INFORMED CONSENT CHECKLIST FOR HREC

Compiled by: Prof Minrie Greeff

Here are just a few pointers when preparing your informed consent documentation

The text in the informed consent:

The text:

is in plain language and appropriate to the participant’s level of understanding, clear and direct

is free of jargon and unexplained acronyms

is clear and explains technical terminology e.g. randomisation

is translated into other languages as appropriate to the context

(The translation has to reach the HREC within one week after the final informed consent document was approved in English)

conforms to the proposal

the readability level is on grade 8 level

the language and translation is appropriate

Examples of readability tests:

Flesh Readability Formula (Flesh, 1948)

Fry Readability Scale (Fry, 1968)

Flesh-Kincaid Readability Scale (See Paasche-Orlow MK, Taylor HA, Brancati FL) – informed consent should be at the 8th-grade level (USA)

TICK LIST FOR YOUR CONVENIENCE:

These are important aspects that should be included in the informed consent documentation as expected by the National Health Research Ethics Council (2014):

Make a tick in each block. If not applicable indicate N/A

Item	Yes	No	N/A
The informed consent document is official and on the letterhead of the NWU
The information should explain:
that the person is being asked to participate in the research
who the researchers are and the nature of their expertise (qualifications)
what the research is about (purpose and nature)
the choice whether to participate is voluntary
the refusal to participate will not be penalised
that choosing to participate can be reversed, i.e. the person may decide to terminate participation at any time without explanation or prejudice
that a participant is free at any time to withdraw consent without having to face negative consequences
a description of the procedures to which the subject will be subjected
the expected duration of participation
the nature of the researcher’s responsibilities
the total number of participants that will be involved in the research
the anticipated risks of harm or discomforts
If risk of bodily harm how this will be covered by insurance
how these risks or discomforts will be managed
the potential benefits, if any, for participants themselves (direct) and for others after the research (indirect)
the extent to which privacy and confidentiality is possible
what will happen to the findings or samples - only for this study or further studies - If further studies for what and related to what - further studies will be approved by a REC on their behalf - how the data/samples will be used - where will it be stored and analysed - permission that it can be done overseas if that is the intension
whether there will be any financial implications e.g. out of pocket costs like travel
whether there will be any remuneration
identify the funder, where applicable and any potential conflict of interest
how the person will be informed of findings and when
their right to be informed of relevant new findings and how this will be done
that sponsors of the research and regulatory authorities (HREC) may inspect research records
that the research has been approved by a registered HREC (include identifying details)
that queries about the research may be directed to the researcher concerned (include contact details)
that queries and complaints about being a research participant may be directed to the HREC concerned (include contact details)
Only add if applicable
that the research may be terminated early in particular circumstances
the consequences of withdrawal
In addition to the above, where clinical trials are intended, the information should explain:
the procedure and the activities that will take place, including whether any is experimental, innovative or novel in humans
that research is separate from clinical care for the illness or condition that the person may have
whether research-related injuries will be treated and remedied at the cost of the sponsor
explanation as to whether compensation will be given for research-related injuries
the contact details of the person to contact in the event of a research-related injury
the alternative procedures or treatment available
the approximate number of participants
the possibility of randomisation and the implications
the meaning and implications of placebo
the difference between experimental and control groups

What the HREC will look for in the proposal:

The process of obtaining informed consent is described in full

The principle of respect for persons was followed, that it is voluntary, and based on information that allows an informed choice

Environment where process of consent is conducted

private, confidential and safe

Assessment of capacity to consent

age

legally informed consent

decisionally impaired persons

legally authorized representation

literacy

Assessment of participant's comprehension

Presentation of all mentioned elements of IC and the process that will be followed

Whether gatekeepers/mediators are involved and their roles in this process

Time to talk to researcher to ask questions

Documentation of IC (language level, language offered in)

Use of delayed consent procedure

time to think

time to discuss with family/friends etc.

Who is going to obtain the consent (independent person)

Ongoing consent/re-consent if necessary due to the nature of the research

Developed by: Prof Minrie Greeff

Original details: (23239522 G:\My Drive\9. Research and Postgraduate Education\9.1.5.6 Forms\Hrec\9.1.5.6_HREC_ICF_Checklist_June2018.docm
26 June 2018

File reference: 9.1.5.6