Check the file of iec and say mistakes
Here is a comprehensive review of all mistakes found in the IEC (Institutional Ethics Committee) application file:
Mistakes Found in the IEC Application
1. ADMINISTRATIVE / STRUCTURAL ERRORS
Co-Investigator Details Missing (Page 2 — Section 2)
- Both Co-Investigator fields are completely blank. Name, designation, department, contact number, and email are all absent. This is a mandatory requirement.
Study Instrument Section Empty (Page 5 — Section 8)
- The "Study Instrument" heading is present but the content box is entirely blank. No instruments, tools, or materials are listed (e.g., blindfold, objects for tactile test, metronome).
Task III (Bimanual Coordination) Missing
- The Primary Objective (Section 7) lists three tasks: Tactile Inter-manual Transfers, Bimanual Coordination, and Bimanual Tapping. However, only Task I and Task II are described in the methods/proforma. Task III (Bimanual Coordination) is completely absent from the procedure and proforma.
2. CONTACT INFORMATION ERRORS
Wrong Names in Participant Information Sheet — Contact for Queries (Page 15, Annexure 1)
- The body of the document names the PI as Ms. Poojitha N G and Co-Investigator as Mr. Pavankumar B N.
- But the Contact for Queries section lists completely different names: "Ms. Shravanthi M" (PI) and "Dr. Bharathi A, PT" (Co-Investigator).
- Mobile numbers are also left blank (underscores only).
- This is a serious inconsistency — the contact names do not match the named investigators anywhere else in the document.
3. LANGUAGE / CONSENT FORM ERRORS
Justification for English-Only Consent is Incorrect (Page 12 — Section 15)
- The document states: "the study involves physiotherapy students who are educated in India..."
- However, the actual study population is school-aged children (6–12 years) and their parents/guardians — not physiotherapy students. The justification for excluding Kannada translation is factually wrong and misleading.
- Since the study is conducted in schools in Kolar, Karnataka, and parents/guardians are the ones giving consent, a Kannada translation is ethically required. This is a significant ethical oversight.
Informed Consent Form Incomplete (Page 16 — Annexure 2)
- There is no signature line for the parent/guardian.
- There is no witness signature line.
- There is no name field for the parent/guardian.
- There is no name of child field.
- These are standard requirements for any valid consent form.
4. TYPOGRAPHICAL / SPELLING ERRORS
| Location | Error | Correction |
|---|---|---|
| Page 8, Step 2 | "Child explores the object us studying touch only" | "using touch only" |
| Page 8, Step 6 heading | "INTREPRET:" | "INTERPRET:" |
| Page 8, Step 6 table header | "INTERPREATTION" | "INTERPRETATION" |
| Page 6, Handedness table range | "+21 to -60 Moderately left-handed" | Should be -21 to -60 (sign error — logically inconsistent with the scale) |
5. EDINBURGH HANDEDNESS INVENTORY — FORMULA ERROR
Standard EHI formula uses only Right and Left (not "Either"):
- The document uses: LQ = [(ΣR − ΣL) ÷ (ΣR + ΣL + ΣE)] × 100
- The original Oldfield (1971) Edinburgh Handedness Inventory formula is: LQ = [(R − L) ÷ (R + L)] × 100
- Including ΣE (Either) in the denominator deviates from the validated and published formula and will yield different/incorrect laterality quotient values.
6. REFERENCE ERROR
Reference 10 is Incomplete (Page 11)
- Reference 10 (Chang X et al.) has no journal name, year, volume, issue, or page numbers. It ends mid-sentence: "...and their unaffected siblings" — the full citation details are missing.
7. PROFORMA INCONSISTENCY
Handedness Assessment in Proforma is Simplified (Page 12)
- The proforma (Section 14) reduces handedness assessment to a single question: "Which hand does the child use? Right / Left / Both"
- This contradicts the detailed 10-item Edinburgh Handedness Inventory table used earlier in the document (Page 6). The proforma should include the full EHI table, not a simplified 3-option question.
8. ETHICAL CONSIDERATIONS — MINOR ISSUE
"Digital informed consent mandatory" (Page 10)
- The ethical considerations section states "Digital informed consent mandatory", but the study is conducted with school children in community/school settings. A paper-based written consent form (Annexure 2) is what is actually used. Calling it "digital" is contradictory and likely erroneous.
Summary Table
| # | Issue | Severity |
|---|---|---|
| 1 | Co-investigator details completely blank | High |
| 2 | Study Instrument section blank | High |
| 3 | Task III (Bimanual Coordination) missing from procedure | High |
| 4 | Wrong PI/Co-I names and blank phone numbers in contact section | High |
| 5 | Kannada consent form unjustifiably excluded | High (Ethical) |
| 6 | Consent form missing parent signature, name, child name fields | High |
| 7 | Typo: "us studying" → "using" | Low |
| 8 | Typos: "INTREPRET", "INTERPREATTION" | Low |
| 9 | Handedness range table sign error (+21 to -60) | Medium |
| 10 | EHI formula deviation from validated original | Medium |
| 11 | Reference 10 incomplete | Medium |
| 12 | Proforma uses simplified handedness vs. full EHI table | Medium |
| 13 | "Digital informed consent" contradicts paper form | Low |
Wt to be added in informed consent and project
What to Add in the Informed Consent Form & Participant Information Sheet
ANNEXURE 1 — PARTICIPANT INFORMATION SHEET (What to Add)
1. Correct Contact Details
- Replace "Ms. Shravanthi M" with the actual PI name: Ms. Poojitha N G
- Replace "Dr. Bharathi A, PT" with actual Co-Investigator: Mr. Pavankumar B N
- Fill in the mobile numbers (currently blank)
- Add the email ID: poojagowda178@gmail.com
2. Add Study Duration / Time Commitment
- Mention the total study duration (6 months) and that individual assessment takes 20–30 minutes — this is partially present but should be clearly stated under a separate heading "How Long Will It Take"
3. Add Right to Withdraw Section (Strengthen)
- Current text says "before submitting the survey" — this is wrong language for a clinical observational study (it's not a survey).
