Johns hopkins Course Module 4

Question 1

Belmont report- difference between practice and research?

Answer 1

the term “practice” refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals.

the term “research’ designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective

Question 2

Belmont report- Table of contents

Answer 2

TABLE OF CONTENTS
 Ethical Principles and Guidelines for Research Involving Human Subjects
 A. Boundaries Between Practice and Research
 B. Basic Ethical Principles 
1. Respect for Persons
2. Beneficence 
3. Justice
C. Applications
1. Informed Consent
 2. Assessment of Risk and Benefits
 3. Selection of Subjects

Question 3

belmont- when does a review need to be done?

Answer 3

the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.

Question 4

2 moral requirments in respect for persons. Belmont

Answer 4

the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

Question 5

belmont- meaning of beneficience?

Answer 5

The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation.

Question 6

belmont- two rules of beneficience

Answer 6

(1) do not harm and (2) maximize possible benefits and minimize possible harms.

Question 7

belmont- justice priciples

Answer 7

(1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.

Question 8

belmont- applications

Answer 8

informed consent,
risk/benefit assessment,
and the selection of subjects of research.

Question 9

belmont- elements of informed consent

Answer 9

information, comprehension and voluntariness.

Question 10

belmont- In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded.
when is that type of trial justified?

Answer 10

only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.

Question 11

belmont- terms risk and benefit

Answer 11

The term “benefit” is used in the research context to refer to something of positive value related to health or welfare. Unlike, “risk,” “benefit” is not a term that expresses probabilities. Risk is properly contrasted to probability of benefits, and benefits are properly contrasted with harms rather than risks of harm.

Question 12

belmont. assessment of the justifiability of research should reflect at least the following considerations:

Answer 12

1-no brutal treatmnt ever
2-do we need human subjects att all
3- When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk
4-volnurable subjects
5- Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.

Question 13

belmont-selection of subjects. Can problem arrise even if individual justice ispreserved?

Answer 13

Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases institutionalized in society.

Question 14

belmont- comisson about social experimentation

Answer 14

they do not say anything, they are only focused on biomedical and behavioral research.

Question 15

Common rule 45CFR46- contents?

Answer 15

Subpart A- Basic Health and Human services policies for protection of Human Research subjects
Subpart B-Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Subpart C- Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Subpart D- Additional Protections for Children Involved as Subjects in Research
Subpart E- Registration of Institutional Review Boards

Question 16

Common rule- one example of choosing IRB members for studies on vurnerable patients?

Answer 16

If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

Question 17

Common rule- when IRB could use expedited review process

Answer 17

An IRB may use the expedited review procedure to review either or both of the following:

(1) some or all of the research appearing
on the list and found by the reviewer(s) to
involve no more than minimal risk,

(2) minor changes in previously approved
research during the period (of one year or
less) for which approval is authorized.

Question 18

common rule- what is important to note when IRB evaluate risk/benefit

Answer 18

In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).

Question 19

common rule- IRB records

Answer 19

• Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
• meetings
• Records of continuing review activities
• correspondece between IRB and investigator
• Statements of significant new findings
• members of IRB

Question 20

common rule: Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

Answer 20

• A statement that the particular treatment or procedure may involve risks to the subject which is currently unforeseeable
• circumstances by which subjects participation can be terminated without their consent
• aproximate number of participans
• ….

Question 21

common rule- What if trial propose benefits only to fetus but not on mother.

Answer 21

then informed consent form is filled just like in section A, and in most cases father also needs to confirm.

Question 22

Who developed decleration of helsinki?

Answer 22

World medical association, as a statement of ethical principles for medical research.

Question 23

to which are adressed decleration of helsinki?

Answer 23

to physicians

Question 24

One prinicple from decleraton?

Answer 24

It is the duty of the physicians to promote and safeguard the health, well-being and rights of patients, inluding those who are involved in medical research.

Question 25

decleration- primary purpose of medical research.

Answer 25

To get knowledge but this goal can never take precedence over the rights and interests of individual research subjects.

Question 26

HIPAA?

Answer 26

Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that protects certain health information. The Privacy Rule
was issued to protect the privacy of health information that identifies individuals who are living or deceased.

Question 27

hipaa-Covered Entity?

Answer 27

A health plan, a health care
clearinghouse, or a health care provider who
transmits health information in electronic form in
connection with a transaction for which HHS has
adopted a standard.Covered entities can be institutions, organizations, or persons.

Question 28

hippa-whom does privacy rula apply for?

Answer 28

The Privacy Rule applies only to covered entities. Many organizations that use, collect, access, and
disclose individually identifiable health information will not be covered entities, and thus, will not
have to comply with the Privacy Rule.

Question 29

permitted disclosures of data under Hippa?

Answer 29

TPO
Treatment
Payement
Health care operations

Question 30

difference betweeen theoretical and clinical equipoise?

Answer 30

In theoretical equipoise would imply that the evidence of benefits of each of the therapies are well balanced.

clinically, we define equipoise as a lack of consensus within the expert clinical community on the preferred therapy. (So it’s possible that individuals within the community may have an opinion that one treatment is better than the others, but what we need for clinical equipoise is for the clinical community as a whole to be in equipoise, not all the clinicians within the trial.)

Question 31

Common rule applies for?

Answer 31

this section applies to any institution that uses federal funds to conduct research on humans.

Question 32

What does IRB needs to review, it is not included in a documnet?

Answer 32

The IRB has to review the provisions that are made for data monitoring.