General
It is the mission of Genge Partners, Inc. (Genge Partners) to accelerate personalized medical care through clinical research and delivering high quality data. At all times Genge Partners is committed to conducting clinical trials in a manner that strictly adheres to all national and international ethical requirements and clinical trial regulations. Effective adherence to clinical trial regulations requires the gathering, recording, processing, storing, and transmitting of personal data of clinical trial participants, clinical trial investigators, vendors, support staff, and employees.
Genge Partners respects the privacy of individuals of all nationalities in the processing of their personal data, recognizing the fundamental rights to lawfulness, fairness, and transparency. Genge Partners, Inc. adheres to the principles of data privacy by design and by default, including data minimization to the extent possible. Genge Partners adheres to laws relating to data protection in all jurisdictions in which it conducts business, including but not limited to HIPAA, the General Data Protection Regulation (EU) 2016/679 (“GDPR”), and The Personal Information Protection and Electronic Documents Act (PIPEDA).
Personal Data of Clinical Trial Subjects
Genge Partners collects medical and health information about the individuals who take part in clinical trials. This information is collected by investigators and Genge Partners’ staff at the Neuro CRU Partner Site(s). The personal data that is collected and processed by Genge Partners is de-identified (coded) when shared with Sponsors. When consent is required for the collection of personal data, the principal investigators overseeing the trial are responsible for ensuring that the individuals understand and consent to the gathering of sensitive personal data relating to their health, including the transfer of such de-identified information to third parties who may be providing services for the clinical trial.
Genge Partners collection of personal data of clinical trial subjects for it is necessary of a task carried out in the public interest. The processing of sensitive categories of data is carried out for reasons of public interest in the area of public health, and/or for scientific purposes in accordance with Article 89(1) of the GDPR.
Sponsors are only allowed to use the de-identified data as dictated between the individual agreements between the Sponsor and Genge Partners.
Personal Data of Investigators and Business Partners
Genge Partners collects personal data from business partners and vendors who are providing services to Genge Partners. This processing is necessary for the fulfillment of Genge Partners’ contracts with these individuals and their employers and may be required for submission of clinical trial data to governmental and regulatory authorities, Research Ethic Boards, and ethical committees. The basis for collection of physician investigator data is the fulfillment of a legal obligation related to ensuring that investigators are qualified to oversee a clinical trial.
The 10 Principals and Procedures of Privacy and Confidentiality
Accountability
Genge Partners is responsible for personal information under its control and to maintain its confidentiality at all times. All Genge Partners staff share in this responsibility. It is Genge Partners’ responsibility to protect information also entail the assurance that third parties maintain the same levels of privacy as Genge Partners.
Staff, vendors, principal investigators, and associates with access to clinical trial subject and employee information are expected to comply with this confidentiality policy. As part of their orientation to Genge Partners they are asked to sign the Privacy and Confidentiality Standard Operating Procedure indicating they understand and agree to abide by the ten principles of this policy. A copy of the signed statement will be kept in the personnel records. The obligation of confidentiality remains in effect even after termination of employment or contractual agreement.
It is the responsibility of the Genge Partners’ Director to ensure that any person having access to clinical trial subject and employee information is made aware of the policies and procedures concerning confidentiality and that each individual sign the Privacy and Confidentiality Standard Operating Procedure.
Confidentiality of Staff and Genge Partners, Inc. Information
Employee Information
Each employee understands they will not disclose confidential information concerning employees or vendors at the Genge Partners to anyone outside of the company as well as to another employee or vendor of the Genge Partners.
It is the employee's right and vendor’s right to share their own information at their own free will and no other Genge Partners employee or vendor will infringe on that right.
Business Affairs
An employee shall not disclose the business affairs of Genge Partners and shall not use for his/her purposes or the purposes of any other organization or individual any information that s/he may acquire about the operations of Genge Partners, as per the conflict of interest policy.
Identifying Purposed: Why We Collect Information
Information will be gathered from the client/participant or employee and/or third parties for specific purposes. Examples are:
Types of information Collected at Genge Partners
Socio demographics
Medical history (details)
ID numbers, card numbers
Family Members and other contacts
Living arrangements, educations, doctors
Reasons for Data Collection
To provide direct care
To contact clinical trial subject's and their caregivers regarding upcoming events
To submit information required by funding agencies (eg. Ministry of Health)
To plan services
Quality Improvement (eg. Evaluation and chart audits)
Genge Partners must identify the reasons for collecting personal information before or at the time of collection explaining why it is needed and how it will be used.
The purposes for collecting data will be defined as clearly and narrowly as possible to ensure the individual can understand how the information will be used or disclosed.
Any new purpose for information will be identified and the individual’s consent will be obtained before using it.
Clinical Trial Subjects or employees must be informed, either orally or in writing, of all purposes of information collection.
All identified purposes and obtained consents will be recorded for easy reference in case an individual request an account of such information.
Genge Partners will not collect more information than is needed for an identified purpose.
Consent
The valid and informed consent of the individual are required for the collection, use or disclosure of personal information, except when inappropriate.
