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Research Ethics

Dr. Basma Damiri School of Medicine


H and ealth Sciences An-Najah National
University
(Fifth edition) 2020-
2021
bdamiri@najah.edu
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Research Ethics
Risks should not
exceed benefits

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Goals and Principles of
Human Subjects Protection
Human subjects are essential to the conduct of research
intended to improve human health. As such, the
relationship between investigAtors and human subjects
is critical and should be based on honesty, trust, and
respect.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Historical
Events
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Nazi Medical War Crimes (1939–1945)
 “Medical experiments” were performed on thousands
of concentration camp prisoners and included deadly
studies and tortures such as injecting people with
gasoline and live viruses, immersing people in ice
water, and forcing people to ingest poisons.
 In December 1946, the War Crimes Tribunal at
Nuremberg indicted 20 physicians and 3
administrators for their willing participation in the
systematic torture, mutilation, and killing of prisoners
in experiments.

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Nuremberg Doctors’ Trial (1946-47)

 Hypothermia survivability and effects


 Bone healing
 High altitude survivability and effects
 Potability of treated sea water
 How to effectively sterilize
 Chemical burn effects
 How quickly poison bullets kill
 Typhus vaccine
 Twins studies
 http://www.ushmm.org/research/doctors/

Dr Basma Damiri / Clinical Scientific Research 2020-2021


The Nuremberg Military
Tribunals found that the
defendants had:
 Corrupted the ethics of the medical and scientific
professions
 Repeatedly and deliberately violated the rights of the
subjects

The actions of these defendants were condemned as


crimes against humanity. Sixteen of the twenty-three
physicians/administrators were found guilty and
imprisoned, and seven were sentenced to death.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
The Nuremburg Code
 In the August 1947 verdict, the judges included a
section called Permissible Medical
Experiments.This section became known as the
Nuremberg Code and was the first international
code of research ethics.
 This set of directives established the basic principles
that must be observed in order to satisfy moral, ethical,
and legal concepts in the conduct of human subject
research.The Code has been the model for many
professional and governmental codes since the 1950s
and has, in effect, served as the first international
standard for the conduct of research.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
The Code provides ten Directives for
Human Experimentation
1. Voluntary consent of the human subject is absolutely essential
2. The experiment must yield generalizable knowledge that could not be
obtained in any other way and is not random and unnecessary in nature
3. Animal experimentation should precede human experimentation
4. All unnecessary physical and mental suffering and injury should be
avoided
5. No experiment should be conducted if there is reason to believe
that death or disabling injury will occur
6. The degree of risk to subjects should never exceed the humanitarian
importance of the problem
7. Risks to the subjects should be minimized through proper preparations
8. Experiments should only be conducted by scientifically qualified
investigators
9. Subjects should always be at liberty to withdraw from experiments
10. Investigators must be ready to end the experiment at any stage if
there is cause to believe that continuing the experiment is likely to
result in injury, disability or death to the subject.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
History
Tuskegee Syphilis Study (1932-72)
 Several hundred black men in Macon County, AL
 Originally a treatment/study (mercury rubs)
 No informed consent, were told some procedures such as
spinal taps were “special free treatments”.
 Subjects not informed when treatment stopped
 Death rate twice as high as control
 Became “Tuskegee Study of Untreated Syphilis in the Negro Male”
 Penicillin available as treatment in 1943
 Provisions were taken to prevent Tuskegee subjects from getting
penicillin
 Formal apology (president Clinton) in 1997

Dr Basma Damiri / Clinical Scientific Research 2020-2021


History: Tuskegee-syphilis-study doctor-injecting-subject

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Tuskegee-syphilis-study

Dr Basma Damiri / Clinical Scientific Research

2020-2021
The Tuskegee Syphilis Study
The Tuskegee Syphilis Study led to the 1979 Belmont
Report and the establishment of the Office for Human
Research Protections (OHRP). It also led to federal laws
and regulations requiring Institutional Review Boards
for the protection of human subjects in studies involving
human subjects.The Office for Human Research
Protections (OHRP) manages this responsibility within
the US Department of Health and Human Services
(HHS).
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Jewish Chronic Disease Hospital Study - 1963

