Portsmouth Hospitals Procedural Document Template s3

Standard Operating Procedure for

Recruiting and Consenting Patients into Clinical Research

The definitive versions of all Portsmouth Hospitals Trust SOPs, Templates and Forms for Research are online at http://www.porthosp.nhs.uk/research-department

If you are reading this SOP in printed form then you are reading an uncontrolled document. You must therefore verify that the version number and date given below are the most recent, by cross-checking with the Trust research website before proceeding with implementation.

Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This SOP has been assessed accordingly

CONTENTS

1 INTRODUCTION 3

2 PURPOSE 3

3 SCOPE 3

4 ABBREVIATIONS & DEFINITIONS 4

5 DUTIES AND RESPONSIBILITIES 4

6 PROCESS 4

6.1 Delegation of Responsibility for Informed Consent 6

6.2 The Mental Capacity Act 2005 7

6.3 Minors 8

6.4 Incapacitated adults 8

7 TRAINING REQUIREMENTS 8

8 REFERENCES AND ASSOCIATED DOCUMENTATION 8

9 VERSION HISTORY LOG 9

Version 9

10 APPENDICES 10

10.1 Training Record 10

1  INTRODUCTION

The ethical principles of informed consent are fully outlined in the Declaration of Helsinki adopted in 1964 by the World Medical Association in relation to the conduct of medical research. Each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without it compromising their medical care and treatment. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

The Medicines for Human Use (Clinical Trials) Regulations 2004 confirm that a person gives informed consent to take part in a clinical trial only if their decision is given freely after that person is informed of the nature, significance, implications and risks of the trial and either:

(1)  is evidenced in writing, dated and signed or otherwise marked by that person so as to indicate consent, or

(2)  If the person is unable to sign or to mark a document indicating consent, then it must be given orally in the presence of a witness and documented.

The Research governance Framework for Health and Social Care (2nd Edition 2005) defines the broad principles of good research governance and is key to ensuring that all health and social care research at Portsmouth Hospitals NHS Trust is conducted to high scientific and ethical standards; informed consent is at the centre of ethical research.

2  PURPOSE

The purpose of this document is to describe the Standard Operating Procedures for obtaining written informed consent from a potential study participant. Freely given informed consent should be obtained from every participant prior to clinical trial participation. Consent is legally valid and professionally acceptable only where the participants are competent to give consent, have been properly informed, and have agreed without coercion.

3  SCOPE

The principles outlined in this document apply to:

·  All Investigators and Investigation Teams involved in the process of consenting potential study participants in research studies conducted at Portsmouth Hospitals NHS Trust, or at external sites for research sponsored by Portsmouth Hospitals NHS Trust.

All relevant staff working on studies must be completely familiar with the recruitment and consent procedure.

The Trust recognises that some external sponsors, networks, funders and employers may require the use of their own SOPs for the good governance of research. In such cases it is the responsibility of the Portsmouth Hospitals Trust user (including those individuals contracted to work on behalf of the Trust), to ensure that the external SOP is compatible with the procedure outlined below. If the external SOP contradicts the Trust’s procedure then approval must be sought in writing from the Director of Research.

In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety

4  ABBREVIATIONS & DEFINITIONS

ICH GCP International Committee on Harmonisation Good Clinical Practice

SOP Standard Operating Procedure

PHT Portsmouth Hospitals NHS Trust

PI Principal Investigator

CI Chief Investigator

CTIMP Clinical Trial of an Investigational Medicinal Product

REC Research Ethics Committee

5  DUTIES AND RESPONSIBILITIES

Investigator and investigation team are responsible for:

·  Familiarising themselves with the study recruitment and consent procedure in the study protocol

·  Assessing a potential participant’s cognitive ability to consent to the study

·  Conveying information in a way that is easily understood by the potential study participant, providing and explaining complex protocol information in a way that is not ambiguous or confusing.

·  Ensuring the participant is provided with approved versions of written information sheet and informed consent form.

·  Ensuring that the written information sheet and informed consent form used have received approval from the relevant REC, printed on Trust headed paper, and are identifiable by a date and version number; it must be

·  Documenting the informed consent process in the medical notes

·  Ensuring a written consent form is signed and dated by the study participant or their legal representative and by the person who carried out the informed consent discussion.

·  Ensuring a copy of the consent form is placed in the medical notes and the original copy in the Trial Master File.

·  Ensuring that informed consent is an ongoing process, which begins when initial contact is made and continues throughout the study.

In addition, The Chief Investigator has overall responsibility for the maintenance of recruitment records as specified in this SOP and in accordance with the study protocol. This may be delegated to authorised personnel at their site and this documented on the Site Delegation Log.

6  PROCESS

The exact procedure for participant recruitment should be detailed in the individual study protocol. The study protocol should state clearly the consent process, the planned number of participants and the time period to achieve this.

The process starts from screening eligible patients for research studies. Best practice includes early discussion with the patient, answering the questions fully, asking if he/she understands, making a record in the notes and use of patient literature to enhance patient’s understanding, but not as a substitute for discussion.

