2 nd Training Seminar on Planning and Preparing for EHES at the National Level Key points regarding informed consent Susanna Conti Istituto Superiore di Sanità (ISS) Italy’s National Institute of Public Health

This presentation Key points i.Informed consent form / information material ii.Performing the field work

Goals of informed consent The goal of obtaining informed consent is to ensure that the participant has a full understanding by providing complete and clear information. This information is provided on what is generally referred to as an “informed consent form”. However, this can actually consist of more than one document (referred to as “information material”).

Documents comprising the information material Invitation letter: serves to introduce the HES to study candidates Information notice: contains the information necessary for understanding the study; can be a separate document or combined with the informed consent form Informed consent form: to be signed by the participant

Strategies for providing information material to study candidates How and when these documents are provided to study candidates can vary. - For example, providing them in advance of the scheduled visit provides participants with time to read/understand the information. The format can also vary. - For example, if most of the information is provided in the information notice, then the invitation letter and informed consent form can be brief. The three documents should be complementary, without excessive overlap, so as not to burden the study candidate with too much reading.

Strategy (Example 1) Invitation letter + exhaustive information notice both sent some days before beginning the study FOLLOWED BY: Synthetic informed consent form provided when the candidate presents for the study

Strategy (Example 2) Invitation letter + synthetic information notice both sent some days before beginning the study FOLLOWED BY: Exhaustive informed consent form provided when the candidate presents for the study

Strategy (Example 3) Invitation letter sent some days before the study exhaustive information notice on a web-site, with toll-free telephone number for questions FOLLOWED BY: written information notice (the same published on the web-site) and informed consent form provided and explained to the candidate when presenting for the study, by the operator (e.g., nurse, physician), who will answer any of the candidate ’ s questions.

Supplementary tools Additional means of providing information may include: Toll-free telephone help-lines for clarifying participants’ concerns Web sites for providing additional information support Translation into other languages

Key points: Informed consent form / Information material Numerous items can be included on the information material We discuss some of the key elements, which can be considered as obligatory: Introductory information on the HES Data collected and tests performed Use of results Confidentiality/Privacy

Introductory information on the HES Clear explanation of what a HES is Why it is being conducted Utility of a HES, with examples Importance of participation, with examples How participant was chosen That participation is voluntary Data will be kept confidential

Data collected and tests performed What information will be collected What analyses will be performed (and NOT performed, for instance, HIV and drug testing) Time needed (including number of visits) (important not to underestimate time)

Use of results Whether or not the participant would like to receive results of analyses Who will have access to data (may depend on legislation) Specifying that persons with access to data will not have information that can be used to identify the participant General practitioners and insurance companies

Confidentiality/Privacy Assure the participant that: information will be kept confidential - describe procedures used - specify the legislation that protects data no one with access to information will be able to identify participant Provide the participant with a contact information for violations of privacy

Additional key points Depending on whether or not certain activities are performed, other key points may be included in the information material: Risks (the low risk of blood sampling could be mentioned) Compensation (may be prohibited by legislation) Record linkage (may be prohibited by legislation) - Explanation - Explicit permission to do so Biobanks (storage time may depend on legislation) - Explanation - What tests will not be performed (e.g., HIV, drug testing) Additional studies and follow-up

Key points: Performance of field work Informed consent is a process of communication between an individual and the healthcare professional who is conducting the study. Thus, it is fundamental that the operators are proficient in communication, especially because they may be the first or only individuals with whom the participant has contact.

Communication Whatever format or materials are used for the information material, the operator should be able to answer any questions the participant may have and to develop a rapport with the participant. This could also affect the willingness of the participate to allow his/her samples to be used for future studies.

Support material provided to operators To help the operators to answer participants ’ questions, some standard, simple definitions and explanations (which can be understood by lay persons) of some terms and concepts could be developed, such as: Importance of a HES, in general and in the specific country Definition of privacy and data protection Definition of an ethics committee

Example: Importance of a HES “State of health of the Polish society is still not satisfactory in spite of some improvement. It is mainly connected with improper style of living of Poles and with not sufficient control of well known cardiovascular risk factors that maintain the highest threat of the modern societies. Therefore under the patronage of the Ministry of Health, scientific teams…have prepared National Multicenter Health Survey….” - WOBASZ (National Multicenter Health Survey, Poland)

Example: Definition of privacy and data protection Data protection is the safeguarding of data against unauthorized access or accidental or deliberate loss or damage. Each country has specific legislation regarding data protection and privacy, generally referred to as a “Data Protection Act”. For example, in Italy, Decree no. 196 of 2003.

Example: Definition of ethics committee Ethics committee An independent group of people that includes doctors, nurses, medical staff, members of the public and sometimes lawyers. This committee decides if proposed studies are ethical: that is, they verify the integrity of the study and ensure the safety, integrity and human rights of the study participants. This committee protects people's fundamental rights and freedoms and in particular their right to privacy with respect to the processing of personal data. In practice it provides a way for individuals to control information about themselves.

Conclusions The issues regarding the obtainment of informed consent are important, in that they can affect the participation rate, not only in the HES but also for further research among the same individuals (follow-up studies). They constitute both a legal and, even more importantly, an ethical obligation.