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119 Cards in this Set

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


-Nuremberg trials
-Syphilis Study at Tuskegee
-Jewish Chronic Disease Hospital Study
-Willowbrook Study
Syphilis Study at Tuskegee
What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)?


Honesty, Trust, Respect
Informed consent, IRB review, Research Integrity
Respect for Persons, Beneficence, Justice
Protections for Pregnant Women, Prisoners, Children
Benificence
Respect for persons
justice
Which entity has regulatory authority for the protection of human subjects for PHS-funded research?


OHRP
NIH
Institutions that receive Federal funds
HHS
OHRP
True or False: All research that involves interaction or intervention with humans or human samples/data, whether they are alive or dead, is human subjects research.


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


True
False
True
Which of the following should be eliminated or minimized in the research design?


Coercion
Research risks
Repeated recruitment of research participants for new protocols
All of the above
All of the above
When might human subjects research require investigators to obtain informed consent?


Investigators must obtain informed consent if the study involves interactions with research participants.
Investigators must obtain informed consent if the study involves interventions with research participants.
Investigators must obtain informed consent if the study involves collection of private information from or about research participants.
All of the above
All of the above
True or False: After informed consent for a research study is given, a research participant must complete the study.


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


True
False
true
In order to participate in research, children must …


Provide written informed consent 1

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

Sign, or put an “X” on the assent document
Provide written permission
Provide assent, unless the IRB determines that they are too young
For research involving pregnant women, participation requires ...


That women have completed the first trimester.
That the study be conducted first in men.
Permission of the father.
Consideration of risks and potential benefits for the fetus and the pregnant woman.
Consideration of risks and potential benefits for the fetus and the pregnant woman.
Why might an individual have diminished autonomy?


They are a neonate.
They are incarcerated or involuntarily confined.
They are unconscious.

All of the above.
All of the above.
True or False: Risks to research participants must be completely eliminated for the study to be considered ethical.


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


For all research involving human subjects
For all research involving children as subjects in research
For all clinical trials

For all research with prisoners
For all clinical trials
True or False: There must be equipoise in order to justify conducting a clinical trial.


True

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


Keeping data in a password-protected database
Storing images in a secured cabinet
Coding data or specimens and keeping the key to the code in a separate, locked drawer
All of the above are ways to maintain confidentiality
All of the above are ways to maintain confidentiality
True or False: 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.


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


The researcher is not a pediatrician
Past experience has shown it is time-consuming and expensive to recruit children
There are scientific and ethical reasons to exclude them

The researcher does not possess the pediatric equipment necessary to involve children in the proposed research
There are scientific and ethical reasons to exclude them
True or False: For HIV antiretroviral treatment trials conducted in developing countries, the NIH expects investigators/contractors to address the provision of antiretroviral treatment to trial participants after their completion of participation in the clinical trial.


True

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


It is illegal to spend NIH funds in research overseas
Research conducted overseas is subject to HHS Human Subjects Regulations (45 CFR 46) and local regulations and policies
Research conducted overseas is only subject to local regulations and policies
Research conducted overseas need not address human subjects protections
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,


A family member’s consent for another individual may be sufficient, as long as community consent is given
Federal regulations preclude the conduct of PHS-funded research
Community consent to participate in the research study is sufficient and no IRB approval is required
In addition to the cultural norm, individual informed consent is required
In addition to the cultural norm, individual informed consent is required
Epidemiological
Cannot prove that a risk factor causes the condition or disease studied

T/F
True
Epidemiological
Can only show that a risk factor is correlated with a higher incidence of the disease in the population exposed to the risk factor

T/F
True
Incidence proportion

a- number of all individuals affected by the disease w/i a specified time.
b- incidence/time.
c- number of new individuals affected who contract a disease w/i a specified time.
c- number of new individuals affected who contract a disease w/i a specified time.
Incidence rate
a- number of all individuals affected by the disease w/i a specified time.
b- incidence/time.
c- number of new individuals affected who contract a disease w/i a specified time.
b- incidence/time.
Prevalence

a- number of all individuals affected by the disease w/i a specified time.
b- incidence/time.
c- number of new individuals affected who contract a disease w/i a specified time.
a- number of all individuals affected by the disease w/i a specified time.
Example of Incidence proportion

a- Measure probability of disease
b- Number of new cases/ size of population at risk x 100
c- total # of cases in the population/ the # of individuals in the population x 100
d- used to estimate how common a condition is w/i a population over a certain period time
Number of new cases/ size of population at risk x 100
Example of Incidence rate

a- Measure probability of disease
b- Number of new cases/ size of population at risk x 100
c- total # of cases in the population/ the # of individuals in the population x 100
d- used to estimate how common a condition is w/i a population over a certain period time
a- Measure probability of disease
Example of Prevalence

a- Measure probability of disease
b- Number of new cases/ size of population at risk x 100
c- total # of cases in the population/ the # of individuals in the population x 100
d- used to estimate how common a condition is w/i a population over a certain period time
both
c- total # of cases in the population/ the # of individuals in the population x 100
d- used to estimate how common a condition is w/i a population over a certain period time
Incidence proportion

Incidence rate (calculation)
incidence proportion - If a population initially contains 1,000 non-diseased persons and 28 develop a condition over 2 years of observation. (28/1000 x 100)

Incidence rate - 14 cases per years b/c the incidence (28 per 1,000) is divided by the # of years (2)
High Prevalence and High Incidence example
If the condition takes a long time to cure, and if 22 cases were recorded in year 1, but only 6 cases were recorded in year 2, then in year one of the condition.
Cause Interference
a conclusion based on evidence and reasoning that an event or process brought about a certain consequence.
The use of date and biomedical and psychosocial theories in a repeatable fashion to make educated, informed assertions about which relationships are causal and how they are causal.
1960's
– NCA becomes the modern ACA
– National Board of Chiropractic Examiners is established (1963)
– FCER focuses money on training faculty in science and research
1963
– AMA states objective:
– “…The complete elimination of the chiropractic profession
1964
- Committee on Quackery
– Primary goal of the committee: to contain and eliminate chiropractic
– (evidence from the Wilk trial 1976)
1967
- Committee on Quackery established that it was unethical for a medical physician:
– To associate professionally with a chiropractor
– To make referrals to a chiropractor
– To teach a chiropractor
– To practice with a chiropractor
1970's
– FCER focuses money on training faculty in science and research
• Scott Haldeman, D.C., M.D., PhD.
• Reed Phillips, D.C., PhD
• John Triano, D.C., PhD
1973
– Chiropractic included in Medicare
1974
- US Office of Education recognizes the CCE Students get federal Funding to attend Chiropractic College
1971
- National College gets regional accreditation
1975
- National Institute of Neurological Diseases and Stroke (NINDS) conference on spinal manipulation
– First formal interaction between chiropractors and medical physicians in an academic forum
1976
– Wilk et al. case
– The AMA was charged of violating the Sherman Anti-Trust act in its efforts to “contain and eliminate” the chiropractic profession
1978
- Journal of Manipulative and Physiological Therapeutics (JMPT) was the first successful chiropractic scientific journal
JMPT has:
– Good editing methods
– Scientific contents
– Peer reviewers from outside and inside chiropractic
- Blinded peer review process
A. Human Participant Protection Education for Research Teams
1. Identify the three fundamental ethical principles that guide ethical human subject research as identified by the Belmont report and codified by the 45CFR 46
Respect for Persons, Beneficence, and Justice
2. Identify the criteria for human research as outlined by 45 CFR 46.120
§46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
(a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the department or agency through such officers and employees of the department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.
(b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.
3. Define informed consent and describe the elements that should be included in an informed consent document
Informed consent —
A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study.
The Belmont principle of respect for persons is primarily applied by requiring that all human subjects research participants provide voluntary ________ ________ to participate in research.
informed consent
The three fundamental aspects of informed consent are:
Voluntariness, Comprehension, Disclosure
Voluntariness
Individuals’ decisions about participation in research should not be influenced by anyone involved in conducting the research: “...consent must be freely given or truly voluntary.”
Comprehension
Individuals must have the mental or decisional capacity to understand the information presented to them in order to make an informed decision about participation in research.
Disclosure
HHS regulations (45 CFR 46.116(a)) require that researchers disclose:
1. The purpose of the study
2. Any reasonably foreseeable risks to the individual
3. Potential benefits to the individual or others
4. Alternatives to the research protocol
5. The extent of confidentiality protections for the individual
6. Compensation in case of injury due to the protocol
7. Contact information for questions regarding the study, participants’ rights, and in case of injury
8. The conditions of participation, including right to refuse or withdraw without penalty
This disclosure must be made in such a way that it provides a ________ _________the information she or he would need in order to make an informed decision.
reasonable person
B. Psychological
Possible ways to protect against psychological risks include reminding participants of their right to withdraw from research or limit their participation if they become uncomfortable, providing counseling or psychological support for participants who experience distress, or thoroughly debriefing research participants after research sessions are completed.
C. Social
Often, minimizing social risks to participants involves protecting confidential data, including not only the data collected, but the fact of participation in the research project itself.
Types of Risk
Because research involves risks, __________, Institutional Review Boards (IRBs), and other members of the research team must take responsibility for protecting participants against the risks of participating in research. Protections vary according to the kind of risk:
investigators
matching

