and the ethical collection and use of data
Obidou HealthCloud provides benefits to multiple stakeholders
The clinician/ collector/ workgroup who assesses mental health
The patient/user of the program who has their mental health assessed
Secondary users of data (Ministry of , Insurance, Employers, School boards, Pharma)
Obidou therefore has a number of overlapping goals and obligations as a company
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
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 Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice.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
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.