CITI - starting from International Research - Social&Behavioral Research

Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?

A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.

Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

Exempt

A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?

If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.

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?

Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is:

Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.

Nuremberg Code

Judged human experimentation conducted by Nazis. Voluntary consent by human subject is absolutely essential

What procedures must be described in an agreement called an "assurance of compliance" with OHRP?

Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.

Which of the following studies need IRB approval?

Studies collecting data about living individuals.

Human subject

a living individual ABOUT whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Research

a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. To test a hypothesis with conclusions to be drawn

Justice

Equals be treated equally. -To each person an equal share. -To each person according to individual need. -To each person according to individual effort. -To each person according to societal contribution. -And to each person according to merit.

The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:

Any equity interest in a publicly held company that exceeds $50,000

Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:

Designated institutional officials

Beneficence

Make effort to secure well-being. -Do not harm -Maximize possible benefits and minimize possible harm/risk

Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?

The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the Internet confidentiality cannot be absolutely guaranteed.

IRB Review

to protect the rights and welfare of human subjects by ensuring equitable subject selection, assuring adequate informed consent, assessing and minimizing risks, and maintaining privacy and confidentiality.

Belmont Report

basic ethical principles for research involving human subjects. -Respect for person's autonomy -Beneficence -Justice

Declaration of Helsinki

basis of good clinical practices. Addresses research protocols, informed consent, risks/benefits, et plus

breach of obligation

describes an actual violation of a moral or legal duty.

Respect for Person

individuals treated as autonomous agents, and those with diminished autonomy are entitled protection

Conflict of Interest

objective fact situation in which there is increased potential for harm or wrongdoing as a result of compromised independence.

Expedited Review

research presents no more than minimal risk. Does not have to be full convened committee.

Full Board (convened) Review

research that involve more than minimal risk require full board review at a convened meeting at which a quorum of IRB members is present. Must receive approval by majority of members.

Exempt Review

research with human subjects that generally involves no more than minimal risk. Does not require ongoing review, unless amended st it no longer fulfills the exempt criteria