NRES Heading | What does NRES say should be included? | Number of studies | Empirical evidence for inclusion in PIS from literature |
What is the purpose of the study? | Purpose is an important consideration for subjects and should be included | 223 32 | Pooled results showed that 76% (95% CI 27% to 100%) participants wanted to know about study purpose |
Why have I been invited? | Why and how participants have been chosen and how many will be in the study | 0 | No empirical evidence |
Do I have to take part?/What will happen if I don't want to carry on with the study? | The voluntary nature of the research should be included | 421–23 32 |
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What will happen to me if I take part?/What will I have to do? | How long the participant will be involved in the research/how long the research will last | 321 23 32 | Pooled results from all three studies20 29 30 showed that 61% (95% CI 16% to 97%) participants wanted to know how long the research would last |
How often they need to attend a clinic | 121 | 68% (27/40; 95% CI 53% to 82%) wanted to know the frequency of additional study visits29 | |
How long visits will be | 0 | No empirical evidence | |
Exactly what will happen to them | 221 22 |
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Expenses and payments | Expense claims available and if there is any kind of payment for participation | 121 | 25% (10/40; 95% CI 11.6% to 38.4%) wanted to know if free medication would be available during or after trial29 |
What is the drug, device or procedure that is being tested? | Short description of the drug, device or procedure and given the stage of development state the dosage of the drug and method of administration, and details of any contraindicated drugs included over the counter drugs | 221 31 |
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What are the alternatives for diagnosis or treatment? | What other managements/treatments are available and a list of all important comparative risks and benefit | 122 | 5% (1/21; 95% CI 0% to 13.9%) wanted as much information about treatment alternatives as they received about the study medication31 |
What are the possible disadvantages and risks of taking part?/What are the side effects of any treatment received when taking part? | Any risks, discomforts or inconvenience should be outlined | 416 23 31 32 | Specific information types varied considerably between studies so no meaningful pooled results could be calculated. Results ranged from no participants that asked about study risks (0/57)20 to 97% (207/213; 95% CI 95% to 99.4%) who wanted to be informed about any possible emotional or physical discomforts and side effects30 |
Radiation and the Ionising Radiation Regulations | If the use of additional ionising radiation is required as part of the study, then information must be given to the participant on the radiation involved | 0 | No empirical evidence |
Harm to the unborn child: therapeutic studies | Clear warnings must be given where there could be harm to an unborn child, if there was a risk in breast feeding or if taking the medication is likely to cause fertility problems | 0 | No empirical evidence |
What are the possible benefits of taking part? | Benefits should be included, but where there is no intended clinical benefit it should be stated clearly | 323 31 32 |
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What happens when the research study stops? | Arrangements for after the trial finishes must be given, and it must be clear if participants will have continued access to any benefits or intervention they may have obtained during the research. If treatment will not be available after the study, it should be explained what treatment will be available instead | 121 | 55% (22/40; 95% CI 39.6% to 70.4%) wanted to know about the availability of medication after the study was over29 |
What if there is a problem? | How complaints will be handled and what redress may be available | 0 | No empirical evidence |
Will my taking part in the study be kept confidential? | How data will be collected, stored, what it will be used for, who will have access to it, how long it will be retained for and how it will be disposed of | 223 32 | Pooled results showed that 44% (95% CI 10% to 82%) participants wanted to be given information about confidentiality and the protection of their privacy |
Involvement of the GP/family doctor | If the participants GP needs to be notified of involvement or asked for consent | 0 | No empirical evidence |
What will happen to any samples I give? | Clear description of whether new samples will be taken, if excess samples will be taken, and if access to existing stored samples will be required. The same type of information as for data is required to be provided | 0 | No empirical evidence |
Will any genetic tests be done? | A separate consent form for genetic studies should be used | 0 | No empirical evidence |
What will happen to the results of the research study? | What will happen to the results of the research, if it is intended to be published and how results will be made available to participants and that they will not be identified in any publication | 328 30 33 |
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Who is organising and funding the research? | The organisation or company sponsoring the research and funding the research if these are different and if the researcher conducting the research is being paid | 620 24–27 34 |
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Who has reviewed the study? | Explain the role of the research ethics committees and which committee reviewed the current study | 123 | No participants asked about institutional review board approval (0/57)20 |
GP, general practitioner; NRES, National Research Ethics Service; PIS, participant information sheet.