Research Ethics Procedures

SCHOOL OF THE BUILT AND NATURAL ENVIRONMENT

RESEARCH ETHICS PROCEDURES

AUTHOR / Dr K Theobald
AUTHORISED BY / School Research Committee
DATE OF ISSUE / November 2011 (Amended March 2012)
SCHOOL RESEARCH COMMITTEE APPROVAL / February 2012
REVIEW INTERVAL / Annual
LOCATION OF COPIES / School Ethics Web Page
School Outlook Public Folders
Appendices / Page (s)

Ethics Registration and Approval Form

/ 8-11

Research Participant Consent Form

/ 12

Data protection in Undergraduate and Taught Postgraduate Research

/ 13-14

File of Evidence Checklist [Taught Programmes]

/ 15

Undergraduate And Taught Postgraduate Programmes: Research Ethics Approval Flowchart [2011 Only]

/ 16

SCHOOL OF THE BUILT AND NATURAL ENVIRONMENT

RESEARCH ETHICS PROCEDURES

SCHOOL ETHICAL CLEARANCE PROCESS

Although an interim year of system operation will be in place in 2011/2012 due to a phased rollout of online system support, it is intended that Ethical Clearance for staff and students will follow the same procedures.

Context

Northumbria University has established policies, frameworks and guidance to address Ethics in Research. This is an ever-changing field and the University’s policies and procedures are continually revised and updated. The latest information is available on the University website by following the links Home Page> Research>Staff Resources>Ethics and Governance>Policies and Procedures. The fundamental principles of good research are that it should maximise benefit and minimise harm.

The University Ethics Policy clarifies the obligations on researchers, promotes awareness of ethical principles and ethical issues in the conduct of all research activities and provides a framework for their consideration at Northumbria University. The University Research and Ethics Governance Handbook contains detailed guidance on best practice in research. There are also a number of other documents which can be accessed from this webpage including a self-evaluation tool for research projects, as well as useful links to other information and advice.

The School of the Built and Natural Environment (BNE) is required to have in place its own procedures for monitoring ethical issues. The BNE procedures derive from the University policy and procedures. They are designed to complement and supplement the University policy and procedures. The BNE procedures do not replace the University procedures: all research activities should be conducted in accordance with the latest University policy and procedures and researchers should ensure they are familiar with them. Please refer to our school web page for further details.

School Research Ethics Committee

Each School has a School Research Ethics Committee that meets at least three times a year and reports to the University Research Ethics Committee. In BNE it is a sub-committee of the School Research Committee (SRC) which determines its membership.

The terms of reference of the SREC are as follows:

To monitor adherence to the University Ethics Policy for all research activities on behalf of the School Research Committee.
To define local guidelines and procedures for the consideration and approval of ethical issues in research projects.
To advise on and disseminate best practice for ethical issues across the School.
To scrutinise and approve when necessary applications for ethical approval
To maintain records of ethical approval of all research projects (including dissertations) within the School.
To monitor adherence to all relevant professional body codes of research ethics
To advise the Dean of School over issues and problems ofnon-compliance, who will take the appropriate action under the University’s policies and guidelines.

Scope

BNE Ethics Procedures apply to all research projects (including theses and dissertations as well as secondary research only) carried out by staff and students of the School. This includes all research activity that involves primary research or the use of secondary data that is not in the public domain (e.g. company data). This includes externally and internally funded research and non-funded research.

It does not usually include consultancy activity arranged through Research and Business Services, which has its own procedures, but if the consultancy activity involves research which may later be published and included in the Research Excellence Framework then the ethics procedures will apply. Anyone engaged in a research project must obtain ethical approval before commencing their research.

Liability

Research activity that does not comply with University and School procedures may not be covered by the University insurance policies and individual researchers may therefore be liable in the situation of a claim arising as a result of their research activity.

Ethical approval

The University has established a risk alert system to determine any risks associated with research projects. Each project will be designated as red, amber or green. The category will then determine the level of ethical scrutiny required and any additional requirements e.g. approval by an external body and additional insurance.

Risk Categories

Note that the vast majority of research projects in the School of the Built and Natural Environment will be graded amber (medium risk). Very few projects are red (high risk) or green (low risk).

