STUDENT RESEARCH ETHICS APPROVAL PROCEDURE 2017-2018

Title / Author / Approved By and Date / Review Date
Higher Education Student Research Ethics Procedure / S Popplewell / Latest update: - S Popplewell
Latest update: - SMT / 6 July 2016
19 Sept 2016 / Sept 2017
Impact Assessment / Sept 2016

CONTENTS PAGE

Student Research Ethics Procedure Guidance

SELBY COLLEGE STUDENT RESEARCH ETHICS APPROVAL FLOWCHART

Selby College Student Research Ethics Checklist

Section 1:

Section 2:

Section 3:

Guidelines for the Student Research Ethics Approval Process

Selby College Student Research Ethics Approval Form

CHECKLIST - INFORMATION TO SUPPORT AN APPROVAL APPLICATION

Selby College Ethics Approval Extension

(EXEMPLAR) PARTICIPANT INFORMATION SHEET

(EXEMPLAR) PARENT/GUARDIAN INFORMATION SHEET (for participants under 18)

(EXEMPLAR) PARTICIPANT CONSENT FORM

(EXEMPLAR) PARTICIPANT CONSENT FORM FOR USE OF IMAGES

(EXEMPLAR) PARENT/GUARDIAN CONSENT FORM

(EXEMPLAR) LETTER OF INVITATION TO PARTICIPATE

(EXEMPLAR) PARENT/GUARDIAN LETTER OF INVITATION FOR CHILD TO PARTICIPATE

RESEARCH PROJECT HEALTH AND SAFETY RISK ASSESSMENT

RESEARCHER HEALTH AND SAFETY RISK ASSESSMENT

Supplementary Approval Questions for Sport Science Student Researchers (to be used with SCSREA)

PRE-EXERCISE MEDICAL QUESTIONNAIRE

APPLICATION FOR EN-BLOC RESEARCH ETHICS APPROVAL

Research Methods: Useful Links and Resources

Student Research Ethics Procedure Guidance

As part of your higher education studies at Selby College you may be required to undertake original research and investigation to gain knowledge and understanding for a project or dissertation. Where this includes ‘Human Participants’ in primary research (or secondary research involving confidential personal information) it is essential to obtain ethical approval before your project can commence. This ensures that research activities are conducted in a manner which is sensitive, safe and ethical for you as the researcher and your participants.Please read this guidance in conjunction with the Selby College Student Research Ethics Policy.

This booklet contains all of the relevant information, guidance and documentation needed to obtain approval for your proposed research project. Low risk project proposals can be evaluated and signed off by your research supervisor. Project proposals deemed to be of potentially higher risk will need to be scrutinised by the Selby College Ethics Panel and either approved, returned for amendment or rejected. Should your request for approval be rejected due to the potential high ethical risk, you will be able to discuss your proposal with your research supervisor in order to make significant amendments to reduce the risk factors or consider a different proposal. If a research project involves participants taking food or other substances, undergoing medical procedures or taking part in physical activity, further screening to include personal health and other factors will need to be disclosed and analysed, and automatically places the project in a higher ethical risk category.

The factors that will be taken into consideration when evaluating your research proposal relate to the following ethics principles:

  • The integrity and quality of data collected and methods used
  • Participants are fully informed of the purpose of your research
  • Confidentiality and anonymity to protect participants
  • Voluntary participation, free from coercion
  • Avoidance of harm (physical, social, psychological) to participants and researchers
  • Independence and impartiality demonstrated by researchers

It will be essential to undertake appropriate risk assessments to identify and classify the level of risk to yourself as a researcher, your participants and members of the general public. You must always secure the consent of participants, or their representative, prior to undertaking research either in written form or recorded verbal agreement. Particular care must be taken and explicit approval sought from your research supervisor and an appropriate representative for any activity involving ‘vulnerable’ participants such as:

  • Children under 18
  • People with physiological, psychological or mental impairment
  • Relatives of sick or recently deceased people
  • People whose knowledge of English is basic or elementary

Potential legal liabilities of researchers

1) If harm occurs to participants or property, this could result in a claim of negligence:

a) Negligence concerns lack of proper process of risk assessment and can be intentional or reckless

b) Adhering to Selby College’s Ethics Procedure provides protection

c) Research conducted without proper procedural accountability severs the protection of the College’s indemnity arrangements and leaves researchers open to personal liability for negligence. In practice this means that if a researcher chooses not to apply for ethical approval, and a claim is made against them by a participant for any reason, then the researcher may be personally liable. This may also apply in cases where a researcher has applied for ethical approval but who chooses to ignore requirements placed upon the research protocol by the Ethics Panel in order for it to proceed, or who subsequently changes the research design previously approved in the protocol submitted to the Ethics Panel, without notification.

d) Participants or their representative must be provided with a copy of any Risk Assessments or informed of where such Risk Assessments can be found.

2) Lack of valid consent:

Without valid consent from participants, researchers may be exposed to/accused of criminal and/or civil assault or battery which may attract a criminal punishment of a fine and/or imprisonment and/or a civil claim for damages.

