Below are simple mistakes that commonly come before the committee and delay the approval of applications. Read on for how you can avoid them.
Participants Information Sheets aren’t covered in this list as we have tips specifically on them here.
When submitting your documentation:
Yes. If you include questions about quality of life or general wellbeing in a survey with, possibly alongside other study measures, there is potential for the nature of the results of these questions to result in an indication of distress or suicidal ideation, or could otherwise trigger the participant.
While these are commonly collected measures, you have an ethical obligation to follow up on answers which signal anything concerning. It is best to be prepared for this to ensure you can respond appropriately and in a timely manner. You can determine the appropriate measures to respond to any distress that comes up based on such things as who the participants are, their experience and how invasive or prompting of distressing topics the questionnaires may be.
The HDEC recommend including in your methodology as a minimum - how soon you will look at the answers and where you could direct participants to for extra support that is realistic when considering what you can provide or have access to. If you are part of an institution that has their own safety plan for mental distress, you should include this in your application.
If you are doing genetic testing, you need to be clear on its scope. If you are seeking broad consent for genetic testing this must be justified and the risks clearly explained. The risks involved are not always made clear to participants, such as the potential harm of knowing prevalence of inheritable genes or potential identifiability of them through broad/undefined genetic testing.
The HDECs do not permit broad, undefined ‘fishing’ exercises with genetic testing, especially if the testing is a mandatory part of participating. If you wish to do this then you will need to provide clear and sufficient justification for how this is relevant to the study in question, and the risks and potential identifiability are thoroughly explained to the participants, so they are fully informed when consenting to this kind of activity.
In short, no. You may not realise it but there is a cognitive bias that needs to be addressed.
White coat bias, or also known as the ‘white coat effect’, describes how clinicians (especially when dressed for a clinical setting) influence patient perceptions of the clinician and their authority. This can affect the decisions of patients to participate in research as patients are likely to want to please their clinician.
As consent must be voluntary and informed, it is preferable that a person’s treating clinician is not involved in the consenting process for a potential participant, such as through a study nurse or a study coordinator. If this cannot be done, then evidence of how this will be managed and mitigated should be documented to demonstrate what considerations have been made surrounding this.
Yes. As their supervisor you should accompany them to the HDEC and help them with their application.
The HDECs strongly recommend that a student’s supervisor has an active role with their HDEC submission. This includes reviewing the submission before it is submitted, and attending full meetings, if any, with their students.
If the PhD student’s research is coming to the HDEC then they are probably embarking on increasingly complex research and their experience of the ethics process up until that point will likely differ in terms of requirements and conditions imposed.
If your target population may include those with diminished capacity which may vary in severity and could be different for each participant (e.g. participants with dementia), you must sufficiently demonstrate how each participant will be assessed for their capacity to consent and participate.
This can be using cognitive measures, or via a suitably qualified clinician making that assessment. In most cases, the Committees must be confident that only participants who are capable of providing their own consent are included, or that inclusion of participants is otherwise appropriate ethically and legally.
Managing vulnerability is covered in more detail in Chapter 6 of the National Ethical Standards(external link).
Yes. Researchers must seek their consent to continue participation if a child turns 16 during the course of a study if they have the capacity to consent (6.20 of the National Ethical Standards). Health information should be kept for 10 years from when they have provided their own consent. Chapter 6 of the National Ethical Standards(external link) contains more information on research with children and young people.
No. Clinician access to patient information in order to provide care does not extend to consent for access to it for any other purpose (such as research). Although they may have a signed hospital admission form which mentions use of data for research, this does not constitute informed consent for research.
This can cause significant delays if it is not right in the application. Applicants often make this mistake on the screening form and have to amend their documentation to ensure it is compliant with seeking a waiver or otherwise obtaining consent.
Yes. If a study involves researchers visiting participant homes, then the protocol must include a home-visit safety plan. This should include how the researchers will ensure someone is aware of the visit and what will happen if the researcher does not report back or an incident occurs during the visit.
Yes. It is quite common in studies like retrospective data-only analysis where it is not practical to contact every participant to seek a waiver of consent from the HDEC.
It is best to explicitly seek a waiver in the protocol (e.g. in the ethical consideration section) as then you can cover the conditions for the waiver as outlined in the National Ethical Standards(external link) and ensure it is part of the study documentation.
Waivers of consent only cover the use of identifiable data or human tissue without consent and cannot be used for active participation without consent.
