INFORMATION SHEET GUIDELINES
· This document must be in plain English
· Technical terms must be explained
· It must be on the letterhead of the initiating Institution i.e. university, hospital, organisation
· It should be phrased in the ‘Second Person’ i.e. ‘You will be asked’
· An Information Sheet is required for every cohort you are researching, e.g. parents, principals, students, focus groups, pilot study groups etc
· Remember that the application form, the Information Sheet and the Consent form must agree in all material ways.
Potential participants must be given sufficient information to be able to make an informed decision whether or not to participate.
The Information Sheet should be addressed to the participant in the form of a personal invitation. Some examples of statements follow:
We would like to invite your participation in the following research….
You will be invited to be involved in a survey….
For most projects this information will be provided as an Information Sheet. An alternative, which may be more appropriate for some projects, is to include the information in an introductory letter to potential participants.
The level of detail necessary to inform the potential participant adequately will vary with the nature of the participation and particularly with the risk of harm and its likely severity. The information should be sufficient and comprehensible to the particular participants, so the investigator should consider their background and circumstances and what information they would like to have. Use everyday language to aid participants’ understanding.
A useful technique in writing an information sheet is to put oneself in the shoes of a proposed participant. Think about what a person would want to know about the project so that he/she could decide whether or not to participate if invited.
Investigators need to identify the information that will raise concerns with participants and make sure that this is brought to their attention; eg by placing it near the beginning of the information sheet. For example, for some projects, the fact that all information will be treated as confidential might be particularly important.
An outline of the information, which normally needs to be covered, is given below. This outline is written in point form simply to assist investigators. An information sheet written in paragraphs usually has a more user-friendly style. It does not need to incorporate the titles shown – these may inhibit the normal flow of the information you are trying to convey.
Date of Information Sheet
The Information Sheet needs to have a provision for the date to be inserted via computer or hand when it is sent out.
Title of investigation
This should come first in the Information Sheet.
Name of chief investigator
Give the name of the chief investigator and their position within the University and also the name of the person who will have direct involvement with research participants if this is not the chief investigator. This is important because not every researcher who signs the information sheet will have direct contact with participants.
Purpose of the study
Explain fully, but in simple language, the purpose of the investigation.
If the study is a student project, explain that the project is being undertaken as part of (or to fulfil) the requirements for a degree (honours/masters/PhD) in a particular discipline (and identify the candidate for the degree by name).
Participant Benefit
There should be a statement detailing the benefits to the participants or others. Ask yourself the question ‘What is the point of being involved in the study?’’
Inclusion and exclusion Criteria
Participants should be informed as to why and how they have been selected for participation in the study. In some contexts it may be necessary to assure participants that the researchers have not accessed their personal contact details or any other information protected by privacy law. This may be the case where, for example, parental consent is requested for childrens’ participation in a school-room activity, in which case the school should distribute the Information Sheets and Consent Forms.
If the inclusion in the research of people with certain characteristics (e.g. elderly people; people with pre-existing health conditions) might be inappropriate or potentially harmful, criteria for exclusion from the study should be specified.
Study procedures
The procedures must be fully explained. Describe in detail what the participant will be asked to do. The duration of the Instruments (how long the surveys, interviews etc. will take) should also be included. If data supplied by a participant is to be audio or video recorded, this should be made clear in the Information Sheet, in which case the researcher should ordinarily give participants the opportunity to peruse a transcript of their data, so as to edit, modify or withdraw it if necessary.
Payment to participants
Details of any payment to participants must be given. Participants may be paid for inconvenience and time spent but such payment must not be so large as to be an inducement to participate. Where university students receive course credit for participating in the study (for example, research participation hours as part of course requirements from psychology students), the amount of course credit must be specified, and also indicate whether that course credit will be forfeited for withdrawal from the study.
Possible risks or discomforts
All risks that might affect a person’s willingness to participate in the study must be stated. “Risks” will depend on the nature of the investigation and might include physical effects (eg the risk of pain), psychological effects (eg the risk of emotional distress or embarrassment), social effects (eg the risk of social harm if information was disclosed), or commercial or legal effects or consequences. (Describe risks carefully and accurately. Quantify the nature and level of the risk if possible.
Risk Mitigation:
Any provision for debriefing participants at the end of the study (or on withdrawal during the study) should be explained. If the risks warrant it, counselling options (including contact details, and any costs involved) should also be outlined. Counsellors should be independent of the researchers and of the institutions that employ them. In other forms of research, debriefing is not applicable because the risk may have, for instance, commercial or legal overtones. In each case, the researcher must explain how the procedures adopted will reduce the risk of adverse commercial or legal consequences. Part of this may involve the issues of confidentiality and protection of information mentioned below. To this end, where transcripts of data supplied are involved in the study, in most cases participants should be given the opportunity to peruse their transcript, and edit, modify or withdraw the data in it.
Confidentiality
Explain the steps that will be taken to maintain the confidentiality of research data.
· If any personal or identifying data is to be included, describe what measures are in place to safeguard the confidentiality of the participants.
· Specify how the data will be stored, e.g. in locked cabinets, password protected computers.
· Indicate where it is to be kept.
