Identify where the research will take place, giving consideration to convenience for participants, privacy issues and health and safety.

ethical approval
Module 6 (SHIM16) Assignment Guidelines

Complete a research proposal ethics application.
Research Proposal
The aim of the assignment is to measure your understanding of the research process. The proposal that you submit is an assignment for this module andneed not be the one you use for your dissertation.As it takes the form of an ethics application, then the proposal must be based on research using data which requires ethical approval.
A research proposal is a little different to the other ‘academic essays’ in the course. It is written in the future tense, has no conclusion and the key aim is to defend the proposal rather than offer critical analysis. It must provide a comprehensive account of each aspect of the research process. There should be sufficient detail to allow someone not familiar with the research to be able to carry it out step by step. All self designed questionnaires, interview schedules, consent forms, information sheets etc should be included.
Defending the proposal means using literature drawn from research text books to support each step in the research process – ie the methodology, the sample, the data collection method, the data analysis and ethical considerations. You can add a ‘References’ section to the end of the form.
The word count is 4000 words maximum. As the blank form contains 524 words, simply aim to have no more than 4524 words in the completed form. When stating the word count, please ensure that it is made clear whether the number stated is inclusive or exclusive of the 524 words in the form. Self-designed questionnaires, interview schedules, consent forms, information sheets etc are an intrinsic part of the proposal and will therefore be included in the word count. Questionnaires designed by others can be referenced and added as an appendix (outside the word count).
The following is adapted from the Departmental Research Ethics Committee’s guidelines on completing the form:
Application for Standard Ethical Approval – Guidance Notes
All research that is carried out by College of Human and Health Sciences / College of Medicine staff and students, that involves data derived from these Colleges, intervention or interaction with human participants, or the collection and or study of data received from human participants that is not publicly available requires ethics approval.

If research involves NHS patients, service users, relatives or carers, staff or NHS premises, it will also require review by a local research ethics committee and the CHHS research committee will require evidence of such approval where required prior to considering the application.

The brief guidance notes below are intended to help you complete an application for standard ethical approval. All questions must be answered. The CHHS Research Ethics meets monthly to consider applications. Your information must arrive two weeks before a meeting in order to ensure consideration. Late applications will not be considered. The application should be submitted as a single file and should include all relevant information. Please ensure that where applicable, the proposal has been reviewed and signed by your research supervisor.
S.1. Include a brief overview of the literature (<1000 words) and describe the rationale and the main aims of the research you wish to undertake, including a statement of the intended benefits of the research.
The Committee will scrutinise the validity of the project. In terms of the intended value of the project, it is important to justify why the research needs to be carried out, particularly if similar research has been carried out in the past or if the same study population has been accessed before.
S.2. Briefly describe the overall study design
State the research paradigm (eg quantitative) and the methodology (eg cross sectional retrospective survey), explaining how this relates to the research question.

S.3. Describe the overall study design and describe and defend methods of data collection and analysis
Describe and defend (using research literature) your research methods and any procedures involved (e,g. semi-structured interviews). It is important that you provide sufficient detail for the Committee to appreciate precisely what you intend to do and how you intend to achieve your research aims. Any and all interview schedules, focus group questions, questionnaires, observation charts, psychological tests etc. that will be used to gain information from participants should be attached.
S.4. Location of the proposed research
Identify where the research will take place, giving consideration to convenience for participants, privacy issues and health and safety.
S.5. Description of the population, sample and likely participants
Give the age range, gender, inclusion and exclusion criteria for participants, and any particular characteristics pertinent to the research project. Actual sample size and predicted number of respondents should be included.
S.6. How will the participants be selected approached and recruited?
Describe how participants will be identified, approached and recruited, providing evidence of authorisation for access to participants where appropriate. Any previous relationship with participants should be disclosed. Where the researcher has access to participants through his or her work, particular consideration should be given to whether privileged information of participant details can be used for recruitment purposes. Consideration should also be given to issues of direct or indirect coercion in recruiting participants. Provide details of sampling procedures (e.g. random, purposive) and sample size.If there is more than one group involved in the study, state how many participants will be recruited in each group and in total.

S.7.What procedures (e.g., interviews, computer-based learning tasks, etc.) will be used to gather information from participants?
Clearly describe the intended research procedures, ensuring that terminology is consistent throughout the application.

