Title: Informed Consent for Research and issue of Standard Operating Procedures

Transcription

1 Title: Informed Consent for Research and issue of Standard Operating Procedures SOP Number and Version: 4, V1 Effective Date: 26 September 2014 Review Date: 26 September 2017 Please check this is the latest version of the SOP on the Joint Research Office website: Author: Name: Todd Gumbleton Position: Clinical Research Facility Lead Research Nurse Signature Date Approved by: Name: Suzanne Binks Position: Quality Assurance Coordinator (Research Governance) Signature Date Authorised by: Name: Rajinder Sidhu Position: Deputy Director of Research Support Signature Date Page 1 of 10

2 Revision Chronology Version Effective Number: date: 1 26 September 2014 Reason for change: Initial standardised SOP for use within UCLH. Author: Todd Gumbleton ACRONYMS CI Co-I CTIMP CTP CRF CV EMA DM GCP IC ICF ISF PI PIS R&D REC RN RM&G SI SOP QA Chief Investigator Co-Investigator Clinical Trial of an Investigational Medicinal Product Clinical Trial Practitioner Clinical Research Facility Curriculum Vitae European Medicines Agency Data Manager Good Clinical Practice Informed Consent Informed Consent Form Investigator Site File Principal Investigator Patient/Participant Information Sheet Research and Development Department Research Ethics Committee Research Nurse Research Management & Governance Statutory Instruments Standard Operating Procedure Quality Assurance BACKGROUND Informed (IC) is the process by which a subject voluntarily confirms their willingness to participate in a particular study having been informed of all aspects of the study that are relevant to the subject s decision to participate. IC is documented by means of a written, signed and dated informed form (ICF). As per Statutory Instrument (SI) 2004/1031 Schedule 1 Part 3 conditions which apply in relation to an adult being able to provide are: 1. The subject has had an interview with the investigator, or another member of the investigating team, in which he/she has been given the opportunity to understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted. 2. The subject has been informed of his/her right to withdraw from the trial at any time. 3. The subject has given his/her informed to part in the trial. Page 2 of 10

3 4. The subject may, without being subject to any resulting detriment, withdraw from the clinical trial at any time by revoking his/her informed. 5. The subject has been provided with a contact point whether he/she may obtain further information about the trial. Schedule 1 Part 1 clause 3b Informed shall be written, dated and signed by the person performing the interview and the subject or his or her legally designated representative after having been duly informed. Where the subject is unable to write, may be given and recorded through appropriate alternative means in the presence of at least one impartial witness. The Principal Investigator (PI) shall follow Sponsor templates and Sponsor SOPs in relation to informed and abide by the Trust s Consent Policy for Research Participants. Templates for different types of Patient/Participant Information Sheets (PIS) and ICFs are available on the Health Research Authority website: PURPOSE This standard operating procedure (SOP) describes the process for obtaining informed from a subject (or their legally designated representative in the case of subjects under the age of 16, vulnerable subjects or incapacitated adults). PROCEDURE Actions (When? How?) 1 The Principal Investigator (PI) has signed the Study Delegation Log confirming that they are willing to delegate the responsibility of informed to the appropriate individuals. The PI is the person ultimately responsible for the subject s care. 2 If non-medical research staff (e.g. RN, CTP) are to accept responsibility for supporting the IC process, it is important the following criteria are met: They are prepared to take on this additional responsibility and feel confident to take informed in line with their professional code of conduct (e.g. Nursing and Midwifery Council Code of Professional Conduct, ICH GCP, etc.). They have a comprehensive understanding of the study, potential pharmacological interactions/treatment toxicities (where applicable) and the associated disease area, which is documented in their training folder. They should be qualified by experience and/or should have received appropriate training for this study (e.g. have attended the site initiation visit where applicable). Responsible s (Who?) PI Co- Investigator (Co-I) Research Nurse (RN) Clinical Trial Practitioner (CTP) Data Manager (DM) They are also required to provide an updated version of their CV and valid GCP training certificate (where applicable) to be filed in the investigator site file (ISF) and in the local central training file if available. Page 3 of 10

