How to apply for research ethics review

Once you have established that ethical review is required (either by a Cross Schools Research Ethics Committee - C-REC) or a School Research Ethics Officer (SREO) you will need to prepare an application

You can access the online ethical review application system via Sussex Direct. (When you have logged into Sussex Direct, click on the 'Research' tab, and then navigate to 'Ethical Reviews'.)

If you are specifically applying to the BSMS Research Governance and Ethics Committee (RGEC) please go to the BSMS RGEC section below. As of May 2017 the Committee only accepts applications submitted through the online ethical review system on Sussex Direct.

A list of Frequently Asked Questions (FAQ) have been created to help BSMS applicants and can be accessed below

User Guide and Guidance Material Guidance Material about applying for ethical review

Help text is available in the online form, but you can also download the User Guide for Online Ethical Review Application System

To help applicants plan their application Word versions of the online ethical review application form are also available:

Research Governance Standard Operating Procedures

The University's Research Governance Standard Operating Procedures provide significant information on the principles behind ethical review and the legislatory and regulatory framework under which research is conducted.

Templates for standard University Consent Forms and Information Sheets to accompany the application

Templates are available below to help you develop a Consent Form and Information Sheet appropriate to your research.

Roles and Responsibilities

The responsibilities for Ethical Review of Research are set out in a specific page for reference.

If you are a student (Undergraduate, PGT or PGR), your research supervisor is responsible for supporting you in completing and submitting an application of a standard required for approval.

Please note that supervisors alone cannot grant ethical approval. Only SREOs and your Cross Schools Research Ethics Committee (C-REC) can do this.

** Commencing research that requires ethical approval without having received it will be considered to be research misconduct as defined in the University's Code of Practice for Research **

APPEALS AGAINST DECISIONS OF A C-REC

The University Research Governance Committee (URGC) has the responsibility to hear appeals against the ethical review decision of a C-REC in the event that all reasonable dialogue between the Committee and the researcher has failed to reach a suitable outcome. Please contact the Research Governance Officer for further information.

Appeals relating to the decisions of supervisors or School Research Ethics Officers (SREOs) should be dealt with in the relevant School of Study.

RESEARCH DATA MANAGEMENT

Guidance on Data Protection and Research (Ethics and the GDPR) - May 2018

Researchers required to undertake a Privacy Impact Assessment should contact the University's Data Protection Officer - dpo@sussex.ac.uk

General Data Protection Regulation (GDPR) - Understanding your legal responsibilties for the use of personal data

University Master Records Retention Schedule and Records Management Policy

Why manage your research data? (University Library guides to research data management including SUssex REsearch Data Repository and Sussex Research Online)

University Privacy Statement

OVERSEAS TRAVEL

All ethical review applications involving overseas travel should be accompanied by a fully completed (including authorisations) Overseas Travel Safety and Security Risk Assessment (ORSSRA) form.

The responsiblities for oversight of risk in travel are set out in the University's Fieldwork Safety Policy.

The University expects that staff with responsibility for signing off research travel or field work activity that falls under the category of 'high risk' are familiar with the principles of the UCEA's Guidance on Health and Safety in Fieldwork .

BSMS RGEC Procedures and Forms

If you are a BSMS researcher or working with human subjects elsewhere in our partner universities, and think your research would be best assessed by the BSMS Research Governance and Ethics Committee please contact Caroline Brooks, BSMS Research Administrator, to discuss your study before submitting an application. Email: c.e.brooks@bsms.ac.uk

* Note that as of July 2017 ALL applications to RGEC are made via the online ethical review system.

A Word version of the online RGEC form can be downloaded for reference and training purposes.

ALL amendments to previously approved research projects are submitted via the online ethical review system and RGEC no longer accepts e-mail amendment submissions.

Page 14 of the user manual provides detailed step by step instructions on the process for submitting amendments, including screenshots.

Please note that ALL amendments, unless very minor, require review at a scheduled RGEC meeting.

A review slot at a scheduled Committee meeting must still be booked in for applications for ethical and governance review submitted via the online system. The Committee receives a high volume of applications from faculty and students and it is essential to book your application in for review before a meeting submission date.

Please contact RGEC at rgec@bsms.ac.uk to book a slot for the review of your application at a meeting.
A list of when the RGEC meetings occur and their submission deadlines can be found here:

https://www.bsms.ac.uk/research/support-and-governance/governance-and-ethics/index.aspx

BSMS RGEC Ethical Review System Manual

BSMS Consent Form and PIS Templates

Good Practice Examples:

How to Apply for a Research Passport

General information about the NHS Research Passport system is available from the NIHR website.

Staff - Consult the University NHS Research Passport guidance note on the procedure to follow.

Students: Contact the Research Governance Officer for more specific University procedures for students.

BSMS students should contact the the BSMS Research Administrator.

