“Informed consent” primarily means that the doctor informs the patient in a comprehensible and as complete a way as possible about the proposed treatment. Treatment refers to all medical procedures performed by the doctor, including examination and follow-up. It should be clear what is the nature and purpose of treatment, what is the diagnosis and prognosis for the patient, what are the risks associated with treatment and what alternatives are possible. You want to treat the participants in your research with integrity. Therefore, ask for your informed consent in advance. You explain to respondents what your research involves, what role they will play in the research, and the possible consequences of participation. Then ask them if they are willing to participate in your research. For any scientific research to which informed consent applies in the aforementioned scheme, there must be a so-called declaration of consent, in which, among other things, one. the content of the study, the duration, possible consequences, risks and rights of the respondent are included. For this reason, the GDPR stipulates that data subjects must have the opportunity to give consent for certain areas of scientific research (“broad consent”) that comply with recognised ethical standards for scientific research.
It is also important to have an eye on other relevant regulations, such as.B. for clinical trials, etc. Informed consent is a procedure in which a person is informed of the possible advantages and disadvantages of medical treatment before deciding whether or not to follow a treatment. Prior consent to information is also an important element of scientific research. Potential subjects receive any information about the study that might be important to them before deciding to participate. Being well informed is often considered desirable for reasons of medical ethics, although it is not always necessary, for example in relatively risk-free treatments or studies. Informed consent can be given by means of a separate form or can also be included in a questionnaire in which the respondent must click on a “tic box” (active action) in case of consent (for the processing of personal data and / or special personal data). This article or an earlier version of it is a (partial) translation of the Informed Consent article in the English Wikipedia, which is licensed under the Creative Commons Attribution/Share Alike License. See the change history here. If a person is unable to give consent (p.B intellectual or other disability, after death or for any other reason), consent must be approved by their legal representative. This consent should preferably be combined with the informed consent that is ethically necessary so as not to burden the respondent too much with the various forms.
The respondent must authorize informed consent (by signature, digitally or on an audio recording) so that their consent is reproducible. According to the KNMG, compliance with the principle of “informed consent” by physicians is not only important from a legal point of view. Good communication with the patient is good for mutual trust and promotes adherence to treatment. A declaration of consent by which, among other things, the defendant is clearly informed of the content of the scientific research and its rights. Yes, informed consent for all respondents with permission for: But even though no consent is required under the GDPR, Tilburg University chooses to obtain informed consent from respondents for new recordings for ethical reasons and where reasonably possible when reusing existing documents. A declaration of consent consists of two parts, the newsletter or brochure and the declaration of consent. In principle, you should always be able to prove that a respondent has given consent. For this reason, ask for active and written informed consent: A respondent indicates that they wish to participate in your research by signing a consent form.
If the basis of the treatment is consent, the declaration of consent must contain at least the following elements: Decision on contact data: Informed consent with consent for: An important starting point of health law is that the patient gives permission to carry out medical treatment. After all, without permission, there is an unauthorized violation of a patient`s integrity. In order to give legally valid consent, the patient needs good information. Therefore, before applying for permission, a doctor must first provide the patient with information about the planned study or treatment. The physician`s obligation to provide information and the requirement for consent form a two-pronged relationship. This is also called “informed consent.” The latter document describes the limitations to be taken into account when using electronic methods to inform a potential subject of a clinical trial and/or to sign the CIF. If a study of diagnostic radiopharmaceuticals (PET/SPECT imaging) is submitted, the text of the following document should be included in the study ICF. To create a research newsletter that does not collect any personal data, we recommend using this template to inform people about the study.
This model was drafted by a working group composed of representatives of BAREC (Belgian Association of Research Ethics Commissions), Pharma.be and patient associations. This working group was coordinated by the CT College of the FPS Public Health, Food Chain Safety and Environment. Consent can only be given by a person if he or she understands and can weigh the facts, implications and consequences of the treatment or research. Therefore, in order to give consent, a person must be sufficiently competent to be able to argue and dispose of all the relevant facts. With certain diseases or disorders, a person himself can not give permission. This may be the case, for example, with high levels of stress in post-traumatic stress disorder, severe mental retardation, severe mental illness, severe sleep deprivation, Alzheimer`s disease or a comatose condition. In the research council for the information of the participants you will find a concrete checklist for the creation of a newsletter. It is very important to document consent (written or oral).
Note: When personal data of minors is processed, there are additional requirements for the security of this data. A “general” permission for “scientific research”, for example, is not valid, as a researcher you need to describe this in more detail (where possible). Consent is not valid even if it is a “take it or leave it” principle where the data subject must agree with all or nothing. .