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Questions for irb presentation

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IRB presentation questions prospective observational study heart failure red cell distribution width prognostic marker

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"heart failure" AND "red cell distribution width"

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~/attachments/fa931af3-c304-4e75-8d58-f1c8b8f6cf36

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python -c "from pptx import Presentation; p=Presentation(r'/tmp/workspace/attachments/fa931af3-c304-4e75-8d58-f1c8b8f6cf36/TITLE_ A STUDY OF RED CELL DISTRIBUTION WIDTH AS A PROGNOSTIC MARKER IN PATIENTS WITH HEART FAILURE.pptx'); print('SLIDES',len(p.slides)); [print('\\n--- Slide',i,'---\\n'+'\\n'.join(sh.text for sh in s.shapes if getattr(sh,'has_text_frame',False) and sh.text.strip())) for i,s in enumerate(p.slides,1)]"

I could not open the uploaded PowerPoint file, so I cannot tailor questions to its methods, sample size, endpoints, or statistics. Please re-upload the presentation.
Meanwhile, common IRB questions for this study are:
  1. Is the study prospective, retrospective, or ambispective?
  2. What is the primary objective and primary outcome, such as in-hospital mortality, 30-day mortality, readmission, or composite outcome?
  3. Why is RDW being studied when established prognostic markers such as BNP/NT-proBNP, LVEF, renal function, and NYHA class exist?
  4. Are patients receiving any additional blood tests, procedures, or visits solely for research?
  5. Will RDW be obtained only from routine complete blood counts? If yes, why is the incremental risk minimal?
  6. What are the inclusion and exclusion criteria for heart failure, and how will heart failure be defined?
  7. How will you address major factors that affect RDW independently of heart failure, including anemia, iron deficiency, vitamin B12/folate deficiency, blood transfusion, kidney disease, liver disease, infection, malignancy, and hematological disorders?
  8. How will acute heart failure be distinguished from chronic stable heart failure?
  9. What is the anticipated sample size, and how was it calculated?
  10. What follow-up period will be used, and how will mortality and readmissions be verified?
  11. What potential confounders will be collected and adjusted for in the analysis?
  12. Will investigators or treating clinicians be blinded to the analysis? Will RDW results influence clinical care?
  13. Is informed consent needed, or is a waiver being sought for use of routine clinical records? What is the justification?
  14. How will confidentiality be protected, including coding, password protection, limited access, and retention/destruction of data?
  15. Will participants incur any cost or receive compensation?
  16. What happens if an incidental abnormal laboratory result is identified?
  17. How will vulnerable patients, such as critically ill patients or those unable to consent, be handled?
  18. What are the study’s foreseeable risks and direct benefits? State clearly if there is no direct clinical benefit.
  19. Who will have access to identifiable data, and will data be shared outside the institution?
  20. How will missing data, loss to follow-up, and deaths outside the hospital be handled?
A concise IRB risk statement could be: “This is a minimal-risk observational study. RDW is derived from a routine complete blood count, and no additional intervention or alteration of standard treatment is planned. The principal risk is potential loss of confidentiality, mitigated through coded data, secure storage, and restricted investigator access.”

Question and answer of irb

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IRB ethics committee questions answers observational prognostic biomarker study heart failure RDW

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~/attachments/fa931af3-c304-4e75-8d58-f1c8b8f6cf36

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"heart failure" AND "red cell distribution width"

Running Command

python -c "from docx import Document; p=r'/tmp/workspace/attachments/fa931af3-c304-4e75-8d58-f1c8b8f6cf36/ayushi irb .docx'; d=Document(p); print('PARAGRAPHS'); [print(f'[{x.style.name}] {x.text}') for x in d.paragraphs if x.text.strip()]; print('TABLES',len(d.tables)); [print('TABLE',ti, [[c.text.replace(chr(10),' | ') for c in r.cells] for r in t.rows]) for ti,t in enumerate(d.tables,1)]"

Likely IRB Questions and Model Answers

1. What is the rationale for this study?

Answer: Heart failure has high morbidity, mortality, and readmission rates. RDW is routinely reported in a complete blood count, requires no extra cost, and may reflect inflammation, iron dysregulation, and nutritional or bone-marrow-related changes. This study will assess whether baseline RDW can help predict severity and adverse outcomes in patients with heart failure in our local population.

