Professional Documents
Culture Documents
Lecture+5 Ethics+in+Research+Scientific+Integrity,+Etiquette+and+Misconduct r1
Lecture+5 Ethics+in+Research+Scientific+Integrity,+Etiquette+and+Misconduct r1
Lecture+5 Ethics+in+Research+Scientific+Integrity,+Etiquette+and+Misconduct r1
2 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Ethics
Research Etiquette
Research Etiquette
• Introduction to the Responsible Conduct
of Research
4 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
Research Etiquette is:
Common sense guidelines for conducting science in a collegial
(friendly) manner
“In general terms, responsible conduct in research is simply good citizenship
applied to professional life. Researchers who report their work honestly,
accurately, efficiently, and objectively are on the right road when it comes to
responsible conduct.
Anyone who is dishonest, knowingly reports inaccurate results, wastes funds, or
allows personal bias to influence scientific findings is not.”
Source: Introduction to the Responsible Conduct of Research,
Nicholas H. Steneck, Office of Research Integrity, US Department of Health and Human Services
5 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Responsible Conduct of Research
Honesty
Conveying information truthfully and honoring commitments
Accuracy
Reporting findings precisely and taking care to avoid errors
Efficiency
Using resources wisely and avoiding waste
Objectivity
Letting the facts speak for themselves and avoiding improper bias.
http://ori.hhs.gov/sites/default/files/rcrintro.pdf
6 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
Research Etiquette is:
7 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
Ensuring that proper credit is given for the conduct of a research project
and for the reporting of its findings:
What are the two main ways for doing so?
1. Authorship
2. Acknowledgements
8 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
• How do you determine the order of authorship?
- In the life sciences, authorship order is determined by the role in the project.
11 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
CRediT (Contributor Roles Taxonomy)
Term Definition
Conceptualization Ideas; formulation or evolution of overarching research goals and aims
Methodology Development or design of methodology; creation of models
Programming, software development; designing computer programs; implementation of the computer code and supporting algorithms;
Software
testing of existing code components
Verification, whether as a part of the activity or separate, of the overall replication/ reproducibility of results/experiments and other
Validation
research outputs
Formal analysis Application of statistical, mathematical, computational, or other formal techniques to analyze or synthesize study data
Investigation Conducting a research and investigation process, specifically performing the experiments, or data/evidence collection
Provision of study materials, reagents, materials, patients, laboratory samples, animals, instrumentation, computing resources, or other
Resources
analysis tools
Management activities to annotate (produce metadata), scrub data and maintain research data (including software code, where it is
Data Curation
necessary for interpreting the data itself) for initial use and later reuse
Writing - Original Draft Preparation, creation and/or presentation of the published work, specifically writing the initial draft (including substantive translation)
Writing - Review & Preparation, creation and/or presentation of the published work by those from the original research group, specifically critical review,
Editing commentary or revision – including pre-or postpublication stages
Visualization Preparation, creation and/or presentation of the published work, specifically visualization/ data presentation
Supervision Oversight and leadership responsibility for the research activity planning and execution, including mentorship external to the core team
Project administration Management and coordination responsibility for the research activity planning and execution
Funding acquisition Acquisition of the financial support for the project leading to this publication
* Reproduced from Brand et al. (2015), Learned Publishing 28(2), with permission of the authors. https://www.elsevier.com/authors/policies-and-guidelines/credit-author-statement
12 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
• Authors Confirmation during submission:
13 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
• Authors Confirmation after acceptance:
14 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
Respectful deliberations and resolution of scientific differences within a
project staff
15 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
• Scientific etiquette should be practiced at all times in all research
• Scientific etiquette is usually directly applied to issues of:
• Data ownership
• Level of involvement in a research project
• Rights to present and publish findings
• Authorship of presentations and publications
• Sharing of data and findings from a research project
• Acknowledging key research staff who are not listed as authors
• Including student researchers as authors
• Each member of a research team must contribute as defined by each member’s defined
responsibilities for a project
16 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
• Citing other’s work:
17 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
• Reviewing of manuscripts
• At some point in your career, you will be asked to review someone else’s work, either for a grant
application, or for a manuscript publication.
- Before you agree to review someone’s work, you need to make sure you do not have a conflict of
interest.
- Potential conflicts of interest:
- Are you a co-author?
- Do you have a recent collaboration?
- Do any of the authors work at your institution?
- Are any of the authors related to you?
- If you suspect or know of a conflict of interest, you should contact the editor and decline to review
the manuscript.
- If you don’t have clear understanding with the topic, then it is better to decline the review request.
18 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Etiquette
• Reviewing of manuscripts
- Such reviews should be confidential, even after the review process is
finished.
