Institutional Review Board, Human Subjects Research, and Ethics: The Responsible Conduct of Research

1
Institutional Review Board,Human Subjects
Research,and Ethics The Responsible Conduct
of Research
The University of Texas at El Paso General
Compliance Training
2
Institutional Review Board (IRB)and Human
Subjects Research

• The following topics will be covered in this
  section
• What are the basic ethical principles of the
  Belmont Report?
• What is the Institutional Review Board?
• What authority does the IRB have?
• What is a good definition for research and
  human subject?
• Can identifiable private data be taken from
  research that can be linked to the subjects?
• How do I know if I need to submit a protocol form
  for IRB approval?
• What are the elements needed in an informed
  consent document?
• When can I begin data collection from human
  subjects?
• Who is responsible for reporting any
  problems/injuries with research subjects?
• Where can I find out more information?

3
What are the Basic Ethical Principlesof the
Belmont Report?

• The Belmont Report, which was issued April 18,
  1979 after a
• conference held in February 1976 at the
  Smithsonian Institutions
• Belmont Conference Center in Maryland, identified
  three basic
• ethical principles that should govern human
  subject research.
• These three principles are
• respect for persons,
• beneficence and
• justice.

4
What are the Basic Ethical Principlesof the
Belmont Report? (continued)
Respect for Persons Each research subject is an
individual capable of making up his or her own
mind about whether to participate in a research
study. Research subjects that have a diminished
capability (whether they are immature,
incarcerated or incapacitated) are vulnerable.
They receive special protection under federal law
(45 Code of Federal Regulations Part 46).
5
What are the Basic Ethical Principlesof the
Belmont Report? (continued)
Beneficence Comes from the Hippocratic maxim do
not harm. Subjects in a research study should
be protected from research risks, have their
decisions respected and their well-being assured.
Researchers need to maximize possible benefits
and minimize possible risks to subjects. An
informed consent document is usually required to
communicate the risk/benefit ratio and other
relevant information to subjects.
6
What are the Basic Ethical Principlesof the
Belmont Report? (continued)
Justice Implies that subjects should be selected
equitably. No one group of subjects, such as the
economically disadvantaged or the
institutionalized, should continually bear the
burden of research.
7
What is the IRB?

• The Institutional Review Board (IRB) at The
  University of Texas at El Paso (UTEP) is a
  committee representing various research
  disciplines.
• It was established by federal law (45 Code of
  Federal Regulations Part 46) and the Multiple
  Project Assurance document signed by UTEP and
  federal officials at the Office for Human
  Research Protections (OHRP).
• The IRB oversees all research involving human
  subjects conducted by faculty, students, or
  staff or the usage of any University property or
  non-public information to contact human research
  subjects.
• IRB members are of varied professions and
  genders. Members may be scientists or
  nonscientists, and some members have no
  affiliation with UTEP.

8
What Authority Does the IRB Have?

• The IRB has the authority to approve, disapprove
  or modify research protocols. The committee can
  also suspend or terminate its approval of a
  research activity.
• The committee uses a deliberative process to
  review protocols. Protocols can either be exempt
  from IRB review reviewed by expedited (review by
  members) or full committee review (review by a
  quorum of members).

9
What is a Good Definition for Research and
Human Subject?

• 45 Code of Federal Regulations Part 46.102 (d)
  defines research as a systematic
  investigation, including research development,
  testing and evaluation, designed to develop or
  contribute to generalizable knowledge.
• 45 CFR 46.102 (f) lists a human subject as 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.

10
Could Private Data be Taken from Research that
Can be Linked to the Subjects?

• It is important that you determine the nature of
  your research data i.e., does it include
  documents, records, pathological specimens, or
  diagnostic specimens. Determine whether the data
  is public or non-public the information that you
  collect can be linked directly or indirectly back
  to the research subjects or if it is entirely
  anonymous.
• Research protocols may be exempt if the data you
  are collecting
• Existed before your research begins
• Is publicly available, and
• Is anonymous.

