Timelines for research review in the UK Back to index

UK research review timelines The next slide depicts timelines for REC research review in the UK. Click over any text box for further explanation. You’ll then be taken to a different slide. To return to the timelines simply click on the slide. More detail is in Health Research Authority Standard Operating Procedures. Back to index

UK research review timelines Book a slot, submit application form and paperwork Notification of final decision R.E.C. Validation by REC office ME E T I NG D E C I S O N STUDY END PROJECT 5 days 7-14 days Letter to researcher Researcher’s response Distribution of papers Monitoring, amendments, adverse events Researcher logs onto the Integrated Research Application System (IRAS) to complete an application form Dialogue 60 DAYS Back to index

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Integrated Research Application System Click in the box when you want to go back to the “Timeline” This is the electronic gateway for researchers. When they wish REC review they must complete the appropriate sections of “IRAS” and submit it electronically. The central document you will receive is the application form, extracted from IRAS. (You’ll also receive others such as the protocol, Participant Information Sheets, questionnaires etc) It’s worth delving into this at some stage to familiarise yourself. Section “A” is the main “ethics section”. There may be other sections depending on the nature of the research. Ways you might explore IRAS Visit the “Help” section. Do the e-learning module. Create your own account and look through questions and “Question Specific Guidance” (the little green “i” button”). Links: IRAS http://www.myresearchproject.org.uk. “Help” section https://www.myresearchproject.org.uk/Help/HelpPage.aspx. Content index: https://www.myresearchproject.org.uk/help/hlpirasindex.aspx.

Click in the box when you want to go back to the “Timeline” Validation This is an administrative check carried out by a REC Co-ordinator to verify that an application is complete and may be accepted for review. Decisions on validation should be made within 5 working days of receipt of an application. Click in the box when you want to go back to the “Timeline”

Distribution of papers The agenda and papers for committee meetings should normally be distributed no later than 7 days prior to the meeting. Click in the box when you want to go back to the “Timeline”

REC meeting (1 of 2) The proper running of the committee to ensure it meets legal and policy requirements is the responsibility of your manager and chair. You’re expected to attend 2/3rds of scheduled REC meetings (with some exceptions). When considering a study, most RECs appoint lead reviewers, using a standard template. You won’t be asked to do this at first. The researcher is strongly encouraged to attend. If you have interests in an application you should declare these at the beginning. Before the researcher attends To hear the lead reviewer’s summary, to resolve uncertainties so the REC has a shared, accurate picture. To put forward and listen to concerns and suggestions. To identify issues to discuss with the researcher along with questions, suggestions and tentative remedies. Discussion with the researcher To resolve remaining uncertainties, to listen to the researchers’ summary of the ethics in the research, to put forward committee concerns and listen to responses. (There is an undoubted subtext to review - the probity and character of the researcher(s).) After the researcher has left To review the discussion with the researcher To reach agreed judgments, decisions and remedies To consider the drafting of a letter to the researcher: comments, agreements, requests and instructions. To vest authority in those who will follow up issues

REC meeting (2 of 2) Click in the box when you want to go back to the “Timeline” The aspects of research project RECs are asked to look at are:- All these are covered in sections of the Integrated Research Application System (IRAS for short) http://www.myresearchproject.org.uk Its worthwhile looking into this web site as it is the key material you will receive. Relevance and value of trial Adequacy of peer review Risks and benefits Selection criteria Inclusion of minors or adults lacking capacity Approach to potential participants Information sheets and consent forms Consent process Notifying other professionals Rewards/payments to subjects Chief Investigator and sponsorship Conflicts of interest Insurance, indemnity and compensation Patient involvement, e.g. in trial design Trial registration and publication of results Protocol 27 May, 2019

Click in the box when you want to go back to the “Timeline” REC decisions Click in the box when you want to go back to the “Timeline” A REC should reach one of the following decisions: Favourable opinion Favourable opinion with additional conditions Unfavourable opinion Provisional opinion with request for further information, clarification or revision Provisional opinion pending consultation with a referee – a written request for information may be made following receipt of the referee’s advice

Click in the box when you want to go back to the “Timeline” Dialogue Where a REC requires further information before confirming its opinion, it may give a provisional opinion and make one written request for further information, clarification or changes to documentation such as the participant information sheet. The clock stops until the REC receives a complete response to the request. The REC may ask for clarification but should not raise new issues. “Committees can only have one bite of the cherry” Terry Stacey former director COREC Click in the box when you want to go back to the “Timeline”

Click in the box when you want to go back to the “Timeline” Final decision A final opinion is reached once the researcher’s responses have been received and reviewed (according to the conditions laid down by the committee). This opinion may be: Favourable Favourable with conditions* Unfavourable *These “conditions” can only be such that, if not followed through, in essence wouldn't change the REC’s opinion. Click in the box when you want to go back to the “Timeline”

Monitoring, amendments and adverse events The REC has a limited role in monitoring the study. Responsibilities lie elsewhere. However the REC should receive an annual report. Amendments Some projects will require amendments after their start. These are classified as substantial or minor, only the former need be reported to the REC and this classification is the responsibility of the sponsor. The REC has 35 days from receipt of a valid notice of amendment to give an opinion. The clock doesn’t stop during this period. Amendments may be reviewed in sub-committee or at a full Committee meeting, but not by the Chair acting alone. Adverse events. Any adverse event that is serious and unexpected must be reported to the REC. These are any event that (a) results in death, (b) is life-threatening, (c) requires hospitalisation or prolongation of existing hospitalisation, (d) results in persistent or significant disability or incapacity or (e) consists of a congenital anomaly or birth defect. These are, by and large, confined to Clinical Trials of Medicinal Products (CTIMPs) and therefore action lies with our Medicines and Health Care products Authority (MHRA). Click in the box when you want to go back to the “Timeline”

Click in the box when you want to go back to the “Timeline” Study end Final report Once the study has ended (within a year), the main REC should receive a final report. This should contain information on whether the study achieved its objectives, the main findings, and arrangements for publication or dissemination of the research including any feedback to participants. This is reviewed by the chair or vice chair. It is at his or her discretion whether it is reported to the committee. JOINING IN Click in the box when you want to go back to the “Timeline”

Current REC statistics 60 days Click in the box when you want to go back to the “Timeline” Back to index