education research and social & behavioral science irb
TRANSCRIPT
Education Research and Social & Behavioral Science
IRB
BACKGROUND
Nuremberg Code Infamous Cases 1950’s through 1970’s 1971 - DHEW Guidelines Pamphlet 1979 - Belmont Report 1981 - 45 CFR 46
FWA
Agreement between UW and DHHS which allows for the conduct of HS research
OHRP/Common Rule UW will be guided by the ethical principals of
the Belmont Report regardless of source of funding
UW IRB WILL REVIEW IF:
Research is sponsored (i.e. funded) by UW Conducted by, or under the direction of, any
UW employee Uses UW property or facilities Requires non-public UW information to
identify or contact subject
DEFINITIONS
Research 46.102(d) A systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to generalizable knowledge
Human Subject 46.102(f) A living individual about whom an investigator
obtains data through intervention or private information
RISK
For a study to be considered “minimal risk”, the risks associated with participating in the study must be equal to or less than the level of risk a participant will encounter in their daily lives
Acknowledgement of risk is acceptable and expected. What the IRB wants to see is the ways you will mitigate those risks (for example, encrypting data, pseudonyms, etc.)
STUDENT RESEARCH
All students conducting human subject research must obtain IRB approval Senior Thesis Hilldale Awards Independent Study Master’s Thesis Doctoral Dissertation
STUDENT RESEARCH
Class Projects May be research if Federal definition is met If the results are for course credit/class
assignment and will not be disseminated beyond the University, IRB approval is probably not required
Course assignments that are not research must be carried out ethically to protect individuals involved
INFORMED CONSENT
Informed consent is a process with its basis in ethical principals – it’s not just a signature Written, signed consent is the default Oral Consent
Literacy concerns Cultural Norms Protection of Participants
Waiver of Documentation of Consent The only link to participants is the signed consent
document
INFORMED CONSENT
Assent Waiver of Consent Waiver of Parental Consent HIPAA Authorization
If the researcher works for or is a member of a HIPAA protected entity
PHI is being collected Passive consent
ELEMENTS OF INFORMED CONSENT
1) Statement that the study involves research Identify it as a UW-Madison research project
2) Description of any risks Can be emotional Risk of a breach of confidentiality
3) Description of any benefits to the subject There are typically NO direct benefits to participating in
research
4) Disclosure of alternative procedures
ELEMENTS OF INFORMED CONSENT 5) Confidentiality of records
Use of pseudonyms Data encryption Password protected laptop Use of audio or video recording
6) If more than minimal risk – steps the research will take to mitigate those risks
7) Contact information for answers to pertinent questions
8) Statement that participation is voluntary Participants can withdraw at any time, skip any
questions they do not wish to answer
ELEMENTS OF INFORMED CONSENT
Compensation – Compensation is NOT a benefit Parking pass Gift cards Drawings, raffles Extra credit If cash is offered, is the amount coercive?
Use the IRB Consent Wizard
The IRB wizard is a tool to help ensure all federally required elements of consent are included:
https://rcr.gradsch.wisc.edu/cfwizard/start.asp?wisc
The majority of modifications requested by the IRB are due to consent form errors. Use the wizard to avoid these errors.
WAIVERS OF INFORMED CONSENT
Waiver of documentation of informed consent Only document linking subject to research and
principal risk is breach of confidentiality Minimal risk and involves no procedures for
which written consent is normally required outside of research
WAIVERS OF INFORMED CONSENT
Waiver of Informed Consent Minimal Risk No adverse affect to rights & welfare of
subjects Research could not practicably be carried out
without waiver If possible, provide subjects with additional
information after participation
EXEMPT RESERACH
Falls within one of the six categories listed at 45 CFR 46.101(b)(1-6)
Minimal Risk Is human subject research, but is “exempt”
from the regulations IRB - not the PI - determines exemption Does not require full IRB review
EXEMPT CATEGORIES
Conducted in established or commonly accepted educational settings, using normal educational practices
Educational tests, survey or interview procedures or observation of public behavior unless information is identifiable and sensitive
EXEMPT CATEGORIES
Educational tests, survey or interview procedures or public observation not exempt under the previous item if subjects are elected or appointed public officials or Federal statutes require confidentiality
Collection or study of existing data or documents if they are publicly available or anonymous
EXPEDITED REVIEW
Minimal risk Falls within one of the categories found at 45
CFR 46.110 All the regulations apply (unlike exempt) The full IRB does not review the protocol
CATEGORIES ELIGIBLE FOR EXPEDITED REVIEW
Research on individual or group characteristics or behavior or employing a survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
CHILDREN AS SUBJECTS
In most cases, children may participate only if the research involves no more than minimal risk
Consent of parent or guardian Assent of the child
Age appropriate language Written assent age 11 and up Oral assent age 10 and under
INTERNATIONAL RESEARCH
Guidelines for International Research Cultural, political or economic conditions that
would increase risk to participants Local IRB or ethics committee Local contact for questions Consent forms in native language of
participants Because traveling internationally increases the
risk of a confidentiality breach, you will need to encrypt your data.
INTERNATIONAL RESEARCH
Consider the most appropriate method for obtaining informed consent Take into account the literacy level of
participants, cultural norms and confidentiality concerns.
All key personnel must complete CITI training, even if they are from outside the U.S.
In many cases it won’t be possible to expedite international protocols.
INTERNET RESEARCH
Surveys administered via the internet How sensitive is the data Security Confidentiality Consent Issues
FaceBook Blogs Chat rooms
Expectation of privacy by the subject Minors
COLLABORATION WITH OTHER INSTITUTIONS
Must be a UW PI PI’s must be tenure or tenure track faculty
Must provide evidence of approval from the other IRB
Must obtain approval from a UW IRB All key personnel must complete human
subject training
OTHER CONSIDERATIONS
Conflict of Interest Status Relationships
Classroom or clinic environment Community-based research
Issues of engagement of the community partner Going into homes?
Sensitive Population Non-English speaking participants