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This fact sheet has been endorsed by the University Research Ethics Committee (^) (^)
Guidance on completing an Information Sheet
An information sheet should provide sufficient information to enable potential recruits to make an informed choice regarding whether or not to participate in a research project, and should clearly state that participants are free to withdraw at any time.
Researchers should take the steps necessary to ensure that all participants in the research (a) understand the process in which they are to be engaged, including why their participation is necessary, (b) understand the purpose of the research and how and to whom its research findings will be reported and (c) understand that their data could be used for future research projects, if they agree to this.
It is recommended that the content of an information sheet i s:
x relevant to the proposed research; x accurate and concise; x clear, simple and understandable from a lay persons perspective (e.g. avoids jargon); x presented on the headed paper of the institution carrying out the research; x appropriate for the cultural and social context in which it is being given.
It is recommended that the content of an i nformation sheet does not include:
x any abbreviations, jargon or technical terms; x bias or coercion or any inappropriate inducements.
How long should an information she et be?
Information sheets should only contain relevant information that a reasonable person would want to know (i.e. in order to decide whether or not to participate in a research project). It is recommended that, where appropriate, an information sheet contains information in the order specified under the headings given on the following page.
The length and design of an information sheet should encourage a prospective participant to read it in full. A participant may take more care when reading a concise information sheet and, thereby, be better informed than if s/he has to read an information sheet that runs into several pages. However, with respect to projects that involve particularly vulnerable participants and/or which require access to sensitive personal data, the information sheet may need to be relatively longer in order to cover more detailed information.
Please turn to next page for examples of the appropriate information to
include in an information sheet
Participant Information Sheet
1. Research Project Title:
Is the title self-explanatory to a lay person?
2. Invitation paragraph
Explains that the prospective participant is being asked to take part in a research project.
Example paragraph:
You are being invited to take part in a research project. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. Thank you for reading this.
3. What is the projects purpose?
The background, aim and duration of the project should be given here.
4. Why have I been chosen?
You should explain how the participant was chosen and how many other participants will be recruited.
5. Do I have to take part?
You should explain that taking part in the research is entirely voluntary and that refusal to agree to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
Example 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) and you can still withdraw at any time without it affecting any benefits that you are entitled to in any way. You do not have to give a reason.
6. What will happen to me if I take part?
You should state how long the participant will be involved in the research, how long the research will last (if this is different), how often they will need to participate and for how long each time. You should explain if travel expenses are available.
You should explain what exactly will happen (e.g. blood tests, interviews etc.?) Whenever possible you should draw a simple flowchart or plan indicating what will happen on each occasion they are to participate.
Where a participant is to be interviewed the questioning style should be explained (e.g. clarify if questions will enable open as well as closed answers to be given in relation to a particular topic; e.g. clarify which aspects of the topic participants should be able to discuss in-depth and which not in-depth).
You should explain the participants responsibilities, setting down clearly what you expect of them.
You should set out simply the research methods you intend to use.
7. What do I have to do?
State if there are any lifestyle restrictions as a result of participating.
8. What are the possible disadvantages and risks of taking part?
Any reasonably foreseeable discomforts, disadvantages and risks need to be stated. Researchers should make known to the participants any predictable detriment arising from the proposed research process. Any unexpected discomforts, disadvantages and risks to participants which may arise during the research, should be brought immediately to their attention.
9. What are the possible benefits of taking part?
Any benefits to the participants that can reasonably be expected should be stated. However, where there is no intended benefit to the participant from taking part in the project this should be stated clearly. It is important not to exaggerate the possible benefits to the particular participant during the course of the project. This could be seen as coercive. Example opening sentence: Whilst there are no immediate benefits for those people participating in the project, it is hoped that this work will …
10. What happens if the research study stops earlier than expected?
If this is the case the reason(s) should be explained to the participant.
11. What if something goes wrong?
You should inform participants how complaints will be handled and what redress may be available (i.e. what the process is). You need to distinguish between handling complaints from participants regarding their treatment by researchers and something serious occurring during or following their participation in the project (e.g. a reportable serious adverse event).
In the first instance you should inform the participants which member of the research project they should contact should they wish to raise a complaint (this is most likely to be the Principal Investigator or Supervisor). However, the participants should also be informed that should they feel their complaint has not been handled to their satisfaction (e.g. by the Principal Investigator or Supervisor) that they can contact the Head of Department, who will then escalate the complaint through the appropriate channels.
12. Will my taking part in this project be kept confidential?
An applicant should consult the Universitys Research Ethics Policy Note on Principles of Consent for advice on what information to provide to prospective participants, available at: https://www.sheffield.ac.uk/rs/ethicsandintegrity/ethicspolicy/further-guidance/homepage
You need to obtain the participants permission to allow restricted access to information collected about them in the course of the project. You should state that all information collected about them will be kept strictly confidential and explain how information will be kept confidential. Example paragraph:
All the information that we collect about you during the course of the research will be kept strictly confidential. You will not be able to be identified in any reports or publications.
Where, due to the nature of the research, it may not be possible to safeguard the confidentiality of the data then the reasons for this should be stated here. Furthermore, the consequences to the participant from data not remaining confidential should be provided here.
13. What type of information will be sought from me and why is the collection of this information relevant for achieving the research projects objectives?
