Module 12

Which of the following is the least important activity when protecting human subjects in international research?

Assessing transportation conditions

Standards include, among others:

Canadian Tri-Council Policy Statement Indian Council of Medical Research (ICMR) Council for International Organizations of Medical Sciences' (CIOMS) "International Ethical Guidelines for Biomedical Research Involving Humans" World Medical Association's Declaration of Helsinki

What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? The points to consider when obtaining informed consent in non-U.S. settings include in addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Sometimes, in non-U.S. communities, people other than the individual taking part in the research may be required to give permission before the potential subject may be asked to participate. These individuals may include a spouse, a head of household, or a group leader. However, another individual's permission should not substitute for a subject's voluntary informed consent unless an IRB or equivalent local review committee has waived that consent process. The witness signature line is an issue in documentation of informed consent; ensuring that consent process does not slow down recruitment is an issue in study design and not a non-U.S. setting specific issue; and maintaining confidentiality is a privacy/confidentiality issue.

The age of majority in international research is determined by the

Laws, customs, and norms in the area in which the research will be conducted

Which of the following activities constitutes engagement in research?

Obtaining informed consent and conducting research interviews.

A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB?

Will the researchers have collaborators at the research site abroad?