FACILITATING CONSENT THROUGH THE PROVISION OF CULTURALLY SENSITIVE INFORMATION

1. FACILITATING CONSENT THROUGH THE PROVISION OF CULTURALLY SENSITIVE INFORMATION Sue Eckstein Research Fellow Centre of Medical Law and Ethics King’s College London

2. CONDITIONS TO ACHIEVE CONSENT Prospective participants must: • be appropriately informed about the nature of the research they are participating in • adequately understand the information • voluntarily decide to participate • explicitly consent to participation

3. Participants must be provided with a explanation of:s • risks and benefits • available alternatives • confidentiality • compensation • contacts • voluntariness • documentation

4. Readability • Talk directly - use “we” and “you” • Use simple words and no jargon • Be positive and direct • Active is better than passive • Don’t turn verbs into nouns

5. Testing readability Dwain Chambers, the fastest man in Europe, and one of Britain’s main hopes for an Olympic gold medal next year, has tested positive for a new banned designer anabolic steroid and could face a life ban from the sport. Britain also faces being stripped of the 4x100m silver medal it won at the world athletics championships in Paris in August as Chambers was part of the team. Guardian Flesch reading ease 49.0, Flesch-Kincaid Grade Level 12

6. Testing readability Top British sprinter Dwain Chambers was last night reported to have tested positive for a new designer steroid. Chambers,26 – the fastest man in Europe and one of our top Olympic hopes – could face a life ban from the sport. Traces of the drug tetrahydrogestrinone (THG) were reportedly found in a urine sample he gave at a training camp in Germany in August. Sun Flesch reading ease 57.9, Flesch-Kincaid Grade Level 10.3

7. Describing the research and what is involved in the participation 1. “Random allocation into control and treatment groups will be performed by a computer.” Flesch reading ease 43.9, Flesch-Kincaid Grade Level 10.3 2. “You are being invited to participate in a research project. Participation in this trial is entirely involuntary and you are free to decline entry into this study” Flesch reading ease 39.5, Flesch-Kincaid Grade Level 11.0

8. Describing the research and what is involved in the participation 1.We will split you into two groups. In the first group you take a new medicine we are testing. In the second group you take the most commonly used medicine. We need to compare the old and new medicines fairly. We do this by randomly choosing the group you go into. We could toss a coin to do this, but use a computer because it is quicker. Flesch reading ease 84.3, Flesch-Kincaid Grade Level 4.2

9. Describing the research and what is involved in the participation 2. “We invite you to take part in a research project. You don’t have to accept our invitation. If you decide not to take part, then you don’t need to give us a reason.” Flesch reading ease 87.9, Flesch-Kincaid Grade Level 3.7

10. Problems with written information • Women and girls may be disadvantaged • Role of family member or interpreter • Limitations of interpretation • Written information must be appropriate for a particular readership

11. Supplementing written material Increasing use of • drama, puppets, role-play • pictures, videos, recordings and visual props

12. Facilitating consent through the provision of culturally sensitive information • Ensure that there has been adequate background research by, e.g: anthropologists/social scientist • Avoid assumptions • Think about information both as written information and the imparting of appropriate knowledge