Designing your informed consent

At present, the informed consent procedure is the most effective way to respect the privacy and autonomy of study subjects and the confidentiality of their medical research data. Informed consent aims at informing a potential study subject of all the aspects of participation, including data handling and anonymity. An informed person can freely decide to participate or not. If someone does participate, he or she understands and accepts the risks and burdens involved in that participation. It is of utmost importance that you make sure the proper consent for any human subjects is in place, both on anonymous use as well as on the use of the pseudonymised data.

The Central Committee on Research Involving Human Subjects (CCMO) has produced guidelines for obtaining informed consent. The ethical committee at your UMC can help you design your informed consent procedure.

Regarding data management, the informed consent should include the person's wishes:

  • about the use and reuse of patient data for research in the current project and in future projects (including the options for data filtering: which data may be used for research);
  • to be notified about the research findings (special concern is required for data and results which cannot be interpreted now, but may be interpretable in the near future);
  • about which data he can access, if applicable;
  • possibility of withdrawing certain aspects of informed consent and the consequences;
  • about data use by commercial parties.

Note that in general, it is very difficult to re-contact patients or study subjects to extend or change the consent. So when you are working with medical data, we advise you to obtain informed consent for storing clinical (and personal) data for the purpose of both healthcare and future scientific research, each with a separate specific informed consent (also see chapter 'Being aware of the data environmentcare research or both?'). In addition, patients should always be able to retract their consent, so your system should allow for data to be removed.

Frequently Asked Questions

The Central Committee on Research Involving Human Subjects (CCMO) has developed the 'Help me on my way' instrument to assist you in the reviewing procedure for medical research. This can help you determine if your research falls under the scope of the Medical Research Involving Human Subjects Act (WMO).

A procedure for non-WMO research in all UMCs is under construction.

  • eBROK cursus;
  • GCP cursus;
  • courses in scientific integrity (research ethics);
  • The Central Committee on Research Involving Human Subjects (CCMO) has developed an e-learning for clinical researchers (in Dutch).
  • The World Medical Association (WMA) has developed the Declaration of Helsinki , a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.