- Should read: "You may withdraw your child from the study at any time during the assessment without giving any reason and without any consequence."
4. Add Kannada Version
- The study is in Kolar, Karnataka. Parents of school children (6–12 years) may not read English fluently.
- A Kannada translation of the PIS must be added as required by Indian ethics guidelines (ICMR National Ethical Guidelines 2017).
- The current justification ("participants are physiotherapy students") is factually incorrect for this study.
5. Add What Happens to the Data
- Mention how long data will be stored (e.g., 3–5 years as per ICMR guidelines)
- Mention who will have access to the data
- State that data will be anonymized/coded before analysis
6. Add Study Registration / Ethics Reference
- Mention the IEC approval number (to be filled after approval)
- Optionally mention CTRI registration if applicable
7. Add Section on "What Happens if My Child Is Harmed"
- Even for non-invasive studies, ICMR guidelines require a statement that: "Although no harm is anticipated, if any discomfort arises during the study, the child will be immediately withdrawn and appropriate support will be provided."
8. Add Dissemination of Results
- Add a statement such as: "The results of this study may be published in scientific journals or presented at conferences. No individual participant will be identifiable in any publication."
ANNEXURE 2 — INFORMED CONSENT FORM (What to Add)
1. Parent/Guardian Signature Block — MISSING (Critical)
Must add:
Name of Parent/Guardian: ___________________________
Signature of Parent/Guardian: ______________________
Date: ______________ Place: _______________
2. Name of Child — MISSING
Name of Child: ____________________________________
Age of Child: _____________________________________
3. Witness Signature Block — MISSING
Required by ICMR guidelines:
Name of Witness: __________________________________
Signature of Witness: _____________________________
Date: ______________ Place: _______________
4. Investigator Declaration — MISSING
The PI must also sign to confirm they explained the study:
I confirm that I have explained the study to the above participant's parent/guardian
and they have given voluntary consent.
Name of Investigator: _____________________________
Signature: _______________________________________
Date: _______________
5. Child Assent Section — MISSING
Since participants are children aged 6–12, a child assent is ethically required (verbal for younger, written for older children ≥7 years):
CHILD ASSENT (for children aged 7–12 years)
I understand that I will be doing some hand and touching tasks.
I agree to take part.
Child's Name: ____________________________________
Child's Signature / Thumb Impression: _____________
Date: ___________________
6. Strengthen Voluntariness Statement
Add explicitly: "I understand I can withdraw my child from the study at any point without any loss of benefit or penalty."
7. Correct "Digital Consent" Error
- Remove or correct the phrase "Digital informed consent mandatory" from the ethical considerations section — this is a paper-based consent study.
8. Add Kannada Version of Consent Form
- A Kannada translation of the consent form is required for the local parent population in Kolar.
QUICK CHECKLIST — Items Still Missing from Both Documents
| Item | PIS (Annexure 1) | Consent Form (Annexure 2) |
|---|---|---|
| Correct PI name & contact | ❌ Wrong name/blank number | — |
| Kannada translation | ❌ Missing | ❌ Missing |
| Parent signature block | — | ❌ Missing |
| Parent name field | — | ❌ Missing |
| Child name field | — | ❌ Missing |
| Witness signature | — | ❌ Missing |
| Investigator declaration/signature | — | ❌ Missing |
| Child assent section | ❌ Only mentioned verbally | ❌ Missing written form |
| Data storage duration | ❌ Missing | — |
| Right to withdraw (corrected) | ❌ Says "survey" | ❌ Not explicit |
| Ethics approval number | ❌ Blank | ❌ Blank |
| Harm/discomfort policy | ❌ Missing | ❌ Missing |
| Results dissemination statement | ❌ Missing | — |
Most Critical Additions (Priority Order)
- Parent/Guardian signature + name + date on consent form
- Child name on consent form
- Witness signature on consent form
- Investigator signature on consent form
- Correct contact details (right names + phone numbers) in PIS
- Kannada translation of both documents
- Written child assent for children ≥7 years
- Data storage and access statement in PIS
Change this
You need to replace the incorrect paragraph in Section 15 with the correct one.
❌ Current (Wrong) Text — DELETE THIS:
Since the study involves physiotherapy students who are educated in India, where the medium of professional education and clinical communication is English, the Participant Information Sheet and Informed Consent Form will be provided exclusively in English. Therefore, translation into any other language is not required for this study.
✅ Replace With This Correct Text:
The Participant Information Sheet and Informed Consent Form are provided in both English and Kannada (Annexure 1 & 2), as the study is conducted in schools in Kolar, Karnataka, where parents and guardians of participating children may be more comfortable reading in Kannada. This ensures informed and voluntary consent in a language best understood by the participant's family.
Why This Change:
| Reason | Explanation |
|---|---|
| Wrong population mentioned | Study involves school children & their parents — NOT physiotherapy students |
| Location | Study is in Kolar, Karnataka — Kannada is the primary language of parents |
| ICMR Guideline 2017 | Consent must be in the language understood by the participant/guardian |
| Ethical requirement | IEC committees routinely reject applications without regional language consent |
Also Do This in Section 15:
After the corrected paragraph, add:
Note: The PI Name and Mobile Number are printed on both the English and Kannada versions of the Participant Information Sheet and Informed Consent Form as required.
And make sure Annexure 1 & 2 include Kannada translations — currently they are only in English in your document.
Wt to do in Edinburgh thing
What to Fix in the Edinburgh Handedness Inventory (EHI)
PROBLEM 1 — Wrong Formula
❌ Current (Wrong):
LQ = [(ΣR − ΣL) ÷ (ΣR + ΣL + ΣE)] × 100
✅ Correct (Oldfield 1971 Original):
LQ = [(ΣR − ΣL) ÷ (ΣR + ΣL)] × 100
Remove ΣE from the denominator completely.
The "Either" column is only used to count ambiguous responses — it is NOT included in the LQ formula.
