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The University requires that approval is obtained by members of staff of the University and by students of the University who wish to engage in the type of research detailed below. Please use this form for an application if your research involves:
1. Gathering information from or/and about individual human beings (and organisations) through:
observation of human behaviour
modifying/disturbing human behaviour
interfering in normal physiological and/or psychological processes
2.Using archived data in which individuals are identifiable.
3.Researching into activities which involves direct observation of or contact with those who are or who might reasonably be supposed to be engaged in or have engaged in criminal activities or activities which are related to criminal activity
4.Research which involves a risk of physical or psychological injury to the researcher or any other person involved in the research
5.Supporting innovation that might impact on human behaviour e.g. Behavioural Studies
[It should be noted that in regard to research into illegal activities there are no exclusions or blanket permissions and the University Insurance cover may not apply if the research activity has not been cleared by the University or, in certain cases with delegated authority, the appropriate Faculty Committee.]
Guidance and support will be given by your supervisor (for student research), your line manager or an appropriate designated officer/ Faculty Research Office. Queries arising out of this should be directed to:
To which ethical codes of conduct have you referred? These are specific to each Faculty and if you have a query please ask your supervisor or Faculty REC for advice.
How have concerns regarding the safety of the researcher and/or the research subject been addressed if applicable?
Checklist for applicant:
Has the research proposal identified any of the following research procedures?
1. Gathering information from or/and about human beings through: Interviewing, Surveying, Questionnaires, Observation of human behaviour
2. Using archived data in which individuals are identifiable
3. Researching into illegal activities, activities at the margins of the law or activities that have a risk of personal injury
4. Supporting innovation that might impact on human behaviour e.g. Behavioural Studies
The following should be considered. Please tick yes as relevant:
Providing participants with full details of the objectives of the research
Providing information appropriate for those whose first language is not English
Voluntary participation with informed consent
Written description of involvement
Freedom to withdraw
Keeping appropriate records
Signed acknowledgement and understanding by participants
Are there other/additional factors that could/will give rise to ethical concerns? E.g. Communication difficulties
List of accompanying documentation to support the application:
(1) A copy of the research proposal
(2) The details of arrangements for participation of human subjects (including recruitment, consent and confidentiality procedures and documentation as appropriate)
(3) A copy of all the documentation provided to the volunteer to ensure the clarity of information provided
(4) Copies of appropriate other ethical committee permissions (internal or external) or supporting documentation
(5) If appropriate: a list of proprietary drugs or commercial drugs to be used in the proposed investigation including formulation, dosage and route of administration and known adverse side effects
(6) A statement of your competence to carry out this research as a student or a brief one page curriculum vitae for each applicant, including recent publications (staff only)
(7) Other documentation as advised necessary:
There are normally four possible outcomes from reviewing the activity against the procedures in place:
1.no ethical issues
2.minor ethical issues which have been addressed and concerns resolved
3.major ethical issues which have been addressed and concerns resolved
4.ethical issues that have not been resolved/addressed
Provisional approval could be given at the discretion of the Research Ethics Committee.
Authorisation is dependent on Faculty. Please refer to your faculty guidelines for details on how outcomes are reached:
The reviewer advises the PMB/SAB/REC of those activities in the first three outcomes.
Activities in the fourth outcome are submitted to the Faculty REC for resolution
The approved form must be kept with project documents, e.g. be included as an appendix in the report.
Signature of researcher / student
Signature of supervisor
Line Manager or Head of School signature (Staff only)
This form complies with the DMU policy statement on Human Research Ethics, a full copy of which can be found in the General Regulations and Procedures Affecting Students.
A separate form is required for each project.
ADVANCE APPROVAL OF RESEARCH ACTIVITY INVOLVING HUMAN RESEARCH ETHICS
1 Respondents’ co-operation in a research project is entirely voluntary at all stages. They must not be misled when being asked for co-operation.
2 Respondents’ anonymity must be strictly preserved. If the Respondent on request from the Researcher has given permission for data to be passed on in a form which allows that Respondent to be identified personally:
(a)the Respondent must first have been told to whom the information would be supplied and the purpose for which it will be used, and also
(b)the Researcher must ensure that the information will not be used for any non-research purpose and that the recipient of the information has agreed to conform to the requirements of any relevant Code of Practice.
3 The Researcher must take all reasonable precautions to ensure that Respondents are in no way directly harmed or adversely affected as a result of their participation in a research project.
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