The three risk categories for research projects are:

Red (High risk)

This includes but is not limited to: medicinal products; clinical trials with human subjects; human tissue; animal subjects (not commercially available animal tissue or invertebrates); vulnerable people such as people with impaired mental capacity and children; NHS staff, patients, premises or equipment; sensitive subjects such as trauma; forensic issues; safety concerns for researcher or participants; national security under the Official Secrets Act. Special arrangements are required in certain circumstances e.g. consent of external body such as NHS REC (see University Research Ethics and Governance Handbook for further information).

The most likely issues encountered in Built and Natural Environment research are:

Vulnerable participants which includes, but is not restricted to, anyone aged less than 18 years, people with health problems or disabilities, anyone with a reduced capacity to give informed consent

Sensitive personal data which is defined under the Data Protection Act as including

Racial or ethnic origin
Political opinions
Religious beliefs
Physical or mental health
Sexual life
Commission of offences or alleged offences

N.B. This excludes personal data such as gender or ethnicity that is used purely for monitoring purposes, or to ensure a representative sample, that is not otherwise part of the research.

Safety concerns for researchers or participants which includes physical risks, emotional distress and professional harm

Research involving vulnerable participants or contact with vulnerable people even if they are not part of the research (e.g. children of participants) may require the researcher to have a Criminal Records Bureau (CRB) check. The University’s Human Resources section co-ordinates all CRB checks and can provide forms for initial risk assessment and application to the CRB.

All Red research projects must be approved by the SREC. This will be obtained at a meeting of the SREC or by agreement of two members of the SREC if there is no suitable meeting date, such agreement to be reported to the next available meeting of the SREC. The secretary to the SREC can provide details of meeting dates and SREC membership

Amber (Medium risk)

This includes but is not limited to research involving human participants; personal data of a living individual; commercially sensitive information or research that may have a significant impact on the environment.

All Amber projects must be approved by the SREC. The SREC approval is delegated to designated members of staff who will usually give approval subject to the condition that University and School ethics procedures as described in the following sections are adhered to (e.g. obtaining informed consent from participants and appropriate storage of private and confidential information).

Green (Low risk)

This would include all other projects. Green projects should not raise any ethical issues and may be approved by a designated member of staff (i.e. typically research that is based purely on secondary data and does not involve human participants).

Ethics Registration and Approval Forms

In 2011, the University launched an Online Research Ethics Approval form for staff and PGR students.

All staff and PGR students must complete an Ethics Registration and Approval Form online for every research project. In the case of joint projects only one form is required which should be completed by the Principal Researcher/Investigator. Depending on research activities undertaken, further data record forms will need to be filled in to ensure due recording and timely processing, in accordance with the University’s red, amber and green designations.

Authorisation will also be given electronically.

Should the research project change, a project amendment form would need to be completed to ensure due changes to the electronic records in place. The form currently in place can be accessed using the hyperlink below.

In 2011, it was confirmed that all taught students must complete a paper Ethics Registration and Approval Form (see Appendix A) for every dissertation or project they undertake which involves research. Forms will usually be supplied by the module tutor or they may be obtained from the programme administrator. Please note that from September 2012, it is anticipated the University Online Research Ethics Approval form will be rolled out to process this category of research records too.

Standard procedures for amber projects

The SREC has established standard procedures to address ethical issues arising from Amber projects as detailed in the following sections.

Informed consent

All research participants must give their informed consent to participation in any research and their consent must be recorded. This includes interviews, focus groups, questionnaires, observation or any other form of participation.

Information sheet

Where information is to be gathered from persons participating in the research the prospective participants must be provided with sufficient information to enable them to make an informed decision as to whether or not they wish to participate. An Information Sheet which will need to be updated onto the online system record should explain clearly the aims of the research project and how any information obtained will be used, including future dissemination. It should include the name and contact details of the researcher. Full guidance on producing an Information Sheet is contained within the University Research Ethics and Governance Handbook.

Consent forms

The following sections provide details of how consent should be obtained, depending upon the circumstances.

A Research Participant Consent Form (RPCF), example shown at Appendix B, or similar record of consent, should be completed by each individual participant. Participants are asked to confirm that they have been briefed about the particular research project and its purpose and consent to their involvement in the research.

The RPCF also considers issues of anonymity and confidentiality and allows for the participant to indicate specific requirements for anonymity or confidentiality including in relation to the use of audio/video recorded interviews.

All staff obtaining information from others through research work must gain consent. This will usually be done using this form, or one using a similar format, but in certain cases other means of recording consent may be appropriate, such as an audio record. Audio records may be appropriate e.g. where the participant has poor literacy skills or where telephone interviews are used. In the case of research students the Principal Supervisor should ensure that the PGR student (PhD/MPhil) complies with this requirement for informed consent.

