MREC Reviewer Comment
Protocol Title
Completely satisfied and informative data
Comments to the applicant
PROTOCOL REVIEW CHECKLIST
IRB # _________
Title of Research Protocol: Development of Alginate-Lignin Composite Materials for Wound Healing Applications in Rat Model
PI: Mona Agwa
Research Path:
Human Subjects Research
✓ Non Human Subjects Research
Research only involves the study of data from existing samples/documents that have been received either without identifiers or does not involve private information
Exempt Research
Research conducted in commonly accepted educational settings involving normal
educational practices.
Research Involves the study of existing samples that are either publicly available or has
identifiers and the investigator will record the data in such a manner that individuals cannot be identified.
Research involves surveys, interviews, focus groups discussions UNLESS the
information is obtained/recorded such that individuals can be identified AND the
data will be damaging to the individual.
Expedite Review
Full Board Review
Purpose/Background/Justification
Briefly summarize study purpose, background, and justification.
The main aim of the research work is to find natural alternatives to wound dressing membranes applied topically by using the potential of lignin/alginate biofilm in vivo on wounded male rats. The authors described in the background the importance of Lignin and its combination with alginate for wound healing applications.
Item for Revision
Yes
No
N/A
Comments
Are the investigators/study team well qualified?
✓
The team of work specializes in microbiology, polymers, and clinical pathology
SOCIAL VALUE
· Does the study address an important health issue of the community/country?
✓
Production of natural alternatives, wound dressing membrane applied topically
· Is the research gap significant enough to justify the conduct of this research?
✓
There is much research work on the same topic
· Does the community need to be involved in the design, implementation, or dissemination of the results of the study?
✓
The production of natural wound dressings is essential for ensuring safe healing.
STUDY DESIGN
· Are the objectives well described?
✓
· Is the scientific design able to address the objectives?
✓
· Is the statistical analysis well described?
✓
· Has a sample size been calculated?
✓
The number of animals needs to be increased
SELECTION OF SUBJECTS
· Is the recruitment of subjects described?
✓
· Does the recruitment process lead to a biased sample?
✓
· Does the setting of recruitment represent a coercive concern or an undue inducement?
✓
· Does the study involve vulnerable populations?
✓
· If yes, are additional safeguards included to protect the rights and welfare of the participants (e.g., limits on risk, parental consent)?
✓
· Are selection of participants justified?
✓
RISK /BENEFIT ASSESSMENT
· Are the foreseeable risks clearly defined?
✓
§ Physical risks?
§ Social risks?
§ Psychological risks?
§ Legal/political risks?
§ Economic risks?
· Are risks minimized as much as possible (e.g., appropriate exclusion criteria, substitution of less risky interventions, etc)?
✓
· Are there potential direct benefits to individuals?
✓
· Is the benefit to society appropriate?
✓
FINAL ASSESSMENT: Are risks to subjects reasonable when compared to anticipated direct benefits, if any, and to the knowledge to be gained?
✓
DATA AND SAFETY MONITORING
Yes
No
N/A
Comments
· Are there plans to monitor the data to ensure the safety of the participants?
✓
The authors did not outline safety precautions for handling animals or how they will dispose of dead animals.
· Is a Data and Safety Monitoring Board needed?
✓
· Other safety issues?
✓
INFORMED CONSENT
· Is the description of the informed consent process well described?
✓
· Does the consent form include the necessary elements of information?
✓
· If the research represent secondary analysis of data do the participants need to be re-contaced for consent?
✓
· Is surrogate consent needed?
✓
· Can informed consent be waived?
✓
· Can parental consent be waived?
✓
· Other informed consent concernss?
✓
PRIVACY and CONFIDENTIALITY
· Does the recruitment process respect privacy?
✓
· Are there provisions to protect privacy (e.g., interviews or focus groups conducted in a private area).
✓
· Are there adequate provisions to maintain the confidentiality of the data?
✓
· Other privacy and confidentiality concerns?
✓
Conflict of Interest
· Have the investigators/study team submitted COI forms?
✓
Informed Consent Document
Statement that study involves research
✓
Explanation of purposes and duration
✓
The 30-day timeframe is insufficient to complete animal experiments and histopathology.
Description of procedures
✓
Identification of experimental procedures
✓
Risks/discomforts
Benefits
✓
Disclosure of alternatives
✓
Confidentiality
✓
Compensation and treatment for injury
✓
Contact information
✓
Voluntary participation / right to withdraw
✓
Future use of data/specimens
✓
Final Decision
Approval
Approval with clarifications
1. Specify the funding source for the experiments, especially since they have Spanish partners.
2. Increase the number of animals used to minimize losses during the experiments.
3. Describe the proper disposal methods for dead animals after sample collection.
4-The Gantt chart was missing.
Approval with modifications
Defer until more information is obtained
Disapprove
CONTINUING REVIEW FREQUENCY
Regulations require continuing review must be at least every 12 months. The review period will reflect an interval appropriate to the degree of risk. More frequent review may be considered for research when the degree of risk warrants closer monitoring.
