This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No. 824021
Informed Consent form
Annalisa Landi
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
ETHICAL & REGULATORY CONTEXT
ETHICAL & REGULATORY CONTEXT
“Participation by individuals capable of giving
informed consent as subjects in medical research
must be voluntary.
Although it may be appropriate to consult family
members or community leaders, no individual
capable of giving informed consent may be
enrolled in a research study unless he or she
freely agrees.”
One of the three fundamental ethical principles for using any human
subjects for research is the Respect for persons:
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. THE BELMONT REPORT - Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1979
protecting the autonomy of all people and
treating them with courtesy and respect and
allowing for informed consent. Researchers
must be truthful and conduct no deception…
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ETHICAL & REGULATORY CONTEXT
• GUIDELINE 9: INDIVIDUALS CAPABLE OF GIVING INFORMED CONSENT
• GUIDELINE 10: MODIFICATIONS AND WAIVERS OF INFORMED CONSENT
• GUIDELINE 11: COLLECTION, STORAGE AND USE OF BIOLOGICAL MATERIALS AND
RELATED DATA
• GUIDELINE 12: COLLECTION, STORAGE AND USE OF DATA IN HEALTH RELATED RESEARCH
• GUIDELINE 16: RESEARCH INVOLVING ADULTS INCAPABLE OF GIVING
INFORMED CONSENT
• GUIDELINE 17: RESEARCH INVOLVING CHILDREN AND ADOLESCENTS
• APPENDIX 2: OBTAINING INFORMED CONSENT: ESSENTIAL INFORMATION FOR
PROSPECTIVE RESEARCH PARTICIPANTS
ETHICAL & REGULATORY CONTEXT
‘Informed consent’ means a subject's free
and voluntary expression of his or her
willingness to participate in a particular
clinical trial, after having been informed of
all aspects of the clinical trial that are
relevant to the subject's decision to
participate or, in case of minors and of
incapacitated subjects, an authorisation or
agreement from their legally designated
representative to include them in the clinical
trial
Reg (EU) n. 536/2014* definition
‘Consent’ of the data subject means any
freely given, specific, informed and
unambiguous indication of the data
subject's wishes by which he or she, by a
statement or by a clear affirmative action,
signifies agreement to the processing of
personal data relating to him or her
Reg (EU) 2016/679 (GDPR) definition
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*It was adopted and entered into force in 2014, but the timing of its application depends on confirmation of full functionality of Clinical Trial Information System through an independent audit, estimated at the end of 2020.
ETHICAL & REGULATORY CONTEXT
The anticipated benefits justify the foreseeable
risks and inconveniences
The subjects, or his or her legally designated
representative, have been informed
The subjects, or his or her legally
designated representative,
have given informed consent
The rights of the subjects to
physical and mental integrity, to privacy and to the protection of the data concerning
them are safeguarded
Little pain, discomfort, fear and any other foreseeable risk for
the subjects and both the risk threshold and the degree of distress specifically defined in the protocol and
constantly monitored
The medical care provided to the subjects is the
responsibility of an appropriately qualified medical
doctor
The subject or his or her legally designated
representative provided with the
contact details of an entity where further information can be
received
No undue influence,
including that of a financial nature,
is exerted on subjects to
participate in the clinical trial
CLINICAL TRIAL REGULATION PROVISIONS ON CONSENT
New clinical trial Regulation-Reg (EU) n. 536/2014
Prior to the beginning of the trial, the investigator should have the favourable opinion of the Ethics Committee on the written informed consent form and any other written
information to be provided to subjects!
A clinical trial may be conducted only where all of these conditions
are met!
CLINICAL TRIAL REGULATION PROVISIONS ON CONSENT
Informed consent:
❖ in emergency situations
❖ in paediatric trials
❖ for incapacitated subjects
❖ in ‘cluster trials’
❖ for pregnant or breastfeeding women
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DETAILS on the content are in CHAPTER V of
the Clinical Trial Regulation -Protection of Subjects and
Informed Consent
“The informed consent foreseen under the Clinical Trial Regulation must not be confused with the notion of
consent as a legal ground for the processing of personal data under the GDPR.
