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How to Apply to HSSREC

Submission of Applications

Amendments

Review process

Submission of Applications

Fully completed and signed application forms should be sent via email to hssrec@warwick.ac.uk. Applications must be submitted at least 2 weeks in advance of the next Committee meeting to allow members appropriate time to review applications. An up-to-date schedule of meetings can be found here.

Applications Checklist

Applications should include the following documents:

If applicable:

  • Copies of any relevant authorisations
  • Copies of any questionnaires/surveys/interview schedules
  • A completed Risk Assessment (For example, Risk Assessment Form or Travel Risk Assessment)
  • Copies of any draft recruitment material, e.g. draft email for email recruitment method, recruitment poster, text for social media post/s
  • For research conducted overseas: a copy of the Information Sheet and Consent Form should also be submitted in the participants' first language.

Further guidance on what required study documents can be found here.

It is acknowledged that researchers in some disciplines may still wish to develop a protocol and include this in 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 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 Data 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 received.

If you have not already done so, you are advised to undertake the Research Integrity Online Training Course. All details relating to this course can be found here.

Amendments

Researchers should submit amendments to HSSREC when required. Amendments are processed differently depending on whether they are Substantial Amendments or Non-Substantial (Minor) Amendments.

Please note there may be other review bodies that also need to be notified of any changes made to the study. Researchers should submit amendments to all review bodies from whom you have received approval.

Substantial Amendments include 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 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
  • 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 project as outlined in the original ethics application.

Non-Substantial (Minor) Amendments include the following:

  • minor changes to the 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 existing PILs for ongoing studies to include GDPR transparency information providing this is using the template wording in the HSSREC template.

To make a Substantial Amendment to a HSSREC approved project:

  1. Complete the HSSREC 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 for student projects). Electronic signatures are acceptable.
  2. 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 application form should be updated to detail the arrangements for the new questionnaire.
  3. Submit copies of any new or changed documents, highlighting the changes so it is easy for these to be identified and reviewed.
  4. Please electronically submit your application for substantial amendments to a project to hssrec@warwick.ac.uk

To make a Non- Substantial (Minor) Amendment to a HSSREC approved project:

Non-substantial amendments do not require further review by HSSREC but notification should be sent to the Committee via the HSSREC Secretary hssrec@warwick.ac.uk. The original application form, date and version number should be updated, with any changes highlighted for HSSREC to hold on file. The HSSREC Secretary will confirm receipt of the notification.

If you are unsure as to whether you need further review of an amendment you need to make to the study, please contact the HSSREC Secretary at hssrec@warwick.ac.uk

Review Process

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 HSSREC Chair confirming whether you have been awarded:

  • Full Approval
  • Conditional Approval
  • 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 HSSREC via HSSREC 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 include a word document summarising the changes you have made. You should receive a final decision from HSSREC 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 HSSREC (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:

  1. 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;
  2. 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 HSSREC Secretary if you would like to discuss the concerns 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 to rewrite or redesign the study for researchers.

Where applicants wish to submit a revised application in response to a 'unable to provide an opinion' outcome, 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.