Responsible Research with Human Participants

Responsible Research with Human
Dr. Elizabeth Hill, Professor
IRB Chair
Voice: 313-578-0405
Fax: 313-578-0507
Cate Caldwell, PhD
Director, OSPRA
Voice: 313-992-1544
Fax: 313-993-1534
 Professional ethics
 Privacy and consent issues are concerns in many contexts
outside of research:
- E.g., American Medical Association, American Psychological
Association codes
- Federal privacy rules
- Health Insurance Portability and Accountability Act (HIPPA)
- Family Educational Rights and Privacy Act (FERPA)
- And others
 Research ethics
Research Ethics
 What is research?
RESEARCH is defined as “a systematic investigation,
including research development, testing and evaluation,
designed to develop or contribute to generalizable
Research Ethics
 What is research?
 Publication of results outside the university is a critical issue
 Distinct from practice
 Individual cases
 Distinct from teaching assessment
 Teaching evaluations
 Distinct from student projects in classes
 Ethical conduct is still required
Research Ethics
 What is research with human subjects?
 HUMAN SUBJECT is defined as “a living individual about
whom an investigator (whether professional or student)
conducting research obtains: (1) data through intervention
or interaction with the individual, or (2) identifiable private
 Research with animals also requires ethics review, conducted
by Institutional Animal Care and Use Committees
Research Ethics
Trigger Events
Ethical Milestones
The Nazi Experiments
Nuremberg Code, 1947
Tuskegee Syphilis Study
National Commission for
the Protection of Human
Subjects of Biomedical &
Behavioral Research, 1974
* Belmont Report, 1978
* Common Rule, 1991
The Belmont Report
The principles of the Belmont Report govern all research supported
by the U.S. Government. The ethical principles outlined in the
report are the basis for subsequent regulations designed to ensure
protection of human subjects in research.
Respect for Persons
The Belmont Report
1. Respect for persons
 Informed consent
 Protection of privacy and maintaining confidentiality
 Additional safeguards for protection of vulnerable populations to
prevent coercion or undue influence
 Protection of individuals with reduced autonomy
The Belmont Report
2. Beneficence
 maximize benefits and minimize harm
 an independent person/board must review all research and assess
the risk/benefit ratio
 this assessment includes evaluation of the study design and the
ability of the researcher
The Belmont Report
3. Justice
 selection of subjects must be equitable
o inclusion of appropriate populations without unnecessary
exclusion of populations-- fairness of inclusion and distribution
of results
 equitable distribution of research burdens and benefits
Federal Regulations
Current regulations were developed to comply with the principles in the
Belmont Report
Title 45 Public Welfare Department Of Health And Human Services National
Institutes Of Health Office For Protection From Research Risks
Part 46 Protection Of Human Subjects
Known as 45 CFR Part 46 or the Common Rule
 Federal protection of human subjects is overseen by the Office of Human
Research Protections (OHRP) at Health and Human Services (HHS)
Federal Regulations
 45 CFR 46
 A set of guidelines-- not meant to be rules
 Each institution interprets the guidelines for their types of
 Research facilities may require more than one review board,
depending on the variety of research conducted at the facility
UDM Policies
 ALL researchers/experimenters working with human subjects in
research investigations are required to obtain clearance from
UDM’s IRB PRIOR to running the experiments/studies
 See our website:
 ALL researchers/experimenters are required to complete the
online training course entitled “Program for the Protection of
Human Research Subjects” conducted by the Collaborative
Institutional Training Initiative
 See the website:
UDM Policies
 For all projects, regardless of the level of review, an
application must be submitted to the IRB prior to the
initiation of any research involving human subjects.
 Most federal agencies have a “Just-in-time” policy. That is,
you don’t need to have IRB approval at the time of proposal
submission, but you must have IRB approval prior to the
acceptance of award funds.
 The IRB chairperson is responsible for determining the
review status of each project.
 Three levels of IRB review / continuing review
UDM Policies
 Exempt- minimal risk to participants (risk equivalent to
everyday life)
o educational research
o anonymous surveys
o secondary/archival data
o naturalistic observation
o quality control
 Please note that exempt research projects still need to be
submitted to the IRB. Exemptions are granted by the IRB
UDM Policies
 Expedited
Only research in categories 1-7 in 45 CFR 46.110(b)(1) may be
reviewed through an expedited procedure.