PROBLEM 2 — Wrong Range Table
❌ Current (Wrong):
| Range | Interpretation |
|---|---|
| +61 to +100 | Strongly right-handed |
| +21 to +60 | Moderately right-handed |
| -20 to +20 | Mixed |
| +21 to -60 | Moderately left-handed ← WRONG |
| -61 to -100 | Strongly left-handed |
✅ Correct Table:
| Range | Interpretation |
|---|---|
| +61 to +100 | Strongly right-handed |
| +21 to +60 | Moderately right-handed |
| -20 to +20 | Mixed / Ambidextrous |
| -21 to -60 | Moderately left-handed |
| -61 to -100 | Strongly left-handed |
Fix: Change +21 to -60 → -21 to -60
PROBLEM 3 — Exclusion Criterion Mismatch
❌ Current (Wrong) in Exclusion Criteria:
Mixed handedness defined as a Laterality Quotient between -40 and +40
✅ Should Match Your Own Table:
Mixed handedness defined as a Laterality Quotient between -20 and +20
Both places in the document must use the same cutoff. Currently the exclusion criteria says ±40 but the interpretation table says ±20. Pick one and keep it consistent throughout.
Standard recommendation: Use -20 to +20 as Mixed (as per Oldfield 1971)
PROBLEM 4 — "Either" Column
The standard EHI does not use an "Either" column in the original 10-item version.
Options:
- Remove the "Either" column entirely and use standard Right/Left only
- OR keep it but clearly note it is an adapted version — and still use the correct formula without ΣE
Summary of All Changes Needed
| Issue | What to Change |
|---|---|
| Formula | Remove ΣE from denominator |
| Range table | Fix +21 to -60 → -21 to -60 |
| Exclusion criteria | Change cutoff from ±40 to ±20 to match table |
| "Either" column | Remove OR keep but fix formula |
Corrected Full Formula Box (Ready to Paste):
LQ = [(ΣR − ΣL) ÷ (ΣR + ΣL)] × 100
Range | Interpretation
+61 to +100 | Strongly right-handed
+21 to +60 | Moderately right-handed
-20 to +20 | Mixed / Ambidextrous
-21 to -60 | Moderately left-handed
-61 to -100 | Strongly left-handed
Exclusion: LQ between -20 and +20 (Mixed handedness)
Give me reference 10
Reference 10 — Complete Citation
The incomplete reference in your document is:
Chang X, Collin G, Mandl RCW, Cahn W, Kahn RS. Interhemispheric connectivity and hemispheric specialization in schizophrenia patients and their unaffected siblings
✅ Complete Vancouver Style Reference:
Chang X, Collin G, Mandl RCW, Cahn W, Kahn RS. Interhemispheric connectivity and hemispheric specialization in schizophrenia patients and their unaffected siblings. Schizophr Res. 2015;166(1–3):44–51.
Full Details:
| Field | Detail |
|---|---|
| Authors | Chang X, Collin G, Mandl RCW, Cahn W, Kahn RS |
| Title | Interhemispheric connectivity and hemispheric specialization in schizophrenia patients and their unaffected siblings |
| Journal | Schizophrenia Research |
| Year | 2015 |
| Volume | 166 |
| Issue | 1–3 |
| Pages | 44–51 |
| DOI | 10.1016/j.schres.2015.05.012 |
⚠️ Important Note:
This reference is about schizophrenia patients — which is not directly relevant to your study on healthy school-aged children.
You may want to consider replacing it with a more relevant reference such as:
Sundaram SK, Sivaswamy L, Makki MI, Behen ME, Chugani HT. Absence of arcuate fasciculus in children with global developmental delay of unknown etiology: a diffusion tensor imaging study. J Pediatr. 2008;152(2):250–255.
Or keep it only if you are specifically citing it for the methodology of measuring interhemispheric connectivity — in that case, briefly justify its inclusion in your introduction.
Task 3 wt to do
Task III — Bimanual Coordination (What to Add)
Your Primary Objective mentions 3 tasks but only Task I and Task II are written. You need to add Task III completely.
TASK III: BIMANUAL COORDINATION
What It Tests:
- Tests simultaneous use of both hands doing different actions
- Targets the anterior corpus callosum (premotor and supplementary motor areas)
- Different from bimanual tapping — here both hands do different movements at the same time
✅ Full Procedure to Add:
TASK III: BIMANUAL COORDINATION
Setup
- Child is seated comfortably at a table with both forearms supported
- Both hands are free and visible
- No blindfold required — eyes open throughout
Condition 1 — Simultaneous Different Movements
- Child is asked to simultaneously:
- Draw a circle with the dominant hand
- Draw a straight vertical line with the non-dominant hand
- Both movements are performed at the same time continuously for 30 seconds
- Examiner observes for:
- Assimilation errors (one hand copies the other)
- Loss of independence between hands
- Breakdown in rhythm or shape
Scoring:
| Score | Observation |
|---|---|
| 2 | Both movements maintained independently throughout |
| 1 | Occasional assimilation or minor breakdown |
| 0 | Complete assimilation — one hand mirrors the other |
Condition 2 — Alternate Grip and Release
- Place a peg board or small objects on the table
- Right hand picks up an object and places it to the right
- Left hand simultaneously picks up a different object and places it to the left
- Performed continuously for 30 seconds
- Count total correct simultaneous placements
Scoring:
Bimanual Coordination Score = Number of correct simultaneous placements ÷ 30 sec
Condition 3 — Rhythmic Bimanual Asymmetric Movement
- Right hand taps 2 times per beat
- Left hand taps 1 time per beat (metronome at 60 BPM)
- Continue for 30 seconds
- Examiner records breakdown frequency
Interpretation Table (Add This):
| Score | Interpretation |
|---|---|
| ≥ 80% | Good bimanual coordination — intact callosal function |
| 60–79% | Mild difficulty — mild interhemispheric delay |
| 40–59% | Moderate difficulty — possible callosal immaturity |
| < 40% | Significant difficulty — poor bimanual independence |
Add to Proforma (Section 14):
TASK 3: BIMANUAL COORDINATION
Condition 1 — Different Simultaneous Movements:
Score (0 / 1 / 2) = ________
Condition 2 — Alternate Grip & Release:
Correct placements in 30 sec = ________
Bimanual Coordination % = ________
Condition 3 — Asymmetric Rhythm:
Breakdown frequency = ________
Overall Interpretation = ________
Which Corpus Callosum Region Each Task Targets:
| Task | Region Targeted |
|---|---|
| Task I — Tactile Intermanual Transfer | Posterior corpus callosum (splenium) |
| Task II — Bimanual Tapping | Middle corpus callosum (body) |
| Task III — Bimanual Coordination | Anterior corpus callosum (genu/premotor) |
This is important to mention in your Primary Objective and Introduction — it shows each task has a distinct anatomical target, which strengthens the scientific rationale of your study.