1900 Practice>>theory>>limited science>>no clinical research
1950 Science>>theory>>clinical research>>practice


2000 Theory>>science>>practice >>clinical research
1900 Practice>>theory>>limited science>>no clinical research
1950 Theory>>science>>practice >>clinical research
2000 Science>>theory>>clinical research>>practice
T/F
1. There were approximately 1,000 scientists in 1800
2. This grew to nearly 1,000,000 in 1900
3. And to more than 3,200,000 by 1975
1. True
There were approximately 1,000 scientists in 1800

2. False
This grew to nearly 100,000 in 1900

3. False
And to more than 3,200,000 by 1972
Scientific investigation was carried out in order to prove or disprove a theory
Most involved belief systems
If discs herniated, then pain originates from the disc, Therefore, proper treatment is removal of the disc
If abnormal posture and aberrant spinal mechanics cause pain, then adjusting and postural exercises are proper treatment
1949 – “Good intentions” from NCA Council On Education to increase research
Assigned research projects to faculty members at chiropractic colleges
1953 – “Good intentions” from Henry Higley, M.A., D.C. organizes NCA to:
Create a research center
intended to collect data gathered by students observing in practitioners’ offices
NCA’s “Good intentions” of 1949 failed
Faculty had few skills in science and research
No training was provided
Chiropractic colleges were in a poverty state
No resources were available (equipment, labs, etc.)
Few colleges were non-profit to receive grant money
1953 “Good intentions” fails due to:
Poor participation from students and colleges
Lack of training
Lack of funding
UCA
what it is
why is was created
In 1906 The “Universal Chiropractic Association (UCA)” was created to help fight for the legalization of chiropractic
Money was needed for legal, not research, purposes
> 25,000 prosecutions of DC’s in first 30 years
Problems with Early
Chiropractic Research
No valid measurements
Poor methodology
Not a reproducible study
Data not published in a scientific journal
1938 What Chiropractic is Doing (a hard bound book):
A collection of testimonials
Published for marketing "chiropractic science“
Problems with What Chiropractic is Doing:
Not experimental nor sound observational studies
No outcome measures
Lillard Marshall, D.C.
(President and founder of the NCA) published a pamphlet:
Case series
Several hundred adolescent inmates 10-20 yrs old
Volunteer doctors provided chiropractic care
Problems with the Pamphlet
Distributed by Lillard Marshall
Problems with Marshall's pamphlet:
Poor study methods
No detailed records
Type of care and outcomes not described
Due to these problems, the “study” was poorly received by the government and health care community thus did not reflect well on chiropractic
Important Date
1935
1935 - 1961 B.J. Palmer Chiropractic Clinic:
Two divisions: a medical side for diagnosis only and a chiropractic side for diagnosis and treatment
Patients were required to go through both to fight against claims of misdiagnosis
Problems with the B.J. Palmer
Chiropractic Clinics
No controlled studies
Little critical thought in study design
Although a lot of data was collected, nothing was done with it
Information was not collected in a scientific way to evaluate a theory, but instead to “prove that chiropractic works”
No publication in scientific journals
1930
- American Chiropractic Association (ACA) and UCA combine to form the National Chiropractic Association (NCA)
1935
– NCA member C.O. Watkins (a Palmer graduate) proposed the creation of the Committee on Education (the forerunner of today's CCE)
He proposed that educational standards be set for the chiropractic colleges
1938 - Watkins viewed clinical research as the missing link in chiropractic's scientific development
In 1944
Watkins inspired the creation of the Chiropractic Research Foundation (CRF)
Today's Foundation for Chiropractic Education and Research (FCER)
Chiropractin Research Foundation - CRF’s purpose
To receive monies for research purposes
To promote science of chiropractic
To promote infrastructure: facilities, equipment, etc.
To promote chiropractic hospitals and clinics
To gather and disseminate scientific information
Problems with CRF
Focused on marketing and fundraising not on research
Money went more to the colleges than research
Lack of fundraising goals and poor public relations resulted in failures (often expensive ones)
Important Names in Research
1970s
FCER focuses money on training faculty in science and research
Scott Haldeman, D.C., M.D., PhD.
Reed Phillips, D.C., PhD
John Triano, D.C., PhD
NINDS
National Institute of Neurological Diseases and Stroke (NINDS)
Conference on spinal manipulation
1975 – between Chiropractors and MDs
1982
JMPT received status in Index Medicus (Pub Med)
First RCT of chiropractic for any health problem
Index to chiropractic literature begun
1987
Judge Getzendanner orders permanent injunction against the AMA on September 25th requiring it to publish the court's judgment in the Journal of the American Medical Association (JAMA)

