
However, there are several updates relative to FDA's 1998 guide on informed consent.
For example, the draft guidance now contains a section on non-English-speaking clinical trial participants. All information given to a patient "must be in language understandable to the potential subject or legally authorized representative." While this means that the information must be in a language the subject can understand, it also means that it must be written in terms the subject can understand as well. FDA cited data indicating that one-third of US adults have basic or worse health literacy, while one-half of US adults have difficulty understanding numbers and data.
The guidance also introduces a new section on dealing with patients with impaired consent capacity, which can range from minor or temporary impairments to complete impairment. Forms to enroll impaired trial participants may require modification, or a process to allow a legal representative to enroll the subject on their behalf. Institutional review boards (IRBs) and investigators should consider if the inclusion of the cognitively impaired or mentally disabled is "ethically appropriate and scientifically necessary," FDA said.
FDA's guidance also includes an extensive section on the inclusion of children in clinical trials, in which FDA asks that, in addition to the permission of the child's parent or legal guardian, investigators obtain the child's "assent" to participate in the research. FDA notes that "assent" means an "affirmative agreements to take part in a clinical investigation, not just the failure to object."
Other new additions include sections on reviewing patient records, subjects participating in more than one clinical trial, and study suspension/termination.
FDA notes that the draft comes just as federal regulators are considering updates to the Department of Health and Human Services' (DHHS) human research protections, better known as the "Common Rule." FDA said it will work with "other relevant Federal Agencies to facilitate consistency across policies" in the event of an "intersect" between the revised rule and the new draft guidance.
Comments on the draft guidance are due to FDA by 15 September 2014.
Informed Consent Information Sheet (FR)
Tags: Informed Consent, Draft Guidance, IRB, Investigator, Sponsor, Obtaining Informed Consent
Regulatory Focus newsletters
All the biggest regulatory news and happenings.