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Best practice for project consent documentation
This flow will help you get into the mindset of best practice for project consent activity creation.
When creating the participant consent documentation there are several important blocks of information to consider in order to create an explanatory material that covers all bases. Follow the below guide of our tips on creating the participant consent documentation.
Please keep in mind!
This blog post has been written by digital analysts, not lawyers. It cannot be considered as professional legal advice. So as privacy legislation, this information is subject to change. We strongly advise administrators to consult privacy professionals and supervisory authorities in order to have the most up-to-date information.
This blog post has been written by digital analysts, not lawyers. It cannot be considered as professional legal advice. So as privacy legislation, this information is subject to change. We strongly advise administrators to consult privacy professionals and supervisory authorities in order to have the most up-to-date information.
- Participation details
- First and foremost you shall provide participants with information regarding their participation. As the Consent documentation might be the participants' first informative contact with the project, it is important to cover any participation and inclusion criteria.
- The participants will definitely want to know the procedures, steps, and the length of the project, as well as the possible benefits or financial reimbursement that they might receive. It is crucial to emphasize that participation is voluntary and refusal to participate will not involve any penalties or denial of benefits.
- Data protection and confidentiality notice
- Another essential block of information is data protection and confidentiality regulations to assure the participants that their personal data will be safe. The categories of personal data that will be collected and the purposes for processing must be identified, as well as the legal basis and the data retention period. In this section you should also cover any recipients or data transfers outside of your organization (that's why Longenesis should be regarded as the Data Processor). Of utmost importance is to notify your participants about their rights to:
- Rectify any incorrect data about them;
- Withdraw consent (where data processing is based on it);
- Restrict processing (if certain conditions apply);
- Access the data collected about them;
- Receive their data in a structured machine readable format (or transport them to another Controller right away).
- NB! If the project is planned to include the data of participants based in the European Union, it is highly recommended to consult the Articles 13 and 14 of the General Data Protection Regulation for details on what information must be communicated to the data subjects when personal data is obtained from them. If your participants happen to be located outside of the EU, it is highly recommended to consult the respective data privacy and confidentiality legislation.
- Another essential block of information is data protection and confidentiality regulations to assure the participants that their personal data will be safe. The categories of personal data that will be collected and the purposes for processing must be identified, as well as the legal basis and the data retention period. In this section you should also cover any recipients or data transfers outside of your organization (that's why Longenesis should be regarded as the Data Processor). Of utmost importance is to notify your participants about their rights to:
- Risks or discomforts
- Yet another important topic to include is the potential risks or discomforts that the participants should consider before committing to the project. Information on any serious or likely risks or discomforts should be included. The disclaimer should not overwhelm your participants with all the possible risks and their likelihood, rather be an overview of the most serious or common ones.
- However, if there are none known, it will be reassuring for the participants to know that, as well.
- Who are we?
- Last but not least, it is important to introduce the research project team for transparency and clarity purposes. This is the best time to let the participants know who the project administrators are, as well as introduce all project partners or sponsors if there are any.
Alongside the introduction of the team, you should provide emergency contact information and individuals to reach out to in the event of pertinent questions or if any problems need to be reported. This way a sense of clarity and safety will be established which will, in turn, encourage honest engagement.
- Last but not least, it is important to introduce the research project team for transparency and clarity purposes. This is the best time to let the participants know who the project administrators are, as well as introduce all project partners or sponsors if there are any.
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