1. Irish Legislation 2. Health and Safety 3. Insurance 4. Garda Clearance 5. Responsibilities 6. Design Project Protocol 7. Risks and Benefits 8. User Engagement Plan 9. Data Management Plan 10. Ethics Protocol 11. Ethical Approval 12. Reimbursement or Payment 13. Understanding the Specific Needs of Your Users 14. Confidentiality and Privacy 15. Participant Information 16. Informed Consent 17. Use of Data 18. Following up with the User
“Who” section could be converted into RACI matrix for whole document, explaining roles for all of the sections Are Actor descriptions appropriate? Non- standard terms. Everything written in terms of academic institution performing study in medical research arena – not allowing for any other scenarios.
Summary Checklists seem to be well written. The Details have too much waffle. Details moved to after Summary Checklists. Could be split into principles and practise – could be better organised with Background etc. References not cited. No section numbers.
Large assumptions made that there will be a Research Ethics Committee available who will be able to provide everything. No direction given for the case where no such committee exists. The “Student” is wholly dependent on the direction given by the Principal Investigator and Lecturer on ethical approval.
Self-contradicting: reimbursing and coercion versus “not out-of-pocket” Suggests that person with learning difficulty send emails instead of written consent.
Student seeking informed consent should be overseen by the Lecturer and Principle Investigator. Specific guidelines should be referred to which define sufficient participant information, perhaps published by the institution. The type of event that would require renewal of informed consent should be defined. The user should be consulted on their specific needs, or the users guardian should be consulted in order to define how the “comfort, wellbeing and dignity” of the user can be ensured. The user's needs should be communicated to all parties involved in the project prior to the commencement of any activity.
Page and section numbers Split “Details” into Principles and Practice Review Data Protection advice- not sure it is correct/ goes far enough. What does “secure manner” actually mean? Put participant information and informed consent into “” to set aside from std text. Check punctuation References not clear to which parts these are relevant.
The sentence structure is too long Is a Participant a user? – if so settle on one term Lack of glossary Separate the what from the how – identify what needs to be done from how or why it needs to be achieved
Needs a hierarchy in the definition Principal investigator and Lecturer do not have sufficiently different defined roles Similarly, Student and User appear to have similar roles
Redefine with hierarchy: Institution: Preparing the code of practice Lecturer: Prepare ethics protocol in line with the institution’s code of practice. Advise students on how to follow the protocol. Student: Follow ethics protocol and provide feedback on the protocol to the lecturer.
Who is the document aimed at? There should be a statement of assumptions and definitions e.g. What is a risk? What is a benefit? Ethics protocol details section description of risk and mitigation too complicated. Type of project will determine risk and benefits e.g. Investigative project to discover outcomes.
Create a protocol template. Need guidelines on how this is done Define what will be done to/by the user, and how the results will be used. References at the end of the document, but no citing in the main body of text.
The description of the users is repeated throughout every section as is their roles even when they remain the same as the preceding sections. The document would benefit from a hierarchical map or table of the users, and their responsibilities.
Legislation is often highlighted with no explanation of its provisions, similarly repeated references occur, while no appendix or bibliography is apparent. The four sections overall appear quite “wordy” and appear to have been generated as stand-alone sections with no attempt to concatenate them.
The legislation highlighted that the following people are involved, the principal, the lecturer, the student, the user and the institution. Their roles differ, the principal, the lecturer and the institution are required to understand their responsibilities and provide advice. The students and users role is just to understand and adhere to it. It identifies the difference between private and public institutions and the legalisations degree of applicability to each. It outlines several types of legalisation. These cover the requirements in engagement ranging from ethical approval, informing users, obtaining consent, retaining and destroying data, confidentiality, storage, provision of access, adherence to legislation and discrimination.
It outlines the five different parties, the principal, the lecturer, the student, the user and the institution. Health and safety is concerned with the engagement of activates. The role of the principal and the lecturer is to identify health and safety issues and inform the students. The student’s role is to adhere to the codes of practice. The user should highlight any requirements they have for health and safety e.g. if the user has a wheel chair and requires mobility access, the institutions role is to provide guidance to staff and students. The nature of the interaction is important e.g. tasks that could affect physical and mental wellbeing should be considered in regards of health and safety.
Insurance needs to be in place for all parties involved in any type of engagement. The roles involved include the principal, the lecturer, the student, the user and the institution. Students and users should raise questions and make sure that insurance is in place. The principal and the lecturer need to discuss with the institution what kind of insurance is in place and if anything further is required. The institution and the principal are responsible for ensuring that any insurance and indemnity are in place before any engagement takes place. It needs to cover both the institution and any sponsor even if the sponsor is outside of the institution. There may be potential issues with regard to the nature of the project and these should be reviewed with regard to health and safety.
The section on Garda Clearance refers to the requirement of all agents involved in user engagement with potentially vulnerable user groups to seek clearance from the National Vetting Bureau in advance. The principal and lecturer should identify if students and staff require clearance well in advance of user engagement. The student should ask if they require Garda Clearance, while the user should consult with their organisation if they have concerns about engaging with designers or design students and discuss these with the with Garda. The institution must advise staff and students. There are details in this section which discuss the change in legislation.
No Difference between the role of the Principal Investigator and Lecturer. Unclear on what students role is “If user feedback is students responsibility” The User section puts the onus on the user to find out how their data is being used.
Good that policy allows follow after the user input Nice that Users can be called out for recognition. User engagement form is mentioned but it could be created so that there is temple sent with the project. A hierarchy of who is in charge and summary of terms would also be useful
No difference between the Principal Investigator and Lecturer The Details part doesn’t offer me any extra information than the Summary Checklist, so it can be replaced with the second one and get rid of the hard language used, that, in my opinion, it is not useful.