2. Why study RDW when BNP/NT-proBNP and echocardiography are already available?

Answer: BNP/NT-proBNP and echocardiography are established tools, but may not always be readily available or affordable in every setting. RDW is routinely available with CBC, inexpensive, and non-invasive. It is not intended to replace established markers, but to evaluate whether it provides additional prognostic information.

3. What is the study design?

Answer: This is a single-center, prospective observational study. We will enroll 100 consecutive eligible adult patients admitted with heart failure and follow them for predefined clinical outcomes. No study-related treatment or intervention will be given.

4. What is the primary aim of the study?

Answer: To evaluate RDW as a prognostic marker in patients with heart failure.

5. What is your primary outcome?

Answer: The protocol should specify one primary outcome clearly. A suitable primary outcome is a composite of all-cause mortality or heart-failure-related readmission during the predefined follow-up period.
Important: Do not say “readmissions and/or mortality” at the presentation. State the exact primary endpoint and follow-up duration, for example: “all-cause mortality or heart-failure readmission within 90 days of enrollment.”

6. How will you define heart failure for enrollment?

Answer: Patients aged 18 years or above with a clinical diagnosis of heart failure supported by clinical findings and echocardiographic evidence will be included. Relevant investigations, including ECG, chest radiograph, echocardiography, CBC, renal function tests, and NT-proBNP where clinically indicated, will be recorded from routine care.

7. How will you classify severity of heart failure?

Answer: Severity will be assessed using the New York Heart Association functional class, vital signs, clinical signs of congestion, need for hospitalization, echocardiographic parameters including left ventricular ejection fraction, and relevant laboratory parameters. The exact severity variables will be predefined in the case-record form.

8. Why is the sample size 100?

Answer: This is a time-bound postgraduate, single-center prospective observational study. We plan to recruit 100 consecutive eligible patients during one year. The study is intended to estimate the association and generate local evidence; results will be interpreted with due consideration of the limited sample size.
Better answer if asked further: “We acknowledge that 100 patients may limit multivariable analysis. We will avoid overfitting and report confidence intervals, effect sizes, and study limitations.”

9. Why use consecutive sampling?

Answer: Consecutive sampling means every eligible patient admitted during the study period will be considered for recruitment. This is practical in a hospital-based observational study and helps reduce investigator selection bias compared with convenience sampling.

10. What additional tests or procedures will participants undergo?

Answer: None. RDW will be obtained from the CBC performed as part of routine clinical management. Other clinical and laboratory data will be taken from routine records. No additional blood sampling, imaging, invasive procedure, or alteration in treatment will be done solely for research.

11. What are the risks to participants?

Answer: There is no additional physical risk because no extra procedure is performed. The principal foreseeable risk is a breach of confidentiality of clinical information. This will be minimized by using coded study IDs, password-protected electronic data, restricted access, and reporting only de-identified aggregate results.

12. What are the benefits to participants?

Answer: There may be no direct individual benefit. The possible societal benefit is better understanding of whether a readily available and low-cost parameter, RDW, can assist future risk stratification of patients with heart failure.

13. Why are patients with anemia or hemoglobin less than 9 g/dL excluded?

Answer: Severe anemia can markedly affect RDW and is itself strongly associated with poor outcomes in heart failure. Excluding patients with hemoglobin less than 9 g/dL reduces confounding and helps assess the prognostic association of RDW more reliably.

14. Why exclude hematological disorders and recent blood transfusion?

Answer: Hemolytic anemia, thalassemia, and other hematological disorders can alter red-cell indices independently of heart failure. Transfusion introduces donor red cells and can distort RDW measurements for a period of time. Excluding these conditions reduces bias.

15. Why exclude active infection, inflammatory disease, malignancy, chronic liver disease, and end-stage renal disease?

Answer: These conditions may independently increase RDW and worsen outcomes. Their exclusion improves internal validity by reducing major non-heart-failure causes of high RDW and adverse prognosis.

