FACILITATING CONSENT FACILITATING CONSENT THROUGH THE PROVISION THROUGH THE PROVISION OF CULTURALLY SENSITIVE OF CULTURALLY SENSITIVE

INFORMATIONINFORMATION

Sue EcksteinSue Eckstein

Research FellowResearch Fellow

Centre of Medical Law and Centre of Medical Law and EthicsEthics

King’s College LondonKing’s College London

CONDITIONS TO ACHIEVE CONDITIONS TO ACHIEVE CONSENTCONSENT

Prospective participants must:Prospective participants must: be be appropriatelyappropriately informed about the informed about the

nature of the research they are nature of the research they are participating inparticipating in

adequatelyadequately understand the understand the informationinformation

voluntarily decide to participatevoluntarily decide to participate explicitly consent to participationexplicitly consent to participation

Participants must be Participants must be provided with a provided with a explanation of:sexplanation of:s

risks and benefitsrisks and benefits available alternativesavailable alternatives confidentialityconfidentiality compensationcompensation contactscontacts voluntarinessvoluntariness documentationdocumentation

ReadabilityReadability

Talk directly - use “we” and “you”Talk directly - use “we” and “you” Use simple words and no jargonUse simple words and no jargon Be positive and directBe positive and direct Active is better than passiveActive is better than passive Don’t turn verbs into nounsDon’t turn verbs into nouns

Testing readabilityTesting readability

Dwain Chambers, the fastest man in Europe, and Dwain Chambers, the fastest man in Europe, and one of Britain’s main hopes for an Olympic gold one of Britain’s main hopes for an Olympic gold medal next year, has tested positive for a new medal next year, has tested positive for a new banned designer anabolic steroid and could face a banned designer anabolic steroid and could face a life ban from the sport. Britain also faces being life ban from the sport. Britain also faces being stripped of the 4x100m silver medal it won at the stripped of the 4x100m silver medal it won at the world athletics championships in Paris in August as world athletics championships in Paris in August as Chambers was part of the team.Chambers was part of the team.

GuardianGuardianFlesch reading ease 49.0, Flesch-Kincaid Grade Flesch reading ease 49.0, Flesch-Kincaid Grade

Level 12Level 12

Testing readabilityTesting readability

Top British sprinter Dwain Chambers was last night Top British sprinter Dwain Chambers was last night reported to have tested positive for a new designer reported to have tested positive for a new designer steroid. steroid.

Chambers,26 – the fastest man in Europe and one of Chambers,26 – the fastest man in Europe and one of our top Olympic hopes – could face a life ban from the our top Olympic hopes – could face a life ban from the sport.sport.

Traces of the drug tetrahydrogestrinone (THG) were Traces of the drug tetrahydrogestrinone (THG) were reportedly found in a urine sample he gave at a reportedly found in a urine sample he gave at a training camp in Germany in August.training camp in Germany in August.

Sun Sun Flesch reading ease 57.9, Flesch-Kincaid Grade Flesch reading ease 57.9, Flesch-Kincaid Grade

Level 10.3Level 10.3

Describing the research and Describing the research and what is involved in the what is involved in the

participationparticipation

1. 1. “Random allocation into control and “Random allocation into control and treatment groups will be performed by a treatment groups will be performed by a computer.”computer.”

Flesch reading ease 43.9, Flesch-Kincaid Grade Flesch reading ease 43.9, Flesch-Kincaid Grade Level 10.3Level 10.3

2. 2. “You are being invited to participate in a “You are being invited to participate in a research project. Participation in this trial is research project. Participation in this trial is entirely involuntary and you are free to decline entirely involuntary and you are free to decline entry into this study”entry into this study”

Flesch reading ease 39.5, Flesch-Kincaid Grade Flesch reading ease 39.5, Flesch-Kincaid Grade Level 11.0Level 11.0

Describing the research and Describing the research and what is involved in the what is involved in the

participationparticipation

1.We will split you into two groups. In the first 1.We will split you into two groups. In the first group you take a new medicine we are group you take a new medicine we are testing. In the second group you take the testing. In the second group you take the most commonly used medicine. We need to most commonly used medicine. We need to compare the old and new medicines fairly. compare the old and new medicines fairly. We do this by randomly choosing the group We do this by randomly choosing the group you go into. We could toss a coin to do this, you go into. We could toss a coin to do this, but use a computer because it is quicker.but use a computer because it is quicker.

Flesch reading ease 84.3, Flesch-Kincaid Flesch reading ease 84.3, Flesch-Kincaid Grade Level 4.2Grade Level 4.2

Describing the research and Describing the research and what is involved in the what is involved in the

participationparticipation

2. “We invite you to take part in a 2. “We invite you to take part in a research project. You don’t have research project. You don’t have to accept our invitation. If you to accept our invitation. If you decide not to take part, then you decide not to take part, then you don’t need to give us a reason.”don’t need to give us a reason.”

Flesch reading ease 87.9, Flesch-Kincaid Flesch reading ease 87.9, Flesch-Kincaid Grade Level 3.7Grade Level 3.7

Problems with written Problems with written informationinformation

Women and girls may be Women and girls may be disadvantageddisadvantaged

Role of family member or Role of family member or interpreterinterpreter

Limitations of interpretationLimitations of interpretation Written information must be Written information must be

appropriate for a particular appropriate for a particular readershipreadership

Supplementing written Supplementing written materialmaterial

Increasing use of Increasing use of

drama, puppets, role-playdrama, puppets, role-play

pictures, videos, recordings and pictures, videos, recordings and visual propsvisual props

Facilitating consent through the Facilitating consent through the provision of culturally sensitive provision of culturally sensitive

informationinformation

Ensure that there has been adequate Ensure that there has been adequate background research by, e.g: background research by, e.g: anthropologists/social scientistanthropologists/social scientist

Avoid assumptionsAvoid assumptions Think about information both as Think about information both as

written information and the imparting written information and the imparting of appropriate knowledgeof appropriate knowledge