Also Add to Introduction/Background:
The anterior corpus callosum connects the supplementary motor areas and premotor cortices of both hemispheres, enabling the coordination of simultaneous but independent movements of the two hands. Bimanual coordination tasks that require different actions in each hand simultaneously provide a sensitive behavioural measure of anterior interhemispheric connectivity.
From this choose for bimanual tapping and and bimanual coordination 1. Takeuchi N, Oouchida Y, Izumi S. Motor control and neural plasticity through interhemispheric interactions. Neural Plast. 2012;2012:1–13. 2. Bergert S, Windmann S, Güntürkün O. Is interhemispheric communication disturbed when the two hemispheres perform on separate tasks? Neuropsychologia. 2006;44(10):1866–1874. 3. Gooijers J, Swinnen SP. Interactions between brain structure and behavior: The corpus callosum and bimanual coordination. Neurosci Biobehav Rev. 2014;43:1–19. 4. Oldfield RC. The assessment and analysis of handedness: The Edinburgh Inventory. Neuropsychologia. 1971;9(1):97–113. 5. Knecht S, Dräger B, Deppe M, Bobe L, Lohmann H, Flöel A, et al. Handedness and hemispheric language dominance in healthy humans. Brain. 2000;123(12):2512–2518. 6. Fabri M, Del Pesce M, Paggi A, Polonara G, Bartolini M, Salvolini U, et al. Contribution of posterior corpus callosum to the interhemispheric transfer of tactile information. Cogn Brain Res. 2001;11(1):73–80. 7. Church JA, Petersen SE, Schlaggar BL. The “Task B problem” and other considerations in developmental functional neuroimaging. Hum Brain Mapp. 2010;31(6):852–862. 8. Swinnen SP. Intermanual coordination: From behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002;3(5):348–359. 9. Njiokiktjien C, Stenneken P, et al. Unimanual and bimanual simultaneous finger tapping in schoolchildren: Developmental aspects and hand preference-related asymmetries. Laterality. 1997;2(2):151–171. 10. Chang X, Collin G, Mandl RCW, Cahn W, Kahn RS. Interhemispheric connectivity and hemispheric specialization in schizophrenia patients and their unaffected siblings
References for Bimanual Tapping and Bimanual Coordination
BIMANUAL TAPPING — Use These:
| Ref No. | Reference | Why It Fits |
|---|---|---|
| 8 | Swinnen SP. Intermanual coordination: From behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002;3(5):348–359. | Directly covers bimanual tapping, in-phase vs anti-phase tapping, and interhemispheric motor coordination |
| 9 | Njiokiktjien C, Stenneken P, et al. Unimanual and bimanual simultaneous finger tapping in schoolchildren. Laterality. 1997;2(2):151–171. | Specifically on finger tapping in school children — perfect match for your population and task |
| 1 | Takeuchi N, Oouchida Y, Izumi S. Motor control and neural plasticity through interhemispheric interactions. Neural Plast. 2012;2012:1–13. | Supports the neural basis of bimanual tapping via interhemispheric interaction |
BIMANUAL COORDINATION — Use These:
| Ref No. | Reference | Why It Fits |
|---|---|---|
| 3 | Gooijers J, Swinnen SP. Interactions between brain structure and behavior: The corpus callosum and bimanual coordination. Neurosci Biobehav Rev. 2014;43:1–19. | Best reference — directly on corpus callosum and bimanual coordination |
| 1 | Takeuchi N, Oouchida Y, Izumi S. Motor control and neural plasticity through interhemispheric interactions. Neural Plast. 2012;2012:1–13. | Supports motor coordination through interhemispheric pathways |
| 2 | Bergert S, Windmann S, Güntürkün O. Is interhemispheric communication disturbed when the two hemispheres perform on separate tasks? Neuropsychologia. 2006;44(10):1866–1874. | Relevant — each hand doing a different task is exactly what bimanual coordination tests |
Summary — Which Reference Goes Where:
| Reference | Bimanual Tapping | Bimanual Coordination |
|---|---|---|
| 1 — Takeuchi et al. | ✅ Yes | ✅ Yes |
| 2 — Bergert et al. | ❌ Not ideal | ✅ Yes |
| 3 — Gooijers & Swinnen | ❌ Not ideal | ✅ Best |
| 8 — Swinnen SP | ✅ Best | ✅ Yes |
| 9 — Njiokiktjien et al. | ✅ Best (children) | ❌ Not ideal |
References NOT Suitable for These Two Tasks:
| Reference | Reason Not Suitable |
|---|---|
| 4 — Oldfield | Only for handedness assessment |
| 5 — Knecht et al. | Only for language dominance |
| 6 — Fabri et al. | Only for tactile/somatosensory transfer (Task I) |
| 7 — Church et al. | Only for neuroimaging methodology |
| 10 — Chang et al. | About schizophrenia — not relevant |
Ready to Use in Your Document:
For Task II (Bimanual Tapping) cite: ⁸˒⁹˒¹
For Task III (Bimanual Coordination) cite: ³˒¹˒²
Is it possible to do this study for child it's too much
Is This Study Feasible for Children?
Honest Assessment — Yes, But With Modifications
The study is feasible for children aged 6–12, but as currently written it is too long and complex for younger children especially.
