Header image designed by Michelle Jordan, UMBC Creative Services, 2009
Updates and Intrigue from the World of IRB
1
Learning Outcomes





Purpose of research compliance
Ethics behind/regulations governing research
human research
Definitions
Role of institutional compliance committees
Dilemmas
2
“Doing the right thing”
“Real integrity is doing the right thing, knowing that nobody’s
going to know whether you did it or not” - Oprah Winfrey 1
Various codes for the proper and responsible
conduct of human research have been
incorporated into researchers interact with
people and how universities conduct business.

Be aware of aspect of being a responsible researcher, know
how to conduct research appropriately and understand one’s
role in the research process
1 http://www.wow4u.com/oprahwinfrey/index.html
3
Circle of compliance
Administration
Compliance
Units
Research
Compliance
Researchers
Compliance
Committees
Required by the federal government as well as the University of
Maryland for the ethical review of research and ensure participants
rights are protected and that they are safeguarded from risk and harm
4
To do the right thing, know about the
ethics

45CFR46 - Protection of Human Subjects - ensures minimal
standards for the ethical treatment of research subjects based on past history

Foundations of ethics in human research



Respect for persons – freedom to make a choice and voluntarily
participate
Beneficience – freedom from harm with maximizing benefits and
minimizing risks
Justice – fair distribution of benefits/risk of participating in
research (impose risks unnecessarily/advantage of benefits who
can afford them)
Protection from risks and safeguard from
harm
5
Understand what research is:

Systematic investigation that contributes to
generalizable knowledge


"Research" is defined in the Code of Federal Regulations as "a
systematic investigation that contributes to generalizable
knowledge" In other words, an investigator will be "engaged in
research", has proposed an intention to explore a particular topic,
while interacting with a living person and either publish (e.g., in
a journal) or present at a conference.
Living individuals about whom an investigator
conducting research obtains data through
intervention or interaction with the individual or
identifiable private information
6
Intrigue
Fascinate
Captivate
http://www.youtube.com/watch?v=y8Kyi0WNg40
7
Institutional Review Board (IRB)


Required by Federal regulation
Provides assurance to comply with the rules and
regulations oversight for the university's human research
use program




Ethical review of research
Ensure participants rights are protected and that they are safeguarded from
risk and harm
Compliance with federal guidelines and principles
Supported by the Vice President for Research
8
IRB oversight
Safeguards from harm




Emotional or psychological harm
Social harm
Financial harm
Legal harm
Protections from Risks

greatest risk is often a breach of confidentiality
risk could lead to social stigma, loss of employment, embarrassment , etc.
Opportunities for voluntary participation

the “consent process” – the process that involves a conversation
that most of the time uses a document
Purpose, Procedures, Confidentiality, Risks, Benefits , Freedom to withdraw
9
IRB Membership

Members include:

Scientists and non scientists from various disciplines on campus as well as
graduate and undergraduate student members, including:







Psychology
Africana Studies
Information Systems
Modern Languages and Linguistics
Sociology/Anthropology
Public Policy
Individuals not affiliated with the Campus who represent the concerns of the
Community
10
IRB process
11
The IRB reviews:
Low or less than risk

Assessment of classroom management strategies

Action research

Analysis of census data

Publicly available information recorded in such a manner that subjects cannot be identified

Surveys or interviews of nonvulnerable adults about nonsensitive topics
Minimal Risk

Research where disclosure of the participant’s identity might result in negative legal, financial, economic or social
consequences

Longitudinal or repeated-measures studies

Interviews or surveys on sensitive topics where the subject can be identified

Studies involve the possibility of a moral wrong
More than Minimal Risk

Research studies that involve vulnerable populations, or involve special circumstances. Sensitive topics include: sex,
drugs, alcohol use, suicide.
May not require IRB review

Activities that are not hypothesis driven

Data collected for educational or teaching purposes and is not disseminated outside the institution.