11
How Do I Know if I Need to Submit a Protocol Form
for IRB Approval?

• If you are engaged in a research project where
  there is an intervention or interaction with a
  living person from whom data/information/specimens
  (identifiable or unidentifiable) will be
  collected using public or non-public sources, you
  are required to submit a protocol form, informed
  consent, questionnaires, and any approval letter
  (from school districts, clinics, hospitals, etc.)
  needed in your particular project.
• This policy applies to all research involving
  human subjects, regardless of funding.

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What Happens Once I Submit the Form?

• Principal Investigators (PIs) submit the protocol
  form and all other documents to the Office of
  Research and Sponsored Projects (ORSP)
  Institutional Review Board (IRB) via IRBNet
  (www.irbnet.org).
• The ORSP reviews the protocol for completeness
  and makes a preliminary determination of the
  review status as exempt, expedited or requiring
  full committee review.
• PIs are generally required to have an IRB
  protocol in pending status before submission of
  a grant application.

13
What Happens Once I Submit the Form?

(continued)

• IRB approval can take two weeks or more to
  complete, depending upon the research project
  involved.
• The protocol must be approved by the IRB before
  any research data collection may begin.
• You will receive an email notification from ORSP
  via IRBNet when the protocol has been approved.
• In your study documents at www.irbnet.org, your
  memo of determination will be available to you
  and your collaborators to be used as needed.

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What Happens Once I Submit the Form?

(continued)

• Protocols are usually approved for a one year
  period.
• PIs must submit their protocols for review at
  least two weeks before the expiration date, and
  is to be reviewed annually until the research has
  concluded.
• ORSP will send a notice of renewal to the PI
  prior to the protocols expiration.
• All changes to the protocols, once approved, must
  be submitted for subsequent review prior to
  implementing any changes.

15
What Are the Elements Needed in an Informed
Consent Document?

• These 10 basic parts should be included in your
  statement of
• informed consent to research subjects
• Purpose of the research, time or costs the
  subject will spend to participate, and a full
  description of all the procedures to be used with
  the subject (in simple terms).
• Risks to the subject.
• Benefits of participating in the research
  project.
• Alternative procedures or treatments.
• Procedures for safeguarding confidentiality of
  records.
• Compensation or medical treatment available for
  injury, if applicable.

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What Are the Elements Needed in an Informed
Consent Document? (continued)

• Contact the ORSP for any questions, injuries or
  for the names and phone numbers of PIs and
  Institutional Coordinator for Research Review.
• Participation is voluntary, and the subject may
  end his/her participation at any time without any
  penalty
• Space for signature date by participant (and
  parent or guardian, if needed) and PI unless a
  waiver of signed consent has been granted by the
  IRB.
• A Spanish (or other subjects languages)
  translation of the English version of the
  informed consent (depending upon the subjects to
  be included in the research) at the level of
  language appropriate for those particular
  subjects.

17
When Can I Begin Data Collectionfrom Human
Subjects?
The involvement of human subjects in research,
including faculty or staff projects, surveys,
theses, dissertations and all student human
subject research projects, may not begin until
the IRB has reviewed and approved the research
protocol, informed consent, and testing
instruments. Approval letters for off campus
research performance sites (such as school
districts, clinics, hospitals, etc.) must be on
file with this office before the study data
collection may begin.

18
When Can I Begin Data Collectionfrom Human
Subjects? (continued)
The PI will receive an email notification
confirming approval of the protocol. In the
study documents at www.irbnet.org, your memo of
determination will be available to you and your
collaborators to be used as needed. Once IRB
approval has been obtained, the PI must obtain
appropriate informed consent from each subject
prior to collecting research information.

19
Who is Responsible for Reporting any
Problems/Injuries with Research Subjects?

• PIs will promptly report to the IRB any injuries
  or other unanticipated problems encountered
  during the course of the research study.
• PIs should call the Office of Research and
  Sponsored Projects (ORSP) at 915-747-8841 to
  report research-related injuries or problems.