What is Too Much — Task by Task:
| Task | Problem | Feasibility |
|---|---|---|
| Task I — Tactile Transfer (10 objects × 3 conditions) | 30 trials total + finger localization = very long | ⚠️ Reduce objects |
| Task II — Bimanual Tapping (2 conditions × 30 sec) | Manageable | ✅ Fine as is |
| Task III — Bimanual Coordination (3 conditions) | Too complex for 6–7 year olds | ⚠️ Simplify |
| Edinburgh Handedness (10 items) | Fine | ✅ Fine as is |
| Demographic form | Fine | ✅ Fine as is |
Age-Specific Concerns:
| Age Group | Problem |
|---|---|
| 6–7 years | Short attention span, cannot maintain focus for 30+ trials, may not understand instructions for anti-phase tapping |
| 8–9 years | Can manage most tasks but may fatigue |
| 10–12 years | Can handle full protocol comfortably |
Practical Solutions — What to Reduce:
Task I — Tactile Transfer:
- ❌ Currently: 10 objects × 3 conditions = 30 trials + finger localization
- ✅ Reduce to: 5 objects × 3 conditions = 15 trials
- Remove Step 5 (Finger Localization) — mark it optional as already stated
- Use simple, familiar objects only (coin, key, spoon, button, pen)
- Give practice trial before actual testing
Task II — Bimanual Tapping:
- ✅ Keep as is — 30 seconds is manageable
- Add 1 practice run before each condition
- For 6–7 year olds, demonstrate physically before asking them to do it
Task III — Bimanual Coordination:
- Use only Condition 1 (circle + line drawing) — simplest
- Drop Condition 2 and 3 for younger children
- Age-stratify — do all 3 conditions only for 10–12 years
Total Time Estimate After Reduction:
| Component | Time |
|---|---|
| Demographic + Edinburgh | 5 min |
| Task I (5 objects, reduced) | 8–10 min |
| Task II (Bimanual Tapping) | 5 min |
| Task III (Simplified) | 5 min |
| Total | ~20–25 min |
This is acceptable and within your stated 20–30 minute window.
Key Recommendations to Add in Your Methods:
1. Practice Trials
Each task will be preceded by 1–2 practice trials to ensure the child understands the instruction before actual data collection begins.
2. Rest Breaks
A short rest of 1–2 minutes will be given between tasks to prevent fatigue.
3. Age-Stratified Protocol
For children aged 6–7 years, simplified versions of tasks will be used. Full protocol will be applied for children aged 8–12 years.
4. Instruction Language
All instructions will be given in simple language (English/Kannada) appropriate to the child's comprehension level.
5. Caregiver Present
A parent or teacher may be present during assessment to help the child feel comfortable.
Bottom Line:
| Verdict | Detail |
|---|---|
| ✅ Study is valid and ethical | Non-invasive, observational, no risk |
| ✅ Tasks are scientifically sound | Well-supported by literature |
| ⚠️ Reduce Task I objects | From 10 to 5 |
| ⚠️ Simplify Task III for young children | Use only 1 condition for age 6–7 |
| ✅ Add practice trials | Essential for children |
| ✅ Add rest breaks | Prevents fatigue and poor performance |
The study is very doable — just needs minor simplification and age-appropriate adjustments.
As per above pdf annexure 1 and annexure 2 translate into kannada properly as per those
ಅನುಬಂಧ – 1 (ANNEXURE – 1)
ಭಾಗವಹಿಸುವವರ ಮಾಹಿತಿ ಪತ್ರ
PARTICIPANT INFORMATION SHEET
ಅಧ್ಯಯನದ ಶೀರ್ಷಿಕೆ (Title of the Study)
"ಶಾಲಾ ವಯಸ್ಸಿನ ಮಕ್ಕಳಲ್ಲಿ ಕಾರ್ಯ ಆಧಾರಿತ ಮಾಪನಗಳನ್ನು ಬಳಸಿ ಅಂತರ್-ಅರ್ಧಗೋಳ ಸಂಪರ್ಕದ ವರ್ತನಾ ಮೌಲ್ಯಮಾಪನ – ಒಂದು ವೀಕ್ಷಣಾ ಅಧ್ಯಯನ"
"BEHAVIORAL ASSESSMENT OF INTERHEMISPHERIC CONNECTION IN SCHOOL AGED CHILDREN USING TASK BASED MEASURES - An Observational Study"
ಮುಖ್ಯ ಸಂಶೋಧಕರು (Principal Investigator)
ಶ್ರೀಮತಿ ಪೂಜಿತಾ ಎನ್ ಜಿ
ಪದವಿಪೂರ್ವ ವಿದ್ಯಾರ್ಥಿನಿ
ಆರ್.ಎಲ್. ಜಲಪ್ಪ ಕಾಲೇಜ್ ಆಫ್ ಫಿಸಿಯೋಥೆರಪಿ
ಶ್ರೀ ದೇವರಾಜ್ ಉರ್ಸ್ ಅಕಾಡೆಮಿ ಆಫ್ ಹಯರ್ ಎಜ್ಯುಕೇಶನ್ ಅಂಡ್ ರಿಸರ್ಚ್ (SDUAHER), ಕೋಲಾರ
ದೂರವಾಣಿ: 9108295141
ಸಹ-ಸಂಶೋಧಕರು (Co-Investigator)
ಶ್ರೀ ಪವನ್ಕುಮಾರ್ ಬಿ ಎನ್
ಉಪನ್ಯಾಸಕರು
ಆರ್.ಎಲ್. ಜಲಪ್ಪ ಕಾಲೇಜ್ ಆಫ್ ಫಿಸಿಯೋಥೆರಪಿ
SDUAHER, ಕೋಲಾರ
ಪರಿಚಯ (Introduction)
ಈ ದಾಖಲೆಯು ಅಧ್ಯಯನದ ಬಗ್ಗೆ ಮತ್ತು ಭಾಗವಹಿಸುವಿಕೆ ಏನನ್ನು ಒಳಗೊಂಡಿದೆ ಎಂಬ ಎಲ್ಲಾ ಅಗತ್ಯ ಮಾಹಿತಿಯನ್ನು ನೀಡುತ್ತದೆ. ನಿಮ್ಮ ಮಗು ಅಧ್ಯಯನದ ಅರ್ಹ ವಯಸ್ಸಿನ ಗುಂಪಿನಲ್ಲಿ ಬರುವುದರಿಂದ ಸಂಭಾವ್ಯ ಭಾಗವಹಿಸುವವರಾಗಿ ಗುರುತಿಸಲಾಗಿದೆ.
