Practical Research 1 Lesson 9 Scope and delimitation.pptx
Research methodoloy
1. Research Methodology
An Introduction
Dr. S. Parasuraman, M.Pharm., Ph.D.,
Associate Professor, Unit of Pharmacology,
Faculty of Pharmacy, AIMST University,
Bedong 08100, Malaysia.
Basrelief sculpture "Research
holding the torch of knowledge"
(1896) by Olin Levi Warner.
Library of Congress, Thomas
Jefferson Building, Washington, D.C.
2. Aristotle, (384–322 BC),
one of the early figures in
the development of the
scientific method.
The research room at the New York Public Library.
Cover of the first
issue of Nature, 4
November 1869.
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3. Topic Learning Outcome
• Upon successful completion of this topic, students
should be able to:
• explain the structure of research, types of research,
research approaches, research process, significance of
research and criteria of good research.
• outline the types of literature and discuss the basic
elements of effective literature search with the
citations.
• describe seven step process of statistical hypothesis
testing and level of statistical significance.
• outline the functions of ethics committee.
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4. Research
Research comprises “creative and systematic
work undertaken to increase the stock of
knowledge, including knowledge of humans,
culture and society, and the use of this stock of
knowledge to devise new applications.”
-- OECD 2015
-- Frascati Manual 2015
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5. Research
Research is…..
• Searching for explanation of events, phenomena,
relationships and causes
• A process
Research is not…..
• Data collection (intermediate step to gain reliable
knowledge)
• Searching out published research results in libraries
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6. Methodology & Method
Methodology
• The study of the general approach to inquiry in a
given field.
Method
• The specific techniques, tools or procedures applied
to achieve a given objective.
• Research methods in economics include regression
analysis, mathematical analysis, operations research,
surveys, data gathering, etc.
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7. Objectives of research
The purpose of research is to discover answers to
questions through the application of scientific
Procedures. Research objectives as falling into following
broad groupings:
• To gain familiarity with a phenomenon or to achieve
new insights into it.
• To portray accurately the characteristics of a particular
individual, situation or a group.
• To determine the frequency with which something
occurs or with which it is associated with something else
• To test a hypothesis of a causal relationship between
variables
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8. General
Specific
General
Introduction
1. Identify problem area and state importance
(Field establishment)
2. Review relevant research literature
(Description of pervious research)
3. Identify a gap or ‘Research space’
(Specific area for research)
4. State research aim – to fill that gap
(Set research question (RQ) and hypothesis)
Specific
Empirical and original
part of your study
Method
Result & interpretation
Discussion
4. Match result with RQ and hypothesis
(Confirm)
5. Implication of specific knowledge area
6. Significant of the field
1. Recommendation for further research
Conclusion
[Reference]
Structure of research
The Hourglass: a dynamic organisational model
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9. Research Process
• Research process consists of series of actions or steps
necessary to effectively carry out research and the
desired sequencing of these steps.
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10. Types of research
• Descriptive vs. Analytical
• Applied vs. Fundamental
• Quantitative vs. Qualitative
• Conceptual vs. Empirical
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11. Types of research
• Descriptive vs. Analytical
– Descriptive research includes surveys and fact-
finding enquiries of different kinds.
– In analytical research, the researcher has to use
facts or information already available, and analyze
these to make a critical evaluation of the material.
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12. Types of research
• Applied vs. Fundamental
– Applied research aims at finding a solution for an
immediate problem facing a society or an
industrial/business organisation, whereas
fundamental research is mainly concerned with
generalisations and with the formulation of a
theory. “Gathering knowledge for knowledge’s
sake is termed ‘pure’ or ‘basic’ research.”
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13. Types of research
• Quantitative vs. Qualitative
– Quantitative research is based on the
measurement of quantity or amount. It is
applicable to phenomena that can be expressed in
terms of quantity.
– Qualitative research, is concerned with qualitative
phenomenon, i.e., phenomena relating to or
involving quality or kind.
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14. Types of research
• Conceptual vs. Empirical
– Conceptual research is that related to some
abstract idea(s) or theory.
– empirical research relies on experience or
observation alone, often without due regard for
system and theory. It is data-based research,
coming up with conclusions which are capable of
being verified by observation or experiment.
