REMOTE ICF

REMOTE ICF: AN MODERNISTIC APPROACH TO CONSENT PROCESS

INTRODUCTION:

Clinical trials play an important role in improving quality and effectiveness of health care by systematically evaluating efficacy and safety of new treatments or interventions. Even though there is a lot of importance clinical trials have few challenges in order to obtain high-quality, timely and actionable evidence through clinical research. These challenges comprise length of the study, budget constraints, ethical and regulatory requirements and difficulty in recruiting & retraining participants. 

While 80% of the general population is responsive to clinical trials and there are several barriers that include adequate requirements, lack of proper physician and awareness among people, and difficulties in informed consent process.

Challenges related to informed consent process include:

1. Patient travel burden

2. Work flow challenges

3. Scheduling differences between research staff and participants

4. Patient difficulty in understanding the consent document

The current widely used consent process involves face to face meeting between the subject and the recruiter. Presently consent can be obtained remotely using telephone, mail, fax or e-consent however these approaches have their shortcomings.

REMOTE ICF IS A SOLUTION?

Yes it is, to avoid time consuming consent process here is a novel idea called REMOTE ICF or in other words it is called TELECONSENT. Teleconsent allows researchers to obtain informed consent from participants through telemedicine technology. By utilizing R-ICF researcher can increase access and improve enrolment in clinical trials. Teleconsent helps researchers to recruit participants anywhere from the world. Teleconsent does not replace consent mechanisms rather it aims to provide details to them in order to increase access to a wider research studies.

Features of Teleconsent:

During a Teleconsent call the researcher can select and display an informed consent document that is viewed and completed during the session. The Remote ICF is coded with HTML, audio, video, images and other interactive capabilities. This allows the participant to have clear picture of the R-ICF. This session has only access to researcher and participant so that the data will be confidential.

Above picture showing the screenshot of the R-ICF session

ELECTRONIC SIGNATURE:

 A common challenge with theses digital documents is to obtain a legally verified signature that complies with 21 CFR Part 11 subpart C, the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures. “Photo signature” approach for obtaining a verifiable signature from users. The user types his name in a form field; the app then takes a snapshot of the user at the time the signature was completed, captures the user's IP address along with the date and time it was signed. Together this information provides the legal verification that person signing the document at that place and time. In addition to photo signature the user has the option to free draw on the touch screen or moving mouse pad on the signature box in the document.

PRIVACY AND SECURITY:

Protecting information of the participants is the primary focus of R-ICF. As R-ICF is built on Doxy.me platform each and every data is encrypted. Once the R-ICF document is finalized and approved saved to a user's computer as a PDF file, it becomes the responsibility of that user and their institutional policies to manage and protect the document.

INSTITUTIONAL REVIEW BOARD APPROVAL:

The role of IRB is to ensure the safety of subjects who are participating in the study. As R-ICF is new approach to obtain informed consent it is subsequently obtain approval form from IRB. 

The primary concern of IRB includes:

1. Participant information is kept confidential

2. The integrity of informed consent document is intact and verifiable.

3. The IRB can remove or change R-ICF template 

ADVANTAGES:

1. R-ICF can overcome gaps and barriers from the traditional informed consent process

2. It helps rural and underprivileged region people to participate in the study

3. R-ICF helps researchers to recruit subject from outside the geographical of the research.

LIMITATIONS OF R-ICF:

1. R-ICF requires the participant to have access to a computer with strong internet connection.

2. Allowing researcher to author their consents and submitting them for approval by IRB. 

3. Automated capture of the consent into the clinical trials system by recording and capturing the participant options via checkboxes as computable data elements for storage and retrieval

CONCLUSION:

Obtaining informed consent for research can be a challenging task, which can impact the ultimate success of a study. R-ICF is a new technology that helps telemedicine technology to overcome barriers related to participant access. With R-ICF, a researcher can interactively complete a consent document with a participant in real time as part of a video call. By making it easier and more convenient for a participant to provide consent remotely, researchers are able to improve study recruitment and accrual rates, leading to more efficient and effective clinical research.

-Rafijani Shaik

Pharm-D

Clinosol Research Pvt. Ltd...

rafisjani@gmail.com