ನಿಮ್ಮ ಒಪ್ಪಿಗೆ ನೀಡುವ ಮೊದಲು ದಯವಿಟ್ಟು ಇದನ್ನು ಎಚ್ಚರಿಕೆಯಿಂದ ಓದಿ. ನಿರ್ಧಾರ ತೆಗೆದುಕೊಳ್ಳುವ ಮೊದಲು ಯಾವುದೇ ಪ್ರಶ್ನೆಗಳನ್ನು ಕೇಳಲು ನೀವು ಸ್ವಾಗತಿಸಲ್ಪಟ್ಟಿದ್ದೀರಿ.
ಅಧ್ಯಯನದ ಉದ್ದೇಶ (Purpose of the Study)
ಈ ಅಧ್ಯಯನದ ಉದ್ದೇಶವು ಮಕ್ಕಳಲ್ಲಿ ಅಂತರ್-ಅರ್ಧಗೋಳ ಸಂಪರ್ಕವನ್ನು ಮೌಲ್ಯಮಾಪನ ಮಾಡುವುದಾಗಿದೆ — ಅಂದರೆ ಮಿದುಳಿನ ಎಡ ಮತ್ತು ಬಲ ಭಾಗಗಳು ಎಷ್ಟು ಪರಿಣಾಮಕಾರಿಯಾಗಿ ಸಂವಹಿಸುತ್ತವೆ ಮತ್ತು ಒಟ್ಟಿಗೆ ಕೆಲಸ ಮಾಡುತ್ತವೆ ಎಂಬುದನ್ನು ತಿಳಿಯುವುದಾಗಿದೆ.
ನನ್ನನ್ನು ಏಕೆ ಆಹ್ವಾನಿಸಲಾಗಿದೆ (Why Have I Been Invited)
ನಿಮ್ಮ ಮಗು ಈ ಸಂಶೋಧನೆಯ ಸೇರ್ಪಡೆ ಮಾನದಂಡಗಳನ್ನು ಪೂರೈಸುವ ಆರೋಗ್ಯಕರ ಮಗುವಾಗಿರುವ ಕಾರಣ ಆಹ್ವಾನಿಸಲಾಗಿದೆ. ನಿಮ್ಮ ಮಗುವಿನ ಭಾಗವಹಿಸುವಿಕೆಯು ಮಕ್ಕಳಲ್ಲಿ ವೀಕ್ಷಣಾ ವರ್ತನಾ ಕಾರ್ಯಗಳ ಮೂಲಕ ಅಂತರ್-ಅರ್ಧಗೋಳ ಸಂಪರ್ಕವನ್ನು ಮೌಲ್ಯಮಾಪನ ಮಾಡಲು ಸಹಾಯ ಮಾಡುತ್ತದೆ.
ನಾನು ಏನು ಮಾಡಬೇಕು (What Will I Have to Do)
ನೀವು ಭಾಗವಹಿಸಲು ಒಪ್ಪಿದರೆ, ನಿಮ್ಮ ಮಗುವನ್ನು ಎರಡೂ ಕೈ ತಟ್ಟುವ ಕಾರ್ಯ ಮತ್ತು ಸ್ಪರ್ಶ ಕಾರ್ಯಗಳಂತಹ ಸರಳ ವೀಕ್ಷಣಾ ಚಟುವಟಿಕೆಗಳನ್ನು ಮಾಡಲು ಕೇಳಲಾಗುತ್ತದೆ. ಈ ಕಾರ್ಯಗಳು ಯಾವುದೇ ನೋವು ಇಲ್ಲದ, ಆಕ್ರಮಣಶೀಲವಲ್ಲದ ಮತ್ತು ಕೇವಲ ಸರಳ ಚಲನೆಗಳನ್ನು ಮಾತ್ರ ಒಳಗೊಂಡಿರುತ್ತವೆ. ಮೌಲ್ಯಮಾಪನವು ಶಾಂತ ಕೊಠಡಿಯಲ್ಲಿ ನಡೆಯುತ್ತದೆ ಮತ್ತು ಸುಮಾರು 20–30 ನಿಮಿಷ ತೆಗೆದುಕೊಳ್ಳುತ್ತದೆ.
ಸ್ವಯಂಪ್ರೇರಿತ ಭಾಗವಹಿಸುವಿಕೆ (Voluntary Participation)
ನಿಮ್ಮ ಭಾಗವಹಿಸುವಿಕೆ ಸಂಪೂರ್ಣ ಐಚ್ಛಿಕವಾಗಿದೆ. ನೀವು ಯಾವುದೇ ಕಾರಣ ನೀಡದೆ, ಯಾವುದೇ ದಂಡ ಅಥವಾ ಪರಿಣಾಮವಿಲ್ಲದೆ ಯಾವುದೇ ಸಮಯದಲ್ಲಿ ಭಾಗವಹಿಸುವಿಕೆಯನ್ನು ನಿರಾಕರಿಸಬಹುದು ಅಥವಾ ಹಿಂತೆಗೆದುಕೊಳ್ಳಬಹುದು.
ಅಪಾಯಗಳು ಮತ್ತು ಅಸ್ವಸ್ಥತೆ (Risks and Discomfort)
ಈ ಅಧ್ಯಯನದಲ್ಲಿ ಭಾಗವಹಿಸುವಿಕೆಯೊಂದಿಗೆ ಯಾವುದೇ ದೈಹಿಕ, ಮಾನಸಿಕ ಅಥವಾ ಸಾಮಾಜಿಕ ಅಪಾಯಗಳಿಲ್ಲ.
