This page briefly covers why in the Faculty we have ethical review of human participant studies, and identifies the steps for preparing a submission for review. Relevant documents and forms are available for download from the “ERGO” Web site, the University on-line submission system.
The Ethical Review Process in FPSE has one main purpose: To ensure that research studies which involve human participants are carried out in a way that minimises any potential for harm and improves the potential for benefit.
There are generally several key components in ensuring this care, including:
- Participants receive accurate, appropriate, and sufficient information.
- Informed consent is obtained.
- Risks are identified and appropriate measures are put in place to address them.
- The identity of participants and their personal data are protected at all times.
- Inducements for participation, whether explicit or implicit, are appropriate.
The ethics application form (study protocol) has 3 core requirements:
- To demonstrate how informed consent will be communicated,
- To demonstrate how data will be gathered and protected, and
- To identify risks and demonstrate how they will be addressed.
University policy requires that ANY study involving human participants, whether questionnaires, lab studies, field observations and so on, MUST be submitted for ethics review. If you have any doubt as to whether or not your study requires review, remember “ANY research involving humans participants” requires review, where “humans” includes human data (whether you gathered it or not) and human tissue, and this applies equally to animals. The definition excludes studies which only involve investigators and have no participants, they are covered by the University Health and Safety regulations. If you have other questions that are not addressed by the notes below or the ERGO instructions, guides, and templates, please ask your Research Group representative in the first instance (contact names provided in the “FPSE Ethics Committee Membership 15 July 2013” document).
In FPSE, the primary ethical issue is most often meeting the requirements of the Data Protection Act for the gathering and protection of personal data. Note that this *includes* any data that you might regard as incidental to your study, such as participant e-mail addresses which might find their way into your “contacts” list or be stored in your “sent items” folder. The instructions, guides, and templates, downloadable from ERGO, explain these requirements.
The FPSE Ethics Committee has prepared a document, “Why Submit?”. It briefly discusses eight key reasons why an investigator or researcher in FPSE might want to consider Ethics approval:
- Policy at The University of Southampton
- Legal requirements of The Data Protection Act
- Intrinsic concern for The Human “Good”
- Public relations and The “Kite Mark”
- Insurance Cover
- Professionalism and Appropriate Behaviour
- Funders and their requirements
- Journal & other editorial policies
Steps for Submitting a Proposal for Ethical Review
- Download and fill out the Ethical Review application form from ERGO.
- Prepare the documentation to go with the application.
- Upload the application form and any supporting documents to ERGO.
The application form (study protocol) is constructed around linked definitions of the various terms involved in ethics approval, and you should read the definitions as carefully as the form. Although the application is generally two or three pages long, additional documentation will be required as indicated on the form, involving at least the Participant Information form, the Consent Form, and the participant questionnaire or other data gathering instruments.
Completing and submitting the application for review
In completing and submitting the application form and documentation:
- Address the Ethics Committee (not your supervisor, sponsor, or funding body) in the application form when providing the information that the Committee requires.
- In general, simply reproducing or extracting your project brief, dissertation proposal, or project bid would be inadequate and inappropriate.
- Be explicit about participant recruitment, reward, activities, and debrief. How, specifically, will you identify potential subjects? How, exactly, will you contact them? What, exactly, will you say to them? How, precisely, will they agree to participate? How, specifically, will they receive their instructions? Step by step, what, exactly, will they do in your study?
- Avoid telling the Ethics Committee what to think. Bald statements such as, “Recruitment of participants is completely anonymous” or, “No personal data will be collected” are of little value.
- Address the intended participants (not the Ethics Committee) in the consent form, participant information sheet, questionnaires, and similar information documents.
- Questionnaires should faithfully and specifically reflect what participants will actually be asked to complete.
- Explicitly identify any data items that you might store in addition to that shown in your questionnaires, closed-form reports, or other data gathering instruments. This *includes* any data that you might regard as incidental to your study, such as participant e-mail addresses or copies of e-mails sent to participants.
- If your study involves *any* personal data, explicitly identify how *all* your data will be used, collected, stored, analysed, retained, held securely, and in turn destroyed. How will you collect your data? How will you store your data? How, exactly, will you secure your data? How will you provide access to the data of a particular participant if they request it?
- All information, questionnaires, and/or consent forms should explicitly and conspicuously show the ERGO reference number in the form “ERGO/FPSE/xxxxx”.
- All forms and documentation should carry a version number (this is a University requirement).
How long will it take to receive approval?
The Ethics Committee aims to review straightforward submissions within one week after receipt, and other submissions, such as those involving the processing of personal data, within two weeks. Please note these are aims, and are not guarantees. The Ethics Committee Chair is able to offer informal advice where these timescales may cause an investigator difficulties due to unforseen circumstances. It may also be worth noting that these timescales apply following receipt of an appropriate and complete submission. A submission which fails to provide the information required or represents a study inaccurately or misleadingly will be returned for re-submission; this doubles or trebles the timescales… Note also that student applications are first reviewed and approved by their supervisors before being forwarded to the committee for review; this adds to the timescale.
Changes to approved studies
There is a process for follow-up (incremental revisions) or material changes to a previously-approved study. Investigators must
- submit the study for re-review if any changes, circumstances, or outcomes affect the answers given to the questions or the information provided on the ethical review submission form;
- promptly advise an appropriate authority of any adverse project outcomes, changes, or circumstances;
- seek Committee advice in the event of material changes to the submitted project documentation following approval.
ERGO site downloads
The ERGO site hosts the following five key documents for download: “Instructions”, “Guide”, “Application Form”, “Reviewer Checklist”, and “Templates”.
Other downloads
This site hosts “Why Submit v12” PDF, “FPSE EC overviewV6-1” PPT, and “FPSE Ethics Committee Membership 15 July 2013” PDF.
Other information
A page set up to hold details of all research and enterprise policies that researchers need to be aware of: http://www.southampton.ac.uk/ris/policies/
Lester Gilbert
October 2013