GUIDANCE FOR STUDENTS & SUPERVISORS

Transcription

1 Division of Psychiatry & Applied Psychology (DPAP) School of Medicine, Faculty of Medicine & Health Sciences STUDENT RESEARCH PROJECT ETHICS REVIEW GUIDANCE FOR STUDENTS & SUPERVISORS The University of Nottingham s Code of Research Conduct and Research Ethics (2016) underpins the University s commitment to maintaining the highest standards of integrity, rigour and excellence in all aspects of our research and for all research to be conducted according to the appropriate ethical, legal and professional standards. This is consistent with the national framework published by Universities UK, The Concordat to Support Research Integrity (2012). Ethical review and approval is required for all projects where the research involves human participants. The Division of Psychiatry & Applied Psychology s Research Ethics Sub-Committee is authorised by the Faculty of Medicine & Health Sciences Research Ethics Committee to review and approve certain research project proposals deemed to be of minimal risk being undertaken by its PGR (PhD and professional doctorate), PGT (MSc) and BMedSci students undertaking projects supervised by the Division s staff. Who needs to submit their study for ethical review? An application form for ethical review must be completed for all student research projects and assignments conducted in the Division. Supervisors should ensure they use the most up-to-date version of the form and related documents. These are available to download from the Division s Research Ethics Webpage. PGR projects will be subject to review throughout the year. PGT and BMedSci projects may have required dates for ethical review: if so these will be detailed in Course handbooks or available from Course Directors. Course Directors should advise the Administrators to the DPAP Ethics Sub-Committee of those dates. Supervisors may suggest that ethical review is not required if, for example, the study involves no data (theoretical research or literature review only), is based solely on existing anonymised records (i.e., where individuals cannot be identified), documentary sources or data sets that exist in the public domain, or involve no fieldwork. If the student plans to use existing data sets that are sensitive or would allow individuals to be identified, the proposal must be submitted for ethical review. For these studies, the student and supervisor should also complete Sections 1 (student details) and 2 (very brief description of the study) of the DPAP application form. They should also complete section 9 to explain why ethical review by the DPAP Ethics Sub- Committee is not required. See Section 2 below for further guidance. Training for students: First, students are required to read this guidance and take note of all requirements. This is to ensure they are aware of the approval process that their project will be going 17 Feb

2 through. They will be expected to report on ethical issues when they write up their project. Second, they must read understand and abide by the University of Nottingham s Code of Research Conduct and Research Ethics (2016, available on the University s website). This includes information about data storage and handling, and the requirement to comply with to the Data Protection Act Third, must adhere to the current version of the British Psychological Society s Code of Human Research Ethics (available on the Society s website), and/or other guidance as advised by their supervisor that may be relevant to the topic of their research (for example, on internet-mediated research, or safeguarding and obtaining consent in the case of research with vulnerable populations). Students may find The Research Ethics Guidebook: A Resource for Social Scientists useful background reading. Fourth, PGT and BMedSci students, as advised by their research project module convenor, should attend a face-to-face/on-line lecture on research integrity, ethics and the Division s ethical review process. This is delivered by the Chair/Co-Chair/Vice-Chair of the DPAP Ethics Sub-Committee. PGR students are required to take an online training course on ethics (available all year round in Moodle). This is available from mid-march 2017 and counts as two training points. For the majority of students in the Division, the Social Science course will be the most suitable, although supervisors may advise certain students to take the Medical and Health Sciences course depending on the nature of their topic of study. Training for supervisors: Supervisors should be familiar with the Codes detailed above, and attend DPAP training courses on ethical review as required. COMPLETING THE APPLICATION FORM The application form should be completed in Verdana point 10, single spaced. All sections require a response. Supervisors are advised to ensure all sections of the form are completed. Incomplete forms will be returned directly to the supervisor, without review. This may mean a significant delay during busy and holiday periods. Forms should be spell-checked before submission. SECTION 1: THE STUDENT This gives details about the student, degree programme, year of study and proposed dates for project start and completion (hand-in). SECTION 2: TYPE OF STUDY This section of the form determines whether the study comes within the remit of the DPAP Ethics Sub-Committee and if it does, whether it will require single or dual review. It also asks students to identify the type of study proposed, and alerts them to sources of relevant advice 17 Feb