Generic or 'Blanket' Ethical Approval - Course Convenors ONLY

Course Convenors may apply for Generic or 'Blanket' ethical approval for courses where a number of undergraduate or postgraduate-taught students will be conducting research that is low-risk and of a sufficiently similar nature to be reviewed together. In this procedure, the Course Convenor submits a single application to apply for ethical approval for the students enrolled in the course. Review and approval is required from a local SREO and the relevant C-REC Chair. Approval is only valid for a year at a time with renewal required at the start of each new academic year.

PLEASE NOTE: The application for generic ethics approval must be made using the application form below, and by following the guidance provided. At the moment, it is NOT possible to apply for generic ethics approval via the University's online ethical review application system.

Templates for Preparing an Information Sheet and Consent Form

Templates which you can adapt for use with your research ethics application.

Applicants should note that standard written consent is not always appropriate. Researchers need to be aware that consent should be appropriate to the project and the participants and seek guidance and further advice as required.

Templates in support of Guidance for obtaining consent for research with child participants in schools

FAQs about the Online Research Ethics Application System for BSMS

1. What is the new online ethical review system?

The online ethical review system provides an online Application Form for Ethical Review for applying to the BSMS Research Governance and Ethics Committee (RGEC), including the uploading of supporting study documents.

2. How do I access the online ethical review application system?

You can access the online ethical review application system via Sussex Direct:

https://direct.sussex.ac.uk/page.php?realm=research&page=ethical_review_list

Please note a University of Sussex ITS login is required to access the application system.

3. I do not have a login to Sussex Direct – what can I do?

If you are a member of BSMS faculty please contact the Sussex ITS Team who can assist you with obtaining/confirming your University of Sussex ITS login.

Email: support@its.sussex.ac.uk

General enquiries line: Ext 8090 (+44 1273 678090)

4. Who can use the new online ethical review application system?

All staff and students (in consultation with their Supervisor) are encouraged to use the online ethics application form.

For Individual Research Projects (IRPs) where the supervisor is from an external institution, the medical student is encouraged to submit the ethics application as an integral part of their ethics training.

5. When will the online ethical review application system be available?

You will be able to log on to Sussex Direct from 11^th May 2017, and complete the University's Application Form for Ethical Review for review at a scheduled RGEC meeting.

6. How is my application reviewed?

A review slot at a scheduled RGEC meeting must still be booked in for applications submitted via the online system. Please contact RGEC at rgec@bsms.ac.uk to book a slot for the review of your application at a scheduled meeting. A finite number of slots are available per meeting and are booked on a first come first served basis.

7. Submitting Amendments for Review

All amendments to previously approved research projects are submitted via the online ethical review system and RGEC unfortunately no longer accepts e-mail amendment submissions.

Page 14 of the user manual provides detailed step by step instructions on the process for submitting amendments, including helpful screenshots.

8. Can I use the old system for applying for ethical review (i.e. downloading the old RGEC Application Form for Ethical Review and submitting via email for review)?

Unfortunately, no, the new online application system is now the sole method of applying to the Committee, and only applications for ethical review made online through Sussex Direct will be accepted.

9. Are there any changes to the University's current ethical review procedures and policies?

The new online ethics application system aims to streamline the ethical review application process, but does not include any changes to the BSMS’s current research governance and ethics procedures and policies.

10. Will I be able to save or print out a draft copy of my application?

The online ethics application system allows you to both save and print out a draft version of your application.

11. How will the new system deal with applications from students, whose applications need to be seen by a Supervisor before being submitted to RGEC?

A draft version of an application can be saved (in PDF format), printed and shared with Supervisors and members of the research team.

12. Will I be able to upload supporting documents to my online application for ethical review?

Yes - you will need to save your supporting documents as PDFs first, and then you will be able to upload them to your application. The online system will compile your application form and your supporting documents into a single merged PDF document. To ensure your pdf merges successfully, please follow read the recommendations in the ITS Guidance on Uploading Documents [PDF 200.58KB].

13. Is any training available regarding the new online ethical review application system?

We have designed the system to be as intuitive and easy to use as possible. A comprehensive manual covers all aspects of completing the application form and submitting supporting documents, including amendments. Training sessions will be available for staff and students who would like an introduction to the new online ethical review application system. Dates will be advertised on the University of Sussex Research Governance website. (Individual training sessions can be available on request).

14. Where can I get further advice or information about the online ethical review application system, and other guidance relating to research governance and ethics?

Please see the rest of the Research Governance website for more information and links to relevant documents and guidelines.

General queries about your application can be directed to: rgec@bsms.ac.uk; more complex queries can be directed to BSMS Research Administrator: Caroline Brooks c.e.brooks@bsms.ac.uk

If you have a technical problem regarding access to the new online ethical review application system, please contact IT Services.

If you would like to provide any general feedback / suggestions regarding the new online ethics application system, please send this to: rgoffice@sussex.ac.uk.

Further University Policies and Guidelines