Participant information sheets (PIS) and consent forms (CF) are the main, and sometimes only interaction with what the study is about a potential participant has. It should tell them everything they need to know about what their participation involves as clearly as possible. This is a point of immense scrutiny by the HDECs, as fully informed consent is an essential component of any study with active participants.

Below are some common inconsistencies the HDECs see in review when it comes the participant information sheets.

1. ‘What does my participation involve?’ should be clear on all steps of the participant’s journey.

It may be obvious to researchers what a participant does during the study because of a thorough protocol they wrote, but that doesn’t mean the participant knows any of this. A PIS should detail everything that is required of the participant and their journey in the study and be consistent with what the protocol says. This should include visits, or a rough outline of any questionnaires they are being asked to complete. No participant should have to read between the lines, or be surprised about what their participation involves. 

2. Make sure the PIS is lay-friendly

Participants should not be expected to have to technical knowledge of anything discussed as part of their participation. This means disease names, test names, acronyms etc. Technical terms or acronyms should always be explained the first time they appear. It is a good idea to see if any technical information can be conveyed in more simplistic language.

3. Participant information should be fit for the New Zealand-context

New Zealand is very fortunate to attract a lot of international research. However, New Zealand participants should be provided with information that pertains to them specifically. Sometimes, information from international PIS/CFs gets left in, such as references to overseas laws or other things that are not applicable to the New Zealand populace. Please ensure that any reference to legal representation is correct in the New Zealand context. Relevant New Zealand laws should be referenced, and if anything is being sent overseas, this should be highlighted through a cultural paragraph. Examples of how to word this can be found in the HDEC PIS templates.

4. Pregnant Partner PIS/CFs should typically be submitted for review as an Amendment, not with the application, and should only be submitted if it occurs.

It is important to be prepared in the case of a pregnancy in the case of clinical trials where the effects on the pregnancy need to be monitored. However, given the stringent contraceptive requirements of such trials, the likelihood of pregnancies occurring is low. In addition, when this would occur, it can be very common for a research team to submit these documents as an Amendment as they had to be updated from how the study has progressed and been updated since first approval. Due to this, the HDECs request that the documentation surrounding pregnant partners to consent to their pregnancy being monitored and child followed up on should be submitted if it happens for approval as an Amendment. This ensures the initial review of the application is not cluttered with documents that may never be in use, and that the subsequent information and follow-up is tailored more appropriately to the pregnancy event to be approved.

In addition, use of the child’s data must be consented to after birth, not before.

5. Optional yes/no items in the CF shouldn’t be used where something isn't truly optional

Consent forms are a good way to summarise the content of the PIS when the potential participant is signing that they consent to participate. Sometimes, some optional items can be included, such as return of results, etc., with a YES/NO indication. However, sometimes these can be included for all consent items, with a participant able to indicate YES or NO to a consent form item that is required for their participation. Optional YES/NO tick boxes should remain for what is truly optional. If something is required for them to agree to so they can participate, their agreement to it is by agreeing to participate overall, not by indicating YES. If someone indicated NO, and it wasn’t optional, they would not be fully participating in what was required of them and could cause confusion.

6. Assent forms can sometimes be too difficult. Make sure they are tailored for reading ages.

Assent forms are required when a study requires someone under 16 to provide their assent alongside parental consent. However, assent forms and their paired information are not meant to be the same information as what a fully consenting adult would be expected to understand. It is recommended you have an “older child” and “younger child” level of information if recruiting a large age range of children, and these should be simplified to suit average reading capabilities. For example, the younger child information may rely on more pictures than the older child’s information.

7. Future Unspecified Research (FUR) on tissue must be separate consent if not mandatory. If mandatory, justify!

FUR can be an additional component to participation in a trial. However, as it does not pertain to the study directly, it should not be rolled into the main PIS to avoid confusion. Further, it is preferable this is not mandatory to do if the study questions can be answered without this component. If it is, it is up to the researcher to justify why it is mandatory to the HDECs in their submission.

Last modified: