Writing a Background Section for an IEC (Institutional Ethics Committee) Submission

What is the Background Section?

Structure of a Strong IEC Background

1. Introduce the Disease/Condition/Topic

• Define the condition or subject of study clearly.
• State its epidemiology (prevalence, incidence, burden — global and local/national if available).
• Mention morbidity, mortality, or public health significance.

Example: "Type 2 diabetes mellitus affects approximately 537 million adults worldwide (IDF, 2021), making it one of the leading causes of cardiovascular disease and end-stage renal failure..."

2. Review of Existing Literature (State of Knowledge)

• Summarize what is already known about the topic.
• Cite key landmark studies, systematic reviews, or clinical guidelines.
• Highlight current standard of care or treatment approaches.
• Keep it brief but substantive — 3 to 5 key references is usually sufficient.

3. Identify the Knowledge Gap

• What is not yet known or insufficiently studied.
• Contradictions or inconsistencies in existing literature.
• Why current evidence is inadequate (small sample sizes, heterogeneous populations, lack of local data, etc.).

Example: "However, no studies have evaluated this drug's efficacy specifically in the South Asian population, where metabolic profiles differ significantly from Western cohorts..."

4. Rationale for the Proposed Study

• Explain how your study will fill the identified gap.
• State why this research is timely, feasible, and important.
• Briefly mention the study design and intervention (without going into full methodology — that belongs in a separate section).

5. Ethical Justification (Unique to IEC)

• Beneficence: How will participants or society benefit?
• Non-maleficence: Why is the risk-benefit ratio acceptable?
• Justice: Is the study population appropriate and fairly chosen?
• Necessity: Can the research question be answered without human subjects, or is the human element essential?

Formatting Tips for IEC Submissions

Common Mistakes to Avoid

• Too broad: Spending too much on general background without reaching the specific gap.
• No clear gap statement: Reviewers need to see why this study must be done now.
• Missing ethical dimension: Forgetting the beneficence/risk-benefit angle that IEC specifically looks for.
• Outdated references: Always use literature from the last 5–10 years unless citing a landmark study.
• Copy-pasting from protocol: The background in an IEC form should be written in plain, accessible language.

Example Template (Skeleton)

[Disease/Topic] is a [global/national] health concern affecting [X population]. 
It is characterized by [brief description] and is associated with [morbidity/mortality].

Current evidence suggests [summary of what is known — cite 2–3 studies]. 
The standard of care involves [current management].

However, [knowledge gap — what remains unknown or understudied]. 
[Optional: Contradictory findings in literature].

The proposed study aims to [objective] in [population], which will [how it fills the gap].
The findings will contribute to [clinical/policy/scientific significance].

Given the potential benefits and the acceptable risk profile, this study is ethically 
justified and necessary.

Additional Tips

• Align with ICMR / local guidelines: In India, follow ICMR's National Ethical Guidelines for Biomedical and Health Research (2017) as a reference for what IECs expect.
• Use PICO format (Population, Intervention, Comparison, Outcome) to sharpen your rationale.
• Keep it self-contained: The background should be understandable even to a non-specialist ethics committee member.

Sources to Use for Writing IEC Background

1. Published Research Articles (Primary Source)

• Peer-reviewed journals (PubMed, Google Scholar, Cochrane, etc.)
• Original research studies, RCTs, cohort studies
• Systematic reviews and meta-analyses
• Use recent articles (within 5–10 years) unless citing a landmark study

2. Clinical Guidelines

• WHO, ICMR, AHA, ACC, or relevant specialty society guidelines
• These carry high authority with ethics committees

3. Epidemiological / Burden of Disease Data

• Government health reports (NFHS, ICMR annual reports)
• WHO/CDC global disease burden statistics
• These are used to justify the significance of your research

4. Textbooks

• Used sparingly, mainly to define the condition or establish basic facts

How to Use Articles in the Background

Key Point

You read multiple articles, extract the relevant facts, and write the background in your own words — synthesizing them into a logical, flowing narrative. You do not copy-paste from any article.

Minimum Recommended References for IEC Background

• 3 to 6 references is typically sufficient
• At least 1–2 recent systematic reviews or RCTs
• At least 1 epidemiological source for disease burden
• At least 1 guideline if applicable

What to Copy (Extract) from Articles and How to Write It

1. From Epidemiology / Prevalence Studies

• Prevalence/incidence numbers
• Affected population size
• Country/region-specific data

"[Disease] affects approximately [X million] people worldwide, with a prevalence of [X%] in India (Author, year)."