4 If the IC process relates to a CTIMP the IC must be taken by a medical professional. An effective line of communication is maintained with the PI. 3 Identifying Research Participants Subjects should be identified as potentially eligible for a particular study by a healthcare professional who has clinical responsibility for the subject. This is to ensure medical confidentiality is adhered to. Healthy volunteer studies will identify subjects through a variety of study specific means (including advertising) for consideration of study inclusion and referral. Research participants will be assessed for their potential eligibility for a particular study by a healthcare professional who is authorised to recruit to the particular study or research project. Healthcare Professional All staff delegated to informed The person considering recruiting a subject onto a study should initially consider whether the subject potentially fulfils the eligibility criteria by checking the subject s medical history. Once a subject has been assessed and identified as potentially eligible for a particular study, they should be approached and introduced to the study. This process can include sending the PIS prior to a verbal interview or by conducting a verbal interview and providing the PIS concurrently to the subject. The process used needs to be documented in the patient s medical notes. The person approaching the subject about a particular study must ensure they are familiar with all aspects of the study as described in the latest REC approved version of the protocol. The person IC must have the subject s medical notes, the current REC approved versions of the PIS and ICF available during interview. Other study documents may also be used during the interview (e.g. subject diaries, study schedule sheets). All potential subjects should be provided with the PIS and allowed adequate time to consider inclusion in the trial prior to providing written IC. It is commonly accepted that subject should have a minimum of 24 hours between the date the PIS is provided to the subject and the actual interview where the subject (and/or the subject s legally designated representative) signs the IC. Adequate time may be less if this is approved by the REC. A verbal explanation of the study must be given to the subject (and friends and family if appropriate), and if necessary diagrams may be used to explain the study. Time for questions throughout the discussion must be given and questions adequately addressed. 4 When describing the study, the person should explain the following: What the purpose of the study is and any background information that may be relevant. Why the subject has been approached. That confidentiality will be maintained throughout the study should they decide to participate. Details of the study design Details of the drugs (or interventions) used including any known safety Page 4 of 10

5 profiles. If there is a placebo arm then this should be explained (applicable to clinical trials of investigational medicinal products, CTIMPs). The number of people part in the study and how many have been recruited to date, if information available. The duration of the study and the number of study visits involved. It should be explained where the subject will be seen and by whom. All procedures that are required as part of the study, such as blood tests, electrocardiograms (ECGs), etc. The potential benefits and risks of participation in the study and any alternative treatments available to the subject should be discussed. The availability of compensation should something go wrong That the subject enters the study voluntarily and can withdraw at any time without any prejudice to them or their future care. Similarly if the PI feels that the subject is not tolerating the IMP, the PI has the right to withdraw them from the study in the interest of the subject s safety (applicable in CTIMP trials only). If there are any payments made for participation in the study or for out of pocket expenses. The responsibilities of the subject if they chose to take part, particularly if the study duration is lengthy. A subject giving informed does not necessarily mean that they will be enrolled onto the study if it is discovered that they have not met the inclusion/exclusion criteria for that study (e.g. study specific diagnostic test(s)). That the subject will have 24 hour contact number should they need to contact the clinical team for medical emergencies whilst on the study, and why this is important. (This may not be necessary for all studies; e.g. non-interventional research.) The contact details where the subject may obtain further information about the study. This could be the PI s number and/or the contact number for other members of the study team. 5 Evidence of Informed Consent The date and time the trial was discussed and the date the PIS was given to the subject must be documented in the medical notes. To ensure adequate time for the subject to consider the study a subsequent interview may be necessary where the IC form can be signed. Once the subject has had ample time to read the PIS and has had any questions regarding their participation answered satisfactorily, the person IC will ask the subject to clearly print their name, sign and date the ICF and initial any statements required by the study ICF. The person must also clearly print their name, sign and date the ICF together with the participant (on the same day). If a protocol states any additional signatures are required then this process must be followed accordingly. The person who took signed IC must add to the subject s medical notes the following: The date the subject received the PIS and which version they were provided. The date the subject signed the ICF and which version they were given. The name of the study they have ed to. Confirmation that the subject has given IC and can proceed to trial screening (as required). The form must be signed prior to any study related pre-screening or screening procedures being performed. Page 5 of 10

