Certified Lactation Specialist Study Startup & Feasibility 2 — Questions and Answers
Question 1: When submitting a lactation support program study to an IRB, which factor most commonly triggers full board review rather than expedited review?
- Inclusion of vulnerable populations such as postpartum women with mental health conditions (Correct answer)
- Use of anonymous surveys only
- Observational design with no intervention
- Data collection limited to retrospective chart reviews
Correct answer: Inclusion of vulnerable populations such as postpartum women with mental health conditions
Full board review is required when research involves vulnerable populations or poses greater than minimal risk.
Question 2: A researcher designing a feasibility study on a new breastfeeding education intervention must include which element MOST critically in the informed consent process?
- A guarantee that breastfeeding outcomes will improve
- Disclosure of all reasonably foreseeable risks and benefits (Correct answer)
- A requirement that participants complete all study visits
- Financial compensation details as the primary focus
Correct answer: Disclosure of all reasonably foreseeable risks and benefits
Informed consent must disclose all foreseeable risks and benefits to allow voluntary, fully informed participation.
Question 3: Which of the following best describes a protocol deviation in a lactation feasibility study?
- A participant voluntarily withdrawing from the study
- An unintentional departure from the approved study protocol (Correct answer)
- A change to the primary outcome measure approved by the IRB
- Enrollment of more participants than originally planned with IRB notification
Correct answer: An unintentional departure from the approved study protocol
A protocol deviation is an unintentional, unplanned departure from the IRB-approved protocol.
Question 4: In a lactation study, 'protocol fidelity' refers to:
- Participants following all breastfeeding recommendations given by staff
- The degree to which the intervention is delivered as intended per the protocol (Correct answer)
- IRB approval of all protocol changes before implementation
- Accuracy of financial reporting to the funding agency
Correct answer: The degree to which the intervention is delivered as intended per the protocol
Protocol fidelity measures how consistently and accurately the intervention is implemented according to the study plan.
Question 5: Which regulatory document provides the primary ethical framework for research involving human subjects in the United States?
- HIPAA Privacy Rule
- Declaration of Helsinki
- The Belmont Report (Correct answer)
- Good Clinical Practice (ICH-GCP) Guidelines
Correct answer: The Belmont Report
The Belmont Report (1979) established the three core ethical principles—respect for persons, beneficence, and justice—underlying US human subjects research regulations.
Question 6: A lactation researcher wants to use existing medical records to assess breastfeeding initiation rates. Under HIPAA, what is typically required?
- Full written consent from each patient whose record is reviewed
- A waiver of authorization granted by the IRB or Privacy Board (Correct answer)
- Written approval from the hospital CEO only
- No authorization, as any research use of records is automatically exempt
Correct answer: A waiver of authorization granted by the IRB or Privacy Board
HIPAA permits research use of PHI without individual authorization when the IRB or Privacy Board grants a waiver meeting specific criteria.
Question 7: When designing a feasibility study for a hospital-based lactation program, whose buy-in is considered MOST critical as a 'gatekeeper' before study startup?
- Participants' pediatricians exclusively
- Nursing staff and unit managers where enrollment will occur (Correct answer)
- National breastfeeding advocacy organizations
- Insurance company representatives
Correct answer: Nursing staff and unit managers where enrollment will occur
Nursing staff and unit managers control day-to-day operations and can facilitate or block study enrollment in hospital settings.
Certified Lactation Specialist Study Startup & Feasibility 2
When submitting a lactation support program study to an IRB, which factor most commonly triggers full board review rather than expedited review?