| Course | HCR 574 Scientific and Research Review Boards |
|---|---|
| Module | Module 1 |
| Paper type | Regulatory gap analysis |
| Length | About 628 words, 5 pages |
| Format | APA 7 student paper |
| School | Arizona State University |
| Program | MS in Clinical Research Management |
| Updated | October 2026 |
Free sample paper for HCR 574 Module 1
From 1991 Rules to 2018 Requirements: A Gap Analysis of a University IRB's Procedures
Student Name
MS in Clinical Research Management, Arizona State University
HCR 574: Scientific and Research Review Boards
Instructor Name
Month Day, Year
From 1991 Rules to 2018 Requirements: A Gap Analysis of a University IRB's Procedures
Introduction
The federal Common Rule governs most federally funded human subjects research. Its revision, published in 2017 and generally effective in January 2019, was the first major update since 1991 (Menikoff et al., 2017). Institutions had to revise their IRB procedures to match. This paper reviews the written procedures of a composite university IRB, last revised in 2016, against the revised rule, known as the 2018 Requirements, and identifies the changes needed.
Method
Each section of the IRB's procedures manual was compared with the corresponding section of the revised rule (45 C.F.R. §§ 46.101-46.124). Gaps were classified, following the course text's view of the board's duties (Mazur, 2007), as required changes, where the procedure conflicts with the rule, or optional changes, where the rule permits but does not require something the procedure does not use.
Findings
| Area | Current procedure (2016) | 2018 Requirement | Change needed |
|---|---|---|---|
| Consent form structure | Elements listed in any order | Concise key information first, organized to aid understanding (§ 46.116(a)(5)) | Required: add key information section and template |
| New consent element | Not addressed | Statement on future use of identifiable data or biospecimens (§ 46.116(b)(9)) | Required: add to template |
| Continuing review | Annual review of all approved studies | Not required for minimal-risk studies reviewed by expedited procedure or in data analysis or follow-up only (§ 46.109(f)) | Required update; institution may keep check-ins |
| Exempt categories | Six 1991 categories | Eight categories, some needing limited IRB review (§ 46.104) | Required: revise exemption worksheet |
| Limited IRB review | Not used | Privacy and confidentiality review for certain exemptions (§ 46.111(a)(8)) | Required where those exemptions are used |
| Broad consent | Not used | Optional consent for storage and future research use (§ 46.116(d)) | Optional: decide whether to adopt |
| Cooperative research | Each site's IRB reviews | Single IRB for most federally funded U.S. multisite studies (§ 46.114) | Required: reliance agreements and procedures |
| Posting consent forms | Not addressed | One consent form for federally funded clinical trials posted publicly (§ 46.116(h)) | Required: add to closeout checklist |
Discussion of Key Changes
Key Information
The most visible change is the requirement that consent begin with a concise, focused presentation of the key information most likely to help a person decide whether to participate. The IRB's current template begins with a long description of procedures. The revised template will open with a one-page summary of purpose, duration, main procedures, foreseeable risks and benefits and alternatives.
Continuing Review
The current policy requires annual review of every study. Under the revised rule, many minimal-risk studies no longer need continuing review, which reduces burden on investigators and on the board. The IRB may still require a brief annual status report, but the procedures must state when full continuing review is and is not required.
Exemptions and Limited IRB Review
The new exempt categories, including some secondary research and benign behavioral interventions, require the IRB's exemption worksheet to be rewritten. Some exemptions require limited IRB review to confirm privacy and confidentiality protections, a new process the board must define.
Single IRB Review
For federally funded cooperative research in the United States, one IRB must review the study for all sites, with limited exceptions. The IRB needs procedures for serving as the reviewing IRB, for relying on another and for documenting reliance agreements.
Implementation Plan
The IRB office should first revise templates and the exemption worksheet, then train staff and board members, update the electronic submission system and finally communicate changes to investigators, with a transition rule for studies approved under the old requirements.