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15. Research Approaches
• Two basic approaches to research are
– Quantitative approach
• Inferential approaches: Research is to form a data base
from which to infer characteristics or relationships of
population
• Experimental approaches: Characterised by much
greater control over the research environment and in
this case some variables are manipulated to observe
their effect on other variables.
• Simulation approaches: Involves the construction of an
artificial environment within which relevant information
and data can be generated
– Qualitative approach: to research is concerned with
subjective assessment of attitudes, opinions and behaviour.
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16. Significance of research
• Significance of research are
– to promote the development of logical habits of
thinking and organisation.
– to solve various operational and planning
problems of business and industry.
– to generalisations of new theories.
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17. Criteria of good research
• The purpose of the research should be clearly.
• The research procedure used should be described in
sufficient detail.
• The researcher should report with complete frankness,
flaws in procedural design and estimate their effects
upon the findings.
• The validity and reliability of the data should be
checked carefully.
• Conclusions should be confined to those justified by the
data of the research.
• Greater confidence in research is warranted if the
researcher is experienced.
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18. Qualities of a good research
• Good research is
–Systematic
–Logical
–empirical
–replicable
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20. Types of literature reviews
• Narrative or traditional literature reviews
• Scoping reviews
• Systematic quantitative literature review
• Cochrane reviews
• Campbell collaboration
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21. Types of literature reviews
Narrative or traditional literature reviews:
• A narrative or traditional literature review is a
comprehensive, critical and objective analysis of the
current knowledge on a topic. They are an essential
part of the research process and help to establish a
theoretical framework and focus or context for your
research.
• Four common types of narrative reviews are general
literature review, theoretical literature review,
methodological literature review and historical
literature review.
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Literature Review: Traditional or narrative literature reviews. Available in https://libguides.csu.edu.au/c.php?g=476545&p=3997199 [Last assessed on 24 Feb. 2019]
22. Types of literature reviews
Scoping reviews
• A scoping review is not necessarily less work than a
systematic review.
• A scoping review or scoping study is a form of
knowledge synthesis that addresses an exploratory
research question aimed at mapping key concepts,
types of evidence, and gaps in research related to a
defined area or field by systematically searching,
selecting, and synthesizing existing knowledge.
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Colquhoun, et al. J of Clin Epi. 2014, 67, p. 1292-94
23. Types of literature reviews
Systematic quantitative literature review
• Method for integrating or comparing the findings
from qualitative studies. It looks for ‘themes’ or
‘constructs’ that lie in or across individual qualitative
studies.
Cochrane reviews
• Cochrane Reviews are systematic reviews of primary
research in human health care and health policy, and
are internationally recognised as the highest standard
in evidence-based health care.
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https://guides.mclibrary.duke.edu/sysreview/types
http://www.evidentlycochrane.net/what-are-cochrane-reviews/
24. Types of literature reviews
Campbell collaboration
• The Campbell Collaboration is an international
volunteer network of policymakers, researchers,
practitioners, and consumers who prepare, maintain,
and disseminate systematic reviews of studies of
interventions in the social and behavioral sciences.
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http://ktdrr.org/ktlibrary/articles_pubs/ncddrwork/focus/focus16/
25. Summary of the different types of
literature reviews
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https://www.griffith.edu.au/__data/assets/pdf_file/0018/160506/WEB_What-are-systematic-quantiative-reviews-and-why-use-them-July-2017.pdf
26. Steps in literature review
• Literature search
• Sorting the literature
• Analysing the literature
• Comparison
• Structure of literature review
• Writing the literature review
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Pautasso M. Ten simple rules for writing a literature review. PLoS Comput Biol. 2013;9(7):e1003149.
27. Ten Simple Rules for Writing a Literature Review
• Rule 1: Define a topic and audience
• Rule 2: Search and re-search the literature
• Rule 3: Take notes while reading
• Rule 4: Choose the type of review you wish to write
• Rule 5: Keep the review focused, but make it of broad
interest
• Rule 6: Be critical and consistent
• Rule 7: Find a logical structure
• Rule 8: Make use of feedback
• Rule 9: Include Your own relevant research, but be
objective
• Rule 10: Be Up-to-Date, but do not forget older studies
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Pautasso M. Ten simple rules for writing a literature review. PLoS Comput Biol. 2013;9(7):e1003149.