3 (1) NHS or NOMS patients, staff, premises, data or records, and care homes The DPAP Ethics Sub-Committee is not authorised to approve studies that involve the recruitment of National Health Service (NHS), National Offenders Management Service (NOMS) patients, premises, data, records or staff or studies involving care homes. For studies involving NHS or NOMS staff, patients, prisoners, young offenders, premises, data, or records, or care homes, students should first contact the University of Nottingham Research Governance team who co-ordinate research done in collaboration with these bodies by students and staff of the University of Nottingham. giving an outline of what and who the study involves. They will then advise on the next steps which may include an application for ethical review to the School of Medicine s Faculty of Medicine & Health Sciences Research Ethics Committee or to the Health Research Authority (HRA). The latter will require completion of an IRAS form which will be reviewed by the research governance team as your Sponsor and give Sponsor approval, which is a requirement of both the NHS and NOMs. They will then advise on the right pathway with regard to which Research Ethics Committee and other approvals the study will require. This can vary depending on the type of study. It can be a lengthy process so students should allow plenty of time for this when planning their study. For these studies, the student and supervisor should also complete Sections 1 (student details) and 2 (very brief description of the study) of the DPAP application form. They should also complete section 9 to explain why ethical review is not required by the DPAP Ethics Sub-Committee, and submit to the Administrator of the Committee (MS- DPAPEthics@nottingham.ac.uk). Evidence of external ethical review needs to be seen and approved by the supervisor. (2) Vulnerable populations and/or sensitive topics Studies that intentionally seek to involve vulnerable populations and sensitive topics will be reviewed jointly by two members of the Committee and may require extra time for review. Supervisors are responsible for deciding which projects concern vulnerable populations or sensitive topics. Their decisions will be considered by the DPAP Ethics Sub-Committee s reviewer/s. children people residing in institutional care whether temporarily or permanently people lacking in mental capacity, with a learning disability, cognitive impairment or sensory impairment people with potentially significant previous life experiences such as abuse people with mental health difficulties or diagnosed mental health conditions illegal activities possibly (but not confined to) questions about health, drug use, addiction, religious beliefs, political opinions, gender, sexual orientation, sexual activities, marriage and civil partnership, race and ethnic origin other personal topics with potential to cause embarrassment, upset, trauma or offence recall of distressing events beyond the risks encountered in normal life and other topics as deemed appropriate by supervisors 17 Feb

4 Disclosure and Barring Service (DBS) check Where potential participants are vulnerable and/or aged under 18 years (and where there is any chance of students ever being alone with such participants) students will also be required to undergo a Disclosure and Barring Service (DBS) check to cover the period of study. The responsibility for completing this satisfactorily is the student s and proof of successful completion must be seen by the supervisor. (3) All other studies All other studies are reviewed by a single member of the DPAP Ethics Sub-Committee. (4) Projects undertaken in countries outside of the UK Students and supervisors are required to ensure that they are aware of any research ethical guidelines in the countries other than the UK that may apply to the study s proposed participants. The student must agree to abide by the ethical guidelines provided in the UK (the University of Nottingham s guidelines) or, in the case that the country in question has more stringent guidelines, by those that are the most stringent. Students and supervisors are also required to consider whether cultural sensitivities have been taken into account. Some issues which may not be sensitive in some countries and cultures may be regarded as sensitive in others (for example, asking questions about income). Students who elect to undertake a research study outside the UK are not covered by the University of Nottingham s travel insurance policy. They should make their own arrangements for travel insurance. The University will provide a list of insurance companies that they may like to try on the Financial and Business Services website. Procedures for risk assessment should be discussed with supervisors. Any study that involves research in a high risk country will require additional approval from the University s Insurance Manager. Check the Insurance workspace and the FCO website to see if the travel destination has any warning notices. Type of study: The category which best describes the type of study should be ticked from the list of 12 choices given on page 2 of the application form. More than one category can be chosen. SECTION 3: OUTLINE OF STUDY Project title: The title should indicate concisely the topic of study and nature of participants. Study outline: A brief description of the study should be outlined in a maximum of two pages. Most projects will require following headings: Rationale (explain the scientific value of this study that justifies taking up participants time and effort, with references) Research question/s How access to participants will be gained 17 Feb

