CITI Exam Modules 4-6

Exception to informed consent

In some cases, an oral consent process without documentation may be approved by an Institutional Review Board (IRB). Documentation also may be by audio or video recording as approved by an IRB.

Confidentiality

Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others, in ways that are inconsistent with the understanding of the original disclosure without permission.

Two factors that must be considered in relation to each other when assessing risk

Probability and magnitude of harm AS well as population context

Low-risk, common social and behavioral sciences methodologies:

Surveys, questionnaires, and interviews

Why is independent assessment of risk is critical?

B/c researchers are biased toward downplaying (and believing it) risks, and up-playing benefits

Some concerns about privacy in the context of research:

1) Observational Studies, 2) Focus Groups, 3) Snowball Sampling

Risks of harm in social and behavioral sciences generally fall into three categories

1) Invasion of privacy, 2) Breach of confidentiality, 3) Study procedures

Informed Consent includes

1) Providing specific information about the study to subjects in a way that is understandable to them. 2) Answering questions to ensure that subjects understand the research and their role in it. 3) Giving subjects sufficient time to consider their decisions. 4) Obtaining the voluntary agreement of subjects to take part in the study. The agreement is only to enter the study, as subjects may withdraw at any time, decline to answer specific questions, or complete specific tasks at any time during the research.

How can researchers safeguard data from unauthorized access?

1) Remove all direct identifiers as soon as possible. 2) Substitute codes for identifiers. 3) Maintain code lists and data files in separate secure locations. 4) Use accepted methods to protect against indirect identification, such as aggregate reporting or pseudonyms. 5) Use and protect computer passwords. 6) Encrypt transmitted and stored data. 7) Access and store data on computers without Internet connections. 8) Obtain a Certificate of Confidentiality.

The two parts to informed consent

1) The process of providing information to prospective subjects. 2) The documentation that the process took place and is a record of the subjects' agreement to take part in the study.

The Informed Consent process

A process that begins with the recruitment and screening of a subject and continues throughout the subject's involvement in the research.

(LAR)

A subject's legally authorized representative

Privacy

Can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

Certificate of Confidentiality fact

The NIH issues Certificates of Confidentiality automatically for NIH funded (wholly, or in part) grants.

Safeguards employed for vulnerable subjects

include 1) assessing the decision-making capacity of potential subjects, 2) requiring parental permission from both parents rather than just one parent for some studies with children, and 3) ensuring that incentives are not coercive.

Potentially vulnerable subjects

include children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons