STANDARD OPERATING PROCEDURE SOP 310

Transcription

1 STANDARD OPERATING PROCEDURE SOP 310 DEVELOPMENT OF PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM Version 1.3 Version date Effective date Number of pages 8 Review date April 2019 Author NNUH UEA Joint Research Office Approved by Julie Dawson Role Acting Research Services Manager Signature Julie Dawson Date Authorised for NNUH and UEA by Role Professor Alastair Forbes Chief of Research And Innovation Signature Date 28/3/17 SOP 310v1.2 Effective Date: Page 1 of 7

2 It is the responsibility of all users of this SOP to ensure that the correct version is being used. All staff should regularly check the NNUH R&D website for information relating to the implementation of new or revised versions of SOPs. Staff must ensure that they are adequately trained in the new procedure and must make sure that all copies of superseded versions are promptly withdrawn from use. The definitive versions of all Joint NNUH/UEA health care research SOPs appear online. If you are reading this in printed form please check that the version number and effective date is the most recent one as shown on the NNUH R&D website. TABLE OF CONTENTS 1 ABBREVIATIONS 3 2 INTRODUCTION 3 3 SCOPE 3 4 RESPONSIBILITIES 3 5 PROCEDURE 4 6 RELATED DOCUMENTS 6 7 REFERENCES 6 8 LIST OF APPENDICES 6 Appendix 1: Change Control, Revision and Review Sheet 7 SOP 310v1.2 Effective Date: Page 2 of 7

3 1 ABBREVIATIONS CRTU GCP DH HRA ICF ICH MRC MHRA NNUH NRES PIS R&D REC SOP TMF UEA Clinical Research and Trials Unit Good Clinical Practice Department of Health Health Research Authority Informed Consent Form International Conference for Harmonisation Medical Research Council Medicines and Healthcare Products Regulatory Agency Norfolk and Norwich University Hospital National Research Ethics Service Participant Information Sheet Research and Development Research Ethics Committee Standard Operating Procedure Trial Master File University of East Anglia 2 INTRODUCTION The purpose of this SOP is to outline the process for designing Participant Information Sheet (PIS) and Informed Consent Form (ICF) for a study. A PIS and ICF are essential to the process of obtaining informed consent from trial participants. 3 SCOPE This SOP applies to all healthcare research sponsored by the NNUH and UEA that falls within the scope of the Research Governance Framework (DH 2005), or its successors. It must be used in association and in accordance with all organisational policies and practice related to research within the Sponsoring Organisations. 4 RESPONSIBILITIES The following personnel are responsible for designing participant information sheets and consent forms: Chief Investigator The responsibility of the CI is to ensure that a PIS and ICF are produced. The CI is also responsible for ensuring that ethical and Health Research Authority (HRA) approvals are obtained for the PIS and ICF before trial commencement. In addition the CI must ensure that any subsequent amendments to the PIS or ICF are submitted for ethical & HRA approval. The CI may delegate these processes to a member of the research team, recording any delegation in the Study Delegation Log (SOP 325). SOP 310v1.2 Effective Date: Page 3 of 7

4 Principal Investigator It is the responsibility of the Principal Investigator (PI) at each site to ensure that all research staff associated with the trial are using the current REC/HRA approved versions of the PIS/ICF and have received appropriate consent training, and that training is documented as per SOP 505: Creating and Maintaining Training Records.. The PIS/ICF should be filed in the TMF (including superseded versions) and archived at the end of the study, according to GCP guidelines (SOP 900). Trial Manager /Co-ordinator (if employed) It is the responsibility of the Trial Manager to ensure that all sites are using the current REC and HRA approved versions of the PIS/ICF. 5 PROCEDURE 5.1 Overview / Preparation The person writing the PIS and/or ICF should follow the recommendations of the World Medical Association s Declaration of Helsinki (WMA, 2013) and consult the following sources for up-todate information on the required content and format (web references are available in the reference section below, see section 7): HRA website ( ICH GCP guidelines, particularly Topic E6 (R1) Good Clinical Practice 2002 and addendum for guidance The Office for Public Sector Information (OPSI) for guidance on the Medicines for Human Use (Clinical Trials) Statutory Instruments, 2004 and If the study is being conducted in a country outside the UK, national regulations should be checked. Note: Particular care should be taken when preparing a PIS and ICF for vulnerable groups. These include: Minors (under 16) (see HRA website) Incapacitated adults, defined as adult[s] unable by virtue of physical or mental incapacity to give informed consent. It should be noted that the regulations in Scotland differ from those in England, Wales, and Northern Ireland (see HRA website) People with learning difficulties (see DH November 2010) 5.2 Writing a Participant Information Sheet The major considerations are listed below and outline the required content of a PIS (derived from HRA website). The PIS and ICF are required to be submitted with the protocol and IRAS form for approval by a Research Ethics Committee (REC) and the Health Research Authority (HRA). They should, therefore, be written after protocol development and prior to submission to the REC and HRA. SOP 310v1.2 Effective Date: Page 4 of 7

