Information sheet

Delays in the approval of research projects are often due to inadequate Volunteer Information Sheets 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 Volunteer 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 and dated. 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).

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Volunteer information sheet

This needs to do two things - firstly, present to the volunteer the risks from participation and secondly indicate what would happen should a problem arise.

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 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 layperson.

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.

1. Study title

Is the title self-explanatory to a layperson? If not, a simplified, brief descriptive title (maximum 80 characters) should be included.

2. Invitation paragraph

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........ "

3. What is the purpose of the study?

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.

4. Why have I been chosen?

The selection criteria, if any, should be given here (eg 'males without a history of asthma') together with the number of people to be studied.

5. Do I have to take part?

It should be explained that taking part in the research is 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."

6. What will happen to me if I take part?

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 statement about analysis that will not be undertaken (eg HIV, alcohol, drugs of abuse).

Where blood, urine, or other specific tissue samples (eg skin biopsy, hair or nail clippings) are to be retained beyond the study duration (eg '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 volunteer's responsibilities? Set down clearly what you expect of them. Note any lifestyle restrictions.

7. What are the possible disadvantages and risks of taking part?

Where potential risks may be considered anything other than "minimal", these should be presented. See 9.2 (ii).

Any risks, discomfort or inconvenience should be briefly outlined. However, explanation of risk is notoriously difficult, and researchers should consider carefully how to explain any risk in their study. The published literature should be consulted and material presented to likely participant groups to assess its value. In designing the information sheet you should consider insurance issues and whether volunteers should be informed that their participation may affect insurance cover.

8. What are the possible benefits of taking part?

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.

9. What if something goes wrong?

9.1 The researcher should inform volunteers how complaints will be handled and what redress may be available. These may be considered under the headings 'complaints' and 'harm'.

• Complaints: A contact number should be given. This may be the researcher, who can try to solve the problem in the first instance. However, a participant may not wish to complain to the researcher if he/she is the object of the complaint, and may wish to make a more formal complaint. He/she should be advised to contact the "senior owner" of the research and/or to refer to the risk assessment.

• Harm : Appropriate redress and/or compensation may be available and details of insurance/indemnity schemes should be given. (See 9.2 'Potential for harm to volunteers'.)

This is suggested text for volunteer information sheets:

"In the unlikely event that something does go wrong and you are harmed during the researchand this is due to someone's negligence then you may have grounds for a legal actionfor compensation against (name of Sponsor Organisation)but you may have to pay your legal costs."

9.2 Potential for harm to volunteers

The purpose of this information is to provide researchers with guidance on how to inform volunteers of potential harm within the context of the particular research project. It is for use when there are potential risks to a volunteer's health from research. It is not intended to be prescriptive, and it will not need to be reproduced for every submission to the Research Ethics Committee (REC), which will be the final arbiter in all cases.

1. You must inform volunteers of the potential for harm to them that could be caused during the research project. This applies to both physical and psychological harm, and also to confidentiality and privacy issues. Depending on the risk, or if asked, you must consider the need to inform volunteers of their rights in the event of something going wrong leading to harm, whether due to negligence or not. In addition, you must inform volunteers how any complaints they might make would be handled.
2. Most research submitted to HSE's REC for consideration is not likely to harm volunteers (unlike some NHS based clinical research, for example). However, there needs to be a clear explanation of the hazards and risks inherent in the research with links to other relevant information for volunteers etc, elsewhere in the material submitted to the Committee. If possible, especially if any risk is greater than "minimal"¹ a probability should be given. This should be evidence based - if possible numeric (eg 1 in 100, 1 in 1000 etc), or otherwise qualitative (eg low/medium/high). The REC will comment on this risk estimation where appropriate.
3. Volunteers are normally either HSL/HSE employees or, in field studies, employees of companies outside HSE. Their rights in terms of indemnity, should something go wrong, are no different from those which apply in the ordinary course of their work. This needs to be clearly stated. Where the volunteers are employed by an employer other than HSE/HSL they are likely to be treated by their employer as in the ordinary course of their work. The position should be confirmed with the employer and clearly stated.
4. The legal position may be different for volunteers who are self-employed or who are employees in a small business, but here again their attention should be drawn to the issue of liability and indemnity, and to the need for them to check their cover before proceeding, in the unlikely event of something going wrong. If asked, you should tell volunteers that HSL does not carry its own insurance. Where volunteers are self-employed, you should check that they have insurance. In all other cases, and particularly with small businesses, you should check that the employer has Employers' Liability Compulsory Insurance.
5. It is difficult in law to say in advance what the position is in relation to the existence of a duty of care and what amounts to a breach of it and whether there is/has been negligence. This is what a court decides (in finding a party has been negligent) in a case where the complainant has brought court proceedings.
6. An individual volunteer's life insurance is unaffected by volunteering to participate in research; this has been confirmed by the Association of British Insurers. A volunteer may need to check whether other protections, such as mortgage insurance, are similarly unaffected. Legal expenses insurance, often included with home contents insurance, may enable a civil action to be brought if necessary; "No win, no fee" lawyers will now take on personal injury cases, where negligence is being alleged.

10. Will my taking part in this study be kept confidential?

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 are 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.

11. What will happen to the results of the research study?

Volunteers 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 the results are likely to be published, and where they can obtain a copy of the results and subsequent publications. You might add that they will not be identified in any report/publication.

12. Who is organising and funding the research?

The answer should include the organisation or company sponsoring or funding the research.

13. Role of the Ethics Committee

The role of the HSE Research Ethics Committee (REC) is to independently review the researchers' analysis of risk, to ensure that issues of compensation for negligent and non-negligent harm have been appropriately considered and that the information sheet for volunteers reflects these matters in a proportionate way.

In relation to minimal risk, for example, the Committee need to be assured that the researchers have considered both aspects of risk - hazard and likelihood of occurrence - as well as taken into account volunteer perception.

It should be acknowledged that minimal risk may be age or context dependent and that risks need not be 'physical' in order to be 'more than minimal' (eg a serious privacy risk, confidentiality risk, informational risk or risk of embarrassment may be enough to push a study into the 'greater than minimal' risk category). Finally, investigators should have appropriately interpreted risks in relation to the definition.

The Committee have discussed matters of indemnity and insurance at length. Government indemnity does not offer no-fault compensation (i.e. for non-negligent harm), and Government is therefore unable to agree in advance to pay compensation for non-negligent harm. They are able to consider an ex-gratia payment in the case of a claim. The REC, however, are required to consider in each study whether it is acceptable to seek consent without no-fault compensation, given the risks. If a study (as considered by the REC) carries a significant risk of serious non-negligent harm from study procedures required by the protocol, then the investigators should obtain agreement from their employers for statements on how this might be handled and suitable wording included in the information sheet. This is an unlikely occurrence in the case of the HSE REC but the Committee should be aware that they could justifiably fail to approve a 'high risk' study in the absence of suitable arrangements for non-negligent harm.

The Information Sheet should state that the study has been approved to proceed by the HSE REC.

14. Contact for further information

You should give the volunteer a contact point for further information and make it clear that such requests would be welcome.

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Footnotes

1. In relation to research Minimal Risk has been defined as: "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."