NIH

The Belmont Report is significant because

It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations.

A study proposing to involve pregnant adolescents who are detained in a juvenile detention center would only be allowed if

The requirements of Subparts A, B, C, and D are met.

An "autonomous person" is someone who:

Understands the risks and benefits of his or her participation and is able to make a voluntary decision if adequate information is provided.

45 CFR 46 requires Federal Departments and Agencies to rely solely on IRBs to evaluate risks to subjects, protection against these risks, potential benefits of the research and the importance of the knowledge to be gained.

False

What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)?

Respect for Persons, Beneficence, Justice

An institutionally designated authority, other than the investigator, should determine that proposed studies are exempt from regulatory requirements.

True

Communities may grant emergency waivers of informed consent for research involving pregnant women in the community who are in active labor and call Emergency Medical Services.

False

Research involving prisoners requires both specific IRB membership and approval by OHRP to signify that the proposed research falls within the permissible research categories.

True

When might human subjects research require investigators to obtain informed consent?

A. Investigators must obtain informed consent if the study involves interactions with research participants. B. Investigators must obtain informed consent if the study involves interventions with research participants. C. Investigators must obtain informed consent if the study involves collection of private information from or about research participants.

After informed consent for a research study is given, a research participant must complete the study.

False

In general, informed consent should be a process rather than a one-time event.

True

In order to participate in research, children must:

Provide assent, unless the IRB determines that they are too young

An example of a potential economic risk to a research subject is the potential negative impact research may have on the employment or promotion potential of a research subject.

True

Risk to research subjects includes:

A. Physical, psychological, social, legal or economic harm that may reasonably be anticipated as a result of participation in research B. The probability that a certain harm will occur from disclosure of findings C. Unforeseen physical harm that is possible from participation in therapeutic research

When appropriate, research data should be ___________ to prevent accidental disclosure of private information.

De-identified

When are researchers specifically required by NIH policy to describe Data and Safety Monitoring?

For all clinical trials

If a researcher determines that his/her study poses no more than minimal risk as defined in 45 CFR 46, there is no need for the protocol to have IRB review and approval.

False

The use of placebo in a clinical trial may be justified:

for conditions where there is no approved, effective treatment

IRBs reviewing research in a different geographical location and/or cultural context have a responsibility to:

B. Defer to an IRB that is in the situated within the local research context C. Ask specialists with direct knowledge of the local research context to participate in IRB discussions

Which of the following is TRUE regarding applications for NIH-funded research overseas?

Research conducted overseas is subject to HHS Human Subjects Regulations (45 CFR 46) and local regulations and policies

In localities where community consent is the norm,

In addition to the cultural norm, individual informed consent is required

Which subpart(s) of the 45 CFR 46 is/are sometimes referred to as The Common Rule?

Subpart A which describes the required protections for all human subjects

Identify the most influential event that led to the HHS Policy for Protection of Human Research Subjects:

Syphilis Study at Tuskegee

Which entity has regulatory authority for the protection of human subjects for PHS-funded research?

OHRP

The three fundamental principle of Informed consent are

Voluntariness, Comprehension, Disclosure

If informed consent information is presented orally, it must be documented using a short form that states that all of the required elements were presented orally.

True

Which of the following most accurately describes clinical equipoise:

Scientific uncertainty that one study intervention is superior to another.

Risks to research participants must be completely eliminated for the study to be considered ethical.

False

What is an appropriate method for maintaining confidentiality of private information obtained from human subjects?

1. Keeping data in a password-protected database 2. Storing images in a secured cabinet 3. Coding data or specimens and keeping the key to the code in a separate, locked drawer

Social justice and individual justice are different and distinct, yet compatible, concepts

True

Children must be included in all NIH-supported human subjects research unless:

There are scientific and ethical reasons to exclude them

A study proposing to involve pregnant adolescents who are detained in a juvenile detention center would only be allowed if:

The requirements of Subparts A, B, C, and D are met.

Which subpart(s) of the 45 CFR 46 is/are sometimes referred to as The Common Rule :

Subpart A which describes the required protections for all human subjects

45 CFR 46 requires Federal Departments and Agencies to rely solely on IRBs to evaluate risks to subjects, protection against these risks, potential benefits of the research and the importance of the knowledge to be gained.

False

All research that involves interaction or intervention with humans or human samples/data, whether they are alive or dead, is human subjects research.

False

Requirements specific to informed consent for prisoners include adequate assurance that parole boards do not consider a prisoner?s participation in making decisions regarding parole.

True

One of the requirements of informed consent is that subjects must be told whether they are eligible to receive compensation if they are injured as a result of their participation in the research

True

For research involving pregnant women, participation requires:

Consideration of risks and potential benefits for the fetus and the pregnant woman.

Why might an individual have diminished autonomy?

1. They are a neonate. 2. They are incarcerated or involuntarily confined. 3. They are unconscious.

According to the regulations, to be approvable, research participation must provide a tangible benefit to the individual research subjects.

False

There must be equipoise in order to justify conducting a clinical trial.

True

If a researcher determines that his/her study poses no more than minimal risk as defined in 45 CFR 46, there is no need for the protocol to have IRB review and approval.

False

The concept of individual justice implies that it is acceptable for investigators to offer potentially beneficial research only to favored patients while selecting undesirable persons for riskier research.

False

NIH has specific policies addressing:

1. Inclusion of children in research 2. Inclusion of women and minorities in research 3. Treatment for research subjects in HIV/AIDS antiretroviral studies following completing of trials in developing countries

Excluding children from participation in research, while well intentioned, may deny children the benefits of participation and prevent the collection of sufficient data about the possible effects of potentially therapeutic agents in children.

True

…

…