follow up from the Wilk trial
1991
– First RAND* Study published. Additional studies in 92, 94, 98
*Research ANd Development Health insurance experiment
1994
“Federal Guidelines for Low Back Pain” published
Association of Chiropractic Colleges holds first Educational Conference
Proceedings published in the “Journal of Chiropractic Education”
Epidemiology DEFINITION:
The study of what is upon the people
Epi-upon + Demos-people + logos-study of
Study of disease in a populations in order to determine – How, when, and where- they occur
What Epidemiology Studies
CAN & CANNOT do
Epidemiological studies:
Cannot prove that a risk factor causes the condition or disease studied
Can only show that a risk factor is correlated with a higher incidence of the disease in the population exposed to the risk factor
The higher the correlation, the more certain the association
Example of what Epidemiology
CAN and CANNOT do
EXAMPLE
The discovery of the link between cigarette smoking and lung cancer was based on comparisons of lung cancer rates in smokers and non-smokers
This only showed a higher rate of cancer in smokers, but did not prove the link
To prove the link, controlled studies exposing animals to smoke against animals not exposed to smoke were performed
Incidence proportion
– number of new individuals who contract a disease within a specified time
Number of new cases/size of population at risk X 100
Incidence rate
– incidence/time
Measures probability of disease
Prevalence
- number of all individuals affected by the disease within a specified time
total number of cases in the population/ the number of individuals in the population X 100
used to estimate how common a condition is within a population over a certain period of time
Causal Inference
Correlation does not imply causation
A conclusion based on evidence and reasoning that an event or process brought about a certain consequence
The use of data and biomedical and psychosocial theories in a repeatable fashion to make educated, informed assertions about which relationships are causal and how they are causal
Causal Inference
Simpler view
Even simplest of interaction of bodies physical system are complex.
Most outcomes are caused by a chain or web consisting of many component causes
One to one relationships very rare
Establishing a
Cause-Effect Relationship
Temporal Precedence
Must show CAUSE happened BEFORE the EFFECT
chicken or egg?
Co-variation of the Cause and Effect
Must show that there is a relationship
Not by chance or coincidence
No Plausible Alternative Explanations
Types of Causality
Many Cause for the same effect
Increase in X  increase in Y
Increase in Z  increase in Y
Cause dependency on Time
Increase in X  increase in Y, after 30 minutes of exposure to X, or increase in summer but not fall
Same cause different outcomes
Increase in X  increase in Y and Z
Outcomes are effect of various interdependent causes
Different Values of V + W + X  increase in Y
Circular Causality
Increase in X <- -> increase in Y
IMRaD
Abstract- Summary of the research
Introduction- Importance, literature review, hypothesis
Methods- Design, sample selection, data collection
Results- Data summarized, analysis of data, tables and charts
Discussion- Conclusions supported, no exaggerations, weakness stated
Introduction
Of an Abstract
Discusses the importance and purpose of the research
Reviews previous related research
Demonstrates how study contributes to literature
Relates contents of study to previously published data
Defines unusual terms or words that are essential to the understanding of the paper
States hypothesis being tested
Methods
Of an Abstract
Subject or population used
Subject selection
Inclusion and exclusion criteria
Sample size
Procedures
Outcome measures
Statistical analysis (Descriptive and analytic)
Results
Of an Abstract
Summarizes all pertinent data
Tables and graphs
Results of statistical analysis
Reports all research outcomes related to the stated hypothesis
Does not include any discussion or commentary
Discussion
Of An Abstract
Interprets data and discusses the importance of the research