 Injection of live cancer cells into chronically ill


patients to develop information on the nature of the
human transplant rejection process.
 Researchers said consent was given orally but not
documentedbecause it was customary to undertake
much more dangerous procedures without consent
forms.
 Patients weren‟t told they would receive cancer cells
because it would frighten the patients unnecessarily.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
History
 Willowbrook hepatitis studies
 Institution for “mentally defective persons”
 Infecting “mentally defective” children with hepatitis (fed feces)
 “They‟ll get hepatitis anyhow. Better under controlled conditions.”
 To study the course of hepatitis
 Vaccine studies
 Mid 1950‟s to early „70s

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Non-consensual experiments in Guatemala

In October 2010, it was revealed that in Guatemala,


Public Health Service doctors went even further than
Tuskegee. It was reported that from 1946 to 1948,
American doctors deliberately infected prisoners,
soldiers, and patients in a mental hospital with syphilis
and, in some cases, gonorrhea, with the cooperation of
some Guatemalan health ministries and officials. A total
of 696 men and women were exposed to syphilis without
the informed consent of the subjects.When the subjects
contracted the disease, they were given antibiotics
though it is unclear if all infected parties were cured.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
In October 2010, the U.S. formally apologized to
Guatemala for conducting these experiments.

On May 16, 1997, President Bill Clinton formally


apologized and held a ceremony for the Tuskegee study
participants: "What was done cannot be undone. But we
can end the silence.We can stop turning our heads
away.We can look at you in the eye and finally say on
behalf of the American people, what the United States
government did was shameful, and I am sorry ...To our
African American citizens, I am sorry that your federal
government orchestrated a study so clearly racist

Five of the eight remaining study survivors attended the


White House ceremony.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
After penicillin was found to be an effective treatment for
syphilis, the study continued for another 25 years without
treating those suffering from the disease.
After the study and its consequences became front-page
news, it was ended in a day.

The aftershocks of this study, and other human experiments


in the United States, led to the establishment of the National
Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research and the National
Research Act.

The latter requires the establishment of institutional review


boards (IRBs) at institutions receiving federal support (such
as grants, cooperative agreements, or contracts).
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Outcomes of the Syphilis Study
at Tuskegee
The first accounts of this study appeared in the national press in
1972. The resulting public outrage led to the appointment of an
ad hoc advisory panel by the Department of Health, Education
and Welfare (which later was split into the Department of
Education and the Department of Health and Human Services
[HHS]) to review the study and develop recommendations to
ensure that such experiments would never again be conducted.
Outcomes included:
 National Research Act of 1974
 Basic HHS Policy for Protection of Human
Research Subjects
 National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research

Dr Basma Damiri / Clinical Scientific Research 2020-2021


The Belmont Report identified three principles essential
to the ethical conduct of research with
humans:

1. Respect for persons


2. Beneficence
3. Justice

These three basic principles serve as the foundation of


the current HHS regulations and guidelines for the
ethical conduct of human subjects research supported
by HHS.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Principle Application
Respect for persons Informed consent

 Individuals should be treated  Subjects, to the degree that they are capable,
as autonomous agents must be given the opportunity to choose what
shall or shall not happen to them
 Persons with diminished autonomy
are entitled to protection.  The consent process must include three
elements:
 information,
 comprehension, and
 voluntariness.
Beneficence Assessment of risks and benefits

 Human subjects should not be harmed  The nature and scope of risks and benefits
must be assessed in a systematic manner
 Research should maximize possible
benefits and minimize possible
harms.