The Clinical Trial Subject must be informed in a meaningful way of the purpose for the collection, use or disclosure of personal information.
Consent is only valid if the individuals understand how their information will be used.
The individual’s consent will be obtained before or at the time of collection, as well as when a new use is identified.
Consent will be recorded and included in the individual’s file.
Information disclosure will not be made a condition for supplying service, unless the information requested is required to provide the specific service.
The implications of withdrawing their consent will be explained to the Clinical Trial Subject or employee.
For an individual who does not have the capacity to consent, consent may be obtained from a legal guardian, or person having power of attorney.
Valid and Informed Consent
Informed Consent means that the Clinical Trial Subject or employee or substitute decision maker has received information that a reasonable person in the same circumstances would require in order to decide about the benefits and risks of providing their information and the alternative courses of action and the consequences of not providing their information.
Requirement for Valid Consent
A valid consent must meet the following criteria:
Consent must be voluntary.
The clinical trial subject must have the physical and mental capacity to consent.
The clinical trial subject must have been properly informed.
To ensure informed consent the following criteria should be met:
The service provider must disclose to the clinical trial subject the nature of the information gathering, its purpose, any risks, and the consequences of not providing consent.
The coordinator must answer any specific questions posed by the clinical trial subject as to the risks, side effects or any other foreseeable consequences involved in the information gathering. The clinical trial subject must always be given the opportunity to ask questions or to rescind their consent.
The coordinator must note in the clinical trial subject records when consent explanations have been made, as this can confirm that a clinical trial subject was properly informed.
Where there is a language barrier, interpretation will be provided by either a family member or an interpreter provided by Genge Partners.
Limiting Collection
Genge Partners, Inc. will:
Limit the amount and type of information gathered to what is necessary for the identified purpose.
Ensure that staff members can explain why the information is needed.
Ensure there is a justifiable purpose for obtaining and recording information about a client.
Limiting Use, Disclosure and Retention
Genge Partners, Inc. will:
Use or disclose personal information only for the purpose for which it was collected, unless the individual consents otherwise
Keep personal information only as long as necessary to satisfy the purposes.
Keep personal information used to make a decision about a person for a reasonable time period. This should allow the person to obtain the information after the decision and pursue redress.
Document any new purpose for the use of personal information and obtain necessary consents
Access to Patient/Subject and Employee Information
Authorized Staff
Personally identifiable information should be restricted to:
Principal Investigator
Staff assigned to tabulate and collate data
Appropriate administrative personnel
Consultation, examination and treatment are confidential and should be conducted discreetly. Those not directly involved in the care must have the permission of the client to be present.
Retention
Personal data of clinical trial subjects is stored in a proprietary computer system known as Clinical Conductor Clinical Trial Management System (CTMS) which only authorized individuals can access on a need to know basis and with access records maintained in an audit trail. Access to other personal data is restricted to authorized employees on a need to know basis.
Genge Partners may store some business records or clinical trial documents in hard copy (paper or disk) format, as required by law or regulation, or pursuant to the fulfilment of a legitimate business purpose. Genge Partners has in place a document retention policy, pursuant to which documents are retained for the minimum time necessary, and then securely destroyed. Long-term storage of hard copy documents may be carried out by a qualified third-party vendor.
Accuracy
Genge Partners will:
Make reasonable efforts to ensure that the personal information collected is accurate and complete
Minimize the possibility of using incorrect or incomplete information when making a decision that affects an individual or when disclosing an individual's information to another organization
Safeguards: Protecting Your Information
Genge Partners deploys encryption, firewalls, access controls, and other procedures to protect data from loss, misuse, unauthorized access, disclosure, alteration, and destruction.
Genge Partners reserves the right to take appropriate disciplinary and/or legal action if an employee or vendor is found to misuse patient, employee, or business information.
Openness: Keeping You Informed
Genge Partners will notify Clinical Trial Subjects of what information they collect, the use of that information, prior to obtaining consent. In addition, when feasible and appropriate, Genge Partners will obtain Clinical Trial Subjects of using personal information for a new purpose or before transferring their personal information to the control of a third party.
Access and Correction
Clinical trial subjects should contact Genge Partners, or the Principal Investigator of the study, to enquire about choices and means available for limiting the use and disclosure of their personal data under applicable data privacy laws. The rights available to a clinical trial participant may be limited pursuant to an exception to the applicable data privacy law to preserve the integrity or scientific value of the data collected.
Challenging Compliance
Genge Partners is committed to cooperating to the full extent of applicable law in the exercise of the rights of Clinical Trial subjects. Any Clinical Trial subject who wishes to exercise his or her rights under applicable data privacy law, or to inquire about the processing of his or her data by Genge Partners, should contact Genge Partners pursuant to the Contact Section of this Privacy Policy.
Contact
For more information about Genge Partners’ commitment to protecting data privacy, or to exercise any rights you may have under applicable data privacy laws, please contact Genge Partners at info@GengePartners.com, by telephone at 1 514 906 3876 ex 6026 or by mail at 5100 Boulevard de Maisonneuve Ouest, 6th Floor, Montreal, Quebec, H4A 3T2 Canada Attn: Genge Partners.