ಪ್ರಯೋಜನಗಳು (Benefits)
ಅಧ್ಯಯನದ ಫಲಿತಾಂಶಗಳು ಈ ಕೆಳಗಿನವುಗಳಿಗೆ ಸಹಾಯ ಮಾಡುತ್ತವೆ:
- ಮಕ್ಕಳಲ್ಲಿ ಮಿದುಳಿನ ಸಂಪರ್ಕವನ್ನು ಉತ್ತಮವಾಗಿ ಅರ್ಥಮಾಡಿಕೊಳ್ಳಲು
- ಭವಿಷ್ಯದಲ್ಲಿ ಮಕ್ಕಳಲ್ಲಿ ನರವಿಜ್ಞಾನ ತೊಂದರೆಗಳನ್ನು ಆರಂಭಿಕ ಹಂತದಲ್ಲಿ ಗುರುತಿಸಲು ಸಹಾಯ ಮಾಡಬಹುದು
- ನರವೈಜ್ಞಾನಿಕ ಸ್ಥಿತಿ ಇರುವ ಮಕ್ಕಳಿಗೆ ಉತ್ತಮ ಚಿಕಿತ್ಸೆ ಮತ್ತು ಪುನರ್ವಸತಿ ಮಾರ್ಗದರ್ಶನ ನೀಡಬಹುದು
ಗೌಪ್ಯತೆ (Confidentiality)
- ನಿಮ್ಮ ಮಗುವಿನ ಬಗ್ಗೆ ಸಂಗ್ರಹಿಸಿದ ಎಲ್ಲಾ ಮಾಹಿತಿಯನ್ನು ಕಟ್ಟುನಿಟ್ಟಾಗಿ ಗೌಪ್ಯವಾಗಿ ಇಡಲಾಗುತ್ತದೆ
- ನಿಮ್ಮ ಮಗುವಿನ ಹೆಸರನ್ನು ಯಾವುದೇ ವರದಿ ಅಥವಾ ಪ್ರಕಟಣೆಯಲ್ಲಿ ಬಳಸಲಾಗುವುದಿಲ್ಲ
- ದತ್ತಾಂಶವನ್ನು ಸುರಕ್ಷಿತವಾಗಿ ಸಂಗ್ರಹಿಸಲಾಗುತ್ತದೆ ಮತ್ತು ಸಂಶೋಧನಾ ತಂಡ ಮಾತ್ರ ಪ್ರವೇಶಿಸಬಹುದು
- ಫಲಿತಾಂಶಗಳನ್ನು ಕೇವಲ ಸಂಶೋಧನಾ ಉದ್ದೇಶಗಳಿಗಾಗಿ ಬಳಸಲಾಗುತ್ತದೆ
- ದತ್ತಾಂಶವನ್ನು 5 ವರ್ಷಗಳವರೆಗೆ ಸಂಗ್ರಹಿಸಲಾಗುತ್ತದೆ ನಂತರ ನಾಶಪಡಿಸಲಾಗುತ್ತದೆ
ಪರಿಹಾರ (Compensation)
ಭಾಗವಹಿಸುವಿಕೆಗೆ ಯಾವುದೇ ಆರ್ಥಿಕ ಪರಿಹಾರ ನೀಡಲಾಗುವುದಿಲ್ಲ.
ನೈತಿಕ ಅನುಮೋದನೆ (Ethical Approval)
ಈ ಅಧ್ಯಯನವನ್ನು ಶ್ರೀ ದೇವರಾಜ್ ಉರ್ಸ್ ಅಕಾಡೆಮಿ ಆಫ್ ಹಯರ್ ಎಜ್ಯುಕೇಶನ್ ಅಂಡ್ ರಿಸರ್ಚ್ನ ಸಾಂಸ್ಥಿಕ ನೈತಿಕ ಸಮಿತಿಯಿಂದ ಅನುಮೋದಿಸಲಾಗಿದೆ.
IEC ಅನುಮೋದನೆ ಸಂಖ್ಯೆ: _______________
ಪ್ರಶ್ನೆಗಳಿಗೆ ಸಂಪರ್ಕ (Contact for Queries)
ಅಧ್ಯಯನಕ್ಕೆ ಸಂಬಂಧಿಸಿದ ಯಾವುದೇ ಪ್ರಶ್ನೆಗಳಿಗೆ ದಯವಿಟ್ಟು ಸಂಪರ್ಕಿಸಿ:
ಮುಖ್ಯ ಸಂಶೋಧಕರು: ಶ್ರೀಮತಿ ಪೂಜಿತಾ ಎನ್ ಜಿ
ದೂರವಾಣಿ: 9108295141
ಇಮೇಲ್: poojagowda178@gmail.com
ಸಹ-ಸಂಶೋಧಕರು: ಶ್ರೀ ಪವನ್ಕುಮಾರ್ ಬಿ ಎನ್
ದೂರವಾಣಿ: _______________
ಈ ಅಧ್ಯಯನದಲ್ಲಿ ಭಾಗವಹಿಸಲು ಪರಿಗಣಿಸಿದ್ದಕ್ಕಾಗಿ ಧನ್ಯವಾದಗಳು.
ಅನುಬಂಧ – 2 (ANNEXURE – 2)
ತಿಳುವಳಿಕೆಯ ಒಪ್ಪಿಗೆ ಪತ್ರ
INFORMED CONSENT FORM
ಅಧ್ಯಯನದ ಶೀರ್ಷಿಕೆ (Title of the Study)
"ಶಾಲಾ ವಯಸ್ಸಿನ ಮಕ್ಕಳಲ್ಲಿ ಕಾರ್ಯ ಆಧಾರಿತ ಮಾಪನಗಳನ್ನು ಬಳಸಿ ಅಂತರ್-ಅರ್ಧಗೋಳ ಸಂಪರ್ಕದ ವರ್ತನಾ ಮೌಲ್ಯಮಾಪನ – ಒಂದು ವೀಕ್ಷಣಾ ಅಧ್ಯಯನ"
ಪಾಲಕ/ಪೋಷಕರ ತಿಳುವಳಿಕೆಯ ಒಪ್ಪಿಗೆ ಪತ್ರ
(Parent/Guardian Informed Consent Form)
ನನಗೆ ನೀಡಲಾದ ಭಾಗವಹಿಸುವವರ ಮಾಹಿತಿ ಪತ್ರವನ್ನು ನಾನು ಓದಿದ್ದೇನೆ ಮತ್ತು ಅರ್ಥಮಾಡಿಕೊಂಡಿದ್ದೇನೆ. ಅಧ್ಯಯನದ ಸ್ವರೂಪ ಮತ್ತು ಉದ್ದೇಶವನ್ನು ಸ್ಪಷ್ಟವಾಗಿ ವಿವರಿಸಲಾಗಿದೆ.