MAJOR CONCERNS ABOUT PROTOCOL
MINOR CONCERNS ABOUT PROTOCOL
GENERAL COMMENTS
Prof. Dr. Omaima Kandil 22-10-2025
Signature of Primary Reviewer Date
Comment to the Committee
PROTOCOL REVIEW CHECKLIST
IRB # _________
Title of Research Protocol: Development of Alginate-Lignin Composite Materials for Wound Healing Applications in Rat Model
PI: Mona Agwa
Research Path:
Human Subjects Research
✓ Non Human Subjects Research
Research only involves the study of data from existing samples/documents that have been received either without identifiers or does not involve private information
Exempt Research
Research conducted in commonly accepted educational settings involving normal
educational practices.
Research Involves the study of existing samples that are either publicly available or has
identifiers and the investigator will record the data in such a manner that individuals cannot be identified.
Research involves surveys, interviews, focus groups discussions UNLESS the
information is obtained/recorded such that individuals can be identified AND the
data will be damaging to the individual.
Expedite Review
Full Board Review
Purpose/Background/Justification
Briefly summarize study purpose, background, and justification.
The main aim of the research work is to find natural alternatives to wound dressing membranes applied topically by using the potential of lignin/alginate biofilm in vivo on wounded male rats. The authors described in the background the importance of Lignin and its combination with alginate for wound healing applications.
Item for Revision
Yes
No
N/A
Comments
Are the investigators/study team well qualified?
✓
The team of work specializes in microbiology, polymers, and clinical pathology
SOCIAL VALUE
· Does the study address an important health issue of the community/country?
✓
Production of natural alternatives, wound dressing membrane applied topically
· Is the research gap significant enough to justify the conduct of this research?
✓
There is much research work on the same topic
· Does the community need to be involved in the design, implementation, or dissemination of the results of the study?
✓
The production of natural wound dressings is essential for ensuring safe healing.
STUDY DESIGN
· Are the objectives well described?
✓
· Is the scientific design able to address the objectives?
✓
· Is the statistical analysis well described?
✓
· Has a sample size been calculated?
✓
The number of animals needs to be increased
SELECTION OF SUBJECTS
· Is the recruitment of subjects described?
✓
· Does the recruitment process lead to a biased sample?
✓
· Does the setting of recruitment represent a coercive concern or an undue inducement?
✓
· Does the study involve vulnerable populations?
✓
· If yes, are additional safeguards included to protect the rights and welfare of the participants (e.g., limits on risk, parental consent)?
✓
· Are selection of participants justified?
✓
RISK /BENEFIT ASSESSMENT
· Are the foreseeable risks clearly defined?
✓
§ Physical risks?
§ Social risks?
§ Psychological risks?
§ Legal/political risks?
§ Economic risks?
· Are risks minimized as much as possible (e.g., appropriate exclusion criteria, substitution of less risky interventions, etc)?
✓
· Are there potential direct benefits to individuals?
✓
· Is the benefit to society appropriate?
✓
FINAL ASSESSMENT: Are risks to subjects reasonable when compared to anticipated direct benefits, if any, and to the knowledge to be gained?
✓
DATA AND SAFETY MONITORING
Yes
No
N/A
Comments
· Are there plans to monitor the data to ensure the safety of the participants?
✓
The authors did not outline safety precautions for handling animals or how they will dispose of dead animals.
· Is a Data and Safety Monitoring Board needed?
✓
· Other safety issues?
✓
INFORMED CONSENT
· Is the description of the informed consent process well described?
✓
· Does the consent form include the necessary elements of information?
✓
· If the research represent secondary analysis of data do the participants need to be re-contaced for consent?
✓
· Is surrogate consent needed?
✓
· Can informed consent be waived?
✓
· Can parental consent be waived?
✓
· Other informed consent concernss?
✓
PRIVACY and CONFIDENTIALITY
· Does the recruitment process respect privacy?
✓
· Are there provisions to protect privacy (e.g., interviews or focus groups conducted in a private area).
✓
· Are there adequate provisions to maintain the confidentiality of the data?
✓
· Other privacy and confidentiality concerns?
✓
Conflict of Interest
· Have the investigators/study team submitted COI forms?
✓
Informed Consent Document
Statement that study involves research
✓
Explanation of purposes and duration
✓
The 30-day timeframe is insufficient to complete animal experiments and histopathology.
Description of procedures
✓
Identification of experimental procedures
✓
Risks/discomforts
Benefits
✓
Disclosure of alternatives
✓
Confidentiality
✓
Compensation and treatment for injury
✓
Contact information
✓
Voluntary participation / right to withdraw
✓
Future use of data/specimens
✓
Final Decision
Approval
Approval with clarifications
1. Specify the funding source for the experiments, especially since they have Spanish partners.
2. Increase the number of animals used to minimize losses during the experiments.
3. Describe the proper disposal methods for dead animals after sample collection.
4-The Gantt chart was missing.
Approval with modifications
Defer until more information is obtained
Disapprove
CONTINUING REVIEW FREQUENCY
Regulations require continuing review must be at least every 12 months. The review period will reflect an interval appropriate to the degree of risk. More frequent review may be considered for research when the degree of risk warrants closer monitoring.
MAJOR CONCERNS ABOUT PROTOCOL
MINOR CONCERNS ABOUT PROTOCOL
GENERAL COMMENTS
Prof. Dr. Omaima Kandil 22-10-2025
Signature of Primary Reviewer Date