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Ethics The Responsible Conduct of Research

• The following topics will be covered in this
  section
• What is misconduct in science?
• What constitutes fabrication of research data?
• Describe falsification in reporting on research
  findings.
• Plagiarism How do I know if I have pirated
  someones ideas?
• How can I avoid conflict of interest situations?
• How do I renew or make changes to an approved IRB
  protocol?
• When do I cease research on an approved IRB
  protocol?
• How do I file an amendment to my approved
  protocol?
• What do I do if problems/injuries occur with my
  subjects after IRB approval of my research?

21
What is Misconduct in Science?
According to the Office of Research Integrity,
DHHS, Misconduct will be limited to
fabrication, falsification, or plagiarism in
proposing, performing or reviewing research or in
reporting research results. (From ORI Annual
Report, 1999)
22
What Constitutes Fabrication ofResearch Data?

• Fabrication of data means that a scientist
  manufactures a fake set of research results,
  makes up data or distorts the truth of the
  experiment.
• An example would be a researcher who concocts
  fake data to plot a graph, thus inventing false
  research conclusions.

23
Describe Falsification in Reportingon Research
Findings

• Falsification implies an alteration of data, or
  distortion of experimental results.
• For example, a scientist might falsify the
  scoring of taped interviews with subjects. The
  data exists, but has been manipulated and
  misrepresented.

24
Plagiarism How Do I Know if I Have Pirated
Someones Ideas?
When a researcher lifts another persons text,
pictures, cartoons, quotations, surveys, graphs,
or other ideas into his/her own research paper,
without clearly stating who is really responsible
for the work, this is plagiarism. Edward E.
David, Jr. in Ethics and Values in Science, from
a presentation at the February 25-26, 1993 Sigma
Xi forum on Ethics, Values and the Promise of
Science, defines Plagiarism - appropriating
without proper credit not only others words, but
also their ideas.
25
How Do I Avoid Conflict of Interest Situations?
UTEPs policies/procedures for Management of
Conflict of Interest in Sponsored Research
states A potential conflict of interest occurs
when an individuals private interests compete
with his/her professional obligations to the
University to a degree that an independent
observer might reasonably question whether the
individuals professional actions or decisions
are determined by considerations of personal
gain, financial or otherwise. Federal
regulations address such conflicts when a
significant financial interest could affect or
may be reasonably expected to bias the design,
conduct or reporting of NSF and/or HHS sponsored
research.
26
How Do I Avoid Conflict of Interest Situations?
(continued)
A researcher (including his spouse and dependent
children) has a significant financial interest in
a company if his/her salary (consulting fees or
honoraria), equity interests (stocks), or
intellectual property rights (royalties) exceed
10,000 or are more than five percent ownership
interest. Could any of my or my immediate
familys financial interests potentially be
affected in any way by my current or proposed
grant/contract supported research? At UTEP, if
a researcher answers yes to this question,
he/she should disclose this financial interest to
the ORSP as a potential conflict of interest.
27
How Do I Avoid Conflict of Interest Situations?
(continued)
An example of a conflict of interest situation
would be a physician working at a University
laboratory who has a significant financial
interest (stock) in a large pharmaceutical
company. He also benefits from research dollars
coming back to fuel his drug testing from that
company. He stands to gain from the increased
value of his stock in the pharmaceutical firm,
when the drugs do well on the market.
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How Do I Renew or Make Changes to an Approved IRB
Protocol?

• Continuing (annual) IRB review of an approved IRB
  protocol must
• be handled in a substantive and meaningful manner
  by the IRB
• before the protocol expiration date (see last
  approval memo for
• expiration date). The researcher (PI) will be
  reminded via email
• that his/her protocol is expiring. Researchers
  need to submit a
• renewal request via www.irbnet.org at least two
  weeks before
• protocols expiration date. The progress report
  questions are
• located in the online document library and this
  must be included
• with the request along with current consent
  documents and any
• changes they wish to make in their protocol and
  other documents
• related to the study. Researchers may elect to
  terminate their
• protocol if the study is no longer active.

