| Course | HCR 558 Technical Writing for the Regulatory Professional |
|---|---|
| Module | Module 2 |
| Paper type | Regulatory response letter |
| Length | About 788 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 558 Module 2
Response to IRB Conditional Approval: Protocol BP-APP-01, Smartphone Blood Pressure Self-Monitoring Study
Student Name
MS in Clinical Research Management, Arizona State University
HCR 558: Technical Writing for the Regulatory Professional
Instructor Name
Month Day, Year
Response to IRB Conditional Approval: Protocol BP-APP-01, Smartphone Blood Pressure Self-Monitoring Study
Part 1: Analysis of the Board's Concerns
The notice granted conditional approval subject to six changes. Each concern can be traced to a regulatory criterion for approval, which shapes how persuasive the response must be.
The analysis shows that five conditions are straightforward and should be accepted without argument; arguing would only delay approval. The sixth concerns equitable selection and requires persuasion: the original exclusion had a practical reason, the app was available only in English, and the strongest response both explains that reason and reduces the exclusion.
| Condition | Board's concern | Regulatory basis | Response strategy |
|---|---|---|---|
| 1 | Consent form reads at grade 12 | Information must be understandable to the subject (45 C.F.R. § 46.116) | Accept; revise to grade 8 and show the score |
| 2 | Unclear where app data are stored and who can see them | Adequate provisions to protect privacy and confidentiality (45 C.F.R. § 46.111) | Accept; describe encryption, storage and access |
| 3 | Flyer says "free blood pressure cuff" in large type | Recruitment must not be unduly influential | Accept; move the cuff to a neutral benefits line |
| 4 | Payment of $150 at study end only | Payment schedule may coerce continued participation | Accept partly; prorate payment by visit |
| 5 | No plan for readings in a dangerous range | Data and safety monitoring for subject safety (45 C.F.R. § 46.111) | Accept; add an alert threshold and call-back procedure |
| 6 | Request to exclude non-English speakers | Equitable selection of subjects (45 C.F.R. § 46.111) | Explain and partly revise; add Spanish materials |
Part 2: The Response Letter
October 10, 2026
Chair, Institutional Review Board
Re: Protocol BP-APP-01, "Smartphone-Supported Home Blood Pressure Self-Monitoring in Adults With Hypertension," Response to Conditional Approval
Dear Chair and Members of the Board,
Thank you for your review of Protocol BP-APP-01 and for the board's careful comments. We have addressed each condition in the notice dated September 26, 2026, as described below. Revised documents are attached with changes tracked.
Condition 1, consent readability. We revised the consent form to an eighth-grade reading level, measured with the Flesch-Kincaid grade level, by shortening sentences, replacing technical terms and adding a one-page key information summary at the beginning, as the revised Common Rule requires (45 C.F.R. § 46.116). For example, "You will utilize the application to transmit sphygmomanometric data" now reads "You will use the app to send your blood pressure readings."
Condition 2, data storage and access. The protocol and consent form now state that readings are encrypted on the phone and in transit, stored on the university's secure research server rather than the app vendor's servers, linked to a study number rather than a name and viewable only by the principal investigator, the study coordinator and the study nurse. Data will be kept for six years after the study ends and then destroyed.
Condition 3, recruitment flyer. The flyer now lists the cuff in a plain line of study details, in the same type size as other information, and the headline describes the study's purpose instead.
Condition 4, payment. Payment is now prorated: $40 after the baseline visit, $40 after the three-month visit and $70 after the final visit. Participants who withdraw keep payments already earned.
Condition 5, dangerous readings. We added a safety procedure. Any reading of 180/120 mm Hg or higher triggers an on-screen message to call 911 if the participant has symptoms such as chest pain or weakness, and an alert to the study nurse, who calls the participant within one business day. Readings below 90/60 with symptoms trigger the same process.
Condition 6, language. We agree that excluding non-English speakers would be inequitable when hypertension is common among Spanish-speaking adults in our area. The app's vendor has confirmed a Spanish interface, and we will add Spanish consent, flyer and instructions, translated and back-translated. Speakers of other languages will remain excluded for this pilot because the app is available only in English and Spanish; we have stated this limitation in the protocol.
