Quality assurance of University of Sheffield sponsored human-interventional studies
Risk Assessment
Checklist for University-Sponsored Human-Interventional Studies
Human-interventional studies whose research governance sponsor is the University of Sheffield are subject to a risk assessment before the start of the study. The first stage in the process is for the study’s Chief/Principal Investigator to complete this checklist. S/he should then sign and date the checklist, where indicated, and arrange for the Head of Department/School to countersign it. All questions on the checklist should be answered (a simple ‘Yes’ or ‘No’), unless they are clearly not applicable.
The completed signed and dated checklist should then be returned to Fidel Budy in the University’s Research and Innovation Services ( / ext. 21400). On receipt, a risk score will then be applied to the answers provided. The risk score will then determine whether the study is categorised as potentially low, medium or high risk (the risk scorehas been tested by a group of senior University academics who undertake human-interventional studies in order to ensure that scores reached are appropriate). Thank you for your support.
Basic Information: / Please provide details below:Full Title of Study:
Acronym of the Study:
Chief/Principal Investigator:
Academic department/school:
URMS Number (6 digits):
Size of grant award (if funded):
Answer:
Questions: / Yes: / No:
1. Do you consider the nature of the study to be potentially controversial?
(Identifying the potential for controversy is a judgment call. In considering how to answer this question, please consider the possible adverse impact on participants and/or on staff and/or on the University and/or on external funders that might result from pursuing the study).
Example: a study of a therapeutic abortion.
2. Is the study invasive?
(invasive means where there is a physical alteration, e.g. as a result of surgery; obtaining tissue; inserting a device; reacting to a drug)
Mark
one box:
3. How frequently has the invasive therapy been used in this type(s) of participant before? / Never?
In small studies?
In large studies?
Routinely?
4. Could the intervention (e.g. surgery and/or interventional radiology and/or medical device(s)) present a significant risk of harm or risk of significant harm to the human participant(s)? [harm can be in terms of the risk to the physical safety of the human participant(s) and/or in terms of the risk that the intervention will not be effective and, therefore, not beneficial to the human participant(s)]
5. Will study participants include infants and children under 18?
6.Will study participants include mentally incompetent people (mentally incompetent as a result of mental disability or illness)?
7.Will study participants include pregnant women?
8.Will study participants include people who are dependant on the protection or under the control/influence of others (e.g. children, pupils, people in care, young offenders, prisoners, employees/fellow staff, students)?
9. Is this an international human-intervention study?
10. Is this a multi-site human-interventional study?
11. Will an accredited Clinical Trials Research/Support Unit support the trial in terms of monitoring the local participating sites (including, in the case of clinical trials of investigational medicinal products, monitoring for pharmacovigilance compliance)?
[skip this question if it is not a multi-site study]
12. Does the Chief/Principal Investigator (the Investigator) have experience of conducting a multi-site human-interventional study? [skip this question if it is not a multi-site study
13. Does the Investigator have experience of conducting this type of human-interventional study?
(whichever is relevant – e.g. medical devices, investigational medicinal product, cosmetic, food, physiotherapy)
14, Does the Investigator have experience of working with this particular investigational medicinal product? [skip this question if it is not applicable]
15. Where the study involves people who are stated in questions 5 – 8 of this checklist, does the Investigator have experience of conducting this type of study with this client group(s)?
16. Can you foresee potential significant obstacles to the delivery of the study that, should they materialise, will need to be overcome in order to ensure that thestudy can be conducted successfully?
16.1. If you answered Yes to question 16, please describe the potential obstacle(s) here:
Example: the task of delivering the study (or an aspect of the study) has been delegated to a third party (e.g. to a drug company) but during the study’s lifetime the third party goes bankrupt.
Insert details here if applicable:
I hereby acknowledge that I have read and understood the questions on the checklist and have answered the questions truthfully.
______ Insert Date Here:
(Signature)
Print Title and Name of Chief/Principal Investigator here:
______
(Signature)
Print Title and Name of Head of Department/School here:
Thank you very much for your time