Below are your responses to the Screening Tool questions.
These response options are weighted.
A ✔️ indicates a "Yes" response. Affirmative responses are identified as areas of ethical risk. Please review.
A ✖️ indicates a "No" Response.
Your score indicates that the most probable purpose of your project is Quality Improvement or Program Evaluation. Please proceed to determine the category of risk to your participants.
Risk Filter for Quality Improvement and Evaluation Does your project involve...
14. Likelihood that a breach of confidentiality could place participants at risk of legal liability, denial of insurance or other damage to financial standing, employability, or reputation?* There is widespread agreement about the rights of individuals to privacy and the corresponding duty of investigators to treat private information in a respectful and confidential manner. This item assesses whether the current project is higher risk in terms of the probability that serious consequences could occur should there be any breach of confidentially of the private information being collected. Informed consent ought to be sought from all participants if this risk applies.
The best protection of the confidentiality of personal information and records is through anonymity. When that is not possible, project leaders should indicate the extent of the confidentiality that can be promised to participants. Strategies or countermeasures to mitigate (ease the response should it occur) this risk should be clearly described in the plan and to the participants. There should also be a plan to limit access to and provide secure storage of the private information for a specified period of time and with a specific plan for its destruction at the end of that timeframe. These should be clearly outlined on the consent form and during the consent process.
Please refer to the Privacy and Information Security Legislation and Regulations in your jurisdiction. For example: Alberta – Freedom of Information and Protection of Privacy Act (FOIPP), Health Information Act (HIA); British Columbia – Freedom of Information and Privacy Association (FIPA); Ontario – Health Information Protection Act (HIPA).
15. A real or potential conflict of interest between an investigator and the sponsor of the investigation?* "Sponsor" means the funder or benefactor or champion of the investigation or project. A conflict of interest between an investigator and a sponsor may exist in any part of the project where decisions are made, including during data collection, data analysis and reporting of findings.
Biases may easily influence decisions at any stage of QI or evaluation projects since they are integral to an organization’s accountability to the public to demonstrate service quality.
Recommended Actions: The conflict of interest needs to be disclosed upfront. Further, measures should be included upfront in the project plan to counteract any undue influence from a conflict of interest on any aspect of the project; for example, dealing with negative findings. Countermeasures can include removal of the influence through recusal in the decision-making process or use of a third party in elements of the project to protect confidentiality of personally identifying information.
Notes on COI: A conflict of interest (COI) occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other. One way to understand this is to use the term "conflict of roles". A person with two roles—an individual who is providing programs or services and is also the leader of a project, for example—may experience situations where those two roles conflict. Ways to mitigate conflicts of interests include removal, disclosure, recusal, third party evaluations and codes of ethics.
16. A power relationship between the investigator and participants (e.g., manager/employee, therapist/client, service provider/recipient, teacher/student)?* If undue influence is present in the context in which the project will be carried out by virtue of the trust and dependency that exists in a power relationship, participants may feel restricted in how free they are to choose to participate in or withdraw from the project. Relationships such as manager/employee, health provider/patient, service provider/recipient and teacher/student are particularly fraught with power imbalances. The potential for any exertion of undue influence by an existing power relationship has to be carefully considered in the design of the project. Consideration should be given to any potential perceptions of the participants that may affect their responses. The design ought to include ways to reduce any form of coercion over participants.
Informed consent should be considered for all participants if this risk applies.
Include measures in the project plan to protect private information to ensure participants are shielded from potential retribution and feel free to share their ideas or information. Suggestions in the case of the manager/employee situation: Have someone else as project lead and data collector. Anonymize all data to the respective manager of the employees. Clearly outline in the informed consent process all risks and the plan to counter them.
Please refer to the Privacy and Information Security Legislation and Regulations in your jurisdiction. For example: Alberta – Freedom of Information and Protection of Privacy Act (FOIPP), Health Information Act (HIA); British Columbia – Freedom of Information and Privacy Association (FIPA); Ontario – Health Information Protection Act (HIPA).
17. Questions that collect information about sensitive issues, illegal behaviour, stigmatizing conditions or behaviours, or religious or cultural beliefs or practices?* Questions that touch on these and other sensitive issues may be anticipated to cause participants to be cautious in how they respond. This private information once collected may have consequences beyond the project that need to be anticipated in advance.
Countermeasures to protect privacy and confidentiality which minimize (reduce or curtail the magnitude of the potential response) or mitigate (ease the response should it occur) any potential negative impacts on participants should be built into the plan. Examples of countermeasures include appropriately trained personnel collecting the information and linkage to appropriate support resources. The need for obtaining informed consent ought to be carefully thought out in the context of the specific project.
