Delays in the approval of research projects are often due to inadequate Subject Information Sheet and Consent Forms. Please ensure these documents are well prepared as this is the key to good communication, recruitment and compliance, as well as serving to reduce the likelihood of complaints.
If volunteers do not understand what they are consenting to then that consent is not valid.
The Subject Information Sheet and the Consent Form are central and important components of all studies. They should be presented to potential volunteers as two parts of a single document. Both parts should be on headed paper of the institution where the research is to be conducted and, once completed, both should be signed. The single document should then be given to the volunteer to retain. Ideally these documents should be double-sided with the Consent Form backing onto the Information Sheet.
The principles on which this guidance is based follow from a number of published guidelines including those of the Department of Health Central Office for Research Ethics Committees (COREC).
Potential recruits to any research study must be given sufficient information to allow them to decide whether or not they want to take part.
The purpose of the Information Sheet is to ensure that participants understand the risks and benefits of participation (compared with non-participation) to both themselves and others.
The Information Sheet should contain information under the appropriate headings provided below. It should be written in simple, non-technical terms, even when the potential volunteers have a scientific background knowledge, and be easily understood by a lay person.
The Information Sheet should be on headed paper of the institution where the research is to be conducted and should be dated.
In some cases it may be more appropriate to use a letter of invitation rather than an Information Sheet, for example, when using a mail-out questionnaire. In these cases, the letter of invitation must contain the information normally included in the Information Sheet. A returned and completed questionnaire implies that consent has been given.
Is the title self explanatory to a lay person? If not, a simplified, brief descriptive title (maximum 80 characters) should be included.
This should explain to potential recruits that they are being asked to take part in a research study. The following would be a suitable example:
"You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please read the following information carefully, discuss it with others if you wish and take time to decide whether or not you wish to take part. If you would like more information or have any questions please contact........ "
The background and aim of the study should be given here. This should clearly state the key issues - what is the problem being addressed, why are the results needed and by whom. The overall duration of the study should also be included.
The selection criteria, if any, should be given here (e.g. males without a history of asthma) together with the number of subjects to be studied.
It should be explained that taking part in the research is entirely voluntary. The following would be a suitable paragraph:
"It is up to you to decide whether or not to take part. If you do decide to take part you will be given this Information Sheet to keep and be asked to sign a consent form. However, even if you sign the consent form you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect your employment."
You should state how long the volunteer will be involved in the research, how long the research will last (if this is different), how often they will need to visit the laboratory (if this is appropriate) and how long these visits will be including whether any overnight stays may be required. If travelling to the laboratory is required, the availability of travel expenses should be stated.
Tests and procedures should be described.
Where biological samples are being sought volunteers should be told that only substances relevant to the study objectives are to be measured. There should be a positive statement as to what will not be analysed for (e.g. HIV, alcohol, drugs of abuse).
Where blood, urine, or other specific tissue samples (e.g. skin biopsy, hair or nail clippings) are to be retained beyond the study duration (e.g. 'banked' for control purposes) volunteers should be given explicit information as to the reason for and the duration of this retention. It should be made clear whether stored samples should be anonymous or linked to the volunteer. There should be specific consent obtained to retain samples and the following would be an appropriate paragraph:
"I understand that with my consent samples of …………….. ….. taken during the study may be stored for up to ……….……….. months for further research and analysis but this will not include any measurement of …………………………. ."
"I understand that the samples will be anonymous and not traceable back to me."
What are the subject's responsibilities? Set down clearly what you expect of them. Note any lifestyle restrictions.
Where volunteers are taking part in studies which involve chemical exposure, the taking of oral preparations or any physical test procedure you should explain the possible side effects. Volunteers should be made aware of whom they should inform if they have concerns or if any of the identified side effects should arise. Where potential side effects are unknown this should be stated.
Whilst the Research Ethics Committee require that they be informed, in detail, of all potential risks (see separate guidance) study risks should be communicated to volunteers in common sense terms, particularly where tests might be considered 'routine' with minimal associated risk (e.g. blood sampling, forced expiratory lung function tests).
For studies where there could be harm to an unborn child if the volunteer were pregnant or became pregnant during the study, the following (or similar) should be included:
"It is possible that participation in this study by a pregnant woman could harm the unborn child. Pregnant women, or women who plan to get pregnant during the study, should not take part. Any woman who finds that she has become pregnant while taking part in the study should immediately tell the study Medical Officer."
There should also be an appropriate warning and advice for men if the study could damage sperm and lead to a risk of a damaged foetus.
You should state what happens if you find a 'condition' of which the volunteer was unaware. What might be uncovered? What are you going to do with this information?
Where there is no benefit to the individual from taking part in the study this should be clearly stated. The potential wider benefits and outcome from the study should be identified.
You should inform volunteers how complaints will be handled and what redress may be available.
Where the study carries risk of physical or significant psychological harm and there are no compensation arrangements for when something goes wrong and it's nobody's fault the following should be included:
"If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for a legal action. This is something you may have to pay for. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, then you may approach the HSE Research Ethics Committee through its secretariat at 0161 952 8289."
NB: we are currently (June 2008) seeking HSE Legal Advisor’s advice on the suggested wording in Section 9. Please check with the Committee Secretariat before completing this section.
You will need to explain that all information collected about the volunteer during the course of the study will be kept strictly confidential. You should explain how long data will be stored and in what form. It should also be made clear if, and how, any samples and data will be made anonymous.
In order to comply with the Data Protection Act (1998) where research data is not made anonymous at source the following should be included:
"The information which you provide in this study will include your name or identify you in some other way. The Data Protection Act (1998) calls this 'personal data' and places obligations on HSE as the 'data controller' to look after your data and not make it freely available. It will, however, be available to ……………………….. The Act also gives you the right to see this information about you and have any mistakes corrected"
Where photographic or video material is to be recorded the following would be an appropriate paragraph:
"I understand that with my consent photographs and video material recorded during the study may be used for illustration purposes in reports and any subsequent journal articles. This is on the understanding that, while every effort will be made to preserve my anonymity, this cannot be guaranteed."
It should be made clear that if a medical 'condition' of which the volunteer was unaware is found they will be advised accordingly, but that information will not be communicated directly to the volunteer's Doctor.
Subjects should be given the opportunity to receive their individual study results and informed how these will be provided.
Where it is anticipated that it will not be possible to interpret the results from biological samples taken during the study on an individual basis, then this must be made clear to volunteers. Volunteers should be given the option of receiving a copy of their own results without comment.
You should be able to tell volunteers what will happen to the overall results of the research - when and where are the results likely to be published and, where can they obtain a copy of the results and subsequent publications. You might add that they will not be identified in any report/publication.
The answer should include the organisation or company sponsoring or funding the research.
This should include the fact that the study has been approved to proceed by the HSE Research Ethics Committee.
You should give the volunteer a contact point for further information and make it clear that such requests would be welcome.
Remember to thank the volunteer for participating in this study.