- However, recently, some journals now publish the reviewers name as well such as
Frontiers in Energy Research.
- You should not share the manuscript or its contents with colleagues.
19 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Ethics
Research Misconduct
Research Misconduct
Research Misconduct
means fabrication,
falsification, or plagiarism,
in proposing, performing, or
reviewing research, or in
reporting research results.
https://www.sketchbubble.com/en/presentation-research-misconduct.html
21 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Misconduct
• Fabrication is making up data or results and recording and/or reporting
them.
• In 2004 and 2005, Dr. Hwang Woo-Suk, published two
papers in the journal Science that claimed his team had
succeeded in creating human embryonic stem cells
through cloning. Allegations later followed from a co-
worker that these paper was based on fabricated data.
http://www.nytimes.com/2009/10/27/world/asia/27clone.html?_r=1&ref=hwangwoosuk
22 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Misconduct
• Falsification is manipulating research or scholarship materials,
equipment, or processes, or changing or omitting data or results such
that the scholarship or research is not accurately represented in the
record.
23 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Misconduct
MMR vaccine and Autism-Case
• Author claimed link between MMR vaccine
and Autism
• Failed to disclose funds from law firm to
discredit MMR vaccine
24 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Misconduct
• Plagiarism is the appropriation of another person’s ideas, processes,
results, or words without giving appropriate credit.
25 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Plagiarism Consequences
• It prevents effective teaching: Plagiarism “damages teachers’ relationships with students, turning teachers
into detectives instead of mentors and fostering suspicion instead of trust.” A successful classroom is one
where students and teachers can engage in open conversations about academic topics, not when teachers can
only be concerned with policing students’ work.
• It damages the university’s reputation and importance of a student’s diploma: “By undermining institutional
standards for assigning grades and awarding degrees, student plagiarism also becomes a matter of significance
to the public. When graduates’ skills and knowledge fail to match their grades, an institution’s reputation is
damaged. For example, no one would choose to be treated by a physician who obtained a medical degree by
fraud,” and the same holds true for a researcher or scholar who has obtained their degree the same way.
• It harms students: “Students who plagiarize lose an important opportunity to learn how to write a research
paper. Knowing how to collect and analyze information and reshape it in essay form is essential to academic
success.” These skills are also essential to becoming a translator, and students who plagiarize cheat themselves
out of the practice they will need for later professional success.
26 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Examples of academic misconduct
• Plagiarism:
• You took notes that did not distinguish summary and paraphrase from quotation
and then you presented wording from the notes as if it were all your own.
• While browsing the Web, you copied text and pasted it into your paper without
quotation marks or without citing the source.
• You repeated or paraphrased someone’s wording without acknowledgment.
• You took someone’s unique or particularly apt phrase without acknowledgment.
• You paraphrased someone’s argument or presented someone’s line of thought
without acknowledgment.
• You bought or otherwise acquired a work and handed in part or all of it as your
own.
27 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Examples of academic misconduct
Collusion:
• Similarly, it is also collusion to allow someone to copy your work when you
know that they intend to submit it as though it were their own, and that will
lay both you and the other student open to a charge of academic malpractice.
28 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Misconduct
Findings of Misconduct are made when:
a) There is a significant departure from accepted practices of the
relevant research or scholarly community AND
b) The misconduct is committed intentionally or knowingly or
recklessly AND
c) The allegation is proven by a predominance of the evidence
29 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Misconduct
• Before making allegations of misconduct, remember that someone’s
career can be destroyed by your allegations.
• Best to approach them directly first. Every story has two sides!
30 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Misconduct
http://ori.hhs.gov/sites/default/files/rcrintro.pdf
31 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Misconduct
http://ori.hhs.gov/sites/default/files/rcrintro.pdf
32 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Ethics and Moral Framework
• Ethics: The philosophy behind a moral outcome and determines the
working of a social system
• Set of rules that dictates right or wrong behavior
• ASME/NSPE Code of Ethics
• Morals: Defines our character and usually address “appropriate” and
“expected” behavior
• Engineering Ethics: “Study of Moral Values, Issues and Decisions as
they relate to Engineering practice”.
33 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Engineering Ethics: Code of Ethics for Engineers- ASME
34 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
The Honor Code – Students’ handbook
35 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Consequences
• It takes years to become a successful engineer or researcher. It takes so much
dedication and hard-work to gain respect in your profession and attain
recognition.
36 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Research Ethics
Data from Fifth Report on the Statistics on the Number of Animals used for
Experimental and other Scientific Purposes in the Member States of the European
Union Commission of the European Communities, published November 2007
• Reduction:
• Use statistical methods to minimize the number of required
animals
• Refinement:
• Improve the experiments to eliminate or minimize animal
suffering
39 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
U.S. Health Research Extension Act of 1985
U.S. Government Principles for the Utilization and
Care of Vertebrate Animals Used in Testing,
Research and Training
Citation: http://grants.nih.gov/grants/olaw/references/phspol.htm
40 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
U.S. Health Research Extension Act of 1985
Rationale:
The development of knowledge necessary for the improvement of the
health and well-being of humans as well as other animals requires in
vivo experimentation with a wide variety of animal species. Whenever
U.S. Government agencies develop requirements for testing, research, or
training procedures involving the use of vertebrate animals.
http://grants.nih.gov/grants/olaw/references/phspol.htm
41 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Considerations for procedures involving animals
(U.S. Health Research Extension Act of 1985)
Transportation of animal, care of animal health, use of animal for advancement of knowledge, good for society.
Animal Welfare Act (7 U.S.C. 2131 et seq.) and other applicable Federal laws, guidelines, and policies.
The living conditions of animals should be appropriate for their species and contribute to their health and
comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be
directed by a veterinarian
Appropriate species, quality and minimum numbers to obtain valid results. Proper use of animals,
minimize the discomfort (distress and pain).
Use appropriate sedation (analgesia, or anesthesia) for procedures involving pain or distress.
Kill painlessly for procedures involving permanent sever or chronic pain or distress (after procedure, if
appropriate during procedure).
Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on
living animals.
42 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
U.S. Health Research Extension Act of 1985
Where exceptions are required in relation to the provisions of these
Principles, the decisions should not rest with the investigators directly
concerned but should be made, with due regard to Principle II, by an
appropriate review group such as an institutional animal care and use
committee (IACUC). Such exceptions should not be made solely for the
purposes of teaching or demonstration.**
**Published in the Federal Register, May 20, 1985, Vol. 50, No. 97, by the Office of Science and Technology Policy [FR Doc. 85-
12059].
http://grants.nih.gov/grants/olaw/references/phspol.htm
43 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
IACUC (Institutional Animal Care and Use Committee)
• At least five members
• A scientist experienced in animal research
• A non-scientific member
• A non-affiliated member
• A veterinarian with proper training and experience in laboratory animal
44 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
In State of Qatar
• State of Qatar, Supreme Council of
Health:
45 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Qatar Supreme Council of Health
• Laboratory Animals Policies and Regulations
• The ultimate responsibility for ensuring compliance with these guidelines rests
with the designated Senior Administrator responsible for animal use for the
institution.
46 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Qatar Supreme Council of Health
• Institutions responsibilities include:
1. Establishing an animal care and use program.
2. Designation of one or more Institutional Animal care and Use committees (IACUCs)
established in accordance with the requirements of this policy, and for which
provisions are made for meeting space and sufficient staff to support the IACUC's
review and recordkeeping duties. Where there is little use of animals for scientific
purposes, institutions may consider accessing an external IACUC or sharing an IACUC
with another institution.
47 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Human Subject in Research
Human Subject in Research
• Human subject:
A living individual about whom an investigator conducting research obtains
• data through intervention or interaction with the individual, or
• identifiable private information (e.g. record review)
https://www.hhs.gov/ohrp/education-and-outreach/online-education/human-research-protection-training/lesson-2-what-is-human-subjects-research/index.html
49 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Human Subject in Research
Decision Tool: Am I Doing Human Subjects Research?
https://grants.nih.gov/policy/humansubjects/hs-decision.htm
50 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Codes & Guidelines
Declaration Of
Nuremberg Code The Belmont
Helsinki (1964-
(1949)
Report (1979)
2000)
QBRI/HBKU-
CIOMS/WHO International
SCH (2010)
Guidelines (1993, 2002)
IRB (2015/17)
51 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
The Nuremberg Code, 1947
Voluntary consent is essential. The experiments should yield fruitful results for the good of society.
Design experiments in a way that anticipated results will justify the performance of the experiment.
The experiment should be so conducted as to avoid all unnecessary physical and mental
suffering and injury. No experiment should be conducted where there is an a priority reason to
believe that death or disabling injury will occur.
The degree of risk to be taken should never exceed that determined by the humanitarian
importance of the problem to be solved by the experiment. The experiment should be
conducted only by scientifically qualified persons.
Proper preparations should be made, and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability, or death.
During the course of the experiment, the human subject should be at liberty to bring the
experiment to an end and the scientist in charge must be prepared to terminate the experiment at
any stage.
52 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
The Declaration of Helsinki, 1964
WITH UPDATES IN 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008 and 2013
The current version includes 37 principles for “medical research involving human
subjects”
The first 15 principles describe the basic responsibility of the physician to the
patient and the physician’s ethical responsibilities.
Principles 16-18 describe risks, burdens, and benefits
Principles 19-20 describe vulnerable groups and individuals
Principles 21-22 describe scientific requirements and research protocols
http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-media-type&footer-right=[page]/[toPage]
53 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
The Declaration of Helsinki, 1964
Principle 23 defines research ethics committees and their responsibilities
Principle 24 defines privacy and confidentiality
Principles 25-32 define informed consent
Principle 33 describes use of placebo
Principle 34 describes post-trial provisions
Principle 35 and 36 describe research registration and publication and
dissemination of results
http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-media-type&footer-right=[page]/[toPage]
54 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
The Belmont Report, 1979
National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research identify the basic ethical principles that should
underlie the conduct of biomedical and behavioral research involving
human subjects and to develop guidelines which should be followed to
assure that such research is conducted in accordance with those principles.
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
55 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Belmont Report
• In 1979 the National Commission published the Belmont Report.
• The Belmont Report identifies three basic ethical principles that underlie all
human subject research. These principles are commonly called the Belmont
Principles.
56 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
The Belmont Principles
• Respect for persons include:
• The requirement to obtain informed consent.
• The requirement to respect the privacy of research subjects.
• Beneficence include:
• The requirement to use the best possible research design to maximize
benefits and minimize harms.
• The requirements to make sure the researchers are able to perform the
procedures and handle the risks.
• The prohibition of research that is without a favorable risk-benefit ratio.
57 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
The Belmont Principles
• The principle of justice include:
• The requirement to select subjects equitably.
• The requirement to avoid exploitation of vulnerable populations or populations of
convenience.
• It was the Commission's intention that each of the three principles should have equal
moral force.
• Researchers required to consider each case separately and on its own merits in light of
all three principles.
58 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Informed Consent Process
Contents:
1. Purpose of the research
2. Procedures (duration) Voluntary Decision
3. Risks
No pressure
4. Benefits
5. Alternatives No undue-encouragement
6. Confidentiality
7. Withdrawal
8. Compensation
9. Who will contact
59 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Institutional Review Board (IRB)
• IRB is a review committee established to help protect the rights and
welfare of human research subjects. Regulations require IRB review
and approval for research involving human subjects.
• Most research institutions, professional organizations, and scholarly
journals apply the same requirements to all human research.
Although federal regulations refer to IRBs, an institution may have
chosen a different name for the committee (Ethics Review
Committee).
60 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
IRB protects:
1- The research subjects
2- The researchers
3- The institutes
4- The community
61 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
The Composition of the IRB
SCH regulations dictate that the IRB membership will include:
• At least five members.
• Members of both sexes.
• Members that come from varied professions.
• At least one member whose primary concerns are in nonscientific areas.
• At least one member whose primary concerns are in scientific areas.
• At least one member who is not otherwise affiliated with the institution.
62 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
The Authority of the IRB
SCH regulations stipulate that an IRB can:
• Approve research.
• Disapprove research.
• Modify research.
• Conduct continuing reviews.
• Observe/verify changes.
• Suspend or terminate approval.
• Observe the consent process and the research procedures.
63 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Consequences of Not Following IRB Regulations
If IRB regulations are not followed, consequences could include:
• Suspension of research project.
• Suspension of all of a PI's research projects.
• Inability to use data or publish results.
• Notification of sponsors, regulatory agencies and funding agencies of noncompliance.
• Inability to receive funding from federal grants.
• Additional monitoring and oversight by the IRB and/or third party monitoring of research
activities.
• Termination of employment.
• Loss of licenses.
• Immediate shut-down of ALL research at an organization.
64 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Exempt Research
Research is exempt from full board review and future review by the IRB
65 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Limitations for Exempt Research
66 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Categories of Exemption #1
• Research conducted in commonly accepted educational settings, involving
normal educational practices, such as:
• Research on special education instructional strategies, (Lectures ,Seminars,
etc..).
• Research on the effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods.
67 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Categories of Exemption #2
• Research involving the use of Survey Procedures, Interview procedures or
Observation of public behavior
UNLESS
• information is obtained and recorded by the investigator in such a way that
the subject can be identified, AND
• disclosure could reasonably place the subject at risk of criminal or civil
liability or be damaging to the subject’s financial standing, employability, or
reputation.
68 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Categories of Exemption #3
• Research involving the collection or study of existing data, documents,
records, pathological specimens, or diagnostic specimens
• If these sources are publicly available OR
• The information is recorded in a way that the subject can not be identified directly Or
through identifiers linked to the subject
69 SENS 601 - Research Methods and Ethics | Ethics in Research, Scientific Integrity, Etiquette and Misconduct | Dr. Yusuf Bicer
Thank You
SENS 601
Research Methods and Ethics