Literature review to support research purpose or research question

Surveys issued or completed by University personnel for the intent and purposes of improving services and programs of the
University
12
Campus Assessment Coordinating
Committee (CACC)


created by UMBC to coordinate assessment activities
centrally track and authorize survey requests and





improve the quality and usefulness of assessment activities on campus
develop an effective strategy for survey management and data collection
coordinate and approve internal and external requests to survey UMBC
students, alumni, staff, and/or faculty
CACC approves surveys that require access to institutional
data/contact information
Supported by the Office of Institutional Research
13
CACC membership







Institutional Research
Academic Affairs
Human Resources
Student Affairs
Institutional Advancement
Office of Information Technology
Residential Life
14
CACC process
15
CACC responsibilities





solicits requests
reviews internal and external requests to survey UMBC
students, alumni, staff, and faculty
interacts with use and compliance entities (IRB, Registrar/
Alumni Affairs/Human Resources, FERPA and other
regulations)
provide advice and guidance with questionnaire design,
sampling, etc.
maintains repository for contributed survey reports
Does not replace the functions of the IRB
16
Examples of CACC review





Importance: Does it provide useful information for academic planning purposes? Does it
provide useful feedback to those providing services to students, alumni, staff, or faculty?
Are other peer institutions conducting the survey and will peer data be available?
Dissemination and Use of Information Collected: Who will have access to the information
collected and how will they use it?
Content and Design of Survey: Is the survey well designed? Is the content appropriate?
Does it follow sound survey methods and practices? Is it of appropriate length? Are the
questions easily understood and interpreted?
Population and Sampling Methodology: What is the target population? Is there a sampling
strategy? What is the sampling methodology and is it sound? What strategies will be used to
ensure adequate response rates? How will confidentiality of responses be ensured?
Timing: Does the project schedule conflict with another approved survey project?
Review and approval usually within two business days
17
Student Affairs Research and the IRB

Special considerations


Ethical considerations in conducting research
Understand and following campus and federal
requirements for conducting an assessment or
program evaluation study



Training
Type of review
Need for review?
18
Examples
www.vancouver2010.com
19
Example #1
Survey designed to assess the level of student interest
and involvement in activities prior to entering
campus or during their freshman year. In four years,
a similar survey will be administered to seniors to
assess the level of faculty support for these activities
and evaluate student interest and involvement in
courses and initiatives offered at the university to see
if the campus is meeting the needs of the students.
Need IRB and/or CACC approval?
20
Example # 2
A student seeks to learn more about customer
behavior. He plans to share his results with
his colleagues in his honor society by posting
the outcome on the society web site. He will
interview children at local middle schools
about their candy purchases. He will record
their names and ages.
Need IRB and/or CACC approval?
21
Example # 3
A survey is proposed to assess the rider-ship of
campus/community transportation. The results
will inform the department of performance
issues and rider's needs. The data and
information gathered will inform scheduling
and routing of the campus’ transit routes.
Need IRB and/or CACC approval?
22
Example # 4
Survey assessment project to measure and understand
the perceptions of the campus climate for a variety
of UMBC student subpopulations, such as
ethnic/racial groups, commuter and transfer students,
and of diversity and/or harassment. The data and
results will be used to improve programs and
services offered on campus to better serve specific
student subpopulations. Results will be also be
presented at a conference.
Need IRB and/or CACC approval?
23
Example # 5
Survey was designed by the National Clearinghouse for
Commuter Publications to better understand the
unique needs of off-campus students. It will allow
the Office of Off-Campus and Transfer Student
Services to improve existing programs and services
and the marketing of those programs and services. It
could also inspire the creation of new programs
within the office.
Need IRB and/or CACC approval?
24
5523 Research Park Drive
Suite 310
Baltimore, MD 21228
[email protected]
www.umbc.edu/ressearch/HARPO
410-455-3868 (FAX)
Tim Sparklin: 410-455-2737
Mary Lilly: 410-455-3958
25
Descargar

Human and Animal Research Protections Office (HARPO)