Post on 05-Feb-2023
DRUG TRIALS VS TRIALS IN PHYSICAL INTERVENTIONS – WHAT ABOUT PATIENT´S INFORMED CONSENT
Prof. Dr. Gerhard FORTWENGEL Prof. Dr. S.Ufuk YURDALAN
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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OUR MOTIVATION
Both areas belong to medical care Strict policy in drug development well known and often discussed – physical interventions ?
Research questions:1. Do patients have to consent
for their participation in new physical therapies to be investigated and if so, what are the requirements?
2. Are there standards for consent in physiotherapy available in Europe?
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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SHORT AGENDA FOR TODAY
Bases and derived consequences Methodological approach Result presentation Conclusion
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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BASES
Consent is based on moral and legal premise of patient
Principle of informed consent - competent individuals are entitled to make their own decision about participation in any type of investigational therapy
Informed consent protects individual´s freedom of choice and thereby respects the individual autonomy
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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CONSEQUENCES
Considering the bases, we concluded: No difference in general aspects between drug- and physiotherapy trials
ICH GCP as golden standard refers to drug development ( clinical trials )!
How is the situation in the development of new physiotherapeutic treatments?
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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METHODOLOGICAL APPROACH
How did we continue? Intensive literature research
Focussing on standards related to physiotherapy with «global / European» character!
Identifying requirements for the consent process
Comparing against ICH GCP as globally applicable in the field of drug development
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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STRUCTURE AND CONTENT OF OUR PRESENTATION
Question and answer style List of compared items as presented are not complete, but should give a flavour on current situation
Interaction is desired – so feel free to raise your hands, whenever something is not clear or you want to comment on something – much appreciated!
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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OUTCOME OF LİTERATURE SEARCH( İNSTİTUTİONAL SUPPORT )
World Confederation for Physical Therapy [WCPT] Policy statements and ethical principles, e.g. Informed Consent
Chartered Society of Physiotherapy [UK] Information paper on Consent and Physiotherapy Practice
Referenced by WCPT
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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REFERENCES İN LİSTED DOCUMENTS
Documents / standards below relate to both areas ( drug and physiotherapy research ) Declaration of Helsinki Council of International Organizations of Medical Science (CIOMS)
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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HOW İS CONSENT DEFİNED?
« Consent is the voluntary agreement given by a person to allow something to happen to them, and/or to be done to them, and/or to allow their participation in something » (ICH GCP)
« A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate » (Chartered Society of Physiotherapy)
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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WHY İS CONSENT NEEDED?
Defence to a claim of battery and / or negligence
Protect rights of individuals / agreement to therapy
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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WHAT İS VALİD CONSENT?
Patient’s legal capacity Voluntariness Sufficient information
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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WHEN SHOULD CONSENT BE OBTAİNED?
Initially prior to assessment or treatment
Reaffirmed Changes to trial / treatment New information about drug / physiotherapy
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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WHAT TYPES OF CONSENT?
Written consent only required ( complex treatment / involvement of significant risk / treatment requiring anaesthesia / where clinical care is NOT the prime aim of the intervention or may result in significant adverse consequences )
Oral consent ( acceptable – to be adequately recorded - not very well specified )
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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WHO GAİNS THE CONSENT?
Researcher ( Physiotherapist / Clinical Investigator )
Delegating the consent process (adequate documentation )
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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ELEMENTS OF CONSENT
Trials involves research PT DT
Purpose of trials PT DT
Treatments; probability for random assignment PT DT
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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ELEMENTS OF CONSENT
Trial procedures PT DT
Subject responsibilities PT DT
Experimental aspects PT (likehood of success) DT
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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ELEMENTS OF CONSENT
Reasonable foreseeable risks and inconveniences PT DT
Reasonable expected benefits PT DT
Alternative procedures PT DT
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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ELEMENTS OF CONSENT
Compensation PT DT
Anticipated prorated payment PT DT
Anticipated expenses PT DT
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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ELEMENTS OF CONSENT
Subject participation is voluntary throughout PT DT
Monitor, auditors, inspectors: access to notes PT DT
Confidentiality ( anoymized data, direct access ) PT DT
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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ELEMENTS OF CONSENT
Pledge to inform subject of new information PT DT
Contact: information, trial-related injury PT DT
Foreseeable circumstances of termination PT DT
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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ELEMENTS OF CONSENT
Duration of subject’s participation PT DT
Approximate no of subjects PT DT
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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ELEMENTS OF CONSENT
Permission to contact GP PT DT
Data protection PT DT
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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PROCEDURAL REQUIREMENTS
Presenting information to patients Answering patients´questions Giving patients time to consider and reflect
Respecting a patient´s decision Recording consent ( when provided in writing )
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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SPECIAL POPULATIONS
Patients lacking capacity Children Vulnerable patients
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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REMEMBER OUR RESEARCH QUESTIONS
Do patients have to consent for their participatıon in new physical therapies to be investigated and if so, what are the requirements?
Are there standards for consent in physiotherapy available in Europe?
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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CONCLUSION
Out of 22 topics to be covered during the consent process based on ICH GCP
8 are required by corresponding guidelines applicable for physiotherapeutic research trials
Procedural requirements as well as requirements related to management of special populations are comparable
Cave: oral vs written consent!
Prof. Yurdalan / Prof. Fortwengel SoCRA Annual Conference 2014, Orlando
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