Submission guidelines

This is central to the submission. The response must be self contained and easily understandable, explaining in lay terms the underlying nature of the problem to be addressed and its importance in terms of severity and numbers of people involved. There should be a list of the study objectives. It should be clear how the proposed research will contribute to the subject under investigation.

Q. 4

It should be made clear here and throughout submitted paperwork that where the title 'Dr' is used this is clarified by appropriate qualifications to distinguish between medical and PhD degrees.

Q. 6

The principal investigator is the person responsible for completing the EthC1 form and who will be the point of contact between the Research Ethics Committee secretariat and the research team. Please do not forget to supply a phone number.

Q. 7

The individual with strategic / policy responsibility for the safe conduct of the study is the person responsible for ensuring that the study meets organisational objectives and is financially secure.
In addition this individual is responsible for ensuring that all health and safety aspects of the study have been addressed and are covered by appropriate specialists.

For example, in an experimental study, to ensure that any Medical Officer is practised in those skills required for the treatment of any foreseen emergency, that equipment operators are trained in emergency shutdown procedures etc.. Normally this would be expected to be a Band 2 or above (eg In HSL a Director/Deputy Director; in FOD/EMAS an SMI)

• Where medical supervision is appropriate as an integral part of the study (eg in relation to chamber exposures or exercise testing), a Medical Officer assuming responsibility must be defined and named (as Qu 7b).
• In principle the individual professionally responsible for the study should not be a member of the study team.
• Where medical input is required solely at the screening/recruitment stage of the study a named Medical Officer should also be recorded at 7b. However, in this particular case the appointed Medical Officer (who may at the same time also be professionally responsible for the study as a whole) may also be recorded as a member of the study team.

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Q. 9

This should be a single sentence, summary statement categorising the study (eg (i) A cross sectional, epidemiological survey of workers in the chemicals industry involving questionnaire and physiological measurement; eg (ii) An experimental, volunteer study involving controlled exposure to chemicals together with blood and urine sampling.)

Q. 11

Where studies are to be conducted in the workplace it is considered important to have reached agreement with BOTH employers and employee representatives.

Q. 12

HSE funded extramural studies are not required to be submitted to the HSE Research Ethics Committee. If the study is a collaborative exercise with an extramural organisation one would normally expect referral to their ethics committee and, that done, the protocol would not require further submission to the HSE Research Ethics Committee. It would nevertheless be considered appropriate for the protocol and accompanying documentation to be tabled at the HSE Research Ethics Committee.

Exceptions to this are -

• where the extramural organisation does not have ready access to an ethics committee
• where the discipline involved lies outwith the expertise of the local ethics committee (eg occupational hygiene)
• where the study is national, extending over a wide geographical area (although Multicentre Research Ethics Committees may be an appropriate alternative)
• The advice of the Medical Secretary should be sought in these instances.

Q. 13

Where a study calls for volunteers, gender unspecified, to be exposed to any physical or chemical agent a statement must be made to indicate that consideration has been given to any potential effect(s) on women of childbearing age in as far as they might be either pregnant or liable to conceive at the time of the study.

• Consideration should also be given to any potential effects on male/female fertility.
• Specific consent should be obtained where any potential risks to the reproductive system have been identified.

Q. 15

Where researchers and volunteers are HSE employees the following wording is considered appropriate:

"HSE volunteers and members of the study team will be considered as being engaged on official duties, and their rights will be no different in any respect from their position when performing their ordinary work."

• Where volunteers are not HSE employees it is likely that response to this question will be: "No arrangements for compensation against non-negligent injury have been made." In this case the committee will wish to be assured that the individual volunteers are fully aware that this is the case.

Q. 19

A statement must be made, if appropriate, that the terms of the Data Protection Act (1998) will be complied with.

• It should be clearly stated that data will be kept for a minimum of ten years and an indication should be given as to the arrangements which have been made to protect the security and confidentiality of the information for this period of time.
• Where information or samples are to be anonymised this should be done as soon as possible following data/sample collection. There should be a full justification if this condition is not to be met.

Q. 20

Where photographic or video material forms a part of the study it is considered necessary to obtain explicit consent (see following guidance on consent forms) and to ensure secure filing. This is considered particularly important where such material will be used to illustrate reports or publications and where it may be used (internally) for presentational purposes.

Q. 21

Proposers should provide the job titles for all those having access to data which is directly identifiable to individual research subjects. It is recognised that a single job title may encompass a number of posts and where this is the case that number should also be given.

Q. 22

It is not considered appropriate to obtain an a priori consent to send information to a study participants General Practitioner. Results should be communicated to the volunteer who, if the findings warrant it, should either be given an appropriate letter to take to their GP or asked to sign a consent for release of information directly.

• The Committee consider that any breaches of Health & Safety legislation identified during the course of a research project should be taken up with employers and, where appropriate, employees. Researchers should make it quite clear to employers that this is the case prior to the study commencement.
• Where there is a foreseen possibility that study information obtained or derived could give rise to health concerns in the research subject facilities for counselling should be in place.

eg (i) where asbestos workers might be found to have been using defective RPE

eg (ii) where during blood analysis subjects are found to have DNA damage