Telephone interviews

In the case of interviews conducted by telephone rather than face to face, the following are indicated as alternative procedures for gaining consent:

The researcher can set up the telephone interview and send the RPCF in advance by post or email. The telephone interview should only to be carried out once the form has been returned by the participant
The researcher telephones the proposed participant and asks for permission to record and obtain consent verbally. Once the recorder is switched on the researcher and the interviewee go through the issues raised in the Research Participant Consent Form and record the answers. This will then create either an audio tape or a digital sound file; either will need to be submitted like a written form.

A report of the telephone interview should be sent to the participant for approval with an accompanying letter which should provide the following statement or similar: “If no response to this request for consent to use the transcribed information from the telephone interview is received within one month of the date of this letter, consent is deemed to have been provided”.

All participants’ consents (completed forms or otherwise) should be retained with the project data.

Questionnaires

Where a researcher intends to use questionnaires to gain primary research information the questionnaire must be accompanied by an information sheet (e.g. in a letter or email as appropriate) explaining the purpose of the research and must include, at the end of the questionnaire, a standard statement - as follows: “I understand the purpose of this research and agree to participate”. The return of the questionnaire with this statement implies that the respondent has given consent.

Emails to student participants

The University has established special arrangements for sending emails to students asking them to participate in research. Emails must not be sent directly to students. All students are given the opportunity via My Northumbria to opt out of research. Researchers who wish to email students must first obtain ethical approval and then should contact the Secretary to the SREC who will arrange for the email to be distributed.

Research Data

All data of a personal or confidential nature must be stored securely and at the end of the project should be retained or destroyed in accordance with University policy and procedures. Full guidance on data protection (in accordance with the Data Protection Act) and secure storage of research data is available on the University website. As a minimum, personal and confidential data should only be obtained if it is required for the purposes of the research and should not be used for any other purpose. Such data should usually be coded with the identifying details and the data itself stored separately. Data should be locked away when not in use and any computer facilities used should be password protected. Requests for devices to be encrypted can be made through the IT Helpline. If researchers require any special facilities to ensure secure storage e.g. lockable cupboard, they should contact the secretary to the SREC, who will also be able to advise on arrangements for data destruction.

Ethical issues and adverse events

Any ethical issues or adverse events which arise during the course of a project must be referred to the SREC for consideration. Staff should inform the secretary to the SREC. PGR students should first inform their Principal Supervisor who will inform the secretary.

Staff and PGR students records will be processed online and, as such, the School Ethics Register will be obsolete for this category of research records from September 2011 onwards.

Partnerships and joint projects

In the case of projects carried out with other organisations or individuals there should be absolute clarity, as part of the agreed working arrangements, as to the responsibility for all ethical issues e.g. obtaining informed consent, storing confidential information, intellectual property rights, insurance and indemnity.

APPENDIX A

School of the Built and Natural Environment

RESEARCH PROJECT: ETHICS REGISTRATION AND APPROVAL FORM

Section One: Registration [To be completed by researcher]

Title of research project/dissertation
Researcher’s name

Please only complete the following if researcher is a student:

Programme of study
Module code (if applicable)
Supervisor’s name

Short description of research project and research methods:

Ethical considerations in the research project / YES / NO
1. Does your research involve human participants?
2. If yes to Q.1, will you inform the participants about the research?
3. Will you obtain their consent using the standard consent form?
4. Is any deception involved?
5. Do any participants constitute a ‘vulnerable group’
6. Will the research involve commercially/personally/ politically sensitive information? Can we separate these out so that there is a clear distinction between commercially sensitive, personally sensitive and politically sensitive information?
7. is the research likely to cause any significant environmental impacts?
8. Are there likely to be any risks for you or for the participants in your research?
9. If yes [to 3, 4, 5, 6, 7 or 8 above] have you identified steps to address the issues?

Statement by researcher

This statement should explain how any issues identified in the answers to the above questions will be addressed

I have read the University and the School Ethics Policy and Procedures and confirm that the answers I have given above are correct. Where further issues arise under items 3, 4, 5, 6 or 7 [above] I have described in writing how I intend to approach these issues in the research.

Researcher’s signature

Date

School of the Built and Natural Environment

RESEARCH PROJECT: ETHICS REGISTRATION AND APPROVAL FORM

Section Two: Approval

Approval can be given as follows