This list of categories can be found on our website at
 Also, the study must
o Be no more than minimal risk
o Collect no sensitive information
o Not recruit protected populations as participants
o Not be classified research
UDM Policies
 Full Committee
o greater than minimal risk
o intervention/experimental studies which require
investigational new drug applications
o vulnerable subjects (prisoners, children, pregnant women)
o These decision tables and others can be found on the Health and
Human Services (HHS) Office for Human Research Protections
(OHRP) website at
UDM Policies
The Make-Up of UDM’s IRB
 At least 5 members with varying backgrounds
 Sufficient diversity (gender, race, expertise) to represent
research facility
 At least one member must be knowledgeable of all
institutional commitments, regulations, and applicable laws
 At least one member must be from outside the research
 At least one member must represent non-scientific interests
 For review of any project, the IRB can invite person(s) with
particular expertise as a temporary non-voting IRB member
UDM Policies
Goals of the IRB
 Review study design and determine risk/benefit of each
 Determine if all requirements of Informed Consent are
 Determine if additional safeguards are provided for
vulnerable populations
UDM Policies
 All forms, procedures, and meeting dates are available at
Proposals must be submitted on the provided form-- a Word file
available on the web page
Proposals submitted for exempt or expedited review may be
submitted at any time—plan on a 1-2 weeks for review
For consideration at a full committee review, the application must
be submitted three weeks prior to the next scheduled IRB
The full committee meets every two months
Exempt and Expedited categories of research are listed on the
UDM Policies
 Data with personal identification should be stored in a
confidential manner.
 To assure confidentiality, unless necessary all identification
should be removed from the actual data.
 When identification of data is necessary, information that would
enable the investigator to readily ascertain the identity of the
individual to whom the private information or specimens
pertain should be replaced with a code number.
 The key to decipher the code, enabling linkage of the
identifying information to the private information or
specimens, should be kept secure, separate from the data.
UDM Policies
Informed Consent:
Each subject must be informed of
 expectations of their participation- including time requirements
and procedural details
 contact information for the investigator and the IRB Chairperson
 expectations of risks and benefits (details of confidentiality,
voluntary nature of participation, with no penalty or loss of
benefits for nonparticipation or withdrawal, explicit statement
that subject may withdraw at any time, compensation, if any)
 details regarding the storage of information, including
identification of stored materials and access by others
Required elements of informed consent are listed on the
IRB webpage, along with an example consent form
UDM Policies
The responsibility for the protection of human subjects does not rest solely
with the IRB.
It is shared between the PI, and the IRB, and rests with the Institutional
Official (at UDM this is the Academic Vice President for Academic
 Institutional Official: AVP Pam Zarkowski
 Special Assistant to the AVP: Lisa Zessin
 IRB Chairperson: Elizabeth Hill
This shared responsibility includes appropriate training of all researchers.
 Cate Caldwell, Director of OSPRA, may also be able to answer your
UDM Policies
CITI ethics training course - online
Go to
Register as a new user (username and password)
Select University of Detroit Mercy
Select a learner group
e.g., Social/Behavioral, Biomedical, Students conducting no
more than minimal risk research,
Archives/Records/Specimens, Educational/Pedagogical
Complete the Basic Course (text and quizzes)
Q: My study participants will be minors. What additional
steps must I take?
A: Research with children or adolescents requires a parental
consent form and a child assent form. The assent form must
be written to be understandable by the age group of your
participants. (Assent forms for children 7-13 are written at
the 3rd grade level, forms for adolescents 13-17 are written
at the 5th grade level.) If the research is minimal risk, only
one parent must consent. If the research is more than
minimal risk, both parents must consent.
Q: If I assign a student research project in one of my classes, do
my students need to go through the IRB?
A: It depends. If the student plans to seek publication, then
yes. If it is only to complete the requirements of the course,
then no. However, it is important that the student take
ethical considerations into account, especially in studies with
more than minimal risk to participants. It is advisable that
they go through the IRB process in these cases, even though
they are not required to submit. (Some universities require
student research with more than minimal risk to go through
the IRB.)
Q: My study was approved by another IRB. Do I still need to
go through the UDM IRB?
A: Yes, but it is an abbreviated process. We ask that you
complete the Project Summary Form and attach the prior
Q: I want to recruit UDM students, faculty, or staff as study
participants on the UDM listserv. Do I need IRB approval to
do that?
A: Yes. The text of the recruitment script, the context in
which the recruitment takes place (e.g. posting a message on
a newsgroup, mass emailing, and websites created for
recruitment of participants) must be reviewed and approved
by the IRB. Please send all such messages to OSPRA and/or
the IRB chair for prior review before distribution.
Investigator Responsibilities
 to obtain IRB approval for all projects prior to recruitment of subjects
and compliance with all IRB determinations
protecting the rights of subjects according to 45 CFR 46
obtaining and documenting the informed consent for all subjects, as
ensuring that each potential participant understands the nature of the
research and their participation
fully debrief all subjects, when necessary
to inform the IRB of any unanticipated events during the conduct of the
to inform the IRB of any changes in protocol following committee
approval prior to implementation of changes-- must obtain IRB approval
for all protocol changes
report to the IRB the status of the protocol one year after approval and,
if necessary, submitting an extension