Only area where author may express opinion
DOES NOT restate results
Identifies limitations to the study
Outlines need for future research
Conclusion
Of an Abstract
Short in length, approximately one paragraph long
Based on data presented in the study
Relates to the purpose of the study
MEDLINE
17 Million records
Covers broadly all areas of biomedicine
Paid for by U.S. tax dollars (approx $250 million last year) “free”
Widely available through most major database sources
Despite size, only indexes 18% of literature
Manual, Alternative, & Natural Therapy Index System - MANTIS
Largest index of scientific Alt. Med. Literature
Indexes ALL chiropractic and osteopathic scientific literature
Used by virtually all chiropractic colleges worldwide
280,000 articles indexed
Types of
Indexes/Journals Discussed
M.A.N.T.I.S. (Manual, Alternative, & Natural Therapy Index System)
Medline
EMbase
CINAHL
Biosis
Aidsline, Toxline, Cancerlit
Types of Keyword
Searches
Keyword search
MeSH term search
Cons of Keyword Searches
Keyword searches bring up ANY article with that keyword
Does not find ALL articles on a subject
Not all the articles would have been within the specific guidelines we wanted
MeSH Terms & What Journals Use Them
National Library of Medicine developed a restricted vocabulary for indexers to use… called MeSH for Medical Subject Headings (MeSH)
There are approximately 35,000 index words used
Indexes like Mantis & the nursing index CINAHL, like Medline, use these terms.
Indexing
Process of assigning a very uniform and restrictive vocabulary or set of words to an article.
Terms used for
Indexing
Medical Subject Headings (MeSH)
Subheadings
Check Tags
Publication Types
Boolean Arguments
Provides powerful method of pulling from a large set of information....only the information you need.
Primarily uses “AND”, “OR” & “NOT” statements
“Sprains and strains” is not valid
Reproducibility
Of Research
Where –the search was conducted
When –the search was conducted
How –the search was conducted
What Mesh or keywords were used
How were the boolean arguments created
Were there any other search restrictions (e.g. language, journal, etc.)
Hierarchy
Of Knowledge
Experiments
Quasi-experiment
Observations
Antidotal Reports
Testimonials
Rumors/Assertions
Qualitative Research/Design
Method of investigation used to gain insight into people's attitudes, behaviors, value systems, concerns, motivations, aspirations, culture or lifestyles.
Used as a precursor to Quantitative research
Seeks out the ‘why’, not the ‘how’ through the analysis of Unstructured information
Quantitative
Design
The systematic scientific investigation of quantitative properties and phenomena and their relationships.
A quantitative attribute is one that can be measured.
Expressed as a specific quantity (unit) that can be multiplied by a number.
ie. distance, mass, time, etc.
Categories of
Quantitative Design
1. Correlational
Uses statistical tests of association/agreement
2. Intervention/Experimental
Uses statistical tests of
difference
Correlation
Design (define)
Observes and Examines a number of instances and variables
Asserts whether there is a co-relationship between variables
Correlation Designs
(Types)
Prospective studies of agreement

Prospective studies of association

Retrospective Studies of agreement/Association
Correlation Design
Types order of
Strongest to Weakest
Strongest to weakest

1 Prospective studies of agreement
2 Prospective studies of association
3 Retrospective Studies of agreement/Association
Prospective Studies
Of Agreement
i.e. Reliability, validity studies

*Studies gathering data in the present
Prospective Studies
Of Association
Quantify the strength of association between two variables
(i.e. Age and BP)
Retrospective Studies of Agreement/Association
Use of pre-existing records for data
** Studies reviewing past records or events
Intervention/Experimental
Tries to prove or disprove a hypothesis with statistical analysis
Classifications of Design
1 Qualitative
- Observational (Pre-experimental)
2 Quantitative
- Quasi-experimental
- True Experimental