28. Common errors made in literature reviews
• Review isn’t logically organized
• Review isn’t focused on most important facets of the
study
• Review doesn’t relate literature to the study
• Too few references or outdated references cited
• Review isn’t written in author’s own words
• Review reads like a series of disjointed summaries
• Review doesn’t argue a point
• Recent references are omitted
• Plagiarism
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30. Research hypothesis
A hypothesis is an assumption, an idea that is
proposed for the sake of argument so that it can
be tested to see if it might be true.
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31. Research hypothesis
• Seven step process of statistical hypothesis testing
– Step 1: State the Null Hypothesis
– Step 2: State the Alternative Hypothesis
– Step 3: Set α
– Step 4: Collect Data
– Step 5: Calculate a test statistic
– Step 6: Construct rejection regions
– Step 7: Based on steps 5 and 6, draw a conclusion about H0
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33. Referencing style
• A referencing style is a set of rules telling you how to
acknowledge the thoughts, ideas and works of others
in a particular way.
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Abbreviation Full Name
ACS American Chemical Society
AMA American Medical Association
AMJ Academy of Management style
APA American Psychological Association
Chicago Chicago Manual of Style
CSE (CBE) Council of Science Editors/Council of Biology Editors
Harvard
MLA Modern Language Association of America
Vancouver
34. Referencing style - APA
• This is the standard style used in Psychology, but it is also
widely used in other disciplines, especially in the Social
Sciences. It is an author-date style; one of the many
variants of the Harvard style.
Citing a book
• APA format structure:
– Author, A. (Year of Publication). Title of work. Publisher City,
State: Publisher.
• APA format example:
– Finney, J. (1970). Time and again. New York, NY: Simon and
Schuster.
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35. Referencing style - APA
Citing a Journal
• APA format structure:
– Author, A. (Publication Year). Article title. Periodical Title,
Volume(Issue), pp.-pp.
• APA format example:
– Cushnie, T. T., & Lamb, A. J. (2005). Antimicrobial activity of
flavonoids. International journal of antimicrobial agents,
26(5), 343-356.
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36. Referencing style - Harvard
• Harvard Reference List Citations for Books with One
Author
• Harvard format structure:
– Last name, First initial. (Year published). Title. Edition. (Only
include the edition if it is not the first edition) City
published: Publisher, Page(s).
• Harvard format example:
– Dahl, R. (2004). Charlie and the chocolate factory. 6th ed.
New York: Knopf.
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37. Referencing style - Harvard
• Harvard Reference List Citations for Chapters in Edited
Books
• Harvard format structure:
– Last name, First initial. (Year published). Chapter title. In: First
initial. Last name, ed., Book Title, 1st ed.* City: Publisher,
Page(s).
• Harvard format example:
– Bressler, L. (2010). My girl, Kylie. In: L. Matheson, ed., The Dogs
That We Love, 1st ed. Boston: Jacobson Ltd., pp. 78-92.
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38. Referencing style - Harvard
Citing a Journal
• Harvard format structure:
– Last name, First initial. (Year published). Article title.
Journal, Volume (Issue), Page(s).
• Harvard format example:
– Ross, N. (2015). On Truth Content and False Consciousness
in Adorno’s Aesthetic Theory. Philosophy Today, 59(2), pp.
269-290.
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39. Referencing style - Vancouver style
Citing a Journal
• Vancouver style format structure:
– Last name First initial. Article title. Journal abbreviation.
Year published; Volume (Issue): Page(s).
• Vancouver style format example:
– Younger P. Using the internet to conduct a literature search.
Nurs Stand. 2004;19(6); 45-51.
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40. General APA Guidelines
• The list of references must be on a new page at the
end of your text.
• The word References should be centered at the top of
the page. Do not underline, bold, enlarge or use
quotes for the word References.
• The reference list must include all references cited in
the text of your paper.
• The only exceptions to this rule are personal
communications and classical works; they are cited in
text only and are not included in the Reference list.