29
When Do I Cease Research on an Approved IRB
Protocol?

• A protocol is considered expired at the end of
  its protocol
• period. All research related to this study must
  cease unless a
• renewal request has been approved by the IRB.
  This renewal
• request must be submitted via www.irbnet.org at
  least two weeks
• before the study expiration date. The IRB office
  will process the
• renewal through IRB review. You will be notified
  by email when the
• review process is complete. The determination
  letter will be
• available with other study documents at
  www.irbnet.org.

30
How do I File an Amendment to My Approved
Protocol?

• An approved IRB protocol may be modified during
  its protocol
• period by submitting a revision package via
  www.irbnet.org.
• This package must include informed consents,
  procedures,
• research sites, subjects, testing instruments, a
  change in PI,
• etc. The PI needs to identify the nature of the
  changes in the
• amendment request i.e., additional questions in
  a survey
• instrument, change in data collection method,
  etc. All amended
• documents need to be included in the revised
  package submitted
• on www.irbnet.org. If a research site is being
  added, an approval
• letter from that site is required in order to
  receive IRB approval.

31
How do I File an Amendment to My Approved
Protocol? (continued)

• When an amendment is approved by the IRB, the
  original
• protocol period (from the date the protocol was
  first approved or
• the last renewal approval) will stay in force for
  the amendment
• approval. Example If a protocol was initially
  approved for a
• protocol period of January 1, 2007 through
  December 31, 2007,
• and an amendment to that protocol is presented in
  June, 2007, the
• date of the amendment approval will reflect the
  date the IRB
• approved the protocol amendment, but the protocol
  period listed on
• the amendment approval will remain January 1,
  2007 through
• December 31, 2007.

32
What Do I Do if Problems/Injuries Occur With My
Subjects after IRB Approval of My Research?

• The PI of a research project has the
  responsibility to protect
• the rights and welfare of human research
  subjects. This includes
• requirements to provide each subject with an
  IRB-approved
• informed consent document, and to promptly report
  to the IRB
• office via phone or email any injuries, adverse
  events, unexpected
• problems, or additional risks of harm or
  discomfort previously
• unrecognized if encountered during the course of
  the study.

33
Where Can I Find Out More?

• Office of Research and Sponsored Projects (ORSP)
• Administration Building, Room 209
• 915-747-5680 or irb.orsp_at_utep.edu
• Institutional Review Board Administrator
• Administration Building, Room 209
• 915-747-5680 or irb.orsp_at_utep.edu
• Office of Research and Sponsored Projects
• Institutional Review Board
• http//research.utep.edu/Default.aspx?tabid47162
  
• Office for Human Research Protections (OHRP)
• http//www.hhs.gov/ohrp/

34
Thank You

• If you are a UTEP employee, a copy of the
  completion certificate for this training module
  needs to be included when submitting a protocol
  to the ORSP Office, unless you have submitted one
  to that office within the past three years.

35
EDPC 5310 Applied Research Design for Educators

• Evaluating Research Reports

36
Major Sections of a Research Report

• Introduction
• Review of Literature
• Results
• Conclusions, Recommendations, and Implications

37
Major Elements of Each SectionI. Introduction

• Research problem
• Research hypothesis
• Variables
• Significance of the research

38
Major Elements of Each SectionII. Review of
Literature

• Reference should be clearly relevant to the
  studied issue.
• Logical flow
• Connecting to the studied issue
• Background information, researchers knowledge
  about the issue.

39
Major Elements of Each SectionIII.
Methods/procedure

• procedure and when each step will take place
• Operationize variables describe Instruments
• Do data sufficient for answering research
  questions or test research hypotheses?
• Is the research design appropriate for answering
  research questions or research hypotheses?
• Sampling technique, sample size
• Analytical procedure Vs. Research questions or
  Research hypotheses?
• Factors that might affect the results of the
  study (validity, reliability)
• The clarity of writing so the reader is able to
  understand the research project.

40
Major Elements of Each SectionIV. Results

• Appropriately and clearly report results from
  data analysis
• 1. organization of the presentation of results
• Tables, its formats, and titles
• Report of critical statistics
• Results for each research question or hypothesis
• Level of confidence

41
Major Elements of Each SectionConclusions,
Recommendations, and Implications

• Address external validity issues of the study and
  closure of the entire study.
• Conclusions not results
• Interpretation of results
• Possible limitations
• Practical significance
• Address generalisability
• Recommendations
• Consistency/inconsistent with existing references
• Summary statement

42
Review

• List one element for each section.