The PI/CI, clinician/research nurse on the delegation log needs to scan the hospital notes to ensure the patient is eligible for participation in the trial.

The PI/CI/clinician/research nurse needs to assess the patient’s cognitive and psychological ability to understand the information and to adhere to protocol requirements.

Every person who is considered a potential candidate for the trial should be recorded on the Participant Screening and enrolment log, regardless of how likely they are to give consent, or whether there might be other reasons that will prevent the person enrolling into the trial.

The Investigator must adhere to GCP and the ethical principles that have their origin in the Declaration of Helsinki. In research involving an Investigational Medicinal Product (IMP) the participant must be told:

·  The purpose of the trial and possible benefits

·  Make it clear that the trial involves research

·  The trial treatment/s

·  The randomisation process

·  The frequency of all trial procedures to be followed including all invasive procedures

·  The participant’s responsibilities

·  The experimental aspects of the trial

·  Any foreseeable risks or inconveniencies

·  The reasonably expected benefits, if any.

·  The current standard treatments and their risks and benefits.

·  The compensation or treatment available in the case of injury relating to the trial

·  Anticipated out of pocket expenses, if any to the participant

·  That participation in the trial is voluntary and the participant can refuse the trial or withdraw at any time without this affecting his or her care

·  The authorised representative of the regulatory bodies, the pharmaceutical company or the research ethics committee will be given access to the participant’s records for the verification of trial procedures and data collected, without violating the participant’s confidentiality. The patients GP will also be informed of the patient’s participation in the trial. The signing of the informed consent authorises this.

·  The records identifying the participant will be kept confidential and will not be publicly available. If the results of the study are published, the participant’s identity will remain confidential.

·  The participant and/or legal representative will be informed if any information becomes available that may be relevant to the participant’s willingness to continue with the trial.

·  The name of the person to contact for further information regarding the trial.

·  The foreseeable circumstances under which participation in the trial might be terminated.

·  The expected duration of the individual’s participation in the trial.

·  The approximate number of patients in the trial.

·  The patient must have the opportunity to ask questions

·  When a patient decides not to enter a trial then the chemotherapy unit will need to be informed and the database updated.

The patient should have the opportunity to ask the doctor about any aspects of the trial. Real consent is informed and given by someone who has the capacity and it is given voluntarily.

Consent should be sought before the patient is examined, treated or information is accessed or shared for research purposes.

The patient will be fully informed prior to giving signed consent. The patient should be given a minimum of 24 hours between information giving and signing consent unless otherwise explicitly approved by the Research Ethics Committee.

Once the patient has agreed to participate in the trial, the informed consent form should be signed and personally dated by: the patient and the investigator taking consent.

Each box requiring the participant’s initials must be completed on the consent form by the participant. Each person’s name should be clearly printed alongside his or her signature. The informed consent discussion should also be documented and dated in the participant’s medical notes and a copy of the signed consent must be kept in the patient’s medical notes. The original signed consent form will be kept with the participant information sheet in the Trial Master File. The participant will be given a copy of the signed consent form and the patient information sheet to keep. A copy may need to be faxed to the trial coordinating centre should the protocol require it.

The consent process is ongoing and the participant’s continued consent should be re-affirmed at each patient visit and documented in the medical notes. Should there be an Amendment to the patient information sheet and informed consent form, then the patient must be re-consented following the same process, unless the sponsor explicitly instructs otherwise.

The patient’s GP will be informed of the patient’s participation in the trial.

Once consent is obtained the participant is enrolled onto the trial and allocated a unique study number. The allocation of a unique study number means that there must be no duplication of study number regardless of the number of participating sites i.e. there should only ever be one participant with the study number 001 or 002 and so on, in the trial as a whole.

The date of enrolment is the date the consent was obtained. The allocation of a unique study number and any trial related interventions must follow or be concurrent with this date.

For multi-site trials each participating site shall keep its own Participant Screening and enrolment log. The entries must be in chronological order but of course will not necessarily be consecutive (see note above).

The Chief Investigator shall keep a master list of all trial participants. This may be generated from the trial database or as a master Participant Screening and Enrolment log which lists all participants recruited at all participating sites.

6.1  Delegation of Responsibility for Informed Consent

Usually only a medically qualified investigator can obtain informed consent, unless the study is a non-interventional study that does not involve drugs or other treatments, or there is no randomisation to therapeutic modalities,

The General Medical Council (GMC) recommends that when doctors delegate the task of informed consent it is their responsibility to ensure that the person delegated is:

·  suitably trained and qualified

·  has sufficient knowledge of the proposed investigation or treatment, and understands the risks

·  acts in accordance with guidance as set out in GMC "Seeking Patients Consent ; the ethical considerations

In addition, A Chief Investigator (CI) or Principal Investigator (PI) for a research study may delegate responsibility for the informed consent process and/or responsibility for being the sole signatory on the Informed Consent Form and record the planned division of tasks in the Delegation of Authority and Signature Log).

In delegating responsibility for informed consent it is the responsibility of the CI/PI to ensure the following criteria are met:

·  The designee is prepared to take on this additional responsibility AND is competent to take informed consent