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41. General APA Guidelines
• Abbreviations:
o ed. = edition
o Ed. or Eds. = Editor(s)
o n.d. = no date (for not date of publication)
o p. or pp. = Page(s)
o Vol. or Vols. = Volume(s)
o No. = Number
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43. Biomedical ethics
Animal ethics
• Animal ethics is a term used in academia to describe
human–animal relationships and how animals ought
to be treated. The subject matter includes animal
rights, animal welfare, animal law, speciesism,
animal cognition, wildlife conservation, the moral
status of nonhuman animals, the concept of
nonhuman personhood, human exceptionalism, the
history of animal use, and theories of justice.
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44. Ethics in research with animals
• Committee on Animal Research and Ethics (CARE)
• American Psychological Association's (APA's) 2002
Ethics Code
– Acquire, care for, use and dispose of animals in compliance
with current federal, state and local laws and regulations,
and with professional standards.
– Ensure that all individuals under their supervision who are
using animals have received instruction in research
methods and in the care, maintenance and handling of the
species being used, to the extent appropriate to their role.
– Make reasonable efforts to minimize the discomfort,
infection, illness and pain of animal subjects.
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45. Ethics in research with animals
• Ethics in research with animals (Cont.,)
– Use a procedure subjecting animals to pain, stress or
privation only when an alternative procedure is unavailable
and the goal is justified by its prospective scientific,
educational or applied value.
– Perform surgical procedures under appropriate anesthesia
and follow techniques to avoid infection and minimize pain
during and after surgery.
– Proceed rapidly when it is appropriate that an animal's life
be terminated, with an effort to minimize pain and in
accordance with accepted procedures.
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Guidelines for Ethical Conduct in the Care and Use of Nonhuman Animals in Research. Available in https://www.apa.org/science/leadership/care/guidelines
[Last assessed on 25 Feb. 2019]
46. Commonly used laboratory animals
• Dog
• Monkey
• Guinea pig
• Hamster
• Gerbil
• Rabbit
• Rat
• Mouse
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47. Biomedical ethics
(Human)
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Edward Jenner vaccinating James Phipps,
a boy of eight, on 14 May 1796. Jenner
failed to use a control group.
48. Biomedical ethics
Human ethics committee:
• Earlier, in the 1900s, there were no regulations
regarding the ethical use of human subjects in
research.
• An ethics committee is a body responsible for
ensuring that medical experimentation and human
research are carried out in an ethical manner in
accordance with national and international law.
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49. Biomedical ethics
HISTORY:
• History of research with human subjects opened on
December 9, 1946, when an American military tribunal
opened criminal proceedings against 23 leading German
physicians and administrators for their willing
participation in war crimes and crimes against humanity.
• As a direct result of the trial, the Nuremberg Code was
established in 1948, stating that ‘The voluntary consent of
the human subject is absolutely essential,’ making it clear
that subjects should give consent and that the benefits of
the research must outweigh the risks.
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Mandal J, Acharya S, Parija SC. Ethics in human research. Trop Parasitol. 2011 Jan;1(1):2-3.
50. Biomedical ethics
History:
• THE TUSKEGEE SYPHILIS STUDY (1932 – 1972)
• One of the turning points in the development of a
consensus for guidelines for ethical conduct in
research was a project conducted by the US Public
Health Service.
• The study sparked off a wide-scale public outrage
when it became publicly known, and the US
government had to close it in 1973.
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Mandal J, Acharya S, Parija SC. Ethics in human research. Trop Parasitol. 2011 Jan;1(1):2-3.
51. Biomedical ethics
History:
• THE TUSKEGEE SYPHILIS STUDY (1932 – 1972)
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https://www.thecoli.com/threads/tuskegee-syphilis-experiments-on-blacks-1932-1972.174212/
https://3goodwords.wordpress.com/2015/02/01/black-history-month-the-tuskegee-experiment/comment-page-1/
52. Biomedical ethics
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• The Nazi Medical War Crimes
• Dachau
• Execution of Dachau SS
• Eisenhower at Ohrdruf
• War Crimes Tribunal at Nuremberg
• The Nuremberg Trial
• The Tuskegee Syphilis Study
• Jewish Chronic Disease Hospital Study
• Willowbrook Study
• Cincinnati Radiation Experiments
• The Radioactive Milk Study
• The Belmont Report
53. Biomedical ethics
THE BELMONT REPORT:
• The Belmont Report was published in 1979, with
attempts to summarize the basic ethical principles
identified by the Commission in the course of its
deliberations. The Report is a statement of the basic
ethical principles and guidelines that should assist in
resolving the ethical problems that surround the
conduct of research with human subjects.