Provisions of Chapter V CTR on informed consent, in particular Article 28, respond primarily to core ethical
requirements of research projects involving humans deriving from the Helsinki Declaration.
The obligation to obtain the informed consent of participants in a clinical trial is primarily a measure to
ensure the protection of the right to human dignity and the right to integrity of individuals under Article 1
and 3 of the Charter of Fundamental Rights of the EU; it is not conceived as an instrument for data protection
compliance.”
Besides the consent to the research, participants MUST provide the researcher with the consent to the processing of their personal data…
The lack of consent to data processing may compromise the
participation in the study!
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Interplay between the Clinical Trials Regulation (CTR)
and the General Data Protection Regulation (GDPR)
GDPR PROVISIONS ON CONSENT
Consent remains cornerstone as main legal basis for the processing of personal data!
Request for consent to be presented in a manner which is clearly distinguishable from the other matters, in an intelligible and easily accessible form, using clear and plain language. (Article 7)
The data subject shall have the right to withdraw his or her consent at any time. (Article 7)
For consent to be informed, the data subject should be aware at least of the identity of the controller and the purposes of the processing for which the personal data are intended. (Recital 42)
It requires an affirmative action: silence, inactivity or pre-ticked boxes should not constitute consent!
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✓ TYPE OF DATA PROCESSED
✓ THE PURPOSES/FUTURE PURPOSES OF THE PROCESSING
✓ THE DURATION OF DATA STORAGE OR THE CRITERIA TO DETERMINE IT
✓ ANY TRANSFER OF PERSONAL DATA TO A THIRD COUNTRY AND THE APPROPRIATE SAFEGUARD MEASURES
✓ ANY AUTOMATED DECISION-MAKING (including profiling)
✓ THE RESPONSIBLE FIGURES FOR DATA PROCESSING (the controller, Data Protection Officer “DPO”, the
recipients of the personal data)
✓ THE MAIN RIGHTS OF THE SUBJECT (right to request access or deletion of personal data, the right to request
rectification of personal data, the right to restrict the processing or to object to processing, the right to data
portability, the right to lodge a complaint with a supervisory authority and the right to withdraw consent)
Information to be provided to the data subject when processing personal data
(Articles 13-14)
GDPR PROVISIONS ON CONSENT
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The informed consent process is a dynamic and continual process which begins when the recruitment of subjects starts BUT does not end
with the signature of the subject…
INFORMED CONSENT PROCESS
INFORMATION
COMPREHENSION
VOLUNTARY DECISION
COMPREHENSION MONITORED AND
MAINTAINED
AVAILABILITY OF NEW
INFORMATION
RE-CONSENT
INFORMED CONSENT FEATURES
freely given
informed
given for a specific purpose
reasons for processing
clearly stated
explicit and given via a positive act
clear and plain
language
possible and easy to withdraw consent
INFORMED CONSENT FORM
Informed Consent Form
Information sheet
Consent form
A signed and dated copy of the full
Informed Consent Form must be given to
study participants
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To share information about the research with the participant
For signatures if the participant agrees to take part
PART I: INFORMATION SHEET
What will be done with the results?
What will we need to do if you/your child takes part?
What about genetic testing?
What should I do if I want to transfer data and samples?
What will happen if we decide not to take part?
Will my confidentiality be respected?
To whom may I address questions about the research?
Who is organizing this research?
What are the possible benefits and disadvantages of taking part?
Why are you doing this study?Why have I/has my child been
asked to take part?
Have been foreseen secondary uses of data and samples?
What will be done with data and samples after the end of the
research?
Information on the Trial
DrugPurpose
Procedures and
Protocol
Duration
Side Effects
Risks
BenefitsReimbursements
Confidentiality
Study results
Right to Refuse or Withdraw
Subject’s rights
Alternatives to
Participating
Contact informa
tion
PART I: INFORMATION SHEET
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Study titleName of
research centre
Name of Principal
Investigator
Name of Sponsor
Protocol code, version and date
[Information sheet for ____________________]
Introduction part containing information on the research study
PART I: INFORMATION SHEET
PART I: INFORMATION SHEET
Talk to anyone they feel comfortable
talking with about the research
Take time to reflect on whether they
want to participate or not
Ask questions on the research at any
time
Receive more explanations of the words or concepts participants do not
understand
Study participants will be given the possibilities to….