6 The person should also inform relevant team members of the treatment decision for the subject. Any research staff involved in giving information during the informed procedure should document in the patient s medical notes the fact they have informed the subject about a particular aspect of the study and when the information was given. The IC process should be documented in the subject s medical notes in a detailed and chronological order. The PIS will be placed in the subject s notes with the ICF to provide study specific information. 6 Participant Documentation PIS and ICFs provided by the sponsor are to be submitted to R&D for approval prior to use. Research Team They must be on local headed paper using authorised templates and contain local contact names and telephone numbers prior to being used in the IC process. The footers of the PIS and ICF should contain the following information: REC reference Short study title Document version and date Page number of total number of pages The header should have the Trust logo on the front page, and contact details of the research team. Once all parties have signed and dated the ICF: One copy should be given to the participant One copy should be placed in the patient s medical notes The signed original should be placed in the Investigator Site File (ISF), unless stated otherwise in the protocol (some trial centres or Sponsors request copies of signed ICFs as explained in the PIS). 7 For Participants Who Do Not Speak English The Trust independent Interpreting Service Language Line should be used for participants who do not speak English. To access this service, call via the UCLH Switch Board. Ideally face-to-face interpreting is preferable to using the telephone interpreting service. Both of these services can be booked by calling Language Line. Face-to-face interpreting requires a minimum of 48 hours notice but telephone interpreting is immediate. Appropriately translated PIS and ICF with REC approval should be used where available. As with all IC processes, check the requirements of the trial s REC application regarding interpreting services for patients who do not speak English or require interpreting assistance. 8 Re-Consent of Participants The IC process should not stop once the ICF has been signed. The practice of giving information about the study to subjects should be an ongoing process. This is particularly significant with the introduction of protocol amendments and the availability of important new information that may be relevant to the subject s Page 6 of 10

7 willingness to continue participating in the study. For any substantial amendments affecting the PIS and ICF, the Sponsor may request recruited subjects to be reed with the approved updated version in addition to their original form in order to continue involvement in the study. The details of when a subject gives additional should also be documented in the subject s medical notes. 9 Withdrawal of Participants Where a subject volunteers to withdraw from a study or the PI/treating clinician responsible for the subject s care decides it is in the best interest of the subject to withdraw them from a study, please ensure the following: The withdrawal process and reasons for withdrawal are fully documented in the medical notes. The withdrawal process in the study protocol is referred to and acted upon Document if the subject withdraws for all study follow-up or confirm if they are willing to continue to have future details sent to the sponsor. The sponsor is informed of the process and the reasons through study specific withdrawal forms or SAE forms as required. 10 Informed Consent of Incapacitated Adults / Those Who Lack Capacity to Consent for Themselves For a person to have capacity, the following conditions must be satisfied: The person must be able to absorb, comprehend and retain relevant information The person must be able to use that information to arrive at a decision The person must be able to communicate that decision in some way Research involving adults unable to for themselves requires specific REC notice of favourable opinion from a recognised Mental Capacity Act Flagged REC. The research provisions of the Mental Capacity Act 2005, sections apply to the conduct of research. There is a hierarchy for determining which type of legally designated representative should be approached to give informed on behalf of an adult who lacks capacity for inclusion in research as described below: 1. al legal representative: a person not connected with the conduct of the trial that is suitable to act as a legally designated representative by virtue of their relationship with the adult, and available and willing to do so. 2. Professional legal representative: a person not connected with the conduct of the trial that is the doctor primarily responsible for the adult s medical treatment, or a person nominated by the relevant healthcare provider (e.g. NHS Trust); a professional legally designated representative may be approached if no suitable personal legally designated representative is available. Once a subject has been assessed and identified as potentially eligible for a particular study and is agreeable, the PI, Co-I or delegated RN should discuss the process for determining which legally designated representative should be approached to introduce the study. The process of IC includes in addition the following conditions: The legally designated representative has had an interview with the PI, or another member of the research team, in which opportunity has been given to Page 7 of 10

