Please read through these guidelines carefully before completing your form as inadequate information may delay your project.
Please ensure your form is completed in a language that is comprehensible to a lay person. It is also recommend that applicants spell-check all files before submission
Ref: This will be completed by the HSSREC Secretary on submission
This should be the Principal Investigator and therefore the supervisor must be this on an application for a student project.
3. Other Investigators
- Please mention all other investigators involved regardless of their host institution.
6.A Conflicts of Interest
- You must identify all financial/personal and any other conflicts of interest that are relevant to this project and disclose any prior relationships which could affect this research.
1. Summary of Project
Please highlight the nature of the project (e.g. pilot, evaluation).
When justifying the scientific benefit please include any hypothesis to be tested and any specific objectives of the project.
If the project is for an educational purpose please specify the qualification sought.
- Please justify the overall design of your project and the methodology you have chosen highlighting any samples/measurements to be taken and what may have influenced your choice of methodology.
- Identify any steps taken to consult with the concerned communities during the course of designing the research.
- Summarise the nature of the participants involvement (e.g. what will happen to the participant – how will it happen, when will it happen).
3. Ethical Issues
- Please note that all research projects involving human participants do have some ethical considerations. Please ensure you complete this section.
- You may like to consider issues such as dependant relationships between researcher and subject; protection from harm; rights to withdraw.
- The HSSREC will need to see evidence that the applicant is aware of relevant issues and how they have planned to address them.
- If any risks are identified please explain how you intend to minimise and/or monitor these risks.
1. Recruitment of Participants
- How will potential participants be identified?
- Please identify inclusion and exclusion criteria and explain the purpose behind such criteria. When designing an advertisement, care should be taken to be restrained in tone and not to overstress payments or other inducements to take part. You should also state who would be the first contact point of potential respondents to adverts.
3. Informed consent
Describe the process you will use to ensure your participants are freely giving fully informed consent to participate. This will usually include the provision of an information sheet, and will normally require the completion of a consent form.
- Written consent from participants will normally be required for all projects (except questionnaires where returning a completed questionnaire is considered to be consent)
- Obtaining informed consent is vital to the ethical conduct of research involving human participants. Fully informed consent is a process by which a participant in research understands the nature and consequences of participating in research and is free to choose to consent to participating.
- Please indicate what process you intend to enact to ensure that fully informed consent is obtained and detail any additional assent procedures where children may be involved.
- If an influential relationship exists between the recruiter and potential participant please explain how you will deal with problems of informed consent for these participants.
- If you are unclear or unsure please see the University’s Guidelines on Ethical Practice for additional guidance on the informed consent process and the template information sheet and consent form.
5. Vulnerable participants
- Important considerations apply to projects involving vulnerable participants. Please identify why it is necessary for the research to include these participants and any additional requirements you have taken into account to protect these participants’ rights.
- Payments may be made to participants to reimburse their travel/out of pocket expenses and must be noted here but any other payment must be fully justified in this section. Financial inducements should not be offered as method of recruiting participants and should not be set at a level of inducement that would encourage people to take part in studies against their better judgement.
- If it is not possible to recompense out of pocket expenses to participants this should be explained before a participant agrees to take part in a study. A clear statement should be included in the information sheet.
7. Participant Benefit/Risk
- Please highlight any possible benefits to the participant of being part of this study (if none please highlight any benefits to future members of this group of participants)
- Please also highlight any potential harm/risks that the participant may suffer as being part of this study. This should include any physical, psychological or social discomfort or harm that may result from their participation in this project.
- Where risks/harms are identified please indicate what steps will be taken to minimise and monitor these risks or harm.
- It is the researcher’s responsibility to ensure compliance with legal requirements of the Data Protection Act.
- Your application should refer to the need to obtain permission if confidential information is to be used in a way which would identify particular participants. You must also indicate what action may be taken should information be discovered that would cause concern.
3 Data Storage
- Detail the security arrangements for the stored data, Original data including signed consent forms and copies of relevant documentation must be kept in a secure locked location.e.g. passwords on files and computers, and locked cabinets and offices for paper records.
4 Length of Storage & Data Destruction
- Data should be accessible for inspection if required for at least 10 years after the work is completed. Responsibility will rest with the Principal Investigator to produce, when required, evidence that informed consent has been obtained.
- Please state the method of disposal: safe methods for destroying papers include shredding, incineration and using confidential waste bins. Make sure you know the policy for each type of data. Portable electronic storage devices (such as floppy disks and CD-ROMs) containing sensitive data should be physically destroyed or overwritten.
6 Audio/Video Recording
- The HSSREC will expect that fully informed consent is obtained from the research participants involved