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➢ Introduction part
PART I: INFORMATION SHEET
ARISE TEMPLATE
➢ Introduction part
Description of the study/ research and the reason of the invitation to participate in the research
➢ Why are you doing this study?➢ Why have I/has my child been
asked to take part?
Details on the project
Details on the disease
Study rationale
Study purposes
PART I: INFORMATION SHEET
➢ Description of the research study
Description of the study/ research and the reason of the invitation to participate in the research
Why are we doing this study?
Details on the project
Details on the disease
Study rationale
Study purposes
Future purposes
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PART I: INFORMATION SHEET
Example: Sickle Cell Disease (SCD) is an autosomal recessive disorder of haemoglobin S (HbS) gene. […] This study is included in a research project developed by a multi-disciplinary workforce of paediatricians, haematologists, laboratory scientists and other health workers in order to foster sharing of best practice in newborn screening, diagnosis and treatment of SCD
leading to improvement in overall disease outcome. <PLEASE INCLUDE STUDY PURPOSES/FUTURE PURPOSES (if any)>We are asking your child to participate in this study because affected by SCD.
<PLEASE ADD OTHER INCLUSION CRITERIA>.
➢ Description of the research study
What are the possible benefits and disadvantages of taking part?
Description of the risk and benefit of taking part in the research
Example: Currently, there is no direct benefit for you. However, your participation will allow us to gain knowledge about SCD and other haemoglobinopathies.
There is no risk for your health. <PLEASE INCLUDE OTHER DETAILS ON THE BENEFITS AND RISKS, if any>.
An ad-hoc insurance must be agreed if needed
PART I: INFORMATION SHEET
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➢ Risks & Benefits
Description of the procedures that will be undertaken
Example: Your participation consists of allowing us to use your data and blood samples. <PLEASE INCLUDE DETAILS ON
DATA AND SAMPLE TYPES AND, IF A PROSPECTIVE COLLECTION IS FORESEEN, THE STUDY PROCEDURES FOR THE COLLECTION> The data and samples will be pseudonymised
under a unique study number and sent to specialized laboratories in … <PLEASE INCLUDE DETAILS ON DATA AND
SAMPLE TRANSFER>. There, we will perform <PLEASE INCLUDE DETAILS ON THE ANALYSIS TO BE PERFORMED>.
➢ What will we need to do if you/your child takes part?
Type of analysis
Sample collection
Data collection
Genetic tests
Secondary use of data
and samples
PART I: INFORMATION SHEET
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➢ Study procedures
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Purposes of the storage
Accessibility conditions of samples and related data
Location and duration of retention
Responsible persons for keeping samples and results
Procedure for handling any stored identifiable samples
Possible transfer of samples and related data
Plans to handle data and samples after the storage period
PART I: INFORMATION SHEET
➢ Study procedures
Sample collection
➢ What about genetic testing?
The consent for genetic testing MUST be different from the consent obtained
for the main research!
PART I: INFORMATION SHEET
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➢ Study procedures
Genetic testing
Use of sample
Genetic tests
Storage of samples
De-identification of samples
Use of data associated with
samples
Being re-contacted for
further research
Receiving information
on the results of the study
Authorisation to….
Description of possible further uses of data and samples
➢ What will be done with data and samples after the end of the research?
➢ Have been foreseen secondary uses of data and samples?
Consent for further purposes should be obtained in the original
consent…
or
Subjects should be re-contacted for being involved in other
studies…
PART I: INFORMATION SHEET
➢ Study procedures
Secondary use
“It is often not possible to fully identify the purpose of personal data processing for scientific research
purposes at the time of data collection. Therefore, data subjects should be allowed to give their
consent to certain areas of scientific research when in keeping with recognised ethical standards for
scientific research […].”
GDPR - RECITAL 32
GDPR - RECITAL 33
Further processing for (…) scientific (…) research purposes (…) shall, in accordance with Article 89(1), not be considered to be incompatible with the
initial purposes!