5 It is good practice, and RECs will look more favourably upon applications, if a Patient Participation Group has been involved in the design of or has reviewed the PIS. The level of detail should be appropriate to the nature of the study and the population to be studied. Shorter information sheets are likely to be acceptable for studies with little or no intervention. The PIS must be written using simple, non-technical terms that a lay person will understand easily. See HRA website for further guidance. All participant information sheets must be version controlled and dated. A reference copy of the PIS should be retained in the Trial Master File (TMF). For each Investigator Site File (SOP 305 Creating and Maintaining a Trial Master File) the PIS retained should be printed on the site letterhead. If changes are made to the patient information sheet, the version and date should be updated, reviewed by the R&D / REN office and submitted for approval by the REC and HRA. The relevant Trust R&D departments and, in the case of CTIMPs and Medical Device Trials, the MHRA should be given copies for information. All previous versions of the patient information sheet must be retained in the TMF. 5.3 Writing an Informed Consent Form The minimum requirements for Informed Consent Form, as well as examples of ICFs, can be found on the HRA website. For some studies a study specific consent form may be required to cover important issues, especially if additional elements are optional for the participant. These may include: Additional invasive tests or samples required for study purposes only. Specific consent for DNA (genetic) testing and for storage of samples for possible future research (see HTA, 2014). Consent to use of audio/video taping, with possible use of verbatim quotation or use of photographs. Transfer of data/samples to countries with less data protection (eg USA and most other countries outside the EU). Agreement to receive individual feedback from testing. Consent to access registry data, DNA testing on gifted samples (highlighting any possible effects on participant s future insurance), sending personal details to the sponsor, and sharing anonymised data with other individuals or organisations In addition: A reference copy of the ICF should be retained in the Trial Master File (TMF). For each Investigator Site File (SOP 305 Creating and Maintaining a Trial Master File) the ICF should be printed on the site letterhead. If changes are made to the consent form, the version and date should be updated, reviewed by the R&D / REN office and submitted for approval by the HRA and REC. The relevant Trust R&D departments and, in the case of CTIMPs and Medical Device Trials, the MHRA should be given copies for information. All previous versions of the consent form must be retained in the TMF. Where a sub-study involves participants undergoing additional procedures, an additional ICF must be written and submitted for approval by the REC. SOP 310v1.2 Effective Date: Page 5 of 7

6 6 RELATED DOCUMENTS SOP 305 Creating and maintaining a Trial Master File SOP 325 Study start-up activities for Clinical Research Trials SOP 505 Creating and Maintaining Training Records SOP 900 Storage and Retention of Research Documents 7 REFERENCES 1. HRA website 2. European Medicines Agency (EMEA) International Conference on Harmonisation (ICH) Topic E6(R1) and addendum: Guideline for Good Clinical Practice Step 5 (CPMP/ICH/135/95). 3. European Union (EU) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 4. Human Tissue Authority (HTA) Code of Practice. Code 1 July Available from: URL: 5. Medicines for Human Use (Clinical Trials Regulations) 2004: Informed consent in clinical trials 6. Office of Public Sector Information (OPSI) Statutory Instrument 2004 No. 1031: The Medicines for Human Use (Clinical Trials) Regulations Available from: URL: 7. Office of Public Sector Information (OPSI) Statutory Instrument 2006 No. 1928: The Medicines for Human Use (Clinical Trials) Amendment Regulations World Medical Association (WMA) Declaration of Helsinki (Adopted by the 64th WMA General Assembly, Fortaleza, Brazil, October ICH GCP Guideline E6 (R1) and addendum 10. Mental Capacity Act HRA: Adults unable to consent for themselves. 12. DoH: Making written information easier to understand for people with learning disabilities. 13. DoH: Consent. 8 APPENDICES Appendix 1: Change Control, Revision and Review Sheet SOP 310v1.2 Effective Date: Page 6 of 7

7 Appendix 1: Change Control, Revision and Review Sheet Revision Form: SOP 310 Version No Change Date Reason for Change Reviewer Signature and Date /01/2012 Updated to reflect UEA/NNUH joint working arrangements /11/2013 Updating references, addition of template informed consent form, numbering correction and combining control and revision sheets. Debbie Kelly - Research Manager RSC D A Kelly 16 th December /12/2016 Update to PIS and References. Providing link with other RD SOPs and HRA website. Michael Sheridan - Research Facilitator Michael Sheridan (authorised by ) Review by Research Governance Operational Group: Example templates for PIS and ICF have been deleted. Information on creating PIS and ICF is available on HRA website. Sarah Ruthven - Research Manager (REN) (following review of RGOG group on the ) S Ruthven (authorized by ) SOP 310v1.2 Effective Date: Page 7 of 7