2. From Review Articles / Textbooks

• Definition of the disease
• Pathophysiology (brief)
• Risk factors

"[Disease] is characterized by [key features] and is associated with risk factors such as [list] (Author, year)."

3. From Original Research / RCTs

• What was studied
• Key finding/result
• Limitation of that study

"A study by [Author] ([year]) found that [key result]. However, this study was limited by [small sample size / single centre / specific population], leaving a gap in knowledge regarding [your focus area]."

4. From Systematic Reviews / Meta-analyses

• Overall conclusion
• Identified research gaps

"A systematic review by [Author] ([year]) concluded that [finding], but noted insufficient evidence on [gap relevant to your study]."

5. From Guidelines

• Current recommended treatment/management
• Areas where evidence is lacking

"Current [WHO/ICMR/AHA] guidelines recommend [treatment], but acknowledge limited data on [your study population or intervention]."

Simple Flow to Follow

1. Disease definition + burden       → from review articles / epidemiology papers
        ↓
2. What is currently known           → from RCTs, reviews
        ↓
3. What is NOT known (the GAP)       → from limitations sections of articles
        ↓
4. Why your study is needed          → your own logical conclusion

Most Important Tip

The "Limitations" and "Future Research" sections of published articles are the best place to find your knowledge gap — this directly justifies your study to the IEC.

What NOT to Do

• Do not copy sentences directly — paraphrase in your own words
• Do not use only one article — use at least 3–5
• Do not ignore the Indian/local context — IECs prefer locally relevant data

How to Do It

In the Text:

"Diabetes mellitus affects over 77 million people in India.¹ Current guidelines recommend metformin as first-line therapy.² However, studies on its efficacy in elderly patients remain limited.³"

At the End (Reference List):

References:

1. Mohan V, et al. Prevalence of diabetes in India. Indian J Med Res. 2018;148(3):307-321.

2. American Diabetes Association. Standards of Medical Care. Diabetes Care. 2023;46(1):S1-S4.

3. Singh AK, et al. Metformin use in elderly diabetics. J Geriatr Med. 2020;12(2):45-52.

Format of Each Reference (Vancouver)

[Number]. Author AA, Author BB. Title of article. 
Journal Abbreviation. Year;Volume(Issue):Pages.

Quick Rules

Example Background Paragraph (with tags)

"Hypertension is one of the leading causes of cardiovascular mortality worldwide, affecting approximately 1.28 billion adults.¹ In India, the prevalence is estimated at 28.5% in adults above 18 years.² Despite availability of multiple antihypertensive agents, blood pressure control rates remain poor, particularly in rural populations.³ A systematic review by Anchala et al. highlighted significant gaps in treatment adherence and follow-up in low-income settings.⁴ The present study aims to address this gap by evaluating a community-based intervention in a rural Indian cohort."

Writing Superscript for References

1. In Microsoft Word (Most Common)

• Type the number (e.g. 1)
• Select it
• Press Ctrl + Shift + =
• It becomes superscript → ¹

• Select the number
• Go to Home → Font → check "Superscript" box (x²)

2. In Google Docs

• Type the number
• Select it
• Go to Format → Text → Superscript

• Select the number
• Press Ctrl + . (Control + period)

3. Simply Type Unicode Superscript Numbers

4. In Square Brackets (Simpler Alternative)

"Hypertension affects 1.28 billion adults worldwide [1] and remains poorly controlled in rural settings [2,3]."

Tip: Square brackets [1] are easier and widely accepted by most IECs and journals. Use superscript only if your institution specifically requires it.

Word Count for IEC Background Section

General Rule

Typical Word Count by Study Type

Simple Thumb Rule

Keep it between 300 to 500 words for most IEC submissions — this is the most commonly accepted range.

Paragraph-wise Word Split (500 word background)

Important Tips

• Do not write too short (less than 200 words) — looks insufficient and poorly researched
• Do not write too long (more than 1000 words) — background is not a literature review
• Check your institution's IEC format — some provide a specific word/character limit in the application form
• Quality over quantity — a focused 350-word background is better than a vague 700-word one

Bottom line: Aim for 400–500 words with 4–5 paragraphs and 4–6 references. This is safe for most IEC submissions.

Background

Suggested References to Fill In

Tips for Customizing This Background

• Replace [specify method] with your actual assessment tool (EEG, DTI, fMRI, etc.)
• Replace [specify population] with your study group
• Search PubMed using the keywords in the table above and insert real article numbers in place of the superscripts
• The limitations paragraph (paragraph 4) is your strongest justification for the IEC — make sure it matches your actual study gap

Recommended Article References

Reference 1 — Corpus Callosum & Interhemispheric Transfer (Foundation)

Banich MT. The missing link: The role of interhemispheric interaction in attentional processing. Brain and Cognition. 1998;36(2):128–157.

