Dr. Elizabeth Hill, Professor IRB Chair Voice: 313-578- 0405 Fax: 313-578-0507 E-mail: [email protected]u Responsible Research with Human Participants Cate Caldwell, PhD Director, OSPRA Voice: 313-992- 1544 Fax: 313-993-1534 E-mail: [email protected]du
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Dr. Elizabeth Hill, ProfessorIRB Chair Voice: 313-578-0405 Fax: 313-578-0507E-mail: [email protected]
EthicsProfessional ethicsPrivacy 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 othersResearch ethics
Research EthicsWhat is research?
RESEARCH is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”
Research EthicsWhat is research?Publication of results outside the university is
a critical issueDistinct from practice
Individual cases Distinct from teaching assessment
Teaching evaluationsDistinct from student projects in classes
Ethical conduct is still required
Research EthicsWhat 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 information
Research with animals also requires ethics review, conducted by Institutional Animal Care and Use Committees
Research EthicsTrigger 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 ReportThe 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 Beneficence Justice
The Belmont Report1.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 Report2. 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 Report3. 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 RegulationsCurrent 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 Rulewww.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
Federal protection of human subjects is overseen by the Office of Human Research Protections (OHRP) at Health and Human Services (HHS)
www.hhs.gov/ohrp/
Federal Regulations45 CFR 46A set of guidelines-- not meant to be rules
Each institution interprets the guidelines for their types of research
Research facilities may require more than one review board, depending on the variety of research conducted at the facility
UDM PoliciesALL 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: http://www.udmercy.edu/academicaffairs/ospra/irb/index.htm
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: http://www.citiprogram.org
UDM PoliciesFor 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 PoliciesExempt- minimal risk to participants (risk
equivalent to everyday life)o educational researcho anonymous surveyso secondary/archival data o naturalistic observationo quality control
Please note that exempt research projects still need to be submitted to the IRB. Exemptions are granted by the IRB chair.
UDM PoliciesExpedited
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 http://www.udmercy.edu/academicaffairs/ospra/irb/guidelines/index.htm#ExemptionExpedited
Also, the study musto Be no more than minimal risko Collect no sensitive informationo Not recruit protected populations as participantso Not be classified research
UDM PoliciesFull Committee
o greater than minimal risko intervention/experimental studies which require
investigational new drug applicationso 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
At least 5 members with varying backgroundsSufficient diversity (gender, race, expertise) to
represent research facilityAt least one member must be knowledgeable of
all institutional commitments, regulations, and applicable laws
At least one member must be from outside the research facility
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 PoliciesGoals of the IRBReview study design and determine
risk/benefit of each projectDetermine if all requirements of Informed
Consent are fulfilledDetermine if additional safeguards are
provided for vulnerable populations
UDM PoliciesAll forms, procedures, and meeting dates are available
at http://www.udmercy.edu/academicaffairs/ospra/irb/index.htm
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 meeting
The full committee meets every two monthsExempt and Expedited categories of research are listed
on the website
UDM PoliciesConfidentialityData 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 PoliciesInformed Consent: Each subject must be informed ofexpectations of their participation- including time
requirements and procedural detailscontact information for the investigator and the IRB
Chairpersonexpectations 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 PoliciesThe 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 Affairs).
Institutional Official: AVP Pam ZarkowskiSpecial 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 questions.
UDM PoliciesCITI ethics training course - onlineGo to www.citiprogram.org.Register as a new user (username and
password)Select University of Detroit MercySelect a learner groupe.g., Social/Behavioral, Biomedical, Students
conducting no more than minimal risk research, Archives/Records/Specimens, Educational/Pedagogical Research
Complete the Basic Course (text and quizzes)
FAQsQ: 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.
FAQsQ: 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.)
FAQsQ: 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 approval.
FAQsQ: 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 determinationsprotecting the rights of subjects according to 45 CFR 46obtaining and documenting the informed consent for all
subjects, as appropriateensuring 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 protocol 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