16. Will exclusion of these common comorbidities reduce generalizability?

Answer: Yes, it may reduce generalizability to patients with these conditions. However, the exclusions are necessary in this initial study to reduce substantial confounding. This limitation will be explicitly acknowledged.

17. How will you account for other confounders?

Answer: We will record age, sex, hemoglobin, comorbidities such as hypertension, diabetes, coronary artery disease and chronic kidney disease, blood pressure, heart rate, NYHA class, echocardiographic findings, renal function, NT-proBNP where available, prior hospitalizations, and treatment details. We will use appropriate multivariable analysis depending on the number of outcome events.

18. Will RDW influence the patient’s treatment?

Answer: No. Treatment will remain entirely under the treating physician’s discretion and according to standard hospital practice. RDW will be used for research analysis only and will not dictate treatment decisions.

19. How will follow-up be performed?

Answer: Follow-up should be defined in the protocol. A suitable answer is: “Patients will be followed for 90 days or 6 months through hospital records and telephone contact. We will document survival status and heart-failure-related readmissions. If follow-up cannot be completed, the participant will be recorded as lost to follow-up.”

20. How will you verify mortality and readmission?

Answer: Mortality will be verified through hospital records, communication with the patient or family, and available death documentation where possible. Readmissions will be verified through hospital records and patient or family history. We will document whether the readmission was due to heart failure or another cause.

21. Why is informed consent necessary if data are from routine care?

Answer: Although no additional intervention is planned, the study involves prospective collection and follow-up of patient data. Therefore, written informed consent will be obtained before enrollment.

22. What if a patient refuses or withdraws consent?

Answer: Participation is voluntary. Refusal or withdrawal will not affect treatment, doctor-patient relationship, admission, or any hospital service. No further study data will be collected after withdrawal. The handling of data already collected will follow the consent form and ethics committee policy.

23. How will consent be obtained from an ill patient?

Answer: Consent will be obtained only after the patient is clinically stable and able to understand the study. If the patient lacks decision-making capacity, enrollment will be deferred unless the IEC-approved protocol specifically permits legally authorized representative consent.

24. Are pregnant or lactating women excluded for safety reasons?

Answer: Yes. Pregnancy causes physiological hematological changes, including changes in red-cell indices, and pregnancy-associated cardiac conditions can differ from usual heart-failure syndromes. Exclusion also keeps the study population clinically more homogeneous.

25. How will confidentiality be maintained?

Answer: Each participant will be assigned a unique study ID. Identifiers and study data will be stored separately. Electronic data will be password protected, access will be limited to the investigator and guide team, and publications will contain no information that can identify individual participants.

26. How long will records be retained?

Answer: “Study records will be retained for the period required by institutional and IEC policy, after which identifiable information will be securely destroyed.” Confirm the exact retention period required by your institution before the presentation.

27. Is there any compensation or payment?

Answer: No payment or financial inducement will be offered because no additional visit, investigation, or procedure is being performed for this study. If an unexpected research-related injury were to occur, it would be managed according to institutional and applicable ethical guidelines, although no additional intervention-related injury is anticipated.

28. What is the risk-benefit assessment?

Answer: The study is minimal risk. There are no additional invasive procedures and no change in standard treatment. The main risk is confidentiality breach, which will be controlled through coding and secure data handling. The possible scientific benefit justifies the minimal risk.

29. Will you report the results to participants?

Answer: Individual research results will not generally be returned because RDW is not being used to guide treatment in this protocol. The overall study findings may be shared through academic presentation and publication. Participants may request a plain-language summary if permitted by institutional policy.

30. What is the scientific basis for RDW as a prognostic marker?

Answer: RDW measures variability in circulating red-cell size. Higher RDW has been associated with adverse outcomes in heart failure, potentially reflecting inflammation, impaired iron mobilization, nutritional deficiencies, renal dysfunction, and bone marrow stress. Prior prospective cohort evidence found RDW to be independently associated with mortality and hospitalization in chronic heart failure, as described in this heart-failure cohort study.

