International joint project for SOCRA 2014

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?


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SHORT AGENDA FOR TODAY

Bases and derived consequences Methodological approach Result presentation Conclusion


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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


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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?


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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


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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!


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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


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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)


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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)


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WHY İS CONSENT NEEDED?

Defence to a claim of battery and / or negligence

Protect rights of individuals / agreement to therapy


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WHAT İS VALİD CONSENT?

Patient’s legal capacity Voluntariness Sufficient information


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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


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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 )


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WHO GAİNS THE CONSENT?

Researcher ( Physiotherapist / Clinical Investigator )

Delegating the consent process (adequate documentation )


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ELEMENTS OF CONSENT

Trials involves research PT DT

Purpose of trials PT DT

Treatments; probability for random assignment PT DT


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ELEMENTS OF CONSENT

Trial procedures PT DT

Subject responsibilities PT DT

Experimental aspects PT (likehood of success) DT


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ELEMENTS OF CONSENT

Reasonable foreseeable risks and inconveniences PT DT

Reasonable expected benefits PT DT

Alternative procedures PT DT


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ELEMENTS OF CONSENT

Compensation PT DT

Anticipated prorated payment PT DT

Anticipated expenses PT DT


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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


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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


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ELEMENTS OF CONSENT

Duration of subject’s participation PT DT

Approximate no of subjects PT DT


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ELEMENTS OF CONSENT

Permission to contact GP PT DT

Data protection PT DT


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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 )


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SPECIAL POPULATIONS

Patients lacking capacity Children Vulnerable patients


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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?


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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!


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THANK YOU FOR YOUR ATTENTION

ANY QUESTION / POINT FOR DISCUSSION?


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International joint project for SOCRA 2014

Documents

Transcript of International joint project for SOCRA 2014