S.8. What potential risks to the participants do you foresee and how do you propose to ameliorate/deal with potential risks?
Describe the potential physical or psychological adverse effects or risks of involvement in the research for research participants. Risk assessment should take account of potential physical harms (e.g. pain, injury), psychological harms (e.g. embarrassment, distress), professional harms (e.g. requirements to report poor practice, bullying or abuse) and social harms (e.g. stigma, socio-economic stereotyping).
• Will individual or group interviews/focus groups/questionnaires address topics that might be sensitive, embarrassing or upsetting?
• Is it possible that criminal or professional disclosures requiring action could take place during the study (e.g. during interviews/group discussions, or use of screening tests)?
• Could the study have a secondary impact on student education, distribution of healthcare resources or access to other benefits?
Issues relating to the potential dangers of coercion to participate in research should be clearly addressed, particularly where the researcher has an existing role in the education/treatment/care/management of participants. Research participants need to be aware of any risks that may occur as a result of their involvement in the research and be informed in advance of the limits to confidentiality where professional ethics may demand disclosure. The researcher should identify how risks will be ameliorated and describe processes for dealing with harms should they ensue.

S. 9. What potential risks to the interests of the researchers do you foresee and how will you ameliorate/deal with potential risks?
Consideration should be given to issues of personal safety when choosing the location for the research and when disclosing personal data to participants. Competing personal or professional interests should also be addressed and consideration given to any support or advisory systems required.
S.10. How will you brief and debrief participants? (Please attach a copy of participant information sheets and relevant debrief information)
The participant information sheet should inform participants of the purpose and processes of the study and time should be provided for the participant to consider their involvement in the study and to ask questions. Language should be clear from jargon and any potential risks arising from participation in the study should be identified. Whenever the possibility of any form of adverse reaction to the research processes is foreseen, the researcher should consider how participants will be debriefed. Opportunity should be given for participants to discuss any concerns and where necessary, information on receiving further external support should be supplied.

S.11.- S.15. Informed consent (Please attach a copy of the consent form)
Informed consent is essential to ethical practice. Consent should be given voluntarily following a period of informed deliberation (see S.10). No individual should feel coerced or be unduly influenced by the promise of reward or by fear of penalties. A signed consent form must be obtained from each participant. If consent is not deemed to be necessary then a clear explanation for this should be provided. If there are doubts about participants’ abilities to give informed consent, then ideally, an appropriate independent assessor should be called upon to assess capacity and to ensure that participants are willing/competent to participate. Laws in the UK regarding research with adults who may lack capacity are complex and will vary according to the type of research. NRES has published a toolkit of ethical guidance for researching adults who lack mental capacity, which can be found at http://www.nres.nhs.uk

If participants are under 18 years of age, then special consideration relate to the issue of consent. Research involving children should seek the child’s
and/or the parent’s consent, where appropriate. Researchers are likely to require an up to date CRB check and evidence of this should be included in the application. Guidance for researchers produced by the National Children’s Bureau can be found in the ‘research’ section of the NCB website: www.ncb.org.ukand theMRC Ethics Guide: Medical Research Involving Children 2004website: http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430
Examples of good practice regarding consent may be found at the home page of the National Research Ethics Service (NRES) http://www.nres.nhs.uk/

S.16. How do you propose to ensure participants’ confidentiality and anonymity?
Where the research involves potential identification of potential research participants and/or organisations the researcher should state what measures have been put in place to ensure confidentiality of personal data (e.g. coding data or assigning participants with pseudonyms). Where focus groups or group interviews are intended, anonymity cannot be assured and participants should be made aware of this potentiality. Group research of this type will require the creation of ground-rules, which specifically address the requirements of confidentiality. All researchers must ensure that participant confidentiality is not breeched and should comply with the Data Protection Act (1988) and Freedom of Information Act (2000). The identity of research participants should not be recognisable in research reports or in any presentation of findings.

S.17.Please describe the arrangements for storing and disposal of data.
All confidential data should be stored in a locked cabinet or on a secure, password protected computer only accessible to the researcher. Details should be given as to when data will be destroyed – in health and social care contexts, data is usually stored for up to five years (RCN 2009).

S.18. Consent for access and research permissions
Where research requires authorisation of agencies, a public or private body (e.g. school, local authority or company), a clinical, educational or managerial lead, a signed letter of consent should be attached to the application.

S.19. See S. 11- 15.

S. 20. Provide an outline timetable of activities
A broad timetable is required, highlighting when key stages in the research process will begin and end.
Useful Resources

Beauchamp T and Childress J (2001) Principles of Biomedical Ethics, 6th edition, Oxford: Oxford University Press.

The British Psychological Society code of ethics and conduct in research:
http://www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf
The Data Protection Act (1998) http://www.legislation.gov.uk/ukpga/1998/29/contents

The Freedom of Information Act 2000, available online at:
http://www.legislation.gov.uk/ukpga/2000/36

The General Medical Council guidance on good practice http://www.gmc-uk.org/guidance/

Medical Research Council http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/index.htm

Royal College of Nursing (2009) Research Ethics: www.rcn.org.uk

The World Medical Association – Ethics Manual, available online at:
http://www.wma.net/en/30publications/30ethicsmanual/index.html

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