SOP 05: Patient Information and Informed Consent

Background

Adequate patient information with particular emphasis onthe fact that participation in the study is voluntary is aparticular concern of the ‘Declaration of Helsinki’ [1] andGuidelines on Good Clinical Practice. Great care musttherefore be taken in formulating and adapting a writtenpatient information sheet to the particular requirements ofa given study. The written patient information must besubmitted to the relevant Ethics Committee together withthe trial protocol.

Elements of Information to Patients

There are no regulations specifying the format of the pa-tient information sheet. Information material should bewritten in layperson’s terms.According to ICH-GCP [2; chapter 4.8.10], both the in-formed consent discussion and the written informed consentform and any other written information to be provided tosubjects should include explanations of the following:– That the trial involves research.– The purpose of the trial.– The trial treatment(s) and the probability for random

assignment to each treatment.– The trial procedures to be followed, including all inva-

sive procedures.– The subject’s responsibilities.– Those aspects of the trial that are experimental.– The reasonably foreseeable risks or inconveniences to

the subject and, when applicable, to an embryo, fetus,or nursing infant.

– The reasonably expected benefits. When there is no in-tended clinical benefit to the subject, the subject shouldbe made aware of this.

– The alternative procedure(s) or course(s) of treatmentthat may be available to the subject, and their impor-tant potential benefits and risks.

– The compensation and/or treatment available to thesubject in the event of trial-related injury.

– The anticipated prorated payment, if any, to the subjectfor participating in the trial (comment: commonly notaccepted for studies in patients).

– The anticipated expenses, if any, to the subject for par-ticipating in the trial.

– That the subject’s participation in the trial is voluntaryand that the subject may refuse to participate or with-draw from the trial, at any time, without penalty or lossof benefits to which the subject is otherwise entitled.

– That the monitor(s), the auditor(s), the IRB/IEC, andthe regulatory authority(ies) will be granted direct ac-cess to the subject’s original medical records for verifi-cation of clinical that procedures and/or data, withoutviolating the confidentiality of the subject, to the extentpermitted by the applicable laws and regulations andthat, by signing a written informed consent form, thesubject or the subject’s legally acceptable representa-tive is authorizing such access.

– That records identifying the subject will be kept confi-dential and, to the extent permitted by the applicablelaws and/or regulations, will not be made publicly avail-able. If the results of the trial are published, the sub-ject’s identity will remain confidential.

– That the subject or the subject’s legally acceptable repre-sentative will be informed in a timely manner if informa-tion becomes available that may be relevant to the sub-ject’s willingness to continue participation in the trial.

– The person(s) to contact for further information re-garding the trial and the rights of trial subjects, andwhom to contact in the event of trial-related injury.

– The foreseeable circumstances and/or reasons underwhich the subject’s participation in the trial may be ter-minated.

– The expected duration of the subject’s participation inthe trial.

– The approximate number of subjects involved in thetrial.

# 2003 S. Karger GmbH, Freiburg

Fax +49 761 4 52 07 14 Accessible online at:E-mail Information@Karger.de www.karger.com/onkwww.karger.com

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Approval: June 28, 2001

Implementation: June 29, 2001

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Please note: Ethics Committees commonly require the inclu-sion of standard text sections, e.g. on mandatory insuranceof trial subjects (with local address, policy number, as well asphone and fax numbers of the insurance). Clear and simpledefinitions of technical terms are mandatory. Since these re-quirements are not uniform, it may be necessary to preparealternative versions of the patient information sheet for indi-vidual participating centers. In order not to delay the activa-tion of a study, all members of the study group are expectedto inform the Coordinating Investigator and sponsor of anysuch standard elements. It is the responsibility of each parti-cipating center to provide the sponsor with a copy of theadapted information sheet together with the approval by therelevant Ethics Committee.

Model Texts

Attached are model texts for the patient information sheetand the informed consent form. The texts contain the mini-

mal elements required for all studies. These have to besupplemented with additional details as needed for a parti-cular study and investigational drug.

References

1 Der Weltarztebund: Deklaration von Helsinki – Empfehlung fur �rzte,die in der biomedizinischen Forschung am Menschen tatig sind. (revisedin Edinburgh, October 2000).

2 ICH-GCP: EMEA. Note for Guidance on Good Clinical Practice(CPMP/ICH/135/95).

Appendix

Attachment 1: Model Patient Information/Informed Con-sent (Template for phase II studies; NCI/Bethesda)Attachment 2: Dokumentvorlage fur Patienten-Einverstand-niserklarung (Template for Patient Information/InformedConsent derived from template of the NCI)

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