Table 2

Empirical evidence linked to NRES participant information sheet recommended headings

NRES HeadingWhat does NRES say should be included?Number of studiesEmpirical evidence for inclusion in PIS from literature
What is the purpose of the study?Purpose is an important consideration for subjects and should be included223 32Pooled 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 study0No 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 included421–23 32
  • Pooled results from the 3 quantitative studies20 29 30 showed that 39% (95% CI 2% to 100%) participants wanted to know about voluntariness

  • The one qualitative study reported that it was the most important piece of information to be included in a participant information sheet31

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 last321 23 32Pooled 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 clinic12168% (27/40; 95% CI 53% to 82%) wanted to know the frequency of additional study visits29
How long visits will be0No empirical evidence
Exactly what will happen to them221 22
  • Specific information types varied considerably between studies, so no meaningful pooled results could be calculated

  • The proportion of people wanting to know what would happen to them ranged from 9.5% (2/21; 95% CI 0% to 22.1%)31 to 20% (8/40; 95% CI 7.6% to 32.4%)29 depending on what the specific information was. For example, 20% (8/40; 95% CI 7.6% to 32.4%) wanted to know about burdens to friends or family caused by study participation,29 12% (5/40; 95% CI 2.3% to 22.8%) wanted to know how much work they would miss because of study participation,29 10% (4/40; 95% CI 0.7% to 19.3%) wanted to know how much time would be spent waiting in clinic during study visits29 and 9.5% (2/21; 95% CI −3% to 22.1%) wanted to know practical information about trial procedures31

Expenses and paymentsExpense claims available and if there is any kind of payment for participation12125% (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 drugs221 31
  • The one quantitative study29 showed that specific questions about the medication regime ranged from 25% (10/40; 95% CI 11.5% to 38.4%) that wanted to know what control they had over medication dose during the study to 70% (28/40; 95% CI 55.8% to 84.2%) that wanted to know the frequency with which study medication must be taken.29 The study also showed that 62% (25/40; 95% CI 47.5% to 77.5%) wanted results of previous studies of safety and 45% (18/40; 95% CI 29.5% to 60.4%) of efficacy, and 15% (6/40; 95% CI 3.9% to 26.1%) wanted to know if study medication had been approved for clinical use29

  • The one qualitative study showed that participants wanted to know how to use the intervention21

What are the alternatives for diagnosis or treatment?What other managements/treatments are available and a list of all important comparative risks and benefit1225% (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 outlined416 23 31 32Specific 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 RegulationsIf the use of additional ionising radiation is required as part of the study, then information must be given to the participant on the radiation involved0No empirical evidence
Harm to the unborn child: therapeutic studiesClear 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 problems0No 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 clearly323 31 32
  • Pooled results of the two quantitative studies20 30 suggest that 57% (95% CI 7% to 98%) wanted to know about study benefits

  • Two studies provided relevant data relating to specific benefits.29 31 Specific requests ranged from 14% (3/21; 95% CI −0.7% to 29.3%) that wanted to know about hopes for better treatment31 to 55% (22/40; 95% CI 39.5% to 70.4%) that wanted an opportunity to learn about condition or medication under study.29 Specific information types varied considerably between studies so no meaningful pooled results could be calculated

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 instead12155% (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 available0No 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 of223 32Pooled 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 doctorIf the participants GP needs to be notified of involvement or asked for consent0No 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 provided0No empirical evidence
Will any genetic tests be done?A separate consent form for genetic studies should be used0No 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 publication328 30 33
  • Pooled results showed that 91% (95% CI 85% to 95%) wanted to know about study results

  • Specific information types varied considerably between studies, so no meaningful pooled results could be calculated. Two studies provided relevant data relating to specific aspects of what they wanted to know about results.23 28 78% (31/40; 95% CI 64.6% to 90.4%) of participants wanted a description of what researchers had learnt that was important,23 35% (14/40; 95% CI 20.2% to 49.8%) wanted it to include follow-up contacts for the researcher23 and 98% (29/40; 95% CI 58.7% to 86.3%) wanted a list of medical publications written as a results of the research.23 90% (46/51; 95% CI 82% to 98.4%) wanted their family or loved ones to be informed of the results if they were unable to learn them28

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 paid620 24–27 34
  • Pooled results from the four quantitative studies showed that 48% (95% CI 27% to 69%) wanted to know about any type of CoI, but there was general disagreement over whether patients wanted to be told about financial CoI

  • Three studies provided relevant data relating to what participants wanted to know about specific aspects of COI.24 27 34 When financial CoI were broken down into subcategories, 82.5% (4519/5478; 95% CI 81.48% to 83.5%) wanted to be told about commercial funding,27 69% (3779/5478; 95% CI 67.8% to 70.2%) about personal income,27 between 41% (105/259; 95% CI 34.6% to 46.5%) and 82% (4492/5478; 95% CI 81% to 83%) about patents and stocks and shares27 34 and 40% (101/253; 95% CI 34% to 46%) thought researchers should have told participants only about the oversight system24

  • One study reported that participants wanted to know specifically how money was spent, with proportions ranging from 25% (65/259; 95% CI 19.8% to 30.4%) that wanted to know how much of the funding was spent on administration34 to 38% (98/259; 95% CI 31.9% to 43.8%) that wanted to know how spare accrued funds were used at study completion34

  • One qualitative study reported that participants wanted to know the name of the sponsor27 and one quantitative study reported that 57% (148/259; 95% CI 51.1% to 63.2%)34 wanted to know the name of the funder

  • Some participants wanted help understanding the potential consequences of CoI, some did not25

  • Specific information types varied considerably between studies so no meaningful pooled results could not be calculated

Who has reviewed the study?Explain the role of the research ethics committees and which committee reviewed the current study123No participants asked about institutional review board approval (0/57)20
  • GP, general practitioner; NRES, National Research Ethics Service; PIS, participant information sheet.