HCR 574 Module 2 Paper 2: Common Rule Application, Narrated Slides Example

Reviewed by Emmett Rockwell, MBA Arizona State University Updated October 2026

This HCR 574 Module 2 sample is Paper 2 in Scientific and Research Review Boards, the narrated presentation that ASU Clinical Research Management students complete in the course's Week 4 exercise. Paper 2 in ASU HCR 574 asks students to apply the revised Common Rule in a PowerPoint with narration. Building on the gap analysis in Paper 1, the composite student takes one composite submission, a federally funded study at three sites testing text-message reminders for adults with type 2 diabetes, and walks IRB staff through the six decisions the rule requires: review level, consent structure and key information, single IRB review, continuing review, secondary data use and posting of the consent form. Each of the ten slides carries narration notes that explain the rule section behind the decision.

CourseHCR 574 Scientific and Research Review Boards
ModuleModule 2
Paper typeNarrated slide presentation
LengthAbout 544 words, 4 pages
FormatAPA 7 slide deck with speaker notes
SchoolArizona State University
ProgramMS in Clinical Research Management
UpdatedOctober 2026

Free sample paper for HCR 574 Module 2

1

One Study, Six Decisions: Applying the Revised Common Rule to a Multisite Text-Reminder Trial

Student Name

MS in Clinical Research Management, Arizona State University

HCR 574: Scientific and Research Review Boards

Instructor Name

Month Day, Year

What this page is doingThe title tells the audience how many review decisions the deck walks through and which study it uses.
2

Slide 1: One Study, Six Decisions

Applying the revised Common Rule to a real-world submission. For IRB staff and new board members.

Speaker notes: Welcome. Rather than list the rule's changes, we will follow one study from submission to approval and see where each change applies.

Slide 2: The Study

Federally funded. Three U.S. clinics. 600 adults with type 2 diabetes randomized to text reminders or usual care for 12 months. Outcome: HbA1c from clinic records.

Speaker notes: This is a minimal-risk behavioral intervention with a clinical outcome, the kind of study the revised rule was designed to make easier to review without lowering protection.

Slide 3: Decision 1, Review Level

Not exempt: it is a randomized clinical trial with health outcomes. Eligible for expedited review as minimal risk under the expedited categories.

Speaker notes: The new benign behavioral intervention exemption does not fit because the study collects clinical data and measures a health outcome. Expedited review by an experienced reviewer is appropriate (45 C.F.R. § 46.110).

Slide 4: Decision 2, Key Information

Consent opens with a one-page summary: purpose, 12 months, texts several times a week, main risks (privacy, message burden), benefits, alternatives.

Speaker notes: The rule requires a concise key information section first (45 C.F.R. § 46.116). Here it fits on one page, and the full details follow.

Slide 5: Decision 3, Single IRB

Three U.S. sites, federally funded cooperative research: one reviewing IRB; the other two rely on it through reliance agreements.

Speaker notes: Since January 2020, most federally funded U.S. multisite studies use a single IRB (45 C.F.R. § 46.114). Our IRB serves as the reviewing IRB; local context comes from each site's input.

Slide 6: Decision 4, Continuing Review

Minimal risk and approved by expedited review: no continuing review required. The institution asks for a brief annual status update instead.

Speaker notes: The revised rule removed continuing review for this type of study (45 C.F.R. § 46.109). The status update lets us track enrollment without a full re-review.

Slide 7: Decision 5, Future Use of Data

Consent states whether identifiable data may be stripped of identifiers and used for future research. Broad consent not used.

Speaker notes: The new consent element on future use is required. The investigators chose not to use broad consent, so any future identifiable use will need new review or a waiver.

Slide 8: Decision 6, Posting Consent

After enrollment closes and within 60 days of the last study visit, one IRB-approved consent form is posted on a federal website.

Speaker notes: Federally funded clinical trials must post a consent form publicly (45 C.F.R. § 46.116). We added this to the closeout checklist.

Slide 9: Protections That Did Not Change

Risk minimized. Equitable selection. Privacy protected. Consent sought and documented. Additional safeguards for vulnerable participants.

Speaker notes: The criteria for approval in § 46.111 still apply in full. The revised rule changed process, not the core protections (Menikoff et al., 2017).