Justice Selection of subjects

 The benefits and risks of research  There must be fair procedures and outcomes
must be distributed
Dr Basma Damirifairly.
/ Clinical Scientific 20- in the selection of research subjects
The principle of respect
The principle of respect for persons can be broken
down into two basic ideas:
1. Individuals should be treated as autonomous agents
2. Persons with diminished autonomy are entitled to
additional protections

Dr Basma Damiri / Clinical Scientific Research 2020-2021


The challenges in applying the Belmont
principle of respect for persons are in:

 Making sure that potential participants comprehend


the risks and potential benefits of participating in
research
 Avoiding influencing potential participants‟
decisions either through explicit or implied threats
(coercion) or through excessive compensAtion
(undue influence)
Dr Basma Damiri / Clinical Scientific Research 2020-2021
An autonomous person is able to:
 Consider the potential harms and benefits of a situation
 Analyze how those risks and potential benefits relate to
his or her personal goals and values
 Take action based on that analysis
 Prospective research participants must be given the
information they need to determine whether or not they
want to participate in research.There should be no pressure
to participate and ample time to decide. Respect for
persons demands that participants enter into the research
voluntarily and with adequate information. This is called
informed consent, and will be covered in detail in other
sections of IRB report.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Persons with diminished autonomy are
entitled to additional protections
Special provisions may need to be made when an
individual‟s comprehension is severely limited or when a
class of research participants is considered incapable of
informed decision making (e.g. children, people with
severe developmental disorders, or individuals suffering
from dementias). Even for these persons, however,
respect for persons requires giving them the opportunity
to choose, to the extent they are able, whether or not they
wish to participate in research activities. In some cases,
respect for persons may require seeking
the permission of other parties, such as a parent or legal
guardian.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
The Belmont principle of beneficence

Two general rules have been articulated as


complementary expressions of beneficent actions:
 Do no harm
 Maximize possible benefits and minimize possible harms

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Issues to be covered under
Beneficence include:
 Protections against risks
 Definition of miniMAl risk
 Methods of weighing risks against anticipated benefits
 Potential benefits for the research participants
 The use of compenSAtion for participation in research
 Equipoise and need for there to be genuine uncertainty about
whether one treatment is superior to another
 Privacy & Confidentiality of research participants and research data
 Use of coded private information to protect confidentiality
 Use of an IRB to provide oversight for research involving
human subjects
 Situations that allow for an IRB expedited review procedure
 Data and Safety monitoring for cliniCAl triALS

Dr Basma Damiri / Clinical Scientific Research 2020-2021


The definition of justice has two parts:
1. Fair procedures and outcomes are used to select
research participants, and
2. There is a fair distribution of benefits and
burdens to populations who participate in
research
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Ethical Principles
1.The principles of respect for persons
A.Obtain an informed consent:
 To protect participants with impaired decision-making capacity.
 To maintain confidentiality.
 Individuals rights and welfare must be respected.
B.Principle of beneficence:
 The risks of the research be acceptable in relation to the benefits (e.g
drugs in clinical trial).
 The risks of participating in the study can be reduced:
 Screening participants to exclude those likely to suffer adverse effects
 Monitoring participants for adverse effects.

Dr Basma Damiri / Clinical Scientific Research 2020-2021


2. Protecting private information:
 Information expected of not being observed or recorded
(question not related to research topic, just for curiosity purposes)
 Information that has been provided for specific
purposes and expected not to be made public.
3. Information provided to Participants
 The nature of the research project:
 What is the purpose of the research
 How participants are being recruited
 The actual study hypothesis need not be stated (Specially if it
affects the result e.g testing habits as a variable).

Dr Basma Damiri / Clinical Scientific Research 2020-2021


 The Procedures of the Study:
 What they will be asked to do in the research project (e.g frequency of
taking
tablets, reporting side effects etc)
 How much time will be required for the study.
 In interview or questionnaire research, participants should be
informed of the topics to be addressed.
 If the study involves blinding or randomization, these concepts better to
be
explained.
 The Risks and Potential Benefits of the Study and the
Alternatives to Participating in the Study.
 Investigators should make clear that it is not known whether the
study drug is more effective than standard therapy and that promising
drugs can cause serious harms.
 Freedom of choice (Decision not to participate will not affect patient
rights)
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Consent Forms
“Is a document which proves that discussions between an
investigator and the subject has occurred”.
 Important things about Consent form:
 The consent form needs to contain all the information that must be
disclosed.
 In discussions and consent forms, researchers should avoid technical jargon
and
complicated sentences.
 If informed consent have been presented orally (In special cases e.g
elderly, illiterates etc), there must be a witness to the oral
presentation, both must sign.
 Researchers must not use pressure or influence to sign the form.
 Participants must understand that declining from the study will not
affect their medical care and that they may withdraw from the project
at any time.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Informed Consent
 The hallmark of consent are
 informed
 understood
 voluntary
 These hallmarks provide respect for persons by
honoring their autonomy
 The consent/process would maximize the
likelihood that consent is an informed autonomous
decision
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Informed Consent
 Information:
Items included in informed consent are:

