The application form required for both a light touch and full review application to BSREC is exactly the same. Both review processes will also require submission of any supporting documents relevant to the study e.g. Participant Information Leaflet (PIL), consent form, interview schedule, questionnaire etc.
As of October 2018, it is no longer a requirement for applicants to submit a study Protocol or Proposal with their BSREC submission. This is because the updated BSREC Application form is more comprehensive and has been designed to provide applicants with more structure and guidance to help guide researchers to provide BSREC reviewers the level of detail and information to be able to undertake a research ethics review. It is acknowledged that researchers in some disciplines may still wish to develop a protocol and submit this with their ethics submission, however the ethics will predominantly be reviewed by the content in the application form. Reference to 'see protocol' will not be accepted.
The new application form also includes specific questions relating to processing of personal data for research purposes to avoid researchers having to complete a separate form for projects where a Data Protection Impact Assessment (DPIA) may be required. A guidance note to help researchers complete section 8 of the application form (Data Processing) has also been produced. This is intended to be a live document that will be updated with guidance following queries receieved.
Please find the updated application form and template documents below:
The linked documents are templates for adaption to any study. Where studies are aimed at children, overseas participants or vulnerable individuals, researchers need to ensure that the documentation is culturally appropriate and age specific to meet the needs of the participant group. For further information on seeking informed consent, please refer to the Consent and Participant Information Guidance developed by the Health Research Authority (HRA) and Medical Research Council (MRC). The HRA also provides guidance on applying proportionality to seeking consent.
Please note, the PIL and consent form have been updated to include the required transparency information to ensure compliance with the current Data Protection Legislation: the Data Protection Act 2018 and the GDPR. If researchers prefer to use their own templates or those of a collaborator, then they must ensure this transparency information is included in the PIL.
Applicants must ensure that they submit a signed copy of the application form to BSREC, BSREC at warwick dot ac dot uk along with copies of their relevant supporting documents. Where an application falls under the remit of a full review, researchers need to ensure they meet the deadline for the anticipated meeting date. Late submissions will not be accepted. Applications for a light touch review do not need to meet any deadlines as these are reviewed by circulation outside of BSREC meetings.
Student applications must be signed by the Academic Supervisor or BSREC can accept an e-mail confirming that they agree to abide by the statements made in part 4.2 of the application form, providing it is sent by their Warwick email address. Please note there is no need to send a hard copy of the application.
Once your application has been reviewed, whether this has been via a full or a light touch review, you will receive a letter from the BSREC Chair confirming whether you have been awarded full or conditional approval, or you may be advised that the Committee were unable to form an opinion based on the information provided.
If you are awarded conditional approval, you will be required to meet all of the conditions set out in the letter and to resubmit your application to BSREC via BSREC at warwick dot ac dot uk, highlighting all of the amendments you have made in a different colour so that they are easy to locate. You should receive a final decision from BSREC for all resubmitted documents that meet all of the required conditions within 10 working days of the receipt of a valid resubmission.
You are reminded that you should not start your study until you have received full approval from the Chair of BSREC (or delegate) in writing.
If you are awarded full approval, you will be advised that the application has been approved with no changes required and you may begin the study, subject to seeking any additional approvals that may be required.
Where applicants are advised that the Committee were unable to provide an opinion on the application, this is likely to be because of one of two reasons:
- the application does not provide sufficient information for the Committee to be able to provide an opinion, and numerous queries have been raised that require clarification before an ethical opinion can be given;
- the Committee have concerns about the study that may be related to one or a number of the following: the proposed methodology; the feasibility of the study relating to the timeframes, level of support required etc.; significant concerns about researcher safety or University reputation.
Applicants who receive this outcome are advised to do the following:
- review the feedback provided by the Committee and discuss with colleagues, collaborators and supervisors where appropriate;
- depending on the nature of the feedback, consider whether it is possible to make the suggested changes to the study, or whether the project could be adapted to satisfy the Committee's concerns;
- contact the BSREC Secretary if you would like to discuss the concens raised, further.
Please note, although the Committee will aim to provide guidance and suggestions where possible, it is not the role of the Ethics Committee ot rewrite or redesign the study for researchers.
Where applicants wish to submit a revised application in response to a 'no opinion', this will be reviewed as a new application. This means you will need to bear in mind the Committee meeting dates when planning the resubmission.
Amendments are changes made to a research project after approval from a review body has been given. If you plan to make an amendment to your research project, you will need to determine whether you need to notify the review bodies from whom you have received approvals. Please note there may be other review bodies that also need to be notified of any chnages made to the study.
If you receive full approval from BSREC and you find that you need to make a change to your study, you may need to apply to BSREC for ethical approval of the changes that you would like to make.
Substantial amendments require further review by BSREC and are defined as the following:
- changes to the design or methodology of the study, or to background information that is likely to have a significant impact on its its scientific value;
- addition of a new group of participants or data set;
- changes or additions to the procedures undertaken by participants;
- changes likely to have a significant impact on the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study;
- significant changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation, letters to other key stakeholders e.g. GPs or clinicians, information sheets for parents or carers etc.;
- appointment of a new lead investigator for the study, or transfer of the project to another organisation;
- addition/inclusion of new payments/incentives for participants e.g. gift tokens, vouchers etc.
- any other significant change to the protocol or the terms of the original ethics application.
To make a substantial amendment to a BSREC approved project:
- Complete the BSREC Substantial amendment application form. This is to provide the Committee with a summary of the changes you wish to make to the study. This form should be signed by the researcher and supervisor where applicable. Electronic signatures are acceptable.
- Submit a revised copy of the original application form, updating the date and version number on the first page, and highlighting any changes or additions (this document should be a live document detailing how the project will be conducted). Please ensure all sections are updated as appropriate. For example, if the amendment involves a new questionnaire for participants to complete, then the recruitment section, informed consent section and data section of the original appliction form should be updated to detail the arrangements for the new questionnaire.
- Submit copies of any new or changed documents, highlighting the changes so it is easy for these to be identified and reviewed.
- Please electronically submit your application for substantial amends to a project to BSREC at warwick dot ac dot uk.
Non-substantial amendments do not require further review by BSREC but notification should be sent to the Committee via the BSREC Secretary BSREC at warwick dot ac dot uk. The original application form, date and version number should be updated, with any changes highlighted for BSREC to hold on file. The BSREC Secretary will confirm receipt of the notification.
Examples of non-substantial amendments are as follows:
- minor changes to the protocol or other study documentation, e.g. correcting errors, updating contact points, minor clarifications;
- changes to the research team;
- changes in funding arrangements or receipt of additional funding;
- extension of the study beyond the period specified in the original application form.
- updates to exisiting PILs for ongoing studies to include GDPR transparency information providing this is using the template wording in the BSREC template.
If you are unsure as to whether you need further review of an amendment you need to make to the study, please contact the BSREC Secretary at BSREC at warwick dot ac dot uk.