Questions the IEC/IRB May Raise About Your Current Protocol

  1. Follow-up duration is not specified. Add 90 days, 6 months, or 1 year.
  2. Primary endpoint is not defined. State one primary endpoint clearly.
  3. “Disease severity” is vague. Define it using NYHA class, LVEF, length of stay, need for ICU/inotropes, or a predefined severity scale.
  4. Statistical plan is vague. Mention correlation/comparison tests, ROC analysis for discrimination, and regression analysis adjusted for confounders.
  5. Consent text needs correction. Remove: “Doctor/Hospital won't be liable to give any compensation.” This wording is inappropriate. Replace it with an IEC-approved statement on voluntary participation, contact details, and compensation/medical management according to institutional policy.
  6. Gujarati consent text appears corrupted in the document extract. Ensure that the final Gujarati form displays properly, is understandable, and is back-checked before submission.
  7. Add participant and IEC contact details to all consent forms.
  8. Clarify whether phone follow-up will occur and include explicit consent for telephone contact and the use of telephone numbers.
The WHO protocol format similarly expects a clearly specified study design, eligibility criteria, duration, privacy safeguards, quality procedures, and dissemination plan, as described in the WHO ethics protocol guidance.

Prevalance and sample size calculation

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heart failure prevalence India 2024 sample size calculation prognostic observational study RDW

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"heart failure" AND "red cell distribution width"

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https://pmc.ncbi.nlm.nih.gov/articles/PMC11097740/

Prevalence

For the background section, you may state:
Heart failure prevalence: The estimated prevalence of heart failure in India is approximately 1% of the general population, corresponding to about 8 to 10 million people. In the National Heart Failure Registry of India, 3-month mortality was reported as 14.2% and readmission as 8.4%.
Source: a 2024 Indian heart-failure study.
Do not use “prevalence of elevated RDW” unless you define an RDW cutoff first, because the cutoff differs between hematology laboratories and studies.

Sample-size calculation for your protocol

Best practical wording for your current study

Your study is prospective observational and evaluates RDW as a prognostic marker. A prevalence-based calculation can be shown for the IEC/IRB, but it should be acknowledged that 100 patients is a feasible exploratory sample and may have limited power for a large adjusted prognostic model.

Formula

[ n = \frac{Z^2 \times p \times q}{d^2} ]
Where:
  • n = minimum sample size
  • Z = 1.96 at 95% confidence level
  • p = prevalence of heart failure in India = 1% = 0.01
  • q = 1 - p = 0.99
  • d = allowable absolute error = 2% = 0.02
[ n = \frac{(1.96)^2 \times 0.01 \times 0.99}{(0.02)^2} ]
[ n = \frac{3.8416 \times 0.0099}{0.0004} ]
[ n = 95.08 ]
Therefore, the minimum calculated sample size is approximately 96 patients. To account for incomplete data and possible loss to follow-up, the sample size is rounded to 100 patients.

Text to put in the IRB protocol / presentation

Sample size calculation:
Based on the estimated prevalence of heart failure in India of 1%, the sample size was calculated using the formula (n = Z^2pq/d^2), with 95% confidence level (Z = 1.96) and allowable absolute error of 2%. The calculated sample size was 95.08, rounded to 96. Considering possible incomplete data and loss to follow-up, a final sample size of 100 consecutive eligible patients will be recruited.

If the IRB asks: “Why use prevalence when this is a prognostic study?”

Say:
“This is a one-year, single-center postgraduate prospective observational study. The prevalence-based calculation was used to establish a feasible minimum recruitment target. However, we recognize that prognostic studies are ideally powered on the expected number of outcome events. Therefore, this study will be considered exploratory, and the results will be interpreted with confidence intervals and appropriate caution. We will avoid overfitting in multivariable analysis.”

Important limitation

For a true multivariable prognostic study, 100 patients may be small, especially if mortality/readmission events are few. Avoid claiming that you will develop a definitive prediction model. Use wording such as:
“To assess the association and preliminary prognostic utility of RDW.”
Existing evidence supports the rationale: high RDW has been associated with increased mortality in heart failure. One recent meta-analysis reported higher all-cause mortality among patients in the highest RDW quartile, though there was substantial heterogeneity between studies, as described in this RDW heart-failure meta-analysis.
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