 a statement that the study involves research


 the research procedures and their purposes
 risks and anticipated benefits
 alternative procedures
 a statement offering the opportunity to ask questions
 confidentiality

 compensation for research injury


 the option to withdraw anytime from the study
 participation is voluntary
 who to contact for answers to questions
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Informed Consent
 Additional elements of informed consent may be
added at the desecration of the IRB:
 unforeseeable risks
 termination by the investigator
 additional costs to the subject
 significant new findings
 the number of subjects to be involved
 the consequences of a decision to withdraw

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Informed Consent
 Overly optimistic language should be avoided
 The form serves as a baseline of information for
initial presentation and a reference source during the
study as well as documentation of voluntary
participation
 For long and/or complicated studies, investigators
should stress to subjects the importance of keeping
their copy of the consent form for reference
 The original consent form, which is to keep in the
investigator‟s records, needs to be signed BEFORE
ANY RESEARCH TAKES PLACE and dated by
the subject
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Confidentiality

 There must be strategies for protecting


confidentiality particularly if the research addresses
sensitive topics such as psychiatric illness,
alcoholism, or sexual behaviours etc.
 Strategies for protecting confidentiality include:
 Coding research data
 Storing it in locked cabinets
 Protecting or destroying the key that identifies subjects
(When not required any more)
 limiting personnel who have access to identifiers.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Equipoise

Substantial scientific uncertainty about which


treatments will benefit subjects most, or a lack of
consensus in the field that one intervention is superior
to another.

A state of “equipoise” is required for conducting


research that may pose risks to research participants.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Case Study
There are two standard treatments for autistic children
who display a specific set of characteristics. One
treatment is a cognitive behavioral intervention, and the
other is a dietary and biomedical intervention. Both
treatments have equally strong clinical evidence
supporting their efficacy. A researcher proposes a
comparison of the two interventions to determine which
is preferable.The children will be randomized to one of
two groups: half of the children will receive the
cognitive behavioral intervention and the other half of
the children will receive the dietary and biomedical
intervention.
Is this study in equipoise?
Dr Basma Damiri / Clinical Scientific Research 2020-2021
This study is in equipoise because there is insufficient
data to persuade investigators or physicians that one
approach is preferable to the other for a child
displaying the specific characteristics.

Dr Basma Damiri / Clinical Scientific Research 2020-2021


The HHS Regulations – Protection
of Human Subjects
 The ethical principles for research involving human subjects
described in the Belmont Report are codified in the Code of
Federal Regulations, 45 CFR 46.The NIH follows all
Subparts of the HHS regulations:
 Subpart A – Basic HHS Policy for Protection of Human
Research Subjects
 Subpart B – Additional Protections for PreGNANT
Women, Human Fetuses and NEONAtesInvolved in
Research
 Subpart C – Additional Protections Pertaining to
Biomedical and Behavioral Research InvolvingPrisoners
as Subjects
 Subpart D – Additional Protections for Children Involved as
Subjects in Research
 Subpart E – Registration of Institutional Review Boards
(effective July 14, 2009)
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Research Participants who Require
Additional Protections
1. Vulnerable persons:
 Who have difficulty giving information (e.g elderly, children)
 Signing or understanding informed consent
 Susceptible to adverse events.
Types of Vulnerability:
 Cognitive or Communicative Impairments
 Persons who reside in institutions; such as prisoners or nursing home
residents (feeling the pressure to participate).
2. Social and Economic Disadvantages:These Persons generally
have poor access to health care, reason of participation:
 To obtain payment
 Physical examination
 Screening tests
Dr Basma Damiri / Clinical Scientific Research 2020-2021
 Special Federal Regulations for Vulnerable Participants
 Research on Children
 Investigators must obtain both the permission of the parents
and the assent (agreement) of the child
 The research on children must be of direct benefit with minimal risk.
 Research on Prisoners
 Federal regulations limit the types of research that are
permitted on prisoners.
 Research on Pregnant Women and Embryos
 Extra protections and restrictions are required when research is
carried out on and embryos or pregnant women

