Suggest Changes Consent Form

Title of research project:

CLEAN Meds Study: Carefully selected and Easily Accessible at No charge Medications – Development of a List of Essential Medications (Phase 1)

Investigators:

Nav Persaud, MD, MSc (Principal Investigator, Li Ka Shing Knowledge Institute of St. Michael’s hospital): (416) 864-6060 ext. 77578.

Sponsor/Funding:

None

Introduction:

You are being invited to consider participating in a research study. Before agreeing to participate, it is important that you read and understand the following explanation of the proposed study procedures. The following information describes the purpose, procedures, benefits and risks associated with the study. It also describes your right to refuse to participate or withdraw from the study at any time. To decide whether you wish to participate in this research study, you should understand enough about its risks and benefits to be able to make an informed decision. This is known as the informed consent process. Please make sure all your questions have been answered to your satisfaction before agreeing or signing this document.

Background & Purpose of Research:

The purpose of this study is to utilize experts (family physicians, nurse practitioners, pharmacists and consultants) and to gather input from other stakeholders to make changes to a draft list of essential medications for Canada. This draft list was adapted from the World Health Organization’s list of essential medicines. Studies have shown that adoption of such a list will reduce errors and costs. Clinicians make better decisions and fewer errors when prescribing from a limited number of familiar medications. Increased adherence to the Swedish evidence-based “Wise List” in Stockholm by 1% was shown to correspond to €4 million or more in savings. The list generated in this study will be evaluated to determine if it covers a high proportion of prescriptions in current practice to be considered useful, whether Canadian society would realize economic benefits from adopting the list and whether physicians would make fewer errors. The results of this project will help inform debates about the merits of introducing a list of essential medications in Canada.

Eligibility:

You have been invited to participate in this study because you are a family physician, nurse practitioner, pharmacist, consultant or other stakeholder in Canada.

Procedures:

If you are eligible and choose to participate as a peer reviewer, you will use this website to review the draft list of essential medications, and answer three questions with explanations. You will be asked the following:

  1. What medications on the list should be replaced with alternatives? (List 3 with explanation)
  2. What medications should be added to the list? (List 2 with explanation)
  3. What medications on the list should be removed without replacement? (List 2 with explanation)

Risks and Benefits:

There are no significant risks to participants. Information learned from this study will be used to make revisions to the draft list. Participants have an opportunity to contribute to the body of research that will inform future debates about medication prescribing in Canada. Results showing that the adoption of a list of essential medications in Canada reduces costs and inappropriate prescribing could influence future healthcare reforms.

Privacy & Confidentiality:

All information obtained during the study will be held in strict confidence. Your name and information will be recorded but your suggestions will be de-identified using a coding document that will assign them a unique participant ID. Original consent forms and identifiable information will be stored in a secured network or locked cabinet until the end of the study. After the study, these records will be similarly secured until a decision to dispose of the study materials.

Participation:

Your participation in this study is voluntary. You can choose to not participate or you may withdraw at any time without any consequences.

Publication of research findings:

We will publish each suggested change including relevant research and conclusions as individual reports. These reports will be posted publicly alongside the final list of essential medications. A list of peer reviewers will be posted publicly to acknowledge contributions, but suggested changes will not be linked to a peer reviewer. The names of core research members and methodologists involved in the decision-making and review of literature for a specific suggestion will be published in the associated report.

Dissemination of findings:

When submitting your peer review suggestions you will be asked if you would like a summary of the study findings. If you are interested in receiving this, please select the appropriate option. A website link showing the final list, reports of changes and contributors will be e-mailed to you when finalized.

Contact Person:

If you have any general questions about the study, please call:
Nav Persaud at: 416-864-6060 x. 3011 (email: nav.persaud@utoronto.ca)

Research Ethics Board contact:

If you have any questions regarding your rights as a research participant, you may call:
St. Michael’s Hospital Research Ethics Board at 416-864-6060 ext. 2557, during regular business hours.

Consenting:

Please read the following statements and then click one of the option buttons below:

  • I understand that I have been asked to participate in a research study.
  • I have received and read the information about the study provided above.
  • I understand the risks and benefits involved in taking part in this study.
  • I have had the opportunity to discuss this study, and my questions have been answered to my satisfaction.
  • I understand that I am free to refuse to participate or withdraw from the study at any time.

Please NOTE:
If you do not wish to participate select “I DISAGREE with one or more of the above statements.”
Your consent to participating in this study is implied by selecting “I AGREE with all of the above statements”

 
I DISAGREE with one or more of the above statements

 
 

I AGREE with all of the above statements

 
Before you click the “I AGREE with…” button, please print this consent form (web page) for your records.