8 understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted. The legally designated representative has been provided with a contact point where further information about the trial may be obtained. The legally designated representative has been informed of the right to withdraw the subject from the trial at any time. The legally designated representative has given IC to the subject part in the trial. The legally designated representative may, without the subject being subjected to any resulting detriment, withdraw the subject from the trial at any time by revoking the IC. The subject has received information, according to his or her capacity of understanding, about the trial and its risks and benefits. The investigator must consider the explicit wish of a subject capable of forming an opinion and assessing the information provided. This applies both to the wish of a subject to refuse to take part, or to withdraw from the trial at any time. No incentives or financial inducements are given either to the subject or to the legal representative, except the provision of compensation for injury or loss. There are grounds for expecting that administering the medicinal product to be tested in the trial will produce a benefit to the subject outweighing the risks or produce no risk at all. The trial is essential to validate data obtained (a) in other clinical trials involving persons able to give informed, or (b) by other research methods. The clinical trial relates directly to a life-threatening or debilitating clinical condition(s) from which the subject suffers. Principles IC given by a legally designated representative shall represent the presumed will of an incapacitated adult. The trial has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and the cognitive abilities of the subject. The risk threshold and the degree of distress have to be specially defined and constantly monitored. The interests of the subject always prevail over those of science and society. 11 Informed Consent for Subjects under the age of 16 For subjects under 16, the legally designated representative (often one of the parents) would sign the form on behalf of the minor. The assent form corresponding to their age range will be signed by the minor. If during a clinical trial the minor reaches the age of majority, their express informed shall be obtained before the trial may continue. There is a hierarchy for determining who should be approached to give IC on behalf of a minor prior to their inclusion in the study, see Table 1 below. The provisions for IC by a legal representative only apply in the case of emergency treatment where no person with parental responsibility can be contacted prior to the proposed inclusion of the minor. Page 8 of 10

9 Table 1 - Hierarchy of Informed Consent for a Minor Who Definition May Give Consent 1 Parent A parent or person with 2 al Legal Representative 3 Professional Legal Representative parental responsibility A person not connected with the conduct of the trial who is suitable to act as the legal representative by virtue of their relationship with the minor, and available and willing to do so. A person nominated by the relevant healthcare provider (e.g. an acute NHS Trust or Health Board) who is not connected with the conduct of the trial. Comments Should always be approached when available May be approached if no person with parental responsibility can be contacted prior to the proposed inclusion of the minor, by reason of the emergency nature of the treatment provided as part of the trial. May be approached if no person suitable to act as a personal legal representative is available. Informed must be given before the minor is entered into the trial. 12 The process of includes in addition the following conditions and principles which apply to the inclusion of a minor in a clinical trial. Conditions The parent or legal representative has had an interview with the investigator, or another member of the research team, in which opportunity has been given to understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted. The parent or legal representative has been provided with a contact point where further information about the trial may be obtained. The parent or legal representative has been informed of the right to withdraw the minor from the trial at any time. The parent or legal representative has given IC to the minor part in the trial. The parent or legal representative may, without the minor being subject to any resulting detriment, withdraw the minor from the trial at any time by revoking the IC. The minor has received information, according to their capacity of understanding, about the trial and its risks and benefits. The information must be given by staff with experience of working with minors. The investigator must consider the ability of a minor in forming an opinion and assessing the information provided. This applies both to the wish of a minor to refuse to take part, or to withdraw from the trial at any time. No incentives or financial inducements are given either to the minor or to the parent or legal representative, except the provision of compensation for injury or loss. The clinical trial relates directly to a condition from which the minor suffers or is of such a nature that it can only be carried out on minors. Some direct benefit for the group of patients involved in the trial is to be obtained from the trial. The trial is necessary to validate data obtained (a) in other clinical trials involving persons able to give IC, or (b) by other research methods. The corresponding scientific guidelines of the European Medicines Agency (EMA) are followed. Page 9 of 10

10 Principles IC by a parent or legal representative shall represent the minor s presumed will. The trial has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and the minor s stage of development. The risk threshold and the degree of distress have to be constantly monitored. The interests of the patient always prevail over those of science and society. As soon as the subject is 16 he/she should sign the form to continue on the trial. REFERENCES Trust Consent Policy for Research Participants Health Research Authority: Mental Capacity Act 2005 Statutory Instrument 2004/1031 Page 10 of 10