Dr Basma Damiri / Clinical Scientific Research 2020-2021


IRB
 Institutional Review Boards (IRBs) are specialized
committees required by HHS regulations that
safeguard the rights and welfare of human subjects.
IRBs determine “the acceptability of proposed
research in terms of institutional commitments and
regulations, applicable law, and standards of
professional conduct and practice” (45 CFR 46.107).
Dr Basma Damiri / Clinical Scientific Research 2020-2021
The major roles of IRBs in the
oversight of research are:

1. Initial review and approval or disapproval of the


proposed research activity
2. Ensuring that the proposed informed consent
process meets all of the requirements of 45 CFR
46.116
3. Providing continuing oversight for progress
reports and protocols for ongoing research studies
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Integrity in Science
“For a scientist, integrity embodies above all the
individual‟s commitment to intellectual honesty and
personal
responsibility…”
-- Integrity in Scientific Research, National Academy of
Sciences
Dr Basma Damiri / Clinical Scientific Research 2020-2021
The cornerstone of scientific
research is trust.
The public and other professionals in the discipline must
be able to trust that the research outcomes being reported
are honest, accurate, and as free from bias as possible.

Each scientist has the responsibility to foster this


relationship of trust by conducting ethical, quality
research.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Are Human Subjects Involved?
 A living individual about whom an investigator
(whether professional or student) conducting
research obtains:
Data through intervention or interaction
with the individual, or
Identifiable private information
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Direct vs Indirect Interactions
 Research may involve direct interactions or
interventions such as obtaining data by interview,
obtaining blood samples or treating patients in part
to gain generalizable knowledge.
 May also involve indirect analysis of specimens
or data that already exist.
 Participation in an indirect activity, particularly if
results will be published, constitutes human
subjects research.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
What can happen when research
lacks integrity?
Misdemeanors
 Questionabl
• Unmerited authorship credit e credibility
• Not sharing data / materials  Damaged reputation
• Misleading statistics or graphics
 Tainted future research
• Breaking confidentiality in review
• Maintaining inadequate records
• Failing to disclose conflicts of interest
• Fragmentary publication
• Duplicate publication
Dr Basma Damiri / Clinical Scientific Research
2020-2021
What can happen when research
lacks integrity?

High Crimes Dr Basma Damiri / Clinical Scientific


Research 2020-2021

Research Misconduct
• Plagiarism
• Fabrication of data
• Falsification of data
 Debarment from receipt of federal
funding
 Supervision & certification of
future research
 Halt research
 Termination
 Rescission of degree
 Formal reprimand
 Formal apology
 Ethical training
 Suspension / probation
 Withholding pay
Definition (continued)
(a) Fabrication is making up data or results and
recording or reporting them.
(b) Falsification is manipulating research materials,
equipment, or processes, or changing or omitting data
or results such that the research is not accurately
represented in the research record.

(c) Plagiarism is the appropriation of another person‟s ideas,


processes, results, or words without giving appropriate
credit. (It is considered intellectual property theft)

(d) Research misconduct does not include honest


error or differences of opinion.
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Examples of Falsification
 Substituting one subject‟s record for that of another subject
 Altering dates and results from subject‟s eligibility visits
 Altering results of laboratory tests
 Backdating test or interview dates to fit protocol
time window

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Examples of Fabrication
 Creating records of interviews that were never performed
 Making up progress notes for patient visits that
never took place and inserting them into the medical
record
 Preparing records for calls and follow-up
contacts for participants who had already died
Dr Basma Damiri / Clinical Scientific Research 2020-2021
 Authorship
 Guest authorship: persons who have made only
trivial contributions to the paper
 Ghost authors: who made substantial contributions to the
paper but are not listed as authors
 21% of articles had guest authors and 13% ghost authors