Slide 10: Summary

Expedited, not exempt. Key information first. One IRB for three sites. No continuing review. Future-use statement. Posted consent.

Speaker notes: Six decisions, each tied to a section of the rule, and each one a judgment the board, not the investigator, must own (Mazur, 2007). When you review your next submission, ask these same six questions. Thank you.

References

Cooperative research, 45 C.F.R. § 46.114 (2025).

Expedited review procedures for certain kinds of research, 45 C.F.R. § 46.110 (2025).

General requirements for informed consent, 45 C.F.R. § 46.116 (2025).

Mazur, D. J. (2007). Evaluating the science and ethics of research on humans: A guide for IRB members. Johns Hopkins University Press.

Menikoff, J., Kaneshiro, J., & Pritchard, I. (2017). The Common Rule, updated. New England Journal of Medicine, 376(7), 613-615. https://doi.org/10.1056/NEJMp1700736

What the HCR 574 Module 2 instructions ask for

Paper 2 is the middle part of HCR 574's Week 4 exercise: a PowerPoint presentation with narration that applies the Common Rule. Where Paper 1 identifies what the revised rule changed in an IRB's procedures, Paper 2 shows those changes in use. The clearest way to do that is to follow one study through review and show each decision the rule requires, with the section number behind it. Narration can be recorded audio or written speaker notes, depending on your instructor's instructions in Canvas; either way, the narration should explain why, while the slides show what. Choose a study that triggers several of the revised provisions, such as a federally funded multisite trial, so the presentation has something to apply. Together with Papers 1 and 3, the exercise is worth 200 points.

How this HCR 574 Module 2 example is built

The deck has ten slides with narration notes. It opens by explaining why it follows one study instead of listing changes, then describes the study in one slide. Six decision slides follow, each naming a decision and this study's answer, with the governing section in the notes: review level, key information, single IRB, continuing review, future use of data and posting the consent form. A slide reminds viewers that the core approval criteria did not change, and the summary slide lists the six answers in short phrases so staff can reuse them as a checklist. The narration cites the rule section for every decision, so viewers can look each one up.

HCR 574 Module 2 rubric: what earns full marks

Paper 2 is scored within the 200-point exercise. Readers reward correct use of the revised rule on one concrete study, a section number behind every decision, slides a viewer can read in seconds, notes that give reasons instead of repeating the slide and an order a newcomer could follow. Points are lost when the presentation repeats Paper 1's list without applying it, when decisions are wrong for the study described, when slides are crowded with text and when narration is missing or reads the slides aloud. Readers also appreciate when the presenter shows what did not change, since new board members often assume the revision weakened protections.

HCR 574 Module 2 help: mistakes that cost marks

Pick a study that triggers several revised provisions. Write the six or so decisions first, then build a slide for each. Keep slides to short phrases and put reasoning in the narration. Cite the rule section in the narration for each decision. Include one slide on protections that did not change. End with a checklist slide. Rehearse the narration aloud and time it. If you are unsure whether your study qualifies for an exemption or expedited review, the desk can walk through the categories with you. Finally, check that the study you pick really is federally funded or cooperative where you claim it is, since those facts decide two of the six answers.

Write yours, or have the desk draft it

This paper is an original model document written by our desk, not a submitted student paper and not an official Arizona State University document. Read it for the moves, then write your own to the instructions in your classroom. If you want one built to your exact prompt and rubric, the first custom sample is free and arrives in 24 to 48 hours.

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More HCR 574 and MS in Clinical Research Management sample papers

HCR 574 Module 2 questions, answered

Where can I find a free HCR 574 Module 2 sample paper?

This page carries the complete Paper 2 narrated deck applying the revised Common Rule to a three-site text-reminder trial.

Does a minimal-risk study need continuing review under the revised Common Rule?

Not if it was approved by expedited review or is in data analysis or follow-up only, unless the IRB documents a reason.

When is single IRB review required?

For most federally funded cooperative research conducted at more than one U.S. site.

What is the key information section of a consent form?

A concise opening summary of the facts most likely to help someone decide whether to join.

Which clinical trials must post a consent form?

Federally funded clinical trials must post one IRB-approved consent form on a public federal website after recruitment closes.