Starting the collaboration and permissions
It is always a good idea to invest in initiating the collaboration. In the beginning, the company is informed about the services available, the operating methods and principles. The service provider gains more understanding of the product to be developed, the development resources of the company or its objectives in terms of commercialization and marketing. The initial discussion form assists the parties in the first discussions.
If collaboration is launched, a collaboration agreement in writing helps in dealing with the rights and obligations of the parties. General terms and conditions of development activities should be used in drafting the agreement.
One or more members of the development team, the entrepreneur and possibly also other partners, such as the coordinator of the test environment, participate in drafting the development plan. Development activities are always confidential and, if needed, the parties may sign a non-disclosure agreement.
For the participants, a consent form is needed. For the participant to know where he or she is going to participate, a briefing note is drafted to inform about the objective and organisation of the co-creation, testing and user trial, or the support measures of commercialization, data collection during the event, data processing methods, analysis methods and data retention. The consent form and the briefing note shall always be attached to the research permission application.
What permissions are needed and when?
Fimea is responsible for the testing of medical devices and monitoring the companies in the medical field. Monitoring applies to the conformity of devices and materials with the requirements, medical devices already placed on the market and their proper use, compliance of social and health care information systems with the essential requirements, and marketing of medical devices. If applicable, the company acquires the relevant Fimea permissions before starting testing or user trials.
A research permission is needed if
1) in addition to the usability and functionality of the product or service, data on the testers’ experiences or the use of the product are collected in the testing or user trials phase.
2) implementation of testing or user trials requires input and time of the tester and/or the staff, or it requires change in the daily routines.
The research permission procedures vary between municipalities and organisations. First step to find out whether a research permission is needed is to ask the manager of the unit where testing or user trials will be carried out and data collected. The manager of the participating unit knows its research permission procedures to be complied with. As an example, instructions for the research permission practices of the City of Helsinki can be found here.
In the ethical review, the possible harm and damage in relation to the intended benefits and informational value of the trials are evaluated. When reviewing harms and risks, special attention is placed on encounters between parties and the control of unforeseen factors thereof. In all development activities of products and services, the integrity of research participants, risk and harm avoidance, privacy and data protection shall be assured. In some special cases, an ethical pre-review may be necessary, focusing on the same elements as the research permission application.
Human sciences ethics committees operate within the respective universities and universities of applied sciences. The more accurate local and up-to-date instructions can be found on their respective sites, for example, the Metropolia University of Applied Sciences (only in Finnish). The site has a link to the Human sciences ethics committee of the Helsinki Metropolitan Area universities of applied sciences, should the testing require ethical pre-review. Testing activities may also include university research. If, in that case, the testing environment or the funding entity requires ethical pre-review, it can be granted by the Helsinki University Ethical Review Board in the Humanities and Social and Behavioural Sciences. Regional ethical committees for medical research can be found on the nationwide National Committee on Medical Research Ethics site. Ethics committees of the Helsinki University Hospital can be found at HUS Ethics Committees.
Ethical review is needed in testing and user trials if the following criteria are met
1. The study involves intervening in the physical integrity of the research participants.
2. The study deviates from the principle of informed consent of the participants (the review is nonetheless not required for carrying out research on public or published information, register or documentary material, or archived data).
3. The study focuses on minors under the age of 15, without a separate consent or information of the guardian, on the basis of which the guardian could prevent the child from participating in the study, and the study is not carried out as part of the daily activities of a day care unit or school.
4. The study exposes participants to exceptionally strong stimuli and the evaluation of potential harm requires special expertise (e.g. studies involving violence or pornography).
5. The study may involve a risk of causing long-term mental harm, exceeding the limits of normal daily life, to the research participants (e.g. trauma, depression, insomnia).
6. The study may involve a safety risk to the participants (e.g. studies on domestic violence).
In addition, the researcher may ask for an ethics committee opinion, if the research participant, the sponsor or cooperation partner of the study so requires, or if the study results are planned to be published in a scientific journal that requires an ethical review.