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Table of Contents

  1. Key questions
  2. Example of harm from social science research -
  3. Research merit and integrity
  4. Justice
  5. Special protections for vulnerable communities
  6. Ethics Controversies: Case Studies - Debates about the ethics of the Tearoom Trade Study Methodology
  7. Case 2: The Human Terrain System
  8. Informed consent
  9. Freedom from coercion
  10. Case 3: Gang Leader for a day
  11. When social scientists uncover crime through their research
    1. Confidentiality for research participants when crime occurs
  12. Other ethical problems in Venkatesh's research
  13. Responsibilities to people/cultures being studied
    1. Informed Consent
    2. Informed consent scenario
    3. Best practice:
    4. Protecting identities of participants
    5. Case Study
    6. Protecting identities of participants: scenario
  14. Do no harm: think about the ramifications of the research
  15. Reciprocity: paying people for their contributions
    1. Reciprocity and collaboration with the community you work with
  16. Intimacy in research: maintaining informed consent over time
    1. Case Study:
    2. Intimacy in ethnographic research: sex and the field
  17. Respect for persons:
  18. Protection from psychological or physical harm
  19. Intellectual property
  20. Summary of Principles of Ethical Research
  21. Council for International Organization of Medical Sciences (CIOMS)
  22. Death of Jesse Gelsinger (1999) Conflicts of Interest Example
  23. Respect for Persons
  24. Informed Consent
    1. Voluntariness
    2. Comprehension
    3. Disclosure
  25. Case Study: Study on Campus
  26. Informed Consent
    1. Consent Document 1
    2. Consent Document 2
  27. Requirements for documentation of informed consent
  28. Decisional Capacity
  29. Children's Participation in Research
    1. Lack of assent from a child
  30. Research with prisoners
  31. Community Consultation
  32. Beneficence
  33. Justice
  34. Compensation for Research Participation
    1. Avoiding undue inducement
    2. Case Study involving confidentiality of clinical data
  35. Confidentiality

Consent Document 2

Surface Antigen Expression in Trypanosomes

Dr. X

Dr. X's laboratory studies the parasite which causes trypanosomes, also known as sleeping sickness. This study will look at the effects of different surface antigens (proteins) produced by the parasites in human blood. The goal is to identify how different surface antigens are expressed by the parasites.

You are invited to participate in this study by giving blood on a voluntary basis, but no more than five times in an eight week period. The research project is anticipated to continue for four years.

All blood samples will be obtained by qualified technicians at the Medical Centre Blood Bank. 100ml of blood will be withdrawn from a vein in your arm. None of the procedures are experimental.

During the collection of blood, you may experience discomfort and bruising at the site of collection. To minimize these risks, you will be asked to lie down while an experienced technician collects the blood sample. You may feel light-headed after having blood drawn. If you feel faint, you should not get up and should notify a nurse.

Although you will not benefit directly from participating in this study, you will make a major contribution to the information known about sleeping sickness. In the future, others may benefit because scientists and doctors will learn about how parasites cause sleeping sickness and develop vaccines to prevent it.

A research assistant will keep a record of all blood draws in a secure database. Only the professional staff at the Medical Centre will know the identity of study participants.

You will be paid 5 for the time and travel required to give blood. If you feel that you have been injured as a direct result of participating in the study please contact Dr. X at 123-456-7890.

Your signature on this form means that you understand the information presented, and that you want to participate in the study. You understand that participation is voluntary, and you may withdraw from the study at any time.

1

Which is the better consent document?

Which of the two consent documents would you choose to use?

a)
b)

Consent document 2 is the best choice. In addition to the information given in Consent document 1 consent document 2 includes the following elements of informed consent:

1. The purpose of the study.

2. Foreseeable risks for the individual.

3. Potential benefits to the individual or others.

4. Confidentiality protections for the individual.

5. Compensation plan.

6. Contact information for questions regarding the study, participants' rights and in case of injury.

7. The conditions of participation, including right to refuse and withdraw without penalty

Consent document 2 is the best choice. In addition to the information given in Consent document 1 consent document 2 includes the following elements of informed consent:

1. The purpose of the study.

2. Foreseeable risks for the individual.

3. Potential benefits to the individual or others.

4. Confidentiality protections for the individual.

5. Compensation plan.

6. Contact information for questions regarding the study, participants' rights and in case of injury.

7. The conditions of participation, including right to refuse and withdraw without penalty

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