3) Breach of confidentiality:

a) There could be criminal liability for Selby College under the Data Protection Act, 1998, for serious breaches of the Act, which attracts a maximum fine of £500,000 and a financial claim for damages by participants for breach of common law duty of confidentiality against the College or individual researchers.

b) There is also the potential for criminal sanctions against the College for failure to disclose criminal activity where discovered, if there is a legal duty to report it.

It is therefore crucial to follow the procedures for ethical approval carefully, ensuring that all ethical principles have been evaluated with potential risks identified and disclosed.

You may find the following flowchart useful as it outlines the procedure to follow when seeking approval for your research proposal.

SELBY COLLEGE STUDENT RESEARCH ETHICS APPROVAL FLOWCHART

Selby College Student Research Ethics Checklist

All researchers have a responsibility to follow the Selby CollegeStudent Research Ethics Policy, as well as any academic or professional code of practice or guidelines relevant to the specific research project. This form must be completed prior to the commencement of any data collection.

Name of Applicant / Name of Research Supervisor
Qualification being studied / Proposed start and end dates for research
Title and brief summary of project
(This should explain the aim and methods of research, in terms understandable by a non-specialist)

Section 1:

Does your research involve: / YES / NO
  1. Living human subjects? (this includes surveys, questionnaires, observing behaviour etc.)

  1. Documentary material that is not already in the public domain?[1] (i.e. cannot be used without permission)

If you have answered NO to both of the questions above, ‘ethics release’ is indicated and there is no need to pursue ethical scrutiny any further. CompleteSection 3 and submit to your research supervisor for checking and approval. You must keep the signed/authorised SCSREC document safely with your research material.

If you have answered YES to either question, proceed to Section 2.

Section 2:

Please answer the following questions: / YES / NO
  1. Does the research involve participants who are considered to be vulnerable, who lack capacity or who are unable to give informed consent? (e.g. children, people with learning difficulties)

  1. Will the research require the co-operation of a gatekeeper[2] for initial access to the individuals/groups to be recruited? (e.g. for access to school students or members of an organisation)

  1. Will the research involve access to records of personal or confidential information concerning identifiable individuals, either living or recently deceased?

  1. Will the research involve the use of administrative or secure data?
(e.g. student records or medical records)
  1. Will the deception of participants (including covert observation in non-public places) be necessary at any time?

  1. Will the research involve discussion of sensitive topics?
(e.g. sexual activity, drug use, illegal activity, highly personal information)
  1. Will the research involve members of the public in a research capacity, helping to shape methodology and/or collect data?
(e.g. participatory research)
  1. Will the research involve visual or vocal methods where participants or other individuals may be identifiable in the data used or generated?

  1. Will the research involve any drugs, placebos or other substances (e.g. food substances, vitamins or other supplements) being administered to the participants, or will the study involve invasive, intrusive or potentially harmful procedures of any kind?

  1. Will tissue samples (including blood) be obtained from participants?

  1. Is the research likely to involve or result in participants experiencing pain or more than mild discomfort?

  1. Could the research induce psychological stress or anxiety or cause harm or negative consequences beyond the risks encountered in normal life? (both research participants and their living relatives should be considered)

  1. Will the research involve prolonged or repetitive testing of participants?

Continued: / YES / NO
  1. Will the research involve respondents via the Internet?

  1. Will financial inducements (other than for reasonable expenses and compensation for time) be offered to participants?

  1. Will the study involve recruitment of participants through the NHS, Social Care or the criminal justice system? (if YES you must seek approval through the appropriate external schemes)

  1. Will the research place the safety of the researcher(s) at risk?

  1. Will any research be undertaken outside the UK?

  1. Will the research, or its dissemination, involve data sharing of confidential information beyond the initial consent given?

  1. Will Disclosure and Barring Service (DBS) checks be required? If so please supply details.

  1. Are there any conflicts of interest in you undertaking this research? (if YES, supply details of how this will be addressed)

  1. Would working with the selected sample of a population lead to some form of advantage or disadvantage compared to the non-sampled population? (if YES, supply details of how this will be addressed)

If you have answered NO to all of the questions above, ‘ethics release’ is indicated and there is no need to pursue ethical scrutiny any further. CompleteSection 3 and submit to your research supervisor for checking and approval.You must keep the signed/authorised SCSREC document safely with your research material.

If you have answered YES to any question(s) you must apply for ethical approval by the Selby College Ethics Panel. Please complete the Selby College Student Research Ethics Approval (SCSREA) form (Appendix 3) and submit, using the guidelines in Appendix 2for reference.

If you are studying Sports Science, please also complete the supplementary approval sheet in Appendix 15 and attach to your SCSREA form.

Section 3:

By signing this form, the researcher is agreeing to conform to the Selby College Student Research EthicsPolicyas well as any academic or professional code of practice or guidelines relevant to the specific research project.