Reference 2 — Task-Based Assessment of Interhemispheric Transfer in Children

Hagelthorn KM, Brown WS, Amano S, Asarnow R. Normal development of bilateral field advantage and evoked potential interhemispheric transfer time. Developmental Neuropsychology. 2003;23(3):479–492.

Reference 3 — Interhemispheric Connection and Behaviour in Children

Hines M, Chiu L, McAdams LA, Bentler PM, Lipcamon J. Cognition and the corpus callosum: verbal fluency, visuospatial ability, and language lateralization related to midsagittal surface areas of callosal subregions. Behavioural Neuroscience. 1992;106(1):3–14.

Reference 4 — Development of Interhemispheric Connections in Children

Giedd JN, Blumenthal J, Jeffries NO, et al. Brain development during childhood and adolescence: a longitudinal MRI study. Nature Neuroscience. 1999;2(10):861–863.

Reference 5 — Behavioural Consequences of Interhemispheric Dysfunction

Brown WS, Paul LK. Cognitive and psychosocial deficits in agenesis of the corpus callosum with normal intelligence. Cognitive Neurodynamics. 2000;14(2):135–163.

Reference 6 — Gap / Justification for Your Study

Lassonde M, Sauerwein HC, Chicoine AJ, Geoffroy G. Absence of disconnection syndrome in callosal agenesis and early callosotomy: brain reorganization or lack of structural specificity during ontogeny? Neuropsychologia. 1991;29(5):481–495.

How to Write Your Reference List (Vancouver Style)

1. Banich MT. The missing link: The role of interhemispheric interaction 
   in attentional processing. Brain Cogn. 1998;36(2):128–157.

2. Hagelthorn KM, Brown WS, Amano S, Asarnow R. Normal development of 
   bilateral field advantage and evoked potential interhemispheric transfer 
   time. Dev Neuropsychol. 2003;23(3):479–492.

3. Hines M, Chiu L, McAdams LA, et al. Cognition and the corpus callosum. 
   Behav Neurosci. 1992;106(1):3–14.

4. Giedd JN, Blumenthal J, Jeffries NO, et al. Brain development during 
   childhood and adolescence. Nat Neurosci. 1999;2(10):861–863.

5. Brown WS, Paul LK. Cognitive and psychosocial deficits in agenesis of 
   the corpus callosum. Cogn Neurodynamics. 2000;14(2):135–163.

6. Lassonde M, Sauerwein HC, Chicoine AJ, Geoffroy G. Absence of 
   disconnection syndrome in callosal agenesis. Neuropsychologia. 
   1991;29(5):481–495.

Important Note

These are real published articles — please verify each one on PubMed (pubmed.ncbi.nlm.nih.gov) before submitting to IEC, as page numbers and volume details should be confirmed from the original source.

SPSS Analysis & Statistics Section for IEC Submission

Where to Write This in IEC Form

What to Write (Template)

"All data will be entered and analyzed using IBM SPSS Statistics Version [26/27/28]. Descriptive statistics will be used to summarize demographic and baseline variables. Continuous variables will be expressed as mean ± standard deviation (SD) or median (interquartile range) based on distribution. Categorical variables will be expressed as frequencies and percentages.

Normality of data will be assessed using the Shapiro-Wilk test. For comparison between groups, independent samples t-test or Mann-Whitney U test will be applied for parametric and non-parametric data respectively. Pearson's or Spearman's correlation coefficient will be used to assess the relationship between interhemispheric task performance and behavioural scores. A p-value of <0.05 will be considered statistically significant."

Tests to Mention Based on Your Study

For Your Specific Study (Interhemispheric Tasks + Behaviour in Children)

Sample Sentence for IEC (Copy-Paste Ready)

"Data will be analyzed using IBM SPSS Statistics Version 26.0. Descriptive statistics will be reported as mean ± SD for continuous variables and as frequencies (%) for categorical variables. Normality will be tested using the Shapiro-Wilk test. Pearson's or Spearman's correlation will be used to examine the relationship between interhemispheric task performance and behavioural outcomes in children. Group comparisons will be performed using independent samples t-test or Mann-Whitney U test as appropriate. Statistical significance will be set at p < 0.05."

Additional Things IEC May Ask

Sample Size Statement (Important for IEC)

"Sample size was calculated using GPower software based on a previous study by [Author, year] with an effect size of [X], power of 80%, and significance level of 0.05, yielding a minimum sample of [N] participants."*