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.
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
Challenges with Traditional Practices
Consent Process Diagram
New Risk Information
Change in Research e.g., Procedures, Visits
Loss or Gain of Subject Capacity to Consent
Change in Drug Status e.g. Approval, Withdrawal from Market
End of Study
Follow-up e.g., Lifetime for Gene Transfer or Cancer Studies
Various amendments and approvals, when done using paper-based processes increases the cost, time and efforts of the entire team.
How MSB Docs Helps?
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