You asked: What are the three protected populations as viewed by the IRB?

The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

What are the 3 types of IRB?

IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.

What are protected populations?

This refers to children, prisoners, pregnant women, nonviable neonates, and neonates of uncertain viability. They are examples of vulnerable populations, which may be more susceptible to coercion or undue influence upon their decisions about whether to participate in research. …

What are the three types of IRB reviews that are allowed under federal regulations?

There are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt.

What populations are considered vulnerable populations in research?

The Common Rule lists specific vulnerable groups: children, prisoners, pregnant women, fetuses, mentally disabled persons, and economically and educationally disadvantaged persons (45 CFR §46.107(a)).

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What does the IRB look for?

The IRB needs to be assured that the research is 1) of sound design, given the proposed use of human subjects; 2) that there is equitable selection of subjects; 3) that there is a reasonable balance in the risks and benefits to the participants; and, 4) that the informed consent process is appropriate and comprehensive …

Which type of IRB does not require approval?

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

How can we protect vulnerable populations?

Steps to Reducing Risks to Vulnerable Populations

  1. Improve social determinates to promote healthy living. …
  2. Utilize a global budgeting national healthcare system. …
  3. Provide access to virtual healthcare. …
  4. Match hospitalization needs to surrounding communities. …
  5. Support community-appropriate healthcare access.

What are examples of vulnerable populations?

Vulnerable populations include the economically disadvantaged, racial and ethnic minorities, the uninsured, low-income children, the elderly, the homeless, those with human immunodeficiency virus (HIV), and those with other chronic health conditions, including severe mental illness.

Who are protected by IRB?

The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

What qualifies for expedited review?

Expedited Research

To qualify for an expedited review, research must fall into nine (9) federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects.

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What is determination for exemption?

A determination of “exempt” means that the research protocol is exempt from regulatory requirements of the Common Rule (45 CFR 46), the federal regulations that govern the conduct of human subjects research. However, theses studies must still meet institutional standards.

In which situations do patients have a right to an expedited review?

The list of research categories eligible for an expedited review: (1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.