Conclusion
The procedures reviewed reflect a rule that no longer exists. Eight changes, six of them required, would bring them into compliance, and the two most important for participants, key information and limited IRB review, also make consent and privacy protection clearer.
References
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
Protection of human subjects, 45 C.F.R. §§ 46.101-46.124 (2025).
HCR 574 Module 1 instructions, in plain terms
HCR 574 has one three-part exercise worth 200 points, all due in Week 4, the week on board operations and IRB member roles. Paper 1 asks you to review IRB processes and procedures and identify the changes that should be made to comply with the Common Rule; Paper 2 applies the rule in a narrated PowerPoint; Paper 3 compares federal regulations for human and animal research. For Paper 1, the most useful approach is a gap analysis: take an IRB's written procedures, or a realistic set of them, and compare each part with the revised rule, the 2018 Requirements in 45 C.F.R. Part 46. Classify each gap as required or optional, cite the section of the rule that drives it and recommend a change. Mazur's Evaluating the Science and Ethics of Research on Humans is the course text and explains how boards apply these requirements in review.
How this HCR 574 Module 1 example is built
The sample opens with the history of the revision and the paper's purpose. A short method section explains how sections were compared and how gaps were classified. The findings appear in one table with the current procedure, the 2018 Requirement with its section number and the change needed, marked required or optional. Four changes are then discussed in more depth under their own headings: key information, continuing review, exemptions with limited IRB review and single IRB review. A brief implementation plan puts the changes in order, and the conclusion counts the required changes and names the two that matter most for participants. A margin note explains why required and optional changes are separated.
Where the marks sit in the HCR 574 Module 1 rubric
Paper 1 is graded as part of the 200-point three-part exercise. Credit goes to an accurate understanding of what the revised Common Rule changed, a systematic comparison with an IRB's procedures, citations to the specific sections of the rule, a clear distinction between required and optional changes and practical recommendations. Points are lost when changes are described from memory or secondary summaries and misstated, when the paper lists the revisions without applying them to an IRB's procedures, when single IRB review or limited IRB review are confused and when recommendations are missing. Because the exercise continues in Papers 2 and 3, a clear Paper 1 gives the narrated presentation a foundation to build on.
HCR 574 Module 1 help: mistakes that cost marks
Get the revised rule itself and keep it open while you work. Use a real IRB's public procedures if you can find an outdated version, or a realistic composite. Compare section by section and record the rule's section number for each gap. Mark each change required or optional. Spend most of your words on the changes that affect participants directly. Add a short implementation order. If you are unsure whether a change applies to studies approved before 2019, the desk can help you check the transition provisions. Remember that Papers 2 and 3 build on this one, so keep your table in a form you can reuse in the narrated presentation.
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.
More HCR 574 and MS in Clinical Research Management sample papers
- HCR 574 Module 2: Paper 2: Common Rule Application, Narrated Slides
- HCR 574 Module 3: Paper 3: Federal Regulations for Human and Animal Research
- HCR 561 Module 5: Assignment 2: Essay on Vulnerable Populations
- HCR 557 Module 6: Paper 3: Local and International Studies
- HCR 566 Module 2: Capstone Proposal
- HCR 593 Module 12: Applied Project Final Research Paper
HCR 574 Module 1 questions, answered
Where can I find a free HCR 574 Module 1 sample paper?
This page has a full HCR 574 Paper 1 sample: a gap analysis of a university IRB's procedures against the revised Common Rule.
What changed in the revised Common Rule?
Key information in consent, less continuing review for minimal-risk studies, new exempt categories, limited IRB review, broad consent, single IRB review and posted consent forms.
When did the revised Common Rule take effect?
It was published in 2017 and generally took effect in January 2019, with single IRB review required from January 2020.
What is limited IRB review?
A review of privacy and confidentiality protections required for certain exempt research under the revised rule.
Which textbook does HCR 574 use?
Mazur's Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members.