By signing this form, the research supervisor is confirming that the SCSREC has been read and that the research described is in accordance with their understanding of the project proposal. Where ethical approval has been sought from the Selby College Ethics Panel, the research supervisor is signing to confirm that approval has been granted and research can commence.

Stage at which approval granted / Stage 1
(non-human participants) / Stage 2
(human participants but low risk) / Stage 3
(higher risk but approved by Ethics Panel)*
(Please indicate)

Signature of Applicant

I declare that I have read the Selby College Student Research EthicsPolicy and will follow the guidelines therein:

Signature:

Date:

Signature of Research Supervisor

I declare that I have read and agree the completed SCSREC Ethics Checklist, the research described accords with my understanding of the project proposal and Ethics Panel approval has been attained where necessary:

Signature:

Date:

______

* for stage 3 approved projects only, please obtain Programme Leader signature below:

PL Name: ______Signature: ______

Date: ______

Once all declarations have been signed (as appropriate), research can commence.

  • The signed and completed SCSREC forms should be retained by the researcher with their research materials as evidence that the Selby College Student Research EthicsPolicy has been followed.
  • The research supervisor will need to keep a record of the approval decision for each student researcher.
  • Programme leaders must take copies of all signed SCSREC forms and save them in S:Drive/Higher Education/Subject Area/ for audit purposes.

Please note that Ethical Approval by the panel does not connote an expert assessment of the research or of the possible risks involved, nor does it detract in any way from the ultimate responsibility of researchers for all research undertaken by them, and for any effects on human subjects.

Guidelines for the Student Research Ethics Approval Process

Make sure that you are familiar with the Selby College Student Research Ethics Policy. Work with your research supervisor to identify potential ethical risks within your research proposal using the SCSREC checklist (Appendix 1)and any industry-related ethics codes of practice relating to your project discipline.

Complete the SCSREA approval form (Appendix 3) with as much detail as possible so that the Selby College Ethics Panel has sufficient information with which to make an approval decision. This process is important in protecting you, as a researcher, and your participants by identifying risks and taking mitigating action to ensure your research activity is conducted in a manner that is sensitive, safe and ethical. Sports Science students will additionally need to complete a supplementary approval form (Appendix 15) alongside SCSREA.

Critical Success Factors:

Timeliness – make sure that you explore ethical considerations and complete the necessary paperwork in good time. You cannot proceed with any research until you obtain approval from your research supervisor or the Selby College Ethics Panel.

Summarise – the sections about purpose of, and justification for, your research need to be concise and written in a way that is easy to understand. You need to highlight your case for conducting this research and why it is important. You also need to summarise the section identifying potential risks and the steps you will take to minimise them. Exemplar Risk Assessment forms can be found in Appendix 13 and Appendix 14.

Research methods and samples – time taken to choose the most appropriate data collection techniques, sampling methods and sample size is time well spent. You need to be able to justify your choices which should also ultimately result in the best possible data for your project findings.A comprehensive list of useful resources can be found in Appendix 18.

Recruitment and consent – your sampling method will indicate whether you are recruiting random participants or planning a more specific, stratified approach. Whichever method you are using, all participants must give their consent (or a representative consenting on their behalf) either in writing or verbally via recorded consent. You need to explain the way(s) in which you intend to secure the consent of your participants. Where the participants require the consent of a gatekeeper, or representative, before research can begin, allow plenty of time for all the necessary information and documentation to be scrutinised and completed. Exemplar letters and consent forms can be found in Appendices 8 - 12 both for adult participants and those under 18 or classed as vulnerable.

Analysis and evaluation – before starting to gather data, you need to have considered how you will handle, analyse, manipulate and store this information. This can help the panel to determine how critical this research will be for your project. You need to consider the reliability and validity of information gathered using a variety of means, which could be outlined in your request for approval.

Confidentiality – you need to consider how you will ensure anonymity and confidentiality during and after any data collection activity. How will data be gathered, used, stored and disposed of? This will be a key consideration by the Selby College Ethics Panel when making their decision.

Health and Safety –when planning your research, you need to consider the health, safety and security of your participants but also of yourself. You may find it useful to complete the Risk Assessment Forms in Appendix 13 and Appendix 14 and include them with your approval documentation.Participants or their representative should be given access to a copy of your Risk Assessments to inform their consent decisions.

Further Guidance:

It is expected practice to create a ‘Participant Information Sheet’ (see Appendix 6 and 7); you will need to research and discuss all of the issues that are outlined in the ethics approval process when compiling this information sheet. The exemplars provided are standard forms and you may need to amend them as appropriate to reflect the specifics of your research project.

In Appendix 4 you will find a useful checklist that identifies all of the necessary documentation required for ethics approval by the Selby College Ethics Panel. Do not underestimate how much time will be needed to undertake the necessary planning and preparation to ensure that your project will not involve unnecessary ethical risk.

If your project has to be approved by the Selby College Ethics Panel, any such approval will be time-bound as per your extimated timeframe for completion of your research. If you need to extend your research beyond the time approved by the Selby College Ethics Panel, you will need to complete the extension form in Appendix 5 and await approval by the panel.