5 Participants How data will be collected (eg. observation, interview, survey) Where data will be collected (eg. telephone, workplace, on-line) Justification of materials and measures (experimental tasks, interview guides, questionnaires, including if appropriate information on their reliability and validity) Justification of final sample size Key references (up to ten) The supervisor (or, subsequently, the DPAP Ethics Sub-Committee) may recommend an additional caveat in the PARTICIPANT INFORMATION and PARTICIPANT CONSENT forms to highlight to participants that the only aim of the study is to help the student gain an academic qualification. SECTION 4: PARTICIPANT INFORMATION Participant information is designed to communicate with people who are not researchers, technical experts or scientists. Such documents are challenging to write properly and require very careful consideration. They should be concise and written in layperson s language. Any technical research terms should be replaced with words that laypersons will understand. For example, words like mediated, organisational learning, negative relationship or self-efficacy should not be used. In such outward-facing documents particular attention should be given to correct spelling and grammar. It easy comprehensible they are to understand. The Division of Psychiatry & Applied Psychology s PARTICIPANT INFORMATION template (available to download from the DPAP Research Ethics webpage) should be used for guidance about format and content. It will need to be adapted for the study and its intended participants. Participant Information should accurately describe all parts of the study that participants will be asked to be involved in. It should be explained why they are being asked to take part. It should make clear the voluntary nature of participation and avoid implied and explicit coercion. This may be the case where potential participants are known to the researcher, for example, as friends. This may also be pertinent or where there is an actual or perceived imbalance of power. For example, where potential participants are employees in an organisation managed by a member of the student s family they may feel obliged to participate. They may feel obliged to take part where a third party invites participation on behalf of the researcher. Such a third party is known as a gatekeeper : any person whose help is needed to gain access to participants. This could be a senior manager, company director, or Head of School/Division. Care must be taken to ensure that a gatekeeper does not coerce potential participants nor learn who has/has not agreed to participate. It is important where participants have been assured of anonymity that such a gatekeeper cannot later identify participants or their responses (directly or indirectly) from any findings presented. For example, mentioning the country of origin, age, or even gender might enable participants to be identified indirectly even though the findings from a questionnaire or interview are reported without names attached. At all stages of the study, and in its reporting, students must prioritise confidentiality and take great care to avoid compromising participants anonymity. Interview transcripts, for example, should never contain people or place names. For sensitive topics, if concern or distress is possible, information must be provided about where participants can find advice and help. If such help may require significant input from a particular source (for example, an employer-provided counselling or occupational health service), consider whether that source needs to be advised. A 17 Feb

6 debriefing form after participation (in addition to a Participant Information form) is not necessary for most projects but supervisors will advise if they are needed. As appropriate, PARTICIPANT INFORMATION should be made available in languages other than English and in other formats. Copies of back translations should also be provided (see Section 7 below). If not available at the time of review they should be later logged with the Administrator to the Committee and may be audited. It should be produced on formal paper, attributing the Division, as it may be retained by participants as a record of the research. Internet-mediated (on-line, electronic) studies should include a statement such as We believe there are no known risks associated with this research study; however, as with any online related activity the risk of a breach is always possible. We will do everything possible to ensure your answers in this study will remain anonymous. We will minimize any risks by... Describe how confidentiality will be secured, maintained, and when raw data will be destroyed. The Participant Information form should also advise the participant that with anonymous internet-mediated contributions, that it is not usually possible to withdraw data once submitted. Exceptions to this are possible, where the student has set up procedures for so doing, for example by offering participants the opportunity to set their own unique identifying code for use in future correspondence to a given address within a set cooling off period. Students undertaking internet-mediated research studies are advised to read the British Psychological Society s (2013) Ethics Guidelines for Internet-Mediated Research and the University s Social Media Policy for Students (see the section below on further reading for links). Details about sources of further information and complaints procedures should be given. Participants and potential participants will be asked to contact the student s primary supervisor in the first instance. If this does not resolve the query to their satisfaction, they are asked to write to the Administrator of the Division s Ethics Sub-Committee, who will pass the query onto the Chair/Co-Chair/Vice-Chair as appropriate. Before final use, an Ethics Reference Number (which will be allocated by the Committee s Administrator once the project has successfully passed ethical review) should be inserted on the PARTICIPANT INFORMATION form in the space indicated. SECTION 5: PARTICIPANT CONSENT The Division of Psychiatry & Applied Psychology s Standard PARTICIPANT CONSENT form provides guidance about the format of a written consent form. The form should reflect each component of the study. For example, if the participant is being asked to take part in an interview and answer a questionnaire, there should be I agree boxes to reflect each component. The guidance given in the section above about writing clearly for a lay audience also applies to the consent form. When a potential respondent declines to give consent, the researcher is allowed to offer further information or explanation about the research but must not apply any pressure. As appropriate the consent form should be made available in languages other than English and in other formats. Copies of back translations should also be provided (see Section 7 below). If not available at the time of review they should be later ed to the Administrator to the Committee and may be audited. Two copies of the consent form should be signed. One should be given to the participant. The other is securely retained by the researcher. At the end of the project 17 Feb

