- Scope and remit of the HSSREC
- Application process
- Review Procedure
- Chair’s Action
- Light Touch Review
- Changes to research projects
- Complaints about a research project should now go to
The University is committed to promoting a quality research culture by ensuring high standards of research management, administration and governance. In practice this means that no research can take place until all of the required approvals and authorisations have been given from the appropriate institutions.
Any University of Warwick student or member of staff who wishes to undertake research involving human participants, their data (this may also include research involving the data of deceased participants), or their tissue under the auspices of the University, must obtain appropriate ethical approval.
Definition of 'human participants' in The British Psychological Society's Code of Human Research Ethics: "including living human beings, human beings who have recently died (cadavers, human remains and body parts), embryos and foetuses, human tissue and bodily fluids and human data and records (such as but not restricted to medical, genetic, financial, personnel, criminal or administrative records and test results including scholastic achievements."
a) All staff research from the Faculty of Social Sciences, Faculty of Arts, and Department of Psychology that does not fall within the scope of NHS ethical approval* and involves human participants or their data must be sent to the HSSREC committee for appropriate approval.
* - Any research involving the NHS will need to follow the appropriate process, further information can be found on the Research Support Services (RIS) web page: 'NHS Research Ethics Committees'.
b) The HSSREC Committee would not, normally expect to review studies/research involving:
- Literature/Systematic Reviews
- Documentary Analysis
In addition, the Committee would not normally require ethical review for:
- Interviews/consultation with key informants/service users during the development of research proposals
- Stakeholder consultations during the developmental stage of research proposals
c) If the University of Warwick is not the lead organisation for the research and ethical approval has been granted by another institution’s ethics committee it should not be necessary to submit the work for approval at Warwick but HSSREC will require a copy of the approval granted before the research at Warwick commences. Please send a copy of the approval and supporting documents to firstname.lastname@example.org Please note that this only applies where the project has undergone formal ethical review.
Additional information on research ethics can be found at ESRC Research Ethics Framework
Departments (identified in section 1a above) will be responsible for ensuring the ethical review of all student research in accordance with the following Guidelines for student research.
Any research which is deemed by the Head of Department/Nominated Ethics Representative to require full ethics committee approval should be sent to the HSSREC in accordance with procedures for staff research. Any research which falls within the circumstances under which NHS ethical approval is required will need to go through HRA Approval, as outlined in 1a above.
Departments from the Faculty of Social Sciences, the Faculty of Arts and the Department of Psychology must be able to demonstrate to the HSSREC robust mechanisms to thoroughly review all student research involving participants that are not sent to the HSSREC for review and must keep clear records in writing of any applications that have been approved.
If in doubt, researchers or student supervisors should discuss their research with the HSSREC Secretary. Applicants who wish to discuss their application before submission should, in the first instance, contact email@example.com who will, if appropriate, refer them to an appropriate member of the Committee.
The HSSREC is accountable to the University's Research Governance and Ethics Committee and is required to report regularly to the University through this Committee.
- The Committee will normally only accept applications for ethical approval after funding has been awarded (in the instances where external funding is sought), except when ethics approval forms part of the requirements of a grant application or where it is helpful to the applicant for the review to take place earlier. Applications relating to internally funded or own account research may be submitted at any time but must be before the commencement of any research.
- Principal Investigators should apply using the HSSREC Application Form and all applications must be supported by the signature of the Head of Department. Any applications submitted without the necessary signatures cannot be accepted.
- Fully completed applications should be sent in email format to hssrec at warwick dot ac dot uk. Please ensure the signature page on the application form is complete, i.e. contains the signatures of all relevant parties. 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.
- Applicants are not invited to present their submissions as a matter of course. However, in the event of particular issues, the Committee may request the applicant to attend to assist the Committee in its deliberations.
a) Applications will be made available to all HSSREC members prior to the meeting and comments will be collected, discussed and recorded at the meeting.
b) Applicants will be notified of the HSSREC’s decision in writing as soon as possible after the meeting. The HSSREC’s decision will be one of the following and details of any amendments required will be included:
- Approved – no amendments required
- Conditionally Approved – minor/major amendments required.
- Resubmit – needs to be resubmitted with substantial amendments.
- Rejected – ethically unsound.
c) Where changes to an application are requested, the applicant/s will need to submit the updated documentation with changes clearly highlighted. Note. A project must not commence until formal full approval has been issued by the Committee.
d) Applicants have a right to appeal the Committee’s decision to reject an application. The appeal process is carried out by the University Research Governance and Ethics Committee. For details, please contact Jane Prewett (tel: 22746 email: firstname.lastname@example.org).
Chair’s Action may be taken (with the advice of other Committee members if appropriate) to:
- Determine whether or not an application falls within the remit of the committee;
- Confirm the approval of conditionally-approved protocols when the conditions have been met;
Light Touch review of research can occur where the potential for risk of harm to participants and others affected by the proposed research is minimal, for this reason the following may be undertaken via a light touch review process:
- The review of substantial amendments to studies previously approved by HSSREC;
- Research involving only secondary or historical data
Applications eligible for a light touch review are examined by circulation by one independent reviewer. There are no deadlines for receipt of light touch applications as these are reviewed on a continuum. Applications should be submitted to email@example.com
Substantial amendments require further review by HSSREC 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
- 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.
To make a substantial amendment to a HSSREC approved project:
- 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.
- 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 amendments to a project to firstname.lastname@example.org
Non-substantial amendments do not require further review by HSSREC but notification should be sent to the Committee via the HSSREC Secretary email@example.com. 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.
Examples of non-substantial amendments are as follows:
- 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 exisiting PILs for ongoing studies to include GDPR transparency information providing this is using the template wording in the HSSREC 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 HSSREC Secretary at firstname.lastname@example.org
Research involving only secondary or historical data requires review by HSSREC. This includes:
- Research using previously collected data from human participants which is not publically available;
- Research using previously collected data from which human participants are individually identifiable or recognizable;
- Research using publically available data which may require consent (consider how data from social media websites is being used for research purposes);
- Research using routinely collected student assessment data within a course or Department/School where the data has been anonymised prior to its passing to the researcher/s
For any queries about whether a project requires ethical review of secondary data, please contact the HSSREC Secretary, Dr Rosie Bellamy at email@example.com
- For any changes to research projects which have received approval from HSSREC, please see the above section 'Light Touch Review'