LESS IS MORE: How Much Information do you need to be informed Dr N icole Gerrand Manager Research Ethics and Governance, Hunter New England Local Health District Conjoint Fellow School of Arts and Humanities University of Newcastle

Informed Consent in Research Purpose is to provide all the information necessary for a person to make an informed decision whether to participate in research Primary means of providing this information is through written information statements

The Problems Contexts and time constraints not conducive to understanding complexities of research Documents are daunting and so potential research participants may not fully understanding what they have consented to

The Problem Continued Becoming increasingly complex, ridiculously long and providing extraneous information Can be up to 30 pages in length in some specialties – oncology, paediatric research Some may not even read the document, but still agree to participate

Part of the Solution Introduce “Short Versions”(acute research) or “Executive Summaries” (non-acute research) of Information Statements Provide salient information from or overview of documents to enhance the consent process What information should be included in such documents

Acute Research Short Information Statement vital for research conducted in the acute setting – so the challenge is: - Provide the information needed to make the decision to participate within a short time period usually in a stressful context - What information and how much

Introduction You are being invited to participate in this research study because you have had a stroke, which means there is a blood clot in your brain which may result in you becoming disabled. The aim of this study is to determine which of two-clot dissolving medications, Drug A or Drug B, results in patients with less disability three months following their stroke. Drug A is not currently approved for use in acute stroke care, but has shown very promising results in recent stroke studies, with a lower risk of bleeding than treatment with Drug B, which is the usual treatment for stroke patients. Your participation in this study is voluntary. If you decide to participate, you may withdraw at any time without a reason and without any adverse affect to your patient care. This Information Statement will tell you what needs to happen immediately, if you decide to participate in this study. In the next few hours we will give you a longer document that provides more information about the study and your rights as a research participant. You can then decide whether you wish to remain in the study.

What does participation in this research involve? If you consent to participate in this study the following procedures will occur: You will be randomly assigned (tossing a coin) to received either Drug A or Drug B. You have an equal chance of receiving either drug. If you are female and of child-bearing potential, you will be asked to provide a urine sample to confirm that you are not pregnant, as this treatment may affect the developing foetus. At 24 hours after treatment: a scan of your brain [either by computerised tomography (CT) or magnetic resonance imaging (MRI)] and a neurological assessment. This is standard care for all stroke patients. At 3 months after your stroke: we will contact you by phone and ask how you are managing with your day-to-day activities.

What are the possible risks? As the two drugs are chemically similar, they have similar side effects. The major risks are: - Bleeding (mostly into the brain) risk is about 5%, this is the major side effect. - Serious allergic reaction (about 1 in 10,000 treatments), this can lead to low blood pressure, airway swelling and obstruction. This could potentially be fatal, but there have been no deaths reported due to allergy with either drug. You should advise medical staff if you suspect any of these side effects are occurring to you. A complete list of side effects is listed in the full version of the Information Statement which you will receive after your treatment. Other Information If you wish to participate in this study we will ask you to sign a consent form. Please ensure we have answered all your questions before you sign this form. This study has been approved by the Hunter New England Human Research Ethics Committee.

Logistical Problems When should participants or persons responsible receive the long version or complete Information Statement What information should be in the long version and how should it be presented Need to resign the consent form based on the long version of the Information Statement

Non-Acute Research Same problem -Length and complexity of the Information Statement means potential participants will not give informed consent Executive summaries of Information Statements important for non-acute research - Provides a overview or roadmap of the research - Makes it easier to review main document

You are invited to participate in the above research study because [for example recent diagnosis, not responding to current treatment etc] and your doctor believes this could be a suitable treatment option for you. A detailed Information Statement about the study is attached and this is a summary of the essential information about the trial and where to find the relevant detailed information later in the Information Statement. You should read the Information Statement in full and discuss it with your family and medical practitioners before deciding to participate in this study. You may contact the study staff [or provide a name] to discuss or asks questions about the study on [phone number] or by [ address]. This study aims to [brief description eg. compare two drugs, include an addition drug in existing treatment etc]. You may receive the study treatment or [the standard treatment or placebo, that is a drug/infusion that looks like the study medication but has no active ingredients]. For a full description of purpose and rationale for this research see pages XX to XX Participation in this study is voluntary and refusal to participate or withdrawal from the study at a later stage will not affect the treatment you receive at [department/hospital]

If you decide to participate in this study you will need to attend the clinic XX times for XX months/years. The study visits will be XX(-XX) hours and your travel and parking costs will be reimbursed. During these visits you will have a number of tests and assessments, such as a physical examination, blood tests and other medical assessments. The schedule for study visits and a full list of all tests and procedures is on page XX – XX. After the study treatment has finished you will [describe any follow up phone calls, routine or special visits, surveys] for the next XX years. The most common risks to participants from the [study, new medication] is [list the most common side-effects]. A full list of the side-effects from the study drug and other risks associated with the study procedures see pages XX to XX There is additional information about what information will be collected about you during the study, [pages XX-XX] how that information will be used [pages XX-XX] and your privacy protected [pages XX-XX]. Your rights as a participant [XX-XX] and additional regulatory information that we are obligated to provide. [pages XX-XX] Please make sure you have completely understood what the study involves before you decide to participate.

SectionsShort Version (Ideally one page) Long Version Introduction & What is the purpose of the Study 1 paragraph (Need to make it clearer that a longer document will be forthcoming) 5-6 paragraphs (a lot of superfluous information ie. What is Clinical Research, What is consent) What is required of participants, including a list of test and assessments Acute Research: those that will happen immediately with a summary of future requirements Non-Acute Research: Summary including number of visits and list of assessments (Length – 1-2 paragraphs) Detailed description of tests and assessments, time involved (3-6 pages) Risks and BenefitsOnly mention the most common risks with reference to a longer list in long version Complete List (2-12 pages) Voluntary Participation/ Withdrawal from the project One sentenceComplete Statement 91 paragraph) Confidentiality Compensation Complaints Statement (Standard paragraph of approving HREC) Do not includeInclude (2 pages)

Ethical justification Need to rethink informed consent -Not just the provision of detailed written or verbal information - A particular type of communication is required -Need to achieve the appropriate balance between written information and this form of communications Short versions or Executive Summaries of Information Statements may enhance this process