7 scanned copies of all consent forms must be securely deposited with the supervisor and the originals destroyed. This is not possible for on-line studies. Advice about obtaining consent for online studies can also be found in the British Psychological Society s (2013) Ethics Guidelines for Internet-Mediated Research and the University s Social Media Policy for Students (see the section below on further reading for links). Consent with vulnerable populations When seeking consent, adults are assumed to be competent to do so unless the supervisor and student judge that they are unable to assess the information provided to make a decision. Additional consent forms are required for a relevant third party (for example a family member, or carer). In such cases the consent form will invite the third party to sign a statement that they have read and understood the Participant Information form, and agree that the potential participant can take part in the research. In the case of individuals under the age of 18, they should be asked to assent to their parents signed consent forms. Under certain circumstances, opt-out consent is applicable. For example, where a Head Teacher considers that explicit parental consent is not required, the student (having obtained the written consent of the Head Teacher), provides parents with information explaining the proposed research project and gives them the opportunity to opt their children out by filling in and returning a form to the school. Supervisors should advise students accordingly and note BPS and other relevant guidance as appropriate. SECTION 6: ORGANISATIONAL PERMISSIONS or EXTERNAL ETHICAL REVIEW Students undertaking projects in outside organisations need to provide evidence (an or headed letter) that the project has been approved by a suitably authorised person from that organisation. If the study is to be conducted in an outside organisation it also needs to be established whether that organisation has its own ethical scrutiny procedures. If appropriate, evidence of approval from such an authority must be seen by the supervisor. SECTION 7: ADDITIONAL DOCUMENTATION Insert materials such as questionnaires, interview guides, advertisements, posters, other marketing materials, initial invitations to participate, cover letters and translations. SECTION 8: ETHICAL CONSIDERATIONS Students and their supervisors should conduct their own initial ethical review, checking the list of ethical considerations to identify possible risks to ethical conduct. Ethics review is still required even if they deem none of these risks to apply. Risks are listed in order: issues relating to the topic of study procedural issues before starting data collection during the process of data collection 17 Feb

8 after collection of data, and after completion of research. Two examples are provided below. Yes No Will participants be under any coercion (direct or indirect or implied) to participate? Will participants be advised that non-identifiable data from the study might be used in academic research reports or publications? Ticking a shaded box indicates a potential risk, but does not mean that students will not be able to conduct their study. It simply means that further discussion needs to take place, additional actions undertaken or alternatives considered. It must briefly be explained, in the boxes provided below each section, what procedures will be used to allay those identified risks. Note beside each explanation the allocated number of the ethical risk question. In order for the suitable insurance to be in place, supervisors and students should conduct a risk assessment. They must discuss any possible personal risks to the health, wellbeing and safety of the student as researcher whilst undertaking the research. Lone working is discouraged. Supervisors and students should consult the University s Lone Working Policy. Consideration must also be given to risks arising from the research for example to participants and the organisation in which the study takes place. In all cases steps must be taken to mitigate those risks and those steps described in the form. Any studies which give rise to concern should be discussed with the University s Insurance Manager. Supervisors should also discuss with their students how they will handle and store data securely in accordance with the requirements of the University s Code of Research Conduct and Research Ethics (2016). Even once ethical approval has been granted, students are advised to be constantly alert for potential ethical issues during their studies and undertake to discuss with their supervisor any emerging problems or unexpected developments (such as poor recruitment) that may arise. If it is proposed that an approved project is subsequently subject to any significant change, an AMENDMENT FORM should be completed and submitted for further approval (MS-DPAPEthics@nottingham.ac.uk). SECTION 9: DECLARATION BY SUPERVISOR Students are encouraged to complete as much of the application form as possible. However, supervisors are required to conduct a final review and indicate EITHER that in their view the project does not require ethical review OR that it has their initial approval and can now be reviewed by the Committee. The supervisor also confirms that the Participant Information and Consent forms are fit for purpose, and that the student has ed a fully completed STUDENT DECLARATION (see below) indicating understanding and agreement to abide by appropriate working procedures. For some projects, supervisors also need to confirm that a Disclosure and Barring Service (DS) check has been successfully completed and they have seen proof of success. 17 Feb