43
Fundamental Concepts of Statistics

• Statistics
• Describing data
• The application of data to the studied issue.

44
Data AnalysisDescriptive Statistics

• Distributions
• Observations/scores of studied variables.
• Frequency distribution
• Histogram
• Poll in class and demonstration

45
Frequency of Distribution

• number of observations falling into each of
  several ranges or category.
• Data Set High Temperatures for 30 Days
• 50 45 49 50 43 49 50 49 45 49 47 47 44 51 51 44
  47 46 50 44 51 49 43 43 49 45 46 45 51 46
• Cumulative Frequency Distribution for High
  Temperatures

Temperature 51 50 49 48 47 46 45 44 43 Tally //// //// ////// /// /// //// /// /// Frequency 4 4 6 0 3 3 4 3 3 Cumulative Frequency 30 26 22 16 16 13 10 6 3
46
Frequency Distribution
Options Degree of agreement Number
1 Strongly agree 20
2 Agree somewhat 30
3 Not sure 20
4 Disagree somewhat 15
5 5 Strongly disagree 15
47
Frequency Polygon
48
Frequency Histogram
49
Data AnalysisDescriptive Statistics

• Measures of Central Tendency
• Location of a distribution
• Measures of Variability
• The dispersion of a distribution

50
Understand Group Performance

• Central tendency
• Statistics that describe the typical value of a
  data set
• score(s) with the most frequency
• The score that has an equal number of points
  above and below it
• The arithmetic average score of a data set

51
Computing Central Tendency

• Mode
• Median
• Arranging score in a descending/ ascending order
• Odd number of scores the score of the middle
• Even number of scores sum up the two scores in
  the middle, and then, divide the sum by 2
• Mean
• Sum up all scores, then divide the sum with the
  number of scores

52
Measures of variability

• How scattered the scores are?
• Range
• the distance between the highest score and the
  lowest score of a data set
• Variance
• The difference of an individual score away from
  the mean
• Standard distribution
• The average difference of scores away from the
  mean

53
Computing Measures of Variability

• Range
• Variance
• s2 S ( Xi - µ )2 / N
• s2 S ( xi - M )2 / ( n - 1 )
• Standardized Deviation
• Square root of variance

54
Score Distribution

• Normal Distribution
• Negatively skewed distribution
• Positively skewed distribution

55
Shapes of Distributions

• Normal distribution and Skewed distributions
• Negative skewed distribution

56
Standard Scoresz score

• Properties of standard scores
• Identical distribution as that of observation
• Mean
• Standard distribution

57
Correlation A measure of Relationship

• A relationship between two variables
• r
• Sign indicated
• The number indicate

58
Data AnalysisInferential Statistics

• Inferred from statistics computed from sample
• Statistics Vs. parameter

59
Testing Hypotheses and Estimating Parameter

• Testing Hypotheses
• Step1 State the null and alternative hypotheses
• Step 2 Establish sampling distribution for the
  null hypotheses
• Step 3
• Step 4 Reference the sample statistics in the
  sample distribution
• Step 5
• Significance
• Determined by researchers
• Common value for social science p

60

• Confidence interval

61
Possible Errors in Hypothesis Testing
Null Hypotheses True Null Hypotheses False
Accept Correct Error
Reject Error Correct
62
Summary

• A Central Tendency
• B Measurement of variability
• 1. Mean
• 2. Range
• 3. Standard deviation
• 4. Mode

63
Identify data distribution

• A Normal Distribution
• B Positive Skewed Distribution
• C Negative skewed distribution

64

• A Normal Distribution
• B Positive Skewed Distribution
• C Negative skewed distribution

65
A Mean B Median C Mode

• 1. Sum up all scores, then divide the sum with
  the number of scores
• 2. The score with the most frequencies.

66

• Questions?