Informed Consent Process Let’s Digitize It to Conduct the Research Ethically

MSB Docs lets you digitize the way you provide subjects with the information they need to decide to volunteer for a research study. Going digital with us will let you keep up with all the key information elements intact as well as the consent requirements that are set forth in FDA’s regulations on Protection of Human Subjects.

list-icon

A statement that the project is research and participation is voluntary

list-icon

A summary of the research, including:

  • Purpose
  • Duration
  • List of procedures

list-icon

Reasonable, foreseeable risks or discomforts.

list-icon

Reasonable, expected benefits

list-icon

Alternative procedure or course of treatment, if any

Informed Consent Process Goals as per FDA

  • Give clear and intact information about the research to the subject
  • Making sure that the subject has time to have a look and consider all options
  • Answer all the queries raised by the subject before the final decision is made
  • Assuring that subject has a clear understanding of all information
  • Obtain a voluntary informed consent from the subject for his/her participation
  • Continue to give updates to the subject throughout the research study
  • Continue to re-affirm the consent from the subject for his/her participation throughout the research study
FDA-image-new

Challenges with Traditional Practices

Consent Process Diagram

Recruitment Process

Initial Consent

Consent Form

New Risk Information

Change in Research e.g., Procedures, Visits

Loss or Gain of Subject Capacity to Consent

Study Extention

Change in Drug Status e.g. Approval, Withdrawal from Market

End of Study

Long Term

Follow-up e.g., Lifetime for Gene Transfer or Cancer Studies

Ongoing Discussion / Interaction during Study Visits

Various amendments and approvals, when done using paper-based processes increases the cost, time and efforts of the entire team.

How MSB Docs Helps?

electronic-signatures-icon

Avail consent from the subject at various stages using electronic signatures.

amendments-icon

Make as many amendments as required on the documents.

cloud-repository-icon

Easy sync of the updated document in the cloud repository

Include-appropriate-icon

Include appropriate signature and date lines for consent as applicable.

Keep-track-icon

Keep track of records with Audit Trail for each document

Set-alerts-icon

Set alerts to notify the subject about the changes and required signatures

Need more information? Get in touch with us!





    MSB Docs needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, please review our Privacy Policy.