Burns and Groves The Practice of Nursing Research 9th
Edition Test Bank. (complete updated answers 2025
Principal for respect for persons - Holds that persons have the right to self-
determination and the freedom to participate or not participate in research
DHHS regulations are known as - The common rule because they are applicable
across multiple DHHS agencies.
Individually identifiable health information IIHI - According to HIPAA privacy
provisions, that information which specifically identifies the patient to whom the
information relates, such as age, gender, date of birth, and address
1. Is created or received by healthcare provider, health plan, or healthcare
clearinghouse
2is related to past, present, or future physical or mental health or condition of an
individual, and that identifies the individual
DHHS developed the following guidelines to help researchers, healthcare
organizations, and healthcare providers determine the conditions under which
they can use and disclose IIHI - The PHI has been de-identified under the HIPPAA
Privacy rule
The data are part of a limited data set, and a data use agreement with the
researcher(s) is in place
The individual who is a potential participant for a study authorizes the researcher
to use and disclose his or her PHI
a waiver or alteration of the authorization requirement is obtained from an IRB or
a privacy board
Five categories of studies based on levels of discomfort and harm - 1. No
anticipated effects
2. Temporary discomfort
3 unusual levels of temporary discomfort
4. Risk of permanent damage
5. Certainty of permanent damage
, Broad Consent - In the context of research, permission for an unspecified range of
tests, experiments, or uses of donated samples.
Required elements of broad consent - Potential risks and discomforts
Possible benefits
Extent to which private information will be kept confidential
Participation is voluntary
Refusal to participate involves no har or loss of benefits
May stop participation at any time
Specimens and information (identifiable and non identifiable) may result in
commercial products and process
Whether participant will share any profits
Whether whole genome sequencing is planned
Requirements for authorization to release PHI for Research - Types of PHI to be
used, such s medical diagnosis or assessment data identified in an understandable
way
Name of researcher who will use the PHI and affiliated institution
How the PHI will be used in this specific study
Authorization expiration date, which may be the end of the study or 'none' if data
will become available part of a research database or repository
Signature of the participant, legal representative if appropriate, and date
The IRB reviews the protocol and form to determine whether the researcher has
demonstrated that - 1. The benefits of the study outweigh the risks
2. The risks will be minimized
3. The consent process and document are appropriate for the intended
participants.
The functions nad operations of an IRB involve the review of research at three
different levels of scrutiny - 1.exempt from review
2.expedited review
3 full board review
Ethical principals (there are three) - The principle of respect for persons
The principle of justice
Principle of beneficence
Edition Test Bank. (complete updated answers 2025
Principal for respect for persons - Holds that persons have the right to self-
determination and the freedom to participate or not participate in research
DHHS regulations are known as - The common rule because they are applicable
across multiple DHHS agencies.
Individually identifiable health information IIHI - According to HIPAA privacy
provisions, that information which specifically identifies the patient to whom the
information relates, such as age, gender, date of birth, and address
1. Is created or received by healthcare provider, health plan, or healthcare
clearinghouse
2is related to past, present, or future physical or mental health or condition of an
individual, and that identifies the individual
DHHS developed the following guidelines to help researchers, healthcare
organizations, and healthcare providers determine the conditions under which
they can use and disclose IIHI - The PHI has been de-identified under the HIPPAA
Privacy rule
The data are part of a limited data set, and a data use agreement with the
researcher(s) is in place
The individual who is a potential participant for a study authorizes the researcher
to use and disclose his or her PHI
a waiver or alteration of the authorization requirement is obtained from an IRB or
a privacy board
Five categories of studies based on levels of discomfort and harm - 1. No
anticipated effects
2. Temporary discomfort
3 unusual levels of temporary discomfort
4. Risk of permanent damage
5. Certainty of permanent damage
, Broad Consent - In the context of research, permission for an unspecified range of
tests, experiments, or uses of donated samples.
Required elements of broad consent - Potential risks and discomforts
Possible benefits
Extent to which private information will be kept confidential
Participation is voluntary
Refusal to participate involves no har or loss of benefits
May stop participation at any time
Specimens and information (identifiable and non identifiable) may result in
commercial products and process
Whether participant will share any profits
Whether whole genome sequencing is planned
Requirements for authorization to release PHI for Research - Types of PHI to be
used, such s medical diagnosis or assessment data identified in an understandable
way
Name of researcher who will use the PHI and affiliated institution
How the PHI will be used in this specific study
Authorization expiration date, which may be the end of the study or 'none' if data
will become available part of a research database or repository
Signature of the participant, legal representative if appropriate, and date
The IRB reviews the protocol and form to determine whether the researcher has
demonstrated that - 1. The benefits of the study outweigh the risks
2. The risks will be minimized
3. The consent process and document are appropriate for the intended
participants.
The functions nad operations of an IRB involve the review of research at three
different levels of scrutiny - 1.exempt from review
2.expedited review
3 full board review
Ethical principals (there are three) - The principle of respect for persons
The principle of justice
Principle of beneficence
