Unit 2: Ch. 5 Flashcards

Question

Self determination

Answer 1

Prospective participants have the right to decide voluntarily whether to participate in a study, w/o risking penalty or prejudicial tx Also means people have the right to ask questions, to refuse to give info, and to withdraw from the study Includes freedom from coercion

Answer 2

Involves explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate

Answer 3

Right of people who can't protect themselves to be protected by the researcher -ex: children and the elderly

Answer 4

fair and equal distribution of benefits/risks across all groups in the study Includes right to fair tx and their right to privacy

Answer 5

Researcher has fully described the study, the person's right to refuse participation, and possible risks and benefits.

Answer 6

Designed to evaluate whether the benefits of participating in a study are in line w/ the costs, be they financial, physical, emotional, or social - i.e., whether the risk/benefit ratio is acceptable.

Answer 7

Participants have adequate info about the study, comprehend the info, and have the power of free choice, enabling them to consent to decline participation voluntarily. Typically 1 page (but can be a couple of pages). Means participants have adequate info about research, have freedom of choice to decline being participant

Answer 8

Must be planned and in place so info about participants aren't leaked at any time. Results are reported in aggregate; data kept in locked file behind locked door. If taping interviews, transcribe the interview tape and destroy the actual tape

Answer 9

A risk expected to be no greater than those ordinarily encountered in daily life or during routine tests or procedures

Answer 10

Researchers may not obtain written informed consent when data collection is through self-administered questionnaires. Researchers often assume implied consent (i.e., the return of a completed questionnaire reflects the person's voluntary consent to participate). However, this assumption may not always warranted (e.g. if pts believe that their care might be affected by failure to cooperate)

Answer 11

In a qualitative study Consent may be an ongoing process, called process consent, in which consent is continuously renegotiated

Answer 12

Most secure means of protecting confidentiality Occurs when researchers can't link participants to their data Rarely possible in qualitative studies -b/c the results are narrative someone has to be there to write down responses

Answer 13

A pledge that any info participants provide will not be publicly reported in a manner that ID's them and will not be made accessible to others

Answer 14

The certificate (obtained from NIH) allows researchers to refuse to disclose info on study participants in any civil, criminal, administrative, or legislative proceeding

Answer 15

Qualitative

Answer 16

A session following data collection so that participants can ask questions or air complaints. Especially important when data collection has been stressful or when ethical guidelines had to be "bent" (e.g., if any deception was used) Must be in place so that if researcher stirs up feelings during the study participants have somewhere to go to contact/talk about it

Answer 17

Protection of groups who can't protect themselves Includes children, mentally disabled, pregnant women (really protecting the unborn), terminally ill Vulnerable populations may be incapable of giving fully informed consent or may be at high risk of unintended side effects

Answer 18

Before undertaking a study, researchers must submit research plans to the IRB, and must also undergo formal IRB training. An IRB can approve the proposed plans, require modifications, or disapprove them The IRB is there to deal w/ ethical issues (not to mess w/ science...but it's a gray area. IRB may have to suggest changes to science behind the study)

Answer 19

Each section of the consent form must address a research issue 1st paragraph usually discusses what the research is about. Risks/benefits also addressed. Some of this is standard, some will be tailored to specific research being done. IRB has various ways of labeling consent forms so that not just anyone can print one up (may be a stamp/seal, may be something else) Consent form has to be renewed annually if the study isn't completed w/in a year

Answer 20

Ethical use of animal subjects - there's a whole different board concerning animal research - IRB is for humans only (not going to discuss animal research in this class) Research misconduct - plagiarism/originality - fabrication of results - falsification of data - other types of scientific misconduct

Answer 21

Fabrication, falsification, or plagiarism in proposing, conducting, or reviewing research, or reporting results Betrayal of the trust of the public Includes: - plagiarism/originality - fabrication of results - falsification of data - other types of scientific misconduct

Answer 22

Involves making up data or study results

Answer 23

Involves manipulating research materials or processes; it also involves changing or omitting data, or distorting results

Answer 24

Involves the appropriation of someone's ideas, results, or wording w/o giving due credit Intentionally or unintentionally claiming ideas as your won Can't cite a citation --> must cite original author (more of an issue w/ finding things online)

Answer 25

Conflict of interest: look at funding sources of research to see if there is one (there may be a "no conflict of interest" statement at the end of the article) Inappropriate financial arrangements, failure to comply w/ research regulations, unauthorized use of confidential data

Answer 26

1. Was the study approved by the appropriate IRB? - first think to ask. Usually only 1 line in the article ("this study was approved by IRB BEFORE data collection began."). IRB must approve BEFORE data collection begins 2. Was informed consent obtained from subjects? - or was it implied consent? do you have consent forms signed? 3. If subject is incompetent, did legally authorized representative give consent? 4. Were rights protected during sampling, data collection, and analyses? - typically if there's an IRB approval, a lot of these things are implied. But ask/critique anyway 5. Was privacy protected during study and in final report? 6. Was benefit/risk ratio of the study acceptable?

Unit 2: Ch. 5 Flashcards

(50 cards)