EC1 - Version 2 July 2013

School of Health & Life Sciences

Application for Ethical Approval for Research

This is an application to(please indicate with an X)

Psychology/Allied Health:

Health & Community Sciences:

Life Sciences:

Category of principal applicant (please indicate with an X)

Staff:Research student (PhD/Prof D/DPsych):

Taught postgraduate student: Undergraduate student:

Location of research work (please indicate with an X)

On campus:Off campus:

All documents should be submitted electronically to SLS Ethics; 2 copies of each document are required, one of which must be anonymised.

School of Health & Life Sciences Ethics Committee Application Form
Project Title:
Lead Investigator (s): / Email address:
Supervisor:
Other academic staff involved:
Project start date: / Project Duration:
Date application Submitted: / Version Number:
Is this a clinical trial: / GCU Ref no. (LEAVE BLANK)
YOU MUST ANSWER ALL QUESTIONS / YES / NO / N/A
1 / Will youprovide participants with a written information sheet in advance of the study describing the main procedures so that they are informed about what to expect in your study? / / /
2 / Will you tell participants that their participation is voluntary? /
3 / Will your participants be able to read and understand the participant information sheet? /
4 / Will you obtain written informed consent for participation? /
5 / Will you tell participants that they may withdraw from the research at any time without penalty and for any reason? /
6 / With questionnaires, will you give participants the option of omitting questions they do not want to answer? /
7 / Will you tell participants that their data will be treated with full confidentiality and that, if published, it will not be identifiable as theirs? /
8 / Will you give participants a brief explanation of the purpose of the study at the beginning of their participation in it, and answer any questions? /
9 / Will your project involve deliberately misleading participants in any way? If YES, you must provide a justification in the research proposal. Will an explanation be offered following participation? /
10 / Is there a realistic risk of the participant/researcher experiencing either physical or psychological distress or discomfort? If YES, give details in the research proposal and state how you will address these risks (e.g. who they can contact for help). /
11 / Do the participants fall into any of the following special groups? If the answer is YES, indicate which group(s) by ticking the appropriate box(es): /
Children (under 18 years of age)
Children (under 5 years of age)
People with a disability such as learning and communication difficulties.
Please specify disability:
Pregnant women
People studied with respect to contraception or conception
People in custody
People engaged in illegal activities (e.g. drug-taking)
Non-human animals
Patients/service users
NOTE: You may also need to obtain clearance from PVG or an equivalent authority.

You must tick either Box A or Box B below and provide all relevant information in support of your application. If you answered NO to any questions 1 – 9, or YES to any questions 10 – 12, then you must check Box B.

A / I consider that this project has no significant ethical implications to be brought to the attention of the University Research Ethics Committee.
Please provide a short study proposal in a separate attachment of no more than 2sides of A4 (Arial font size 10). The accompanying notes give additional information about how to write the proposal. Your proposal must include the following sections:
  1. Project title (with student name or staff member name clearly stated)
  2. Version number.
  3. Background information.
  4. Aims and objectives of the study.
  5. Brief description of participants and recruitment methods (sample, numbers, access, recruitment and inclusion and exclusion criteria)
  6. Brief description of the research methods and measurements. Include details on how the data will be securely stored and disposed of.
  7. Consent, confidentiality and anonymity
  8. Risks to participants/self
  9. Arrangements for debriefing.
You must also provide the intended (1)Participant Information Sheet(s), (2)Consent Form(s), (3) copies of any non validated questionnaire(s), (4) details of interview questions you plan to use, (5)notices advertising the study and (6) Risk Assessment form (if applicable).
B / I consider that this project may have ethical implications that should be brought to the attention of the University Research Ethics Committee.
Please provide a short study proposal in a separate attachment of no more than 4 sides of A4 (Arial font size 10). The accompanying notes give additional information about how to write the proposal. Your proposal must include the following sections:
  1. Project title (with student name or staff member name clearly stated)
  2. Version number.
  3. Background information.
  4. Aims and objectives of the study.
  5. Brief description of participants and recruitment methods (sample, numbers, access, recruitment and inclusion and exclusion criteria)
  6. Brief description of the research methods and measurements. Include details on how the data will be securely stored and disposed of.
  7. Consent, confidentiality and anonymity.
  8. Risks to participants/self (be sure to include a risk assessment form).
  9. Arrangements for debriefing.
  10. A clear statement of the ethical considerations raised by the project and how you intend to deal with them.
You must also provide the intended (1)Participant Information Sheet(s), (2)Consent Form(s), (3) copies of any non validated questionnaire(s), (4) details of interview questions you plan to use, (5)notices advertising the study and (6) Risk Assessment form

Declaration

I am familiar with the Declaration of Helsinki and professional body code of human research ethics (e.g. BPS), and have discussed them with the other researchers involved in the project. I confirm that my research abides within these guidelines.

SignatureDate

Lead Investigator
Supervisor

There is an obligation on the Lead Researcher and/or the Supervisor to bring to the attention of the Ethics Committee any issues with ethical implications not covered by the above checklists.