Establishment of a PPIE initiative may require consideration of finances, ethics and contracts dependent on institutional requirements, collaborations and funding arrangements. While these are primarily guided by project and context-specific considerations, below are some key points when planning a PPIE initiative.
Budget
Effective and meaningful patient and public involvement and engagement requires finances for personnel, compensation and reimbursement of patient and public partners (Chapter 5), marketing and outreach (Chapters 6-7), meetings (Chapter 8), activities of the PPIE initiative (Chapter 9) and evaluation (Chapter 10). Ideally, each research project and grant application should have a budget for PPIE, as obtaining separate funding for PPIE is challenging - See the funding page on Mesh for potential sources. Coming up with a budget requires clarity on your project plan, proposed activities and local costs. A budget worksheet can be found in Appendix D.
Ethics
No consensus exists nationally or internationally about the necessity of obtaining ethics approval for the establishment of a PPIE group consisting of patients, their families and the public, and each jurisdiction approaches the issue differently. Some argue that the involvement of patients in any activity requires the oversight of an ethics committee, while others maintain that involvement in PPIE groups is fundamentally different to being a research subject and thus does not fall under the remit of institutional review boards. Our recommended approach is to obtain written confirmation from the committee that no ethics is required or an exemption from ethics has been granted for the establishment of the PPIE group. This practical approach ensures that your team has a document to share in case a funder, journal editor, collaborator, senior leader or any other party feels ethics approval is needed. Appendix E provides further guidance and a worksheet for an ethics exemption application for the establishment of a PPIE group. Some PPIE activities may require ethics approval depending on the nature of the activity. It is always best to liaise with your institutional review board in case of uncertainty. The recommendation above pertains only to the establishment of a PPIE group to advise or collaborate with researchers.
Contracts
Depending on your funding arrangements and collaborations, you may need to have contracts or memorandums of understanding to facilitate your PPIE initiative. For example, a Memorandum of Understanding (MoU, Appendix F) can be used to formalise collaborations with other institutions. In cases where a PPIE initiative provides funding to compensate patient and public partners at other institutions, for example, a Research Collaboration Agreement (RCA, Appendix G) may be used. The main difference between the two documents is that an RCA usually requires the involvement of a legal and finance team while the MoU may be simply signed by senior leadership.