Examples of such sensitive issues include sexual orientation and practices. Examples of stigmatizing conditions or behaviours include physical, learning, or another type of disability; mental illness; gender identity; and age.
18. Inexperienced project leads?* There may be potential for greater risk to participants in projects where inexperienced project leads are involved. They may lack the experience or skills needed to carry out projects or may, in some cases, not have the supervision needed to compensate for their inexperience.
Inexperienced project leads may include but are not limited to students, staff, trainees, interns, research assistants, or post-doctoral fellows.
19. Collection of data through technical procedures or diagnostic tools routinely employed in the setting?* This item refers to standard practices in the setting used to collect data as part of the QI or evaluation project at hand. Examples of such technical procedures include BP, Ht, Wt, TPR, ECG readings, and IQ. Another example is assessment to determine accommodation requirements for disabilities or health conditions, and literacy testing.
20. The use of tests, surveys, interviews, oral history, focus groups, or observation of public behaviour where the participants can be directly or indirectly identified through the information recorded?* Tests can include but are not limited to cognitive, diagnostic, achievement, and aptitude. The risk here is that using these methods to collect private information from participants may have the potential to breach their confidentiality by revealing personal information. Beware that small numbers in a group can lead to identification of a person or persons even if all individually identifying features have been removed from the data.
Consider the need for informed consent to be transparent with participants about the risks of their involvement and to inform them how you will be protecting their privacy. Have appropriately trained personnel collect the information. Include in the project plan appropriate strategies regarding access to and secure storage of the private data.
21. Collection of data from voice, video, digital or image recordings?* The risk here is that using these methods to collect private information from participants may have the potential to breach their confidentiality by revealing personally identifying information. Consider the need for informed consent to be transparent about the risks involved and to inform participants how you will be protecting the privacy of their information. Who has access and secure storage of the private data are also important considerations in the project plan.
22. Personally identifiable data, documents, records or specimens originally collected solely for purposes not related to the current study?* Personally identifiable information that was originally collected for the purpose of providing care or service is now proposed to be used for another purpose (i.e., a secondary use). In other words, the information was originally collected for person-centric purposes (i.e., just for the care or service of one person) and now the proposal is to use it for a purpose other than care or service of that specific person.
Projects that propose to use data originally collected for other purposes (e.g. chart reviews, academic transcripts) need to include safeguards to protect against any breach of the privacy and confidentiality of these individuals. As well, there may be consent issues with respect to the individuals from whom the data was originally collected and to be respectful, informed consent ought to be part of the project plan.
Please refer to the Privacy and Information Security Legislation and Regulations in your jurisdiction. For example: Alberta – Freedom of Information and Protection of Privacy Act (FOIPP), Health Information Act (HIA); British Columbia – Freedom of Information and Privacy Association (FIPA); Ontario – Health Information Protection Act (HIPA).
23. Special populations or any individuals or groups in a socially vulnerable position?* Special populations include but are not limited to pregnant women, children, frail elderly, prisoners, refugee claimants, students, staff, persons with disabilities, sexual minorities, Aboriginal people, and visible minority groups. The Canadian Human Rights Act identifies the prohibited grounds of discrimination are race, national or ethnic origin, colour, religion, age, sex, sexual orientation, marital status, family status, disability and conviction for an offence for which a pardon has been granted or in respect of which a record suspension has been ordered.
Examples of individual behaviours that may contribute to vulnerability include but are not limited to perception, cognition, motivation, identity, language, communication, social behaviour and cultural beliefs or practices. Ethical obligations to vulnerable individuals and populations often require special policies or procedures to protect their interests. Anyone can experience feeling vulnerable depending on the context of a specific project; for example, a senior executive who is a patient participant for the purposes of a QI project.
Although asking questions to a person may create feelings of anxiety and concern, under the Canadian Human Rights legislation, the collection of data related to race, disability, sexual orientation and any other provincial Human Rights grounds are allowed. The important point to consider is how the data is collected, maintained, used and destroyed within the organization. By not managing data in alignment with standards set by the provincial Human Rights Code, Protection of Privacy Act and PIPEDA (Personal Information Protection and Electronic Documents Act), organizations can be deemed non-compliant. Similar legislation may exist in other countries.
24. An original or novel process for which it would be difficult to estimate a balance of risk and benefit in advance?* This item refers to the use of a new or innovative approach to a QI or evaluation project where little is known about the risks and benefits to participants in its use. For example, in the recent past the use of digital story telling was once a novel method because it had never been used in the process of collecting data in an evaluation project.
