Chapter 14: Ethical Issues in Data Collection

Question 1

Importance of Ethical Norms

Answer 1

• promote aims of the research (knowledge, truth, avoidance of error)
• promote values that are essential to collaborative work (trust, respect, fairness)
• can help to ensure that researchers can be held accountable to the public
• help to build public support for research

Question 2

Ethical Guideline: US

Answer 2

• FDA

- IRB

Question 3

Ethical Guidelines: International

Answer 3

• Nuremberg Code

- Declaration of Helsinki

Question 4

Stakeholders in Research

Answer 4

• research participants
• researcher
• funding body

Question 5

Ethical Issues: Participants

Answer 5

• collecting information
• incentives: before or after data collection?
• sensitive information
• causing harm to participants
• confidentiality

Question 6

Ethical Issues: Researcher

Answer 6

• avoiding bias
• provision or deprivation of a treatment
• using inappropriate research methodology
• incorrect reporting
• inappropriate use of information

Question 7

Ethical Issues: Sponsoring Organization

Answer 7

• restrictions by the sponsoring organization

- misuse of information

Question 8

Ethical Issues in Collecting Secondary Data

Answer 8

• board needs to confirm that the data is actually anonymous
• if data is freely available in the internet or books, the permission for further use and analysis is implied
• data in form of hard copies should be kept safe
• researcher is responsible for ensuring that further analysis of the data is conducted appropriate

Question 9

The Informed Consent

Answer 9

• researcher is responsible to educate particpant about risks and benefits, obtain their consent before involving them in your research
• it is essential that consent form be written in plain language that research subjects can understand
• can be provided in form of a document, script or paragraph
• it is the opportunity to discuss any questions or concerns with a research team member

Question 10

Key Components of the Informed Consent

Answer 10

• autonomy
• beneficence
• justice

Question 11

Special Requirements for Special Situations

Answer 11

• participants incapable of giving informed consent
  1. provide an appropriate explanation
  2. seek the individuals assent
  3. consider such persons’ preferences and best interests
  4. obtain permission from a legally authorized person

Question 12

Web-based Studies and Obtaining Consent

Answer 12

• informed consent can be obtained by requiring participants to click on a link that
  1. indicates acceptance of the consent form
  2. advances participants to an online study web page that is otherwise inaccessible

Question 13

Assent from minors

Answer 13

• child’s affirmative agreement to participate in research
• child’s passive resignation to submit to an intervention should not be considered assent
• assent of children should be required when they are seven years of age or older
• researcher should take into account the child’s experience and level or understanding and compuse a document that is at the same time respectful of the child and conveys the essential information the child needs to make a decision

Question 14

language appropriate for a child

Answer 14

• brief statement of the purpose
• describe procedures
• affirm the voluntary nature of the process
• describe if necessary any pain or discomfort that may be experienced
• include a brief explanation of alternatives
• describe benefit or compensation
• offer to answer questions

Question 15

Consent Document Revisions in on-going Studies

Answer 15

• participants need to be informed of any new and important information that might affect their willingness to participate
• if new information, knowledge has been discovered, it should be communicated to the subjects
• unexpected complications
• if existing subjects are being re-consented, then the changes should be highlighted instead of just giving them a new form to sign with the changes imbedded