Participant Information Sheet Guidance
Version: / *** / Date: / **/**/****Full Trial Name
Principal Investigator:
PART 1
INVITATION
The standard text, as detailed in the template must be included in the document, to explain the definition of clinical trials to the patient.
The standard text within the template must be included.
WHAT IS THE PURPOSE OF THE STUDY?
Purpose of the study; reasons why the trial is important at this time; why the suggested treatment / procedure is being tested at this time; evidence from other studies regarding the effectiveness of the drug or procedure to be investigated. If different patients in the trial are to receive different treatment schedules, a brief overview of what each patient group will receive should be provided.
Detail whether the study will take place at other hospitals and if so give an approximate total, if known. Include the total number of patients that will be included in the study.
This should be brief and should not mislead.
WHY HAVE I BEEN CHOSEN?
Explain why and how the patient has been chosen; i.e. their suitability and eligibility for the study.
DO I HAVE TO TAKE PART?
The standard text within the template must be included.
With regards to withdrawal of consent; it is important to clearly make your intentions known to the participant and ask for the relevant consent. Should the patient wish to withdraw consent it must be made clear to them whether any data or fluid/tissue samples will be retained or whether they will continue to be followed up.
WHAT WILL HAPPEN TO ME IF I TAKE PART?
A breakdown of all clinical procedures that will take place, highlighting any procedures that will be over and above that which would be carried out during normal clinical management of the patient if they do not agree to take part in the trial. The reason for tests being performed that are over and above normal clinical management should be given.
Details of what the treatment or procedure will involve should be given, including whether the patient will be required to attend hospital and how frequently this will be.
Details of any tissue/fluid samples to be taken, what will happen to these, where they will be stored and for how long they will be stored. Details of any genetic tests that will be undertaken
Expected duration of the patient’s participation in the trial including the length of follow up must be provided, plus any clinical investigations that may be carried out at the follow up visits.
If patients within the trial are to receive very different treatment schedules then the Researcher should split this section into:
What will happen to patients that are allocated to receive treatment/procedure A
What will happen to patients that are allocated to receive treatment/procedure B
What will happen to all patients?
A simple flow chart may be included if applicable.
The research methods intended to be used should be detailed; the following simple definitions may help:
Randomised Trial:
Sometimes we don’t know which way of treating patients is best. To find out, we need to make comparisons between the different treatments. We put people into groups and give each group a different treatment; the results are compared to see if one is better. To try to make sure the groups are the same to start with, each patient is put into a group by chance (randomly. The results are then compared.
The patient should be informed as to what chance they have of getting the study drug/treatment
Blind Trial:
In a blind trial you will not know which treatment group you are in. if the trail is a double blind trial, neither you nor your doctor will know in which treatment group you are (although if your doctor needs to find out he/she can do so).
Cross-over Trial:
In a cross-over trial the groups each have the different treatments in turn. There may be a break between treatments so that the first drugs are cleared from your body before you start the new treatment.
Placebo:
A placebo is a “dummy treatment”, which looks like the genuine medicine but contains no active ingredient.
WHAT DO I HAVE TO DO?
Specific requirements from the patient, such as completion of quality of life questionnaires and their frequency, collection of samples at home, return of tablets if they have not been taken etc.
WHAT IS THE DRUG / TREATMENT / PROCEDURE BEING TESTED?
The Researcher must delete the title as appropriate.
The treatment / procedure that is to be tested must be discussed including details of how widely the treatment or procedure is currently used in the clinical indication within the trial and for what reason it is used in this patient group.
The dosage and method of administration should be detailed, where applicable.
ARE THE ALTERNATIVES FOR DIAGNOSIS OR TREATMENT?
Alternative treatments must be detailed in the information sheet and not just discussed verbally with the patient.
WHAT ARE THE SIDE EFFECTS OF TAKING PART?
Full details of all known side effects must be given; this information may be obtained from the Investigators Brochure or Summary of Product Characteristics and should be explained in terms understandable by a lay person. All information should be prioritised in terms of seriousness, severity and frequency which a participant would understand.
Provide details of how patients will be monitored for side effects and what action will be taken in the event of such side effects occurring.
For relatively new drugs or procedures it should be pointed out that there may be unknown side effects.
The standard text within the template must be included.
If trial subjects suffer these or any other symptoms they should be given clear guidance on when, how and whom to report them. Contact numbers should be given (section 18).
WHAT ARE THE POSSIBLE DISADVANTAGES AND RISKS OF TAKING PART?
Detail any disadvantages or risks for the patient if they choose to participate in the study. This should include discomfort and inconvenience.
The fact that the effectiveness of the treatment/procedure is under investigation and is therefore unknown must be mentioned including the fact that the treatment/procedure may not benefit the patient directly.
The standard text within the template document should be included and the possibility of extra overnight stays included where appropriate.
IRMER If use of additional radiation is required as part of the study then information on the additional amount of radiation must be given, in every day terms that they understand.
Expert advice should be taken to ensure clear and concise information is given.
HARM TO THE UNBORN CHILD
For Women:
A clear warning must be given in trials where there could be harm to an unborn child if the female subject were pregnant or became pregnant during the trial, or there was a risk in breast-feeding a baby.
Information on pregnancy testing should be included and any requirements for use of contraceptives and reporting of pregnancy during the trial.
Complete this section carefully and consider if it is appropriate to have in if the subject group has terminal illness or is elderly.
The standard text within the template must be included
For men:
Appropriate warning / advice should be given for men if the treatment could damage sperm and consequently the foetus.
Information on the importance of contraception should be included and what to do if their partner become pregnant is essential.
The standard text within the template must be included
WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART?
The standard text within the template document must be included and the Researcher must update the highlighted section <disease under investigation>.
The Investigator must give a fair and balanced evaluation of any benefits to the patient.
WHAT HAPPENS WHEN THE RESEARCH STUDY STOPS?
Discuss arrangements after the trial.
If arrangements have been made for the patient to not have further treatment with the drug involved in the study when the study stops then this should be clearly stated.
WHAT IF THERE IS A PROBLEM?
The standard text within the template document must be included.
WILL MY TAKING PART IN THIS STUDY BE KEPT CONFIDENTIAL?
The standard text within the template document must be included.
CONTACT FOR FURTHER INFORMATION
The standard text within the template document must be included. The Investigator should include any other relevant patient information groups where available and appropriate, such as Cancer Bacup. The highlighted section should be deleted for non-cancer trials.
PART 2
WHAT IF NEW INFORMATION BECOMES AVAILABLE?
The standard text within the template document must be included.
WHAT WILL HAPPEN IF I DON’T WANT TO CARRY ON IN THE STUDY?
In a clinical trial, the participant may wish to withdraw entirely or may wish to withdraw from treatment but be willing to continue to be followed up. If there are any restrictions on withdrawal, e.g. a single intervention will take place but they may withdraw from any further data collection, this should be made clear. If continuing follow-up is genuinely in the participant’s own interests, or an ‘exit’ check up will be needed, then this should be stated. The participant, however, retains the right to decide if data from this visit can be used.
The position on retention/destruction of data/samples on withdrawal must be made clear. In a clinical trial it is usually important to retain data already collected, and may be important to collect further outcome data on the ‘intention to treat’ basis.
If the participant’s data is going to be tracked through the NHS Central Register (NHSCR), this also needs to be stated, and consent obtained.
Examples of text to be used is:
‘If you withdraw from the study, we will destroy all your identifiable samples, but we will need to use the data collected up to your withdrawal.’
Or
‘You can withdraw from treatment but keep in contact with us to let us know your progress. Information collected may still be used. Any stored blood or tissue samples that can still be identified as yours will be destroyed if you wish’.
WILL MY TAKING PART IN THIS STUDY BE KEPT CONFIDENTIAL?
The standard text within the template document must be included.
Highlighted sections should be deleted for single centre studies.
If the study is international or involving an international pharmaceutical company and patient information may be given to other organisations in other countries, this information must be provided, including a note regarding differing Data Protection Laws in countries outside the EU.
If information is to be collected about the patient from external sources such as the Office for National Statistics, this must also be noted.
INFORMING YOUR GENERAL PRACTITINER
You should explain that for the subject’s own GP may be notified of their participation in the trial, with the participants consent. This should include other medical practitioners not involved in the research who may be treating the patient. There may be special circumstances in which informing the GP may not be acceptable, possible or may inhibit recruitment.
The participant should be told if significant information is to be exchanged with the GP, e.g. if the GP is asked for additional medical details or given feedback on study findings, and should consent to this.
WHAT WILL HAPPEN TO ANY SAMPLES I GIVE?
It should be clear to the participant, in the description of study procedures, whether
i) new samples will be taken (e.g. blood, tissue, specifically for this study)
ii) samples excess to a clinical procedure will be asked for
iii) access to existing stored samples will be asked for.
The same type of information, as for data, is needed. This should include:
· the secure procedures for collecting, using and storing samples
· any possible intended use in the future for research that cannot yet be specified. A separated or two part consent form is recommended if future use is intended, and it should be clear if further REC approval will be sought
· who will have access
· the level of identifiability (for this study and for storage for future studies)
· provision for destruction.
· procedures for possible feedback of individually significant information from their use.
· whether samples will be transferred outside the UK.
A commonly accepted concept, the “sample as a ‘Gift’” has been proposed by the MRC. If this is how researchers wish to see collection of samples, it will need to be explained to the subject. Any commercial significance or development should be included.
WILL ANY GENETIC TESTS BE DONE?
The MRC recommends a separate study sheet and consent form for genetic studies with information on possible individual implications, feedback, counselling etc.
If genetic testing is to be done then just state in the main information sheet “Please refer to separate genetic testing information sheet”
See Appendix 1 below.
WHAT WILL HAPPEN TO THE RESULTS OF THIS CLINICAL TRIAL?
The standard text within the template document must be included.
If the results of the study are to be used to inform clinical decision making or the development of another trial this should be mentioned.
WHO IS ORGANISING AND FUNDING THIS CLINCIAL TRIAL?
Details must be provided of the name of the organisation sponsoring and / or funding the clinical trial and whether the doctors involved will receive payment for their involvement.
WHO HAS REVIEWED THE STUDY?
The standard text within the template document must be included.
Provide the name of the reviewing Main Ethics Committee.
CONTACT FOR FURTHER INFORMATION?
The standard text within the template document must be included.