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PART I: INFORMATION SHEET
➢ Study procedures
Secondary use
“Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of them”
“If the controller has conflated several purposes for processing and has not attempted to seek separate consent for each purpose, there is a lack of freedom….”
Paragraph 7.2 - Scientific research
“When research purposes cannot be fully specified, a controller must seek other ways to ensure the essence of the consent requirements are served best, for example, to allow data subjects to consent for a research purpose in more general terms and for specific stages of a research project that are already known to take place at the outset. As the research advances, consent for subsequent steps in the project can be obtained before that next stage begins. Yet, such a consent should still be in line with the applicable ethical standards for scientific research…”
PART I: INFORMATION SHEET
➢ Study procedures
Secondary use
Description of the measures to be adopted to safeguard the confidentiality of
participants
➢ Will my confidentiality be respected?
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PART I: INFORMATION SHEET
➢ Subjects’ confidentiality & data protection
ARISE TEMPLATE
Compliance with the European General Data Protection Regulation (GDPR) Reg. (EU) 2016/679 and
with applicable national/local laws
Data subject’s rights
Transfer of data and samples
Responsible figures for data processing
De-identification measures (e.g. pseudonymisation,
anonymisation)
Data storage (i.e. period and location)
Access to data
PART I: INFORMATION SHEET
➢ Subjects’ confidentiality & data protection
DATA MINIMISATION
PRINCIPLE
“Personal data”: any information relating to an identified or
identifiable natural person (‘data subject’); an identifiable natural
person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a
name, an identification number, location data, an online identifier or to
one or more factors specific to the physical, physiological, genetic,
mental, economic, cultural or social identity of that natural person
“Processing”: any operation or set of operations which is performed on
personal data […] such as collection, recording, organisation, structuring,
storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission,
dissemination or otherwise making available, alignment or
combination, restriction, erasure or destruction
“Pseudonymisation”: the processing of personal data in such a manner
that the personal data can no longer be attributed to a specific data
subject without the use of additional information […]
“Genetic data”: personal data relating to the inherited or acquired genetic characteristics of a natural
person which give unique information about the physiology or the health of that natural person [..]
“Biometric data”: personal data [...] which allow or confirm the unique
identification of that natural person (e.g. facial images or dactyloscopic
data)
The GDPR does not concern the processing of anonymous
information!
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PART I: INFORMATION SHEET
➢ Subjects’ confidentiality & data protection
Compliance with the European General Data Protection Regulation (GDPR) Reg. (EU) 2016/679
Please check the other applicable national/local
laws!!
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What will happen if we decide not to take part?
Voluntary Participation!Please indicate clearly that the decision to participate is entirely voluntary. If they
decline to participate, they will continue with their normal care.
Description of what will happen if participants decide not to take part in the study
Example: It is up to you as to whether or not taking part in this study. If you agree to participate, you will sign an informed consent form. If you decline to participate, you will continue with the normal care. Your decision will not have any influence in the management of the disease. Your decision to participate is entirely voluntary.
The study will be conducted on the basis of fair compensation in the case of damage, on the rights and safeguards dictated by law, on the right to refuse or to
withdraw from the study at any time without giving a reason for the decision. Your confidentiality will be maintained at all times.
No further data besides that essential for the study will be collected.
Right to refuse or to withdraw from the study at any time without giving a reason for the decision!
PART I: INFORMATION SHEET
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➢ Subjects’ confidentiality & data protection
Data subject’s rights
Besides the rights to withdraw consent at any time, since the coming into force of the GDPR, the subject should be informed of the following rights:
❖ Right to request access to personal data
❖ Right to request deletion of personal data
❖ Right to request rectification of personal data
❖ Right to restrict the processing or to object to processing
❖ Right to data portability
❖ Right to lodge a complaint with a supervisory authority
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PART I: INFORMATION SHEET
➢ Subjects’ confidentiality & data protection
Data subject’s rights
Ad-hoc DATA SHARING/MATERIAL TRANSFER AGREEMENTS should be set up to ensure that the transfer is performed in compliance with all applicable laws
➢ What should I do if I want to transfer data and samples?
Please consider that for transferring anonymised data the GDPR does not apply!
The transfer is allowed only if the consent has been obtained from the study
participants!
PART I: INFORMATION SHEET
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➢ Subjects’ confidentiality & data protection
Transfer of data and/or samples
“Any transfer of personal data which are undergoing processing or are intended for processing after transfer to a third country or to an international organisation shall take place only if.…”(Article 44)
➢ ADEQUACY DECISION (Article 45) - adequate level of protection assessed by the Commission the transfer does not require any specific
authorisation!
Periodic review of the decision.. at least every four years!
➢ NO ADEQUACY DECISION (Article 46) the transfer is allowed only if appropriate safeguards have been provided by the controller or processor
The data subject has explicitly consented to the proposed transfer, after having been informed of the possible risks of such transfers for the data subject due to the absence of an adequacy decision and appropriate safeguards (Article 49)
DEROGATIONS FOR SPECIFIC
SITUATIONS
✓ Data controller /processor in the EU collecting personal data about a data
subject of any country, anywhere in the world
✓ Data controller/processor based outside the EU collecting personal data
on EU citizens
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PART I: INFORMATION SHEET
➢ Subjects’ confidentiality & data protection
Transfer of data and/or samples
Information on the sponsor and on the main contact for addressing questions on the research
➢ Who is organizing this research?➢ To whom may I address questions
about the research?
Example:This research is organized by <NAME OF THE SPONSOR>
Any question that arises after reading this document should be addressed to:
Dr. _________________________ (center IP)Hospital ______________________Department of __________________Address_________________________
PART I: INFORMATION SHEET
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➢ Subjects’ confidentiality & data protection
Role & responsibilities
Source: Elixir LU. Webinar on Requirements in data protection law and the upcoming General Data Protection Regulation (GDPR). Feb 2018
Additional roles and new
responsibilities
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PART I: INFORMATION SHEET
➢ Subjects’ confidentiality & data protection
Role & responsibilities
➢ What will be done with the results?➢ What will happen in case of incidental
findings that might be relevant for study participants’ health status?
Description of the how the study results will be made public and if the data subject will be informed on study results. Description on how to deal with incidental findings
Example: The summary of the study results will be made publicly accessible through the web portal https://www.ariseinitiative.org/ <PLEASE ALSO INCLUDE
INFORMATION ON THE PUBBLICATION OF ANONYMISED RAW DATA, IF APPLICABLE>.Aggregated study results may also be communicated to the scientific community
through congresses and scientific papers, maintaining full patient anonymity.You can be informed of the overall study results if you wish, at the end of the project.
Aggregated and anonymous data for the dissemination activities
Overall study results at the end of the project
Consent from study participants if disseminating pseudonymised data
PART I: INFORMATION SHEET
➢ Study results
Plan for the management of incidental findings
PART II: CONSENT FORM
Study titleName of
research centreCode of the
patientName of Sponsor
Protocol code, version and date
ARISE TEMPLATE
❑ have read and understood the information sheet (version ..., date....) provided relating the study
<PLEASE INSERT STUDY TITLE> and have received a copy of this document.
❑ have been able to ask questions which have been answered fully.
❑ understand that my child’s participation is voluntary and I am free to withdraw, without giving any
reason and my child’s care will not be affected in any way.
❑ have had enough time to fully consider my child’s participation in the study.
❑ want to be informed of the overall study results at the end of the project.
❑ give permission to be informed of incidental findings that might be relevant for my child’s health status.
PART II: CONSENT FORM
PART I – CONSENT TO THE RESEARCH:
❑ understand that my child’s clinical information may be reviewed by properly authorized individuals as part of the study and that such information will be treated as strictly confidential.
❑ am aware of the type of data and samples that will be collected.
❑ give permission for using of the samples and data for the study purposes stated in the information sheet.
❑ am aware that the persons stated in the information sheet will have the authority to access my child’s study data and medical records.
❑ agree that anonymised study data will be communicated or published in specialized reports.
❑ give permission for storage of the study data and samples until <please include the storage period>.
