During a research study, a researcher may notice something that he or she was not looking for. This is called an “incidental finding.” These unexpected findings are not directly related to the research. However, they may show important information about the health of a research volunteer or any other relevant issues.
About health research
Research is not the same as personal medical care. When you visit your own doctor as part of your medical care, your health and well-being are your doctor’s top priority. However, if you take part in a research study, your personal health is not the focus of the research. Medical research tries to answer a specific scientific question. Research tests and activities are not meant to provide you with medical care.
Participating in research is a choice
Protections are in place for the safety of all research volunteers (also called “research subjects”) and to ensure volunteers are treated with respect. Being part of a research study is voluntary – it’s your choice. Ask for help if you don’t understand something. You should never feel rushed or pressured. You can change your mind at any time, for any reason.
What are incidental findings?
During a research study, a researcher may notice something that he or she was not looking for. This is called an “incidental finding.” These unexpected findings are not directly related to the research. However, they may show important information about the health of a research volunteer.
What are some types of incidental findings?
There are many types of incidental findings. Some examples include:
→ Learning new information about you and your health
→ Learning that you have a medical or psychiatric condition that you did not know about. (This condition may or may not be treatable.)
→ Discovering that you or your family members might have a risk of developing an illness in the future. (This could affect family planning decisions.)
Sometimes researchers may not know what a finding means, or how it might affect your life or your overall health.
Will researchers share their findings with me?
The decision to share research results and unexpected findings depends on the type of information and your preferences as a research volunteer. Researchers may share some or all of their findings with you. However, you may not learn about any findings for a very long time. It is also possible that researchers will not share any results or incidental findings.
Ask the researchers what information they will share with you (if any). Ask what resources are available if you find out something unexpected about your health.
Learning of incidental findings
Benefits: You might benefit from learning about incidental findings. For example, these findings might tell you about your risk of developing a disease. In some cases, you might be able to take steps to reduce your risk. In other cases, this information might help you make decisions in your life. Some findings may also help your blood relatives, who might share your risk of developing a disease or condition. You should discuss any incidental findings with your doctor.
Risks: It can be very upsetting to learn unexpected information about your health. This is especially true if you learn that you have or will develop a condition that has no treatment or cure. There is a chance that incidental findings could affect your family or social relationships, change your family planning decisions, or affect you financially. You might need more tests and procedures to find out what the information really means. It’s also possible that the information might be incorrect, so you would worry without cause.
The study team will go over an Informed Consent Form with you and explain the study goals and possible risks and benefits. Talk with the study team about incidental findings. Ask about the risks and benefits of learning about these sorts of findings. Consider how this kind of information might affect you and your family.
Risks, inconveniences and incidental findings arising from your participation in the study
- Risk for your health and incidental findings
As explained below, the only risk is to ask periodically for health parameters (Blood pressure, heart rate, oxygen saturation, respiratory capacity and sleep quality) and to answer questionnaires about the quality of life.
Likewise, periodic house checks for energy data should be performed. The procedures used to carry out the research are not invasive and cannot cause any physical harm. However, the collection of health data (Blood pressure, heart rate, oxygen saturation, respiratory capacity and sleep quality) and answering questionnaires about the quality of life may provide information about your health status. When our researchers obtain information that makes it advisable for you to consult your doctor, this information will be passed on to the competent municipal or health service so that they can contact you.
For example, if we become aware that you may be at risk of hypertension, this information will be provided to you by the appropriate municipality or medical service.
- House checks for energy data
Likewise, periodic house checks for energy data should be performed. There is no risk in this research activity. However, if our researchers obtain any relevant information from which a risk to your health can be deduced, for example, the use of heating systems that emit excessive CO2, you will be notified.
- Entry into your home.
You authorize the entry of individuals to enter your home to install sensors, monitor energy consumption, collect health information, or interview you. If you feel uncomfortable, believe that your privacy is not adequately respected or consider that there is any inappropriate behaviour by our staff, please notify us at firstname.lastname@example.org (contact person and TF).
- Data Protection.
In order to achieve the objectives of this research, your data will be processed with due guarantees by means of pseudonymization techniques, adopting the appropriate security measures and compliance with current legislation on data protection. For further information, please refer to the seventh section on personal data protection and to the informed consent that you must formalize.