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Mandal J, Acharya S, Parija SC. Ethics in human research. Trop Parasitol. 2011 Jan;1(1):2-3.
54. Biomedical ethics
THE BELMONT REPORT (1979):
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Three basic ethical
principles (Respect for
persons, Beneficence,
Justice) and their
corresponding
applications according to
the Belmont report:
Mandal J, Acharya S, Parija SC. Ethics in human
research. Trop Parasitol. 2011 Jan;1(1):2-3.
55. Biomedical ethics
Declaration of Helsinki:
• The Declaration of Helsinki is a set of ethical
principles regarding human experimentation
developed for the medical community by the World
Medical Association (WMA).
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56. Biomedical ethics
The Declaration of Helsinki:
• In 1964, the World Medical Association established
recommendations guiding medical doctors in biomedical
research involving human subjects.
• Issues addressed in the declaration of Helsinki includes:
– Research with humans should be based on the results from
laboratory and animal experimentation
– Research protocols should be reviewed by an independent
committee prior to initiation
– Informed consent from research participants is necessary
– Research should be conducted by medically / scientifically
qualified individuals
– Risks should not exceed benefits
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Mandal J, Acharya S, Parija SC. Ethics in human research. Trop Parasitol. 2011 Jan;1(1):2-3.
57. Biomedical ethics
• Declaration of Helsinki:
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Seventh revision
(2013)
First revision
(1975)
The Declaration
was originally
adopted in June
1964 in Helsinki,
Finland
58. Biomedical ethics
General Principles Declaration of Helsinki:
• The Declaration of Geneva of the WMA binds the
physician with the words, “The health of my patient
will be my first consideration,” and the International
Code of Medical Ethics declares that, “A physician
shall act in the patient’s best interest when
providing medical care.”
• It is the duty of the physician to promote and
safeguard the health, well-being and rights of
patients
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59. Biomedical ethics
General Principles Declaration of Helsinki:
• The primary purpose of medical research involving
human subjects is to understand the causes,
development and effects of diseases and improve
preventive, diagnostic and therapeutic interventions.
• Medical research is subject to ethical standards that
promote and ensure respect for all human subjects
and protect their health and rights.
• Primary purpose of medical research is to generate
new knowledge, this goal can never take precedence
over the rights and interests of individual research
subjects.
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60. Biomedical ethics
General Principles Declaration of Helsinki:
• It is the duty of physicians who are involved in
medical research to protect the life, health, dignity,
integrity, right to self-determination, privacy, and
confidentiality of personal information of research
subjects.
• Physicians must consider the ethical, legal and
regulatory norms and standards for research
involving human subjects in their own countries as
well as applicable international norms and standards.
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https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
61. Biomedical ethics
National Medical Research Register (NMRR):
• The NMRR is a web-based service initiated by the
National Institutes of Health (NIH) of the Ministry of
Health (MOH).
• It is a web based tool designed to support the
implementation of the National Institute of Health
(NIH) guideline on the conduct of research in the
Ministry of Health Malaysia (MOH)
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62. Biomedical ethics
National Medical Research Register (NMRR):
• Current MOH policy on research
– Registration of all research that involves MOH personnel OR that
is to be conducted in MOH facility OR to be funded by MOH
research grant
– Review & approval of the research by a designated entity to
whom authority has been delegated for the purpose
– In addition, research involving human subjects requires prior
review and approval by the MOH Research and Ethics
Committee (MREC)
– Approval of all research publications, whether in the form of
research report, journal article or conference proceeding, by the
NIH initially and thereafter by the Director General of MOH
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63. Biomedical ethics
COMMON RULE (Human ethics):
• The main elements of the Common Rule include:
– requirements for assuring compliance by research
institutions
– requirements for researchers obtaining and documenting
informed consent
– requirements for Institutional Review Board (IRB)
membership, function, operations, review of research, and
record keeping
– additional protection for certain vulnerable research
subjects – pregnant women, prisoners, and children
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Mandal J, Acharya S, Parija SC. Ethics in human research. Trop Parasitol. 2011 Jan;1(1):2-3.