IRB & Human Research Protection Program Administration Certification — Foundation

Lesson material opens once you are enrolled. The full syllabus and every learning outcome are shown here so you can judge the coverage before you pay.

1. Module 1

   F1

   1 lesson · 5 h

   1. Locked.Why any of this exists, and who says so5 h · Locked

      On completion you will be able to

      • The learner can:
      • Trace the lineage from Nuremberg through Helsinki and Tuskegee to the National Research Act, the National Commission, the Belmont Report and the Common Rule, and explain what each responded to.
      • Map Belmont's three principles onto the operational requirements they generate.
      • Determine which framework governs a study — Common Rule, FDA, both, or neither — and justify the determination.
      • Describe the Federalwide Assurance and what it commits an institution to.
      • Identify the governing body and instrument for research in the UK, Canada, Australia and the EU.

2. Module 2

   F2

   1 lesson · 7 h

   1. Locked.Determinations7 h · Locked

      On completion you will be able to

      • The learner can:
      • Apply both limbs of the human-subjects-research definition and document the determination.
      • Distinguish research from quality improvement, public health practice, programme evaluation, case reports and oral history.
      • Apply the exempt categories, identify which require limited IRB review, and explain why "exempt" is not "out of scope".
      • Apply the expedited categories and the minimal-risk threshold.
      • Determine whether a change to approved research is a minor change.

3. Module 3

   F3

   1 lesson · 4 h

   1. Locked.The convened board4 h · Locked

      On completion you will be able to

      • The learner can verify composition against the requirements; establish and track quorum through a meeting including arrivals, departures and recusals; manage a conflicted member; draft regulatory-compliant minutes; and record board actions with their correct consequences.

4. Module 4

   F4

   1 lesson · 4 h

   1. Locked.Criteria for approval4 h · Locked

      On completion you will be able to

      • The learner can apply each approval criterion to a protocol and identify unmet criteria; classify risk level against the minimal-risk definition; distinguish coercion from undue influence; and distinguish privacy from confidentiality.

5. Module 5

   F5

   1 lesson · 6 h

   1. Locked.Informed consent6 h · Locked

      On completion you will be able to

      • The learner can audit a consent document against the required elements; evaluate the key-information section; determine whether waiver criteria are met and document against each; distinguish waiver of consent from waiver of documentation; and apply the short-form process.

6. Module 6

   F6

   1 lesson · 4 h

   1. Locked.Additional protections4 h · Locked

      On completion you will be able to

      • The learner can determine whether Subparts B, C or D apply; identify the applicable category of permissible research involving children and determine assent and permission requirements; apply the prisoner provisions including the board composition requirement; and identify where FDA's protections differ from HHS's.

7. Module 7

   F7

   1 lesson · 3.5 h

   1. Locked.After approval3.5 h · Locked

      On completion you will be able to

      • The learner can process a modification and determine expedited eligibility; determine whether continuing review is required and document the rationale when it is not; manage lapse; and classify an incoming report and determine its reporting obligation.

8. Module 8

   F8

   1 lesson · 1.5 h

   1. Locked.What an HRPP is1.5 h · Locked

      On completion you will be able to

      • The learner can describe the components of an HRPP and distinguish it from the IRB; explain what a reliance agreement does and what it leaves with the relying institution; and identify the record categories that must be retained.