❑ am aware of the identity of the data controller and of the data protection officer.
❑ am aware of the transfer of data.
❑ am aware that I have the right to request access to and rectification or erasure of my child’s personal data or restriction of processing concerning personal data or to object to processing as well as the right to data portability.
❑ am aware that if I/my child withdraw from the study, samples will be destroyed and data already collected will be anonymised andmay be processed by authorised researchers.
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PART II: CONSENT FORM
PART I – CONSENT TO THE THE DATA PROCESSING:
As detailed in the information sheet
Genetic purposes
Further purposes
Study purposes
When you give your consent, you will asked if you gave permission for using samples and data for…
Please consider that you should obtain consent to
further use existing data/samples or to recontact
participants for obtaining new consent for other researches!
PART II: CONSENT FORM
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PART II: CONSENT FORM
ARISE TEMPLATE
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PART II: CONSENT FORM
I/we authorise the participation of my/our child in this research study
Print Name of Parent(s)/Legally designated representative(s)__________________Signature___________________Date ___________________________
Day/month/year
If only one parent is signing this document, please confirm
☐ I confirm that the other parent does not oppose to the participation of our child in this study, or
☐ I am the only legally designated representative.
For research studies involving minors…
ARISE TEMPLATE
A researcher or the person going over the informed
consent must sign each consent.…
I declare that I have fully informed above mentioned parent(s)/ legally designated representative about this research study. If during the study new information becomes available that could
influence the consent of the parent(s)/ legally designated representative or can help to provide new treatment or healthcare I will immediately inform them.
Researcher: ______________________ Date: ___ / ___ / ___(Please write in capital letters)
Signature: _______________________
PART II: CONSENT FORM
If illiterate but giving oral consent…
PART II: CONSENT FORM
ARISE TEMPLATE
QUESTION
❑YES
❑NO
Considering that information related to the clinical trial as well as to the data protection is included in the same sheet, should the consent to data processing be separated from the
consent to the research in the form?
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QUESTION
❑YES
❑NO
Considering that information related to the clinical trial as well as to the data protection is included in the same sheet, should the consent to data processing be separated from the
consent to the research in the form?
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“The informed consent foreseen under the Clinical Trial Regulation must not be confusedwith the notion of consent as a legal ground for the processing of personal data under theGDPR.Provisions of Chapter V CTR on informed consent, in particular Article 28, respondprimarily to core ethical requirements of research projects involving humans derivingfrom the Helsinki Declaration. The obligation to obtain the informed consent ofparticipants in a clinical trial is primarily a measure to ensure the protection of the rightto human dignity and the right to integrity of individuals under Article 1 and 3 of theCharter of Fundamental Rights of the EU; it is not conceived as an instrument for dataprotection compliance.”(European Data Protection Board. Opinion 3/2019 concerning the Questions andAnswers on the interplay between the Clinical Trials Regulation (CTR) and the GeneralData Protection regulation (GDPR) (art. 70.1.b)). January 2019)The rule is to ask a specific consent for the research study and a consent for dataprocessing, while information on data processing could be included in the sameinformation sheet.
USEFUL MATERIAL
✓ARISE template – Informed consent form_study participants
✓ARISE template – Informed consent form_parents/legally designated representatives
✓ARISE template – Data Sharing & Material Transfer Agreement
✓WHO templates
✓European Data Protection Board. Opinion 3/2019 concerning the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR) (art. 70.1.b)). January 2019
✓Giannuzzi V, Landi A, Bartoloni F, Ceci A (2018) A Review on Impact of General Data Protection Regulation on Clinical Studies and Informed Consent. J Clin Res Bioeth 9: 327. doi:10.4172/2155-9627.1000327
✓https://i-consentproject.eu/i-consent-virtual-workshop-rethinking-informed-consent-emerging-challenges-in-the-digital-era/
✓http://www.hra-decisiontools.org.uk/consent/principles-children.html
Thank you!
Annalisa Landi, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus - [email protected]
CONSENT
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I
This presentation reflects only the author(s)’s view and the EU Research Executive Agency (REA) is not responsible for any use that may be made of the
information it contains.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No. 824021