25. Risks of breaching the confidentiality of any individual's personal information beyond that experienced in the provision of routine service or day-to-day life?* For example, a letter, fax or e-mail to a participant that includes sensitive information. The risk here is that using these methods to transmit private information about participants may have the potential to breach their confidentiality. Consider the need for informed consent to be transparent about the risks involved and to inform participants how you will safeguard the privacy of their information.
26. A person who does not normally have access to participant records and whose use of records is for a secondary purpose?* This item assesses the current project in relation to the following higher risk situation: someone outside of the usual providers of programming, care or service has access to personally identifying information. Plus, this individual(s) is collecting this data for purposes other than the original intent of its collection during routine care, programming or service.
In other words, the information was originally collected for person-centric purposes (i.e., just for the care or service of one person) and now an individual who does NOT normally have access to the data is collecting the information for a purpose other than care or service of that specific person.
It is important to ensure that safeguards are in place to protect against any breach of the privacy and confidentiality of personal information. Consult the appropriate articles in the Health Information Act or other legislation in your province regarding access and other provisions. Consider doing a privacy impact assessment or other consultation to ensure appropriate protections.
Please refer to the Privacy and Information Security Legislation and Regulations in your jurisdiction. For example: Alberta – Freedom of Information and Protection of Privacy Act (FOIPP), Health Information Act (HIA); British Columbia – Freedom of Information and Privacy Association (FIPA); Ontario – Health Information Protection Act (HIPA).
27. Any significant departure from the routine care, program, or service provided to participants or the gathering of information about participants beyond that normally collected?* This item assesses the use in the current QI or evaluation project of a clinical technique or procedure that is a significant deviation from usual care or data collected from the participant. This means the technique or procedure is invasive and different or more than that used in routine care. For example, the collection of additional blood samples for purposes of the QI or evaluation project at hand, administering additional or extended testing (cognitive, psychological), requesting additional assignments or feedback from participants in a pilot program, or observation of participants. Examples of information that is beyond what is normally collected may include demographic information, medical history, or previous experiences (educational).
28. Risks or burdens for participants which are beyond what would be experienced in routine care or beyond what a reasonable person might expect in day-to-day interactions?* Examples of potential risks for participants include physical, psychological, spiritual, and social harm or distress as a result of an element of a QI or evaluation project. Examples of burdens over and above routine care or expectations in day to day interactions may include feelings of intrusiveness, discomfort, or embarrassment arising from an element of a QI or evaluation project.
29. Questions or procedures that might cause participants psychological distress, discomfort or anxiety beyond what a reasonable person might expect in day to day interactions?* For example, questions that raise painful memories or unresolved emotional issues or procedures that involve manipulation in some manner may be anticipated to potentially cause discomfort, anxiety or distress in participants. Project leaders should anticipate all potential reactions that may be triggered by these types of questions or procedures. Countermeasures designed to minimize (reduce the potential for a distress, discomfort or anxiety response) or mitigate (ease the response should it occur) ought to be included in the project plan. Informed consent should be obtained and potential risks identified to all participants with a description of how these risks will be minimized (reduced) or mitigated (eased).
Some countermeasures: Have appropriately trained personnel administer the questions or procedures. Provide appropriate support and resource contact information.
30. Intended deception or intended incomplete disclosure of the nature of the investigation?* This item assesses whether the project has been intentionally designed to deceive or to not completely disclose aspects of the project to the participants. The focus is whether the design is intended to make the participants believe something that is not true. Clear justification ought to be provided for the need for the deception or incomplete disclosure to accomplish project objectives. There should be clear description about how the benefits outweigh the risks of the deception or incomplete disclosure. All associated risks have to be identified and mitigation strategies built into the project design.
Note: Projects with this risk should be considered for the highest level of recognized review within the organization or setting.
31. Evaluation of the safety and effectiveness of a mechanical device, drug, or natural health product?* This item applies to understanding or improving the use of an approved product (under the Health Canada Food and Drug Act regulations or guidelines) in the local context.
32. Clinical studies on a device, drug or natural health product where Health Canada review and approval is not required?* The study involves a product already approved for its intended use in the specific project or it involves a product that does not fall under Health Canada regulations and guidelines.
More information. 33. Therapeutic procedures that are themselves known to pose considerable risks of harm?* Examples of such considerable risks of harm include surgery, chemotherapy, radiation therapy.
34. Any procedures related to anesthetics, sedation, or any alteration of medication that is not normally part of participant care or health?* Examples of alteration of medication includes asking participants to increase, decrease, or refrain from taking medication for anxiety or ADHD.
35. Non-invasive procedures beyond what is normally required for participant care?* Examples of such non-invasive procedures include imaging or microwaves.
Notes You can take notes for each section as you go through the Screening Tool.
