Form Eth C1(rev3 11/00) HSE Study No: ETHCOM/REG/02/xx
Please read 'Guidelines for Submission' before you complete this proforma. Please answer all questions as fully as possible, in plain English without acronyms.
Q. 1 Title of the study
Q. 2 Study details
(a) Study aims and objectives
(b) Potential value of study results
(c) Brief outline of the study
Q. 3 Study timings
(a) Anticipated start date (month and year)
(b) Study duration to report completion (in months)
Q. 4 Name of sponsoring organisation (if HSE please give customer and their Divisional affiliation)
Q. 5 Names of investigators and their parent organisations.
(qualifications and titles of investigators should both be given).
Q. 6 Name and phone number of Principal investigator
(this person will be the point of contact with the Research Ethics Committee.)
Q. 7 (a) Name of individual with overall strategic / policy responsibility for the study (at the level of audit of ethical and safety compliance).
(b) Name of Medical Officer appointed for the study (where appropriate).
Q. 8 Type of participant, e.g. HSE staff volunteers, workers consulting EMAS, occupationally selected people, students, general public.
Q. 9 Type of study. This should be a single sentence, summary statement categorising the study (eg A cross sectional, epidemiological survey of workers in the chemicals industry involving questionnaire and physiological measurement).
Q. 10 The Study Protocol, including all questionnaires, consent forms and information sheets, must accompany the submission. Please confirm that the study protocol is complete. If not please detail and provide reasons for omission.
(a) has a relevant literature review been conducted and included with discussion (if 'no' please give reasons why not)
(b) has a full consideration of the statistical analysis been conducted, including (where appropriate) an assessment of the statistical power of the study in relation to the main research questions, and is this clearly set out in the protocol? The assumptions on which these calculations are based must be set out, including the magnitude of the difference(s) which the study aims to detect, or the accuracy of the estimates to be made. Where the calculated statistical power or precision is low ( for example, less than 80% power to detect difference) the reasons for accepting this level of uncertainty should be explained.
Q. 11 Agreements. Please indicate what agreements have been reached with
(a) management
(b) unions and
(c) other organisations involved
Q. 12 If this study is being conducted by, or involves collaboration with, an organisation external to HSE, has the study been referred to or agreed by any other Ethics Committee. If not please give reasons why.
Q. 13 Potential hazards to the participants
Please summarise, e.g. toxic hazards, ergonomic hazards (lifting, exercise testing), venepuncture, skin biopsy, intrusive questioning, psychological stress, etc.
For each of the hazards identified has a risk assessment been conducted taking into account controls put in place. Where any risk remains uncertain or or is greater than that which may be considered minimal this should be detailed. Where appropriate please indicate that specific consideration has been given to any potential effect on women of childbearing age.
Q. 14 Procedures causing discomfort and inconvenience
Please describe the nature and degree of discomfort. Include problems associated with the time involved and travel difficulties.
Q. 15 Arrangements for compensation should a participant suffer injury as a result of the participation when such an injury results from a non-negligent act.
Q. 16 Explain exactly how the participants are to be recruited. Copies of calling notices etc. must be appended.
Q. 17 Explain the methods of obtaining informed consent. Where questionnaires and 'samples' are taken anonymously an informed, explicit consent for participation (non coercion) needs be assured.
Copies of consent forms must be appended.
Q. 18 Are the volunteers being given any payment or other inducement to participate in the study? Please detail.
Q. 19 What arrangements have been made to protect the security and confidentiality of personal life style, experimental and clinical information.
(It is expected that data will be stored for a minimum of ten years and specific comment should be made if this is not to be the case).
At what stage in the study will data be anonymised ?
Please give details of procedures to protect individual data held on computers.
Q. 20 If photographic or video material of people taking part will be taken during the study what specific arrangements have been taken to them? Does this include consent?
Q. 21 Who will have access to information from study volunteers? Please list job titles where specific named individuals cannot be identified.
Q. 22 What arrangements are in place to handle specific information, of a broader relevance, which may arise during the study :-
e.g.
(a) communication of medical information to a participant's G.P.
(b) communication of a breach of health & safety to an employer.
(c) counselling where study results may have a health implication.
Q. 23 Please give any other information that will help the Committee reach its decision
Name and signature of responsible investigator:
Date:
Social media
Javascript is required to use HSE website social media functionality.
Follow HSE on Twitter:
Follow @H_S_E