Human Research Ethics Committee (HREC)
Project Registration and Risk Checklist
If you are planning a research project that involves human participants (including data and/or biological samples),
you should complete and submit this checklist so that the HREC Chair can decide the level of ethics review that is
required. If you have not already done so, refer to the OU Ethics Principles for Research involving Human
Participants.
Once you have completed the checklist, save it for your records and email a copy to Research-RECReview@open.ac.uk, with any relevant documents e.g. a questionnaire, consent form, participant information sheet,
publicity leaflet and/or a draft bid. You should receive a response within 7 working days as to whether your research
will need full HREC review, but please indicate if you require a more urgent decision. It is essential that no potential
participants should be approached to take part in any research, until you have submitted your checklist and, where
required, obtained a HREC review.
To meet internal governance and highlight OU research, the titles of all projects considered by the HREC (whether
by HREC checklist or proforma), will be added to the Research Ethics website http://www.open.ac.uk/research/ethics/human-research. If you would prefer for your title not to be made public or
have any queries, please email the HREC Secretary on Research-REC-Review@open.ac.uk.
Section I: Project Details
Project title
Brief description
(100 words maximum)
Is your research part of an
application for external funding?
Will your research proceed if
external funding is not awarded?
If yes, please provide the name of the funding
N/A
N/A
Funding body:
body and/or your Awards Management System
(AMS) reference
AMS ref:
Is your research being assessed by the Student
N/A
Research Project Panel? or Staff Research
Project Panel.
Section II: Applicant Details
Name of Primary Investigator (or
Status
research student)
Academic unit
Email address
Telephone number
Other researcher(s)
Date
Section III: For students only:
EdD/MA/MPhil/MRes/MSc/PhD
Supervisor’s email address
(Your supervisor will need to email
N/A
Supervisor’s name
Staff
a brief endorsement, before, or at the same time
this checklist is submitted)
Section IV: Risk Checklist
Please assess your research using the following questions and click yes or no as appropriate. If there is any possibility of risk
please tick yes. Even if your list contains all “no”s you should still return your completed checklist to ensure your proposed
research can be assessed and recorded by the HREC.
Yes
No
Does the study involve children (under 16 years old), or those aged 16 and over who are unable to give
1
informed consent. E.g. participants who are potentially vulnerable, such as people with learning disabilities,
those with cognitive impairment, or those in unequal relationships, e.g. your own students?
2
3
4
5
Will the study require the co-operation of a gatekeeper for initial access to the groups or individuals to be
recruited? (e.g. students at school, members of a self-help group, residents of a nursing home)
Will it be necessary for participants to take part in the study without their knowledge and consent at the time?
(e.g. covert observation of people in non-public places)
Will the study involve discussion of sensitive topics (e.g. sexual activity, drug use, or politics)?
Are drugs, placebos or other substances (e.g. food substances, vitamins) to be administered to the study
participants or will the study involve invasive, intrusive or potentially harmful procedures of any kind?
6
Will the research involve the sharing of data or confidential information beyond the initial consent given?
7
Is pain or more than mild discomfort likely to result from the study?
8
9
Will the research involve administrative or secure data that requires permission from the appropriate
authorities before use?
Could the study induce psychological stress or anxiety or cause harm or negative consequences beyond the
risks encountered in normal life?
10
Will the study involve prolonged or repetitive testing?
11
Will the research take place outside the UK?
12
Does the research involve members of the public in a research capacity (participant research)?
13
14
15
16
Is there a possibility that the safety of the researcher may be in question? (e.g. in international research:
locally employed research assistants)
Will research involve the sharing of data or confidential information beyond the initial consent given?
Will financial recompense (other than reasonable expenses and compensation for time) be offered to
participants?
Will the research involve participants responding via the internet or other visual/vocal methods where
participants may be identified?
17
Will the study involve recruitment of patients or staff through the NHS or the use of NHS data?
18
Will tissue samples (including blood) or other human biological samples be obtained from participants?
If you answered ‘yes’ to questions 17 or 18, you will also have to submit an application to an appropriate National Research Ethics Service ethics
committee). Please note that it is your responsibility to follow the University’s Code of Practice for Research and the Ethics Principles for
Research involving Human Participants, and any relevant academic or professional guidelines in the conduct of your study. Also, to provide
appropriate participant information sheets and consent forms, and ensure secure storage and use of data. FAQS offering advice and guidance on
these issues are available on the Research Ethics website.
http://www.open.ac.uk/research/ethics/human-research
June 2016