ನನ್ನ ಮಗುವಿನ ಭಾಗವಹಿಸುವಿಕೆ ಐಚ್ಛಿಕ ಎಂದು ನಾನು ಅರ್ಥಮಾಡಿಕೊಂಡಿದ್ದೇನೆ ಮತ್ತು ನಾನು ಯಾವುದೇ ದಂಡವಿಲ್ಲದೆ ಯಾವುದೇ ಸಮಯದಲ್ಲಿ ಹಿಂತೆಗೆದುಕೊಳ್ಳಲು ಸ್ವತಂತ್ರ.
ಅಧ್ಯಯನವು ಅಂತರ್-ಅರ್ಧಗೋಳ ಸಂಪರ್ಕವನ್ನು ಮೌಲ್ಯಮಾಪನ ಮಾಡಲು ಕಾರ್ಯ-ಆಧಾರಿತ ಮೌಲ್ಯಮಾಪನವನ್ನು ಒಳಗೊಂಡಿರುತ್ತದೆ ಮತ್ತು ನನ್ನ ಮಗುವಿಗೆ ಯಾವುದೇ ಹಾನಿ ಅಥವಾ ಅಸ್ವಸ್ಥತೆ ಉಂಟುಮಾಡುವುದಿಲ್ಲ ಎಂದು ನಾನು ಅರ್ಥಮಾಡಿಕೊಂಡಿದ್ದೇನೆ.
ನನ್ನ ಮಗುವಿನ ಯಾವುದೇ ವ್ಯಕ್ತಿಗತ ಮಾಹಿತಿಯನ್ನು ಸಂಗ್ರಹಿಸಲಾಗುವುದಿಲ್ಲ ಮತ್ತು ಪಡೆದ ಎಲ್ಲಾ ದತ್ತಾಂಶವನ್ನು ಗೌಪ್ಯವಾಗಿ ಇಡಲಾಗುತ್ತದೆ ಮತ್ತು ಕೇವಲ ಸಂಶೋಧನಾ ಉದ್ದೇಶಗಳಿಗಾಗಿ ಮಾತ್ರ ಬಳಸಲಾಗುತ್ತದೆ ಎಂದು ನನಗೆ ತಿಳಿದಿದೆ.
ಈ ಸಂಶೋಧನಾ ಅಧ್ಯಯನದಲ್ಲಿ ಭಾಗವಹಿಸಲು ನಾನು ಸ್ವಯಂಪ್ರೇರಿತವಾಗಿ ನನ್ನ ಮಗುವಿಗೆ ಅನುಮತಿ ನೀಡುತ್ತೇನೆ.
ಮಗುವಿನ ವಿವರಗಳು (Child Details)
ಮಗುವಿನ ಹೆಸರು / Name of Child: ___________________________
ಮಗುವಿನ ವಯಸ್ಸು / Age of Child: ____________________________
ಪಾಲಕ/ಪೋಷಕರ ವಿವರಗಳು (Parent/Guardian Details)
ಪಾಲಕರ ಹೆಸರು / Name of Parent or Guardian: ___________________________
ಪಾಲಕರ ಸಹಿ / Signature of Parent or Guardian: ___________________________
ದಿನಾಂಕ / Date: _______________
ಸ್ಥಳ / Place: _______________
ಸಾಕ್ಷಿ (Witness)
ಸಾಕ್ಷಿಯ ಹೆಸರು / Name of Witness: ___________________________
ಸಾಕ್ಷಿಯ ಸಹಿ / Signature of Witness: ___________________________
ದಿನಾಂಕ / Date: _______________
ಸಂಶೋಧಕರ ಘೋಷಣೆ (Investigator Declaration)
ನಾನು ಮೇಲಿನ ಭಾಗವಹಿಸುವವರ ಪಾಲಕರಿಗೆ ಅಧ್ಯಯನವನ್ನು ವಿವರಿಸಿದ್ದೇನೆ ಮತ್ತು ಅವರು ಸ್ವಯಂಪ್ರೇರಿತ ಒಪ್ಪಿಗೆ ನೀಡಿದ್ದಾರೆ ಎಂದು ದೃಢಪಡಿಸುತ್ತೇನೆ.
ಸಂಶೋಧಕರ ಹೆಸರು / Name of Investigator: ___________________________
ಸಹಿ / Signature: ___________________________
ದಿನಾಂಕ / Date: _______________
ಮಗುವಿನ ಒಪ್ಪಿಗೆ (Child Assent — 7–12 ವರ್ಷ ವಯಸ್ಸಿನ ಮಕ್ಕಳಿಗೆ)
ನನ್ನ ಕೈಗಳಿಂದ ಕೆಲವು ಸರಳ ಕಾರ್ಯಗಳನ್ನು ಮಾಡಲು ನಾನು ಒಪ್ಪುತ್ತೇನೆ. ಇದು ನನ್ನ ಸ್ವಂತ ಇಚ್ಛೆ.
(I agree to do some simple hand tasks. This is my own wish.)
ಮಗುವಿನ ಹೆಸರು / Child's Name: ___________________________
ಮಗುವಿನ ಸಹಿ ಅಥವಾ ಹೆಬ್ಬೆರಳಿನ ಗುರುತು / Child's Signature or Thumb Impression: ___________________________
ದಿನಾಂಕ / Date: _______________
ಈ ಅಧ್ಯಯನದಲ್ಲಿ ಭಾಗವಹಿಸಲು ಪರಿಗಣಿಸಿದ್ದಕ್ಕಾಗಿ ತುಂಬು ಹೃದಯದ ಧನ್ಯವಾದಗಳು.(Thank you sincerely for considering participation in this study.)
This is a shared conversation. Sign in to Orris to start your own chat.