· Note that raw data must be kept for at least 5 years, and this should be stated on the Information Sheet.
· Detail how it will be destroyed after the expiry of the 5 year period or otherwise when no longer required.
Freedom to refuse or withdraw
Make it clear that participation is entirely voluntary. It must be clear that participants who decide to take part in the study can withdraw at any time without prejudice and, should they wish, also withdraw any data they have supplied to date. In some types of research, the nature of the ‘without prejudice’ statement needs to be expanded, eg, in a study of persons dependent upon financial or other support from an organization, that withdrawal will not affect their entitlements to that support. In the case of studies that entitle students to course credit, any statement that withdrawal is ‘without prejudice’ must be qualified if withdrawal leads to denial of that course credit.
Contact persons
Include names and telephone numbers of people that the participant can contact for more information. The contact person for questions relating to the study will normally be the Chief Investigator, although contact details for one or more of the other researcher(s) are also desirable. Where the research is conducted interstate or overseas, email contacts for the researchers ought also to be provided.
Statement regarding approval
Include a statement that the project has received ethical approval from the Southern Tasmania Social Sciences Human Research Ethics Committee and any other group that are involved e.g. the Royal Australian College of General Practitioners or the Department of Education and the Arts.
If the project uses school children as participants the parents should be informed that the project has the permission and support of the school and the Department of Education or, in the case of private schools, the relevant governing body for the school(s).
Concerns or complaints
Inform participants that, if they have any concerns of an ethical nature or complaints about the manner in which the project is conducted, they may contact the Chair or Executive Officer of the Southern Tasmania Social Sciences Human Research Ethics Committee.
Chair: A/Professor Gino Dal Pont (6226 2078)
Executive Officer: Amanda McAully (6226 2763)
If University of Tasmania students are proposed as participants inform them that, if they have any personal concerns related to the study, they may choose to discuss these concerns confidentially with a University Student Counsellor free-of-charge (and provide contact phone number).
Results of investigation
Participants should be given the option to see their own personal data, to be kept informed during the course of the study or any significant findings that might affect them, and to receive the final overall results.
If relevant, include a statement that the results will be passed on to appropriate people (eg participant's GP or school principal).
If possible, details of the following sources of information should be provided for the participants in the Information Sheet:
· A URL of the School Website where the results will be posted if available.
· An email address or phone number as an alternative to the Website as not all participants will have access to the Web.
Where participants are de-identified, any list that the researcher keeps, of the participants who would like a report, should be kept separately from the data files to preserve anonymity.
Information sheet and consent form
Include a note that the participant will be given copies of the information sheet and statement of informed consent to keep.
The form should end with the signature blocks of the Chief Investigator/s, researchers and students. E.g.
Typed Chief Investigator Name Typed Reseacher/Student name
CONSENT FORM GUIDELINES
The ‘Consent Form’ and the ‘Information Sheets’ are normally separate documents. However, in some cases the investigator might wish to combine information and consent in a single document, for example, if the project is straightforward and requires little explanation. In such cases it is important that the information and consent sections of the form are separated clearly.
Explanation on various items:
Item 3: Include the time that the questionnaires, interviews, focus groups, tests or other procedures will take
Item 5 Describe any risks or possible discomfort, or indicate that there are no foreseeable risks.
Item 7: This clause is only relevant if the participants are indeed, not identifiable. There are instances where public figures or holders of particular offices will be identifiable because of those positions, or where because of the nature of the participants or the industry, profession or trade involved comments made by individuals could be identifiable to them. If this is the case then a clause needs to be inserted e.g.:
I understand that I may be identifiable due to my official position or title.
Item 9: The context of the prejudice that might result if participants do not become involved or withdraw, should be added (e.g. academic standing, employment, medical management). If student credit is forfeited by withdrawal, this should be stated.
Item 10: A "statement by the investigator" is not applicable for a research project in which there is no direct contact between the investigator and the participants i.e. when a questionnaire is filled out via mail with no identifying information on it. In such a case, there may be no need for a consent form at all, in that consent to be involved in the study is evident from the completion of the questionnaire or survey. There should be an alternative statement that indicates that the participants have had the Information Sheet and opportunity to contact the Investigators.
If Children are involved:
Written consent from children is appropriate where they understand the nature of the research and what it means for them. All children under the age of 18 must have parental/guardian consent.
For further information about informed consent see Section 6.1 ‘The principle of informed consent’ in the Handbook.
The following is a template for the Consent Form.
CONSENT FORM
Title of Project:
1. I have read and understood the 'Information Sheet' for this study.
2. The nature and possible effects of the study have been explained to me.
3. I understand that the study involves the following procedures: [outline the procedures]
4. I understand that the following risks are involved: [outline the risks where relevant]
5. I understand that all research data will be securely stored on the University of Tasmania premises for a period of 5 years. The data will be destroyed at the end of 5 years (or, in the researcher plans to retain the data for longer than this period, specify that the data will be securely stored on the University of Tasmania premises until no longer required, at which time it will be destroyed).
6. Any questions that I have asked have been answered to my satisfaction.
7. I agree that research data gathered for the study may be published (provided that I cannot be identified as a participant).[*]