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