RARE Toolkits

Below is a list of all of our current RARE Toolkits.

Shaping Informed Consent

Shaping Informed Consent

By the time a potential research participant is presented with an informed consent form, it has gone through an extensive legal and institutional review board process. It is not the starting point for a negotiation with researchers over the study. They will not be able to alter the conditions spelled out in the document. The individual’s only choice is to sign the consent form and participate in the study, or not.

Shaping Informed Consent

This does, however, represent an important opportunity for rare disease advocacy groups to get involved early in studies, before the consent forms are created to ensure that data from a study is leveraged as best as possible. This includes questions about what information they will have access to from a given study data, whether data will be shared with patients, available to other researchers, and how widely that data will be shared.

Patient advocacy groups working with researchers as sponsors or helping with enrollment of patients have an opportunity to shape how data is used and other ways to enhance the benefits of a study to its participants. Though there is an ongoing dialogue between researchers and patient groups over such issues, it is becoming more common for patient groups to seek a more active role in helping design clinical trials. These groups should make clear from the start that they want to have an active role in shaping the consent form if these are issues of concern.

John Wilbanks, chief commons officer of Sage Bionetworks, a Seattle-based nonprofit organization in Seattle that promotes open science and patient engagement in the research process, says that patient groups may want to consider a set of issues to consider regarding research studies and says if they hope to play an active role in shaping these issues and the consent form, they must play an active role early in the process of designing a study. Among the questions to consider are:

• Will patients get a copy of their own data and if so, in what form and what timeframe?
• Will researchers be required to share their data with other researchers?
• Will the patient organization have access to the study data and under what terms?
• What happens to the insights that are created from the study?
• If drugs are devices created as a result of the study, will patients get anything in return, such as discounts on the drug or device?

Though patient advocacy groups can expect it to be difficult to get researchers to agree to some of these issues, John Wilbanks says they do have leverage because of the important role they can play in recruiting patients to participate in studies and keeping them committed to them. Raising these issues after the informed consent form is created will be too late.

Quote Mark

“Recruitment is unbelievably hard. It’s really expensive and trying to engage patients enough so they stay in the study is really hard. If you can access a source of patients through an organization that has permission—social permission, cultural permission—to contact those people regularly to say, ‘Hey, you should enroll in this,’ or ‘Have you done your tasks this week for the study.’ That’s going to work faster than almost any acquirable resource can.”


John Wilbanks

Chief Commons Officer of Sage Bionetworks