This website is intended for general guidance only, not as a substitute for detailed research or the exercise of professional  judgment. The information herein provided is on an “as is” basis and Obidou makes no representations or warranties, express or implied. This information is not meant to diagnose, treat or manage any mental health condition. If you are concerned about your mental health, please see your primary care provider or go to the nearest hospital emergency service.

Obidou HealthCloud

and the ethical collection and use of data

Obidou HealthCloud provides benefits to multiple stakeholders

 

  1. The clinician/ collector/ workgroup who assesses mental health

  2. The patient/user of the program who has their mental health assessed

  3. Secondary users of data (Ministry of , Insurance, Employers, School boards, Pharma)

Obidou therefore has a number of overlapping goals and obligations as a company

Goals

  • Collect relevant data that can be used primarily for the benefit of the patient/ user and secondarily for the clinician and other stakeholders.

  • Ensure the accuracy and accessibility of data for the benefit of all users

Responsibilities

  • Ethical collection of data

  • Welfare and safety of participants when data is used for research

  • Privacy and security of data in collection, transmission, storage and secondary use

To meet these obligations, Obidou is guided by the following policies, procedures and principles as, documented below.

Tri-council Policy on Ethical Conduct for Research Involving Humans

Canadian Institutes of Health Research

Natural Sciences and Engineering Research Council of Canada

Social Sciences and Humanities Research Council of Canada, 2014

California Bill of Rights

Experimental Research Subject’s Bill of Rights 

California law, under Health & Safety Code Section 24172, requires that any person asked to take part as a subject in research involving a medical experiment, or any person asked to consent to such participation on behalf of another, is entitled to receive the following list of rights written in a language in which the person is fluent. This list includes the right to: 

1. Be informed of the nature and purpose of the experiment. 

2. Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized. 

3. Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment. 

4. Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable. 

5. Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits. 

6. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise. 

7. Be given an opportunity to ask any questions concerning the experiment or the procedures involved. 

8. Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice. 

9. Be given a copy of the signed and dated written consent form. California Subject’s Bill of Rights 08/2011 

 

10. Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s decision. 

Consent for participation and secondary use of data

Documenting Consent

The consent process must be include the following:

  • a restatement of the purpose of the study and the provision of a clear description of study tasks and conditions

  • sufficient prompts to encourage participants to ask questions

  • a reminder of their right to refuse to do anything they find disturbing or uncomfortable

  • an assurance of their right to leave the study at any time without penalty

  • a statement indicating that by consenting, participants do not waive any legal rights

  • the provision of contact information for the researcher and the REB that approved the study

Consent for participation of minors and vulnerable populations 

Assent & Dissent

Even when an individual’s authorized third party (parent) gives consent, it is important to involve the individual (student) to the greatest extent possible.

 

As prospective research participants they may agree (assent) or not agree (dissent) with their parents' decision to consent.

Parents may consent to have their children participate in at the mental health assessment at their school, but if any children choose not to participate, their decision will be respected.

 

Obidou allows both parents and students the opportunity to independently provide or refuse consent.