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Authorship Credit & Responsibility
1. Substantial contribution to:
 Conception & design of study, OR
 Acquisition of data, OR
 Analysis & interpretation of data
2. Drafting the article OR revising it
critically for important intellectual
content
3. Final approval of the version to be
published Authors should meet all 3
conditions
InteDrrnBaatisomnaaDl aCmoirmi /mCitltieneicaol fScMieendtiifcicaRl
eJsoeuarrcnha2l 0E2d0-it2o0r2s1 (ICMJE) Uniform Requirements for Manuscripts.
http://www.icmje.org/
Authorship Credit - Summary
 Each author should have participated sufficiently in
the work to take public responsibility for appropriate
portions of the content. (ICMJE)
 Avoid honorary and ghost authorship
 Acknowledge contributors who do not merit

authorship International Committee of Medical Journal

Editors (ICMJE)
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Good Publication Practices
 Avoid misrepresentation in publications
 Publish accurate, complete, clear, and unbiased work
 Avoid fragmentary publication
 Publish manuscripts that represent substantial findings

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Good Publication Practices
 Avoid duplicate manuscript submission & publication
 Publish research that will add new contributions to the field
 Acknowledge prior publications
 „A suitable footnote might read: “This article is based on
a study first reported in the [title of journal, with full
reference].”‟ – ICJME guidelines

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Responsible Authorship Principles
 Research is not complete until it has been reported
 Integrity in publication depends on objectivity and
avoiding misrepresentation
 Authorship implies both credit and responsibility
 Research publications should impart new and
substantial findings

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Data and Research Integrity
 Research integrity depends on responsible:
 Selection
 Collection
 Handling
 Reporting
 Ownership
 Sharing
……of data

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Responsible Data Management
 Pre-Data Collection: experimental design,
protocol submission, approval by institutional
committee(s)
 Data Collection: ensuring quality & avoiding
bias, adequate recordkeeping
 Analysis & Selection: statistical analyses, criteria
for including & excluding data
 Data Ownership: responsibility and rights for
collection, use, and sharing
 Data Retention: duration, security, and accessibility
 Sharing of Data: what to share, when, and with whom
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Data Management Principles
 Integrity of research depends on the integrity of the data
 Research records document the process and products
of the research
 Integrity of the data is a shared responsibility
among all members of the research team
 Sharing of research data is in the best interest of
knowledge advancement

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Conflicts of Interest
A conflict of interest is when one’s actual or
imputed interest compromises or appears to
compromise one’s ability to impartially
perform one’s duty.

Stokes, L. Key Issues in Conflict of Interest for Scientific, Engineering, and Educational Research. The Journal of Research
Administration/Theme Issue: Conflict of Interest, v. XXXIII (II), 2002.

Ethical challenge: be mindful of outside


influences and personal biases and disclose,
disclose, disclose
Dr Basma Damiri / Clinical Scientific Research 2020-2021
Conflicts of Interests
 Conflicts of Interests impair the objectivity and
undermine public trust in research
 Example of conflict Types:
 Dual roles for clinician-investigators: Investigator may
be the physician of an eligible research participant.
 Financial conflicts of interests: Studies of new drugs
are commonly funded by pharmaceutical companies or
biotechnology firms.
 The ethical concern is that certain financial ties may lead to
bias in the design and conduct of the study
 Over interpretation of positive results.
 Failure to publish negative results.

Dr Basma Damiri / Clinical Scientific Research 2020-2021


Dealing with Conflicting Interests
 Minimize conflicting interests
 Investigators can be blinded to the intervention
 Independent data safety monitoring board
 Can review interim data and terminate the study if the data provide
convincing
evidence of benefit or harm
 If research is funded by a pharmaceutical company, the
sponsor must not have power to veto or censor
publication
 Researchers from academic institutions should not be an
officer (High official Position) in the company that has a
financial interest in the intervention being studied.
Dr Basma Damiri / Clinical Scientific Research 2020-2021

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