Please explain here.
14. What will happen to the results of the research project?
You should be able to tell the participants what will happen to the results of the research (i.e. when the results are likely to be published, where they can obtain a copy of the published results, whether they be told which arm of the project they were involved in) and add that they will not be identified in any report or publication.
It is good practice to consider possible future uses of the data, including opportunities to share data more widely in line with the open access agenda, so it is recommended that you include a statement indicating that the data collected during the course of the project might be used for additional or subsequent research (this should also be explicit on the participant consent form). A suggested statement is as follows: due to the nature of this research it is very likely that other researchers may find the data collected to be useful in answering future research questions. We will ask for your explicit consent for your data to be shared in this way and if you agree, we will ensure that the data collected about you is untraceable back to you before allowing others to use it
15. Who is organising and funding the research?
You should state the organisation or company that is sponsoring or funding the research.
16. Who has ethically reviewed the project?
You should state the name of the academic department that managed the ethics review process i.e. this project has been ethically approved via x departments ethics review procedure (every academic department either administers the Universitys Ethics Review Procedure itself, internally within the department, or accesses the Universitys Ethics Review Procedure via a cognate, partner department). The Universitys Research Ethics Committee monitors the application and delivery of the Universitys Ethics Review Procedure across the University.
17. Contact for further information
You should give the participants contact details for at least two individuals, in case they wish to obtain further information about the project. This would usually be the name, address and telephone number of the lead researcher, and at least one alternative contact should the lead
researcher be unavailable; this could be another researcher involved the project, or the Supervisor of a supervised-student project.
Finally … the information sheet should state that the participant will be given a copy of the information sheet and, if appropriate, a signed consent form to keep.
and remember to thank the participants taking part in the project.
Question to insert into an information sheet if the research
involves producing recorded media:
Will I be recorded, and how will the recorded media be used?
You need to obtain the participants permission to record their activities on audio or video media. You must ensure that there is a clear understanding as to how these recorded media will be used. For instance, if you record a music or theatre performance, you must not publish or broadcast the recording, show it in public, or deposit it in an archive without the performers permission. Storage (and eventual disposal) of interview recordings which contain sensitive material can also be an issue to address.
Example paragraph:
The audio and/or video recordings of your activities made during this research will be used only for analysis and for illustration in conference presentations and lectures. No other use will be made of them without your written permission, and no one outside the project will be allowed access to the original recordings.
If you plan to use the recording in a publication or broadcast or deposit it in an archive, it will usually be best to prepare and sign a separate release form for each item used.
Questions to insert into an information sheet if the research
project is a clinical trial:
What is the drug or procedure that is being tested?
You should include a short description of the drug or device and give the stage of development. You should also state the dosage of the drug and method of administration. Participants entered into drug trials should be given a card (similar to a credit card) with details of the trial they are in. They should be asked to carry it at all times.
What are the alternatives for diagnosis or treatment?
For therapeutic research the participant should be told what other treatments are available.
What are the side effects of any treatment received when taking part?
For any new drug or procedure you should explain to the participants the possible side effects. If they suffer these or any other symptoms they should report them next time you meet. You should also give them a contact name and number to phone if they become in any
way concerned. The name and number of the person to contact in the event of an emergency (if that is different) should also be given. The known side effects should be listed in terms the participant will clearly understand (e.g. damage to the heart rather than cardiotoxicity; abnormalities of liver tests rather than raised liver enzymes). For any relatively new drug it should be explained that there may be unknown side effects.
What are the possible disadvantages and risks of taking part?
For projects where there could be harm to an unborn child if the participant were pregnant or became pregnant during the project, the following (or similar) should be said –
It is possible that if the treatment is given to a pregnant woman it will harm the unborn child. Pregnant women must not therefore take part in this project, neither should women who plan to become pregnant during the project. Women who are at risk of pregnancy may be asked to have a pregnancy test before taking part to exclude the possibility of pregnancy. Women who could become pregnant must use an effective contraceptive during the course of this project. Any woman who finds that she has become pregnant while taking part in the project should immediately tell her research doctor.
Use the above statement carefully. In some circumstances (e.g. terminal illness) it would be inappropriate and insensitive to bring up pregnancy. There should be appropriate warning and advice for men if the treatment could damage sperm that might therefore lead to a risk of a damaged foetus.
If future insurance status (e.g. for life insurance or private medical insurance) could be affected by taking part this should be stated (if e.g. high blood pressure is detected.) If the patients have private medical insurance you should ask them to check with the company before agreeing to take part in the trial. They will need to do this to ensure that their participation will not affect their medical insurance.
You should state what happens if you find a condition of which the patient was unaware. Is it treatable? What are you going to do with this information? What might be uncovered?
What if new information becomes available?
If additional information becomes available during the course of the research you will need to tell the participant about this. You could use the following:
Sometimes during the course of a research project, new information becomes available about the treatment/drug that is being studied. If this happens, your research doctor will tell you about it and discuss with you whether you want to continue in the study. If you decide to withdraw your research doctor will make arrangements for your care to continue. If you decide to continue in the study you will be asked to sign an updated consent form.
Also, on receiving new information your research doctor might consider it to be in your best interests to withdraw you from the study. He/she will explain the reasons and arrange for your care to continue.