9 STUDENT DECLARATION After discussion with their supervisors, students should complete the one page declaration of their understanding and agreement to abide by appropriate working procedures. This should be ed as an attachment to their supervisor from their university of Nottingham address, with the subject header as follows: Student First Name, Student Last Name, Student Number, Student Declaration eg: Jim Smith Student Declaration SUBMISSION The ethical review process is managed electronically. Supervisors should the completed application form in PDF format to the from their University of Nottingham address. Electronic submission from a University of Nottingham address functions as a signature. In order to facilitate the administration of ethical review documentation (particularly helpful for searching), supervisors are requested to submit one form per , with subject header format: Student First Name, Student Last Name, Student Number, Ethics Application: Jim Smith Ethics Application The Administrator to the DPAP Ethics Sub-Committee will check (i) that the most up-todate version of the form (ie that currently available on the DPAP Research Ethics webpage) has been used, (ii) that the application is in pdf format, and (iii) that all sections of the form have been completed. If not, the form will be returned to the supervisor without review. This may result in significant delay. ETHICAL REVIEW AND FEEDBACK The DPAP Research Ethics Sub-Committee s function is to provide a second-level review (the supervisor provides the first level review) and filtering of all its student research projects, and report to the Faculty of Medicine and Health Sciences (FMHS) Research Ethics Committee. It aims to provide initial feedback to supervisors within 21 days of receipt, although there may be some delay during popular holiday periods. Feedback and comments will be ed to supervisors on a standard form, with one of two outcomes Approved Changes required Where a study is subject to dual review, feedback will be combined into a single feedback form. Reviewers will provide brief feedback where they consider ethical issues remain unresolved or where there is insufficient information for ethical issues to be revealed or discussed. Their aim is to comment on shortcomings, not to resolve them; the latter remains the responsibility of the supervisor and student. All student projects (even those that do not require ethical review by the DPAP Ethics Sub-Committee) will be allocated an Ethics Reference Number by the Administrator. This reference number should be given on all subsequent correspondence, reports and forms, including final Participation Information and Participant Consent Forms. When approved by the DPAP Ethics Sub-Committee, the Administrator will provide a letter confirming ethical approval. Where changes are required, the application form should subsequently be resubmitted as a PDF to the Administrator with a letter from the student explaining how (and where) 17 Feb

10 the suggested amendments have been addressed. All sections of the form that have been changed should be highlighted in yellow. The form should be re-submitted with the subject header in the following format: Jim Smith Ethics Application Resubmission. The Committee aims to respond to resubmissions as quickly as possible. Where ethical review by the DPAP Ethics Sub-Committee is not required, the Administrator will issue an Ethics Reference Number and a letter confirming that ethical review is not required, or that review is being provided by another Committee. FURTHER READING & LINKS Please see the Division s research ethics website for links to download forms and advisory documents. Other key documents and links include: University of Nottingham s Code of Research Conduct and Research Ethics (2016). Universities UK (2012). The Concordat to support research integrity ortresearchintegrity.pdf University of Nottingham (2012) Health and safety arrangements for lone working. University of Nottingham (2015). Social Media Policy for students University of Nottingham (2016). Good practice for conducting research overseas. (Research Ethics Workspace, Policies and Good Practice) The research ethics guidebook: A resource for social scientists. British Psychological Society (2013) Code of Human Research Ethics df British Psychological Society (2013). Ethics guidelines for internet-mediated research. British Psychological Society (2014). Best practice guidance: consent in internet-based research s/06_consent_in_internet_research.pdf Disclosure and Barring Service (DBS) check The Division s ethical review process will be kept under review and subject to improvement via consideration of comments from Committee members, supervisors and students. Please the Administrator with queries or suggestions. 17 Feb