Please let us know if the board needs anything further. We appreciate the board's attention to participant protection.
Sincerely,
Study Coordinator, on behalf of the Principal Investigator
Attachments: revised protocol (tracked), revised consent form and key information summary (tracked), readability report, revised flyer, Spanish consent and flyer with translation certificate, data security description, safety alert procedure.
Conclusion
The course text's advice to write for the specific reader applies directly: a board wants to approve safe research quickly (Fossati Wood & Foote, 2009). A response to conditional approval succeeds when it is fast, complete and respectful. Accepting the straightforward conditions without argument preserves credibility for the one condition that needs explanation, and showing revised language rather than describing it lets the board approve without another round.
References
Criteria for IRB approval of research, 45 C.F.R. § 46.111 (2025).
Fossati Wood, L., & Foote, M. (Eds.). (2009). Targeted regulatory writing techniques: Clinical documents for drugs and biologics. Birkhäuser.
General requirements for informed consent, 45 C.F.R. § 46.116 (2025).
Reading the HCR 558 Module 2 assignment instructions
HCR 558 opens with persuasion and audience assessment, and the first major writing task is the IRB Letter, assigned in Week 1 and due in Week 2, worth 100 points with a 50-point analysis. The syllabus describes three steps: review a sample IRB Notice of Conditional Approval, analyze the specific concerns raised by the board and craft persuasive, professional responses to each, using regulatory awareness, critical thinking and the tone and formatting expected in regulatory correspondence. Your notice comes from Canvas, so the content of your letter will follow it, but the method is the same for any notice: trace each condition to the regulation behind it, decide whether to accept, partly accept or explain, then answer every condition in order with the revised language itself. The course text, Targeted Regulatory Writing Techniques, frames regulatory writing as writing for a specific reader, here a busy board that wants to approve safe research.
How this HCR 558 Module 2 example is built
The sample has two parts. Part 1 analyzes the board's six conditions in a table that names each concern, its regulatory basis and the chosen response strategy, followed by a paragraph explaining why five conditions are simply accepted and one needs persuasion. Part 2 is the letter itself, formatted as real correspondence with date, addressee, a reference line naming the protocol, an opening thanking the board, one paragraph per condition in the board's order with revised text or numbers and a closing with a list of attachments. The conclusion states the principle behind the letter: accept quickly where the board is right and save persuasion for the point that needs it.
HCR 558 Module 2 rubric: what earns full marks
The IRB Letter and its analysis are graded together for 150 points. Credit goes to an analysis that identifies each concern accurately and its regulatory basis, a response that addresses every condition in order, revisions that are shown rather than promised, a persuasive explanation where the team disagrees, a respectful professional tone and correct letter formatting with attachments listed. Points are lost when a condition is skipped or merged with another, when the response argues with conditions that should simply be accepted, when revisions are vague ("we will improve the consent form") and when the tone is defensive. Readers in this course also look at layout, because regulatory correspondence is judged on how easily a reviewer can find each answer.
HCR 558 Module 2 help with common mistakes
Number the board's conditions and answer them in the same order and numbering. For each, find the regulation behind the concern; it tells you how much room you have to push back. Accept what is clearly right without argument. Quote the revised language, not just a description of the change. Keep the tone grateful and factual. List every attachment. Read the letter as a board member would: can each answer be checked in under a minute? If your notice includes a condition you disagree with, the desk can help you frame the explanation. Finally, read the letter once for tone alone, since boards notice gratitude and defensiveness quickly.
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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HCR 558 Module 2 questions, answered
Where can I find a free HCR 558 Module 2 sample paper?
This page has a full HCR 558 IRB Letter sample: an analysis of six IRB conditions and a point-by-point response letter.
How do you respond to IRB conditional approval?
Answer every condition in the board's order, show the revised language, explain any disagreement politely and list attachments.
What is an IRB notice of conditional approval?
A decision that research can be approved once specified changes are made and confirmed to the board.
What regulation sets the criteria for IRB approval?
45 C.F.R. § 46.111, including minimized risk, equitable selection, informed consent and privacy protections.
Which textbook does HCR 558 use?
Fossati Wood and Foote's Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics.