Dableo...IERC

Republic of the Philippines Mindanao State University-Iligan Institute of Technology Office of the Vice Chancellor for Research and Extension Department of Research INSTITUTE ETHICS REVIEW COMMITTEE (IERC)

MSU-IIT IERC FORM 01

LOG OF THE INSTITUTE ETHICS REVIEW COMMITTEE MEMBERS RECEIVING SOPs

No. Name of Recipients Designation SOP Code number

No. of Copies

Signature Date

1 Dr. Nimfa L.Bracamonte

Chairperson

2 Dr. Franco G.Teves Co-Chair

3 Dr. Muhammad M. Puting

Member

4 Prof. Gloria Shiela E.Coyoca

Member

5 Ms. Anita T. Sescon Member

6 Member

7 Member

8 Secretary



PROJECT SUBMISSION OVERVIEW

Title of Project/Study

FORMULATION OF Moringa oleifera AQUEOUS SOLUTION AS ADJUNCT RADIOPROTECTIVE AGENT IN IRRADIATED SOMATIC TESTICULAR CELLS OF BALB/C ISOGENIC MICE USING

CYTOGENETIC STUDIES

Names of all Investigators/ Researchers

Princess Marie Grace E. GutierrezMara Queena P. DableoMariza C. Maurin

Adviser: Prof. John Paul Ben T. SilangPanel Members: Prof. Neil M. Martin, Prof. Gloria Shiela E. Coyoca and Prof. Elizalde D. BanaConsultant: Prof. Olive S. AniesIntroduction / Background

Cancer is one of the leading causes of morbidity and mortality worldwide. One of the loco-regional treatment modality for cancer present and utilized in the country is radiotherapy which includes teletherapy and brachytherapy. However, radiation therapy can also damage normal cells, leading to side effects. Hence, the researcher would like to addresses the side-effect of radiation therapy by protecting the normal cells damaged during the radiation therapy by using Moringa oleifera aqueous solution (MOAS) as an adjunctive therapy. The Moringa oleifera aqueous solution (MOAS) will be formulated by the researchers themselves.Aims / Objectives

This nursing research explores the property of Moringa oleifera in aqueous solution as radioprotective agent. The study aims to determine the cytogenetic effects Moringa oleifera in the somatic testicular cells of BALB/c isogenic mice administered before and after exposure to ionizing radiation. Spread of chromosomes and karyotype will be presented based from microscopic examination. Specifically, this study attempts:

1. To formulate various concentration (25% and 50%) of Moringa oleifera aqueous solution2. To determine the mean number of specific chromosomal abnormalities in the treatment

groups with Moringa oleifera aqueous solution before and after exposure to ionizing radiation.

3. To determine the mean number of specific chromosomal abnormalities in the control group without Moringa oleifera aqueous solution before and after exposure to ionizing radiation.


4. To determine the significant difference on the mean number of chromosomal abnormalities in the treatment groups and control group before and after exposure to ionizing radiation.

5. To establish relationship between the mean number of chromosomal aberrations and the varied concentrations of Moringa oleifera aqueous solution.

Design of the Study

This study will utilize an experimental research design. Manipulation will be done by introducing Moringa oleifera aqueous solution to treatment groups before and after introducing ionizing radiation. Treatment group will receive various concentrations of MOAS (25% and 50%). Two concentrations will be utilized since the researchers are considering on the possible cost of having 3 concentrations and to be more efficient. Control of the treatment will be secured providing positive and negative control groups. Non-radiated mice and without the treatment will serve as the negative control group, while irradiated mice without the treatment will serve as the positive control. To complete the experimental approach, randomization will be done in the segregation of the 18 male BALB/c isogenic mice to both the treatment and control groups.

The researcher will use Complete Randomized Design in distributing the 18 mice into their respective group. Lottery method or Fish ball technique will be used in which 2 persons are needed in the selection of mice to different groups. Each of the population members is assigned a unique number. The numbers are placed in a bowl and thoroughly mixed. Then, a blind-folded researcher selects numbers.Study Methodology

Locale of the Study

The study will be conducted at two different locations. Preparation Moringa oleifera aqueous solution will be done at Tuklas lunas Center at the Department of Chemistry and microscopic examination for cytogenetic studies will be conducted at the College of Science and Mathematics- Department of Biological Sciences in MSU—IIT. The test subjects will be reared following proper research protocol at Mara Dableo’s residence located at Bara-as, Iligan City.

Plant AuthenticationMoringa oleifera leaf will be identified and authenticated by the designated botanist at the

Department of Biological Sciences, Mindanao State University – Iligan Institute of Technology (MSU-IIT), Iligan City, Lanao del Norte, Philippines

Preparation of MOAS or Moringa oleifera Aqueous Solutioni. Preparation of Moringa oleifera Mixture. The researcher will collect Moringa

oleifera leaves approximately 4 kg and wash with tap water. Next, the leaves will be air dried for 4 days and pounded with mortar and pestle. Then, the product will be mixed with 8 L of water (ratio of 1kg: 2L). Afterwards, the product will be boiled for 5 minutes and filtered using a filter paper. In this process, the unnecessary organisms will be removed from the leaves.


ii. Lyophilization Process and Production of Aqueous Solution. The filtrate will be transferred in 50 cc vials and will be lyophilized. The product will be placed in the refrigerator for freeze drying at -20 degrees centigrade. Then, the crude will be taken from the bottom of the container. By following the right proportion, the product will be dissolved in distilled water to produce the varied concentration of Moringa oleifera aqueous solution.

Determination of Maximum Tolerable Dose. One mouse will be used in determining the maximum tolerable dose of Moringa oleifera

Aqueous Solution (MOAS). This is the standard formulation dose but increment dosage will start at 5%. MOAS will be

given through oral gavage. Tolerance dose will be determined at a percent below the Moringa oleifera aqueous solution that exert lethal or severe adverse effects on the mouse.

Administration of Radiation and Moringa oleifera Aqueous Solution or MOASThe aqueous solution of M. oleifera will be administered to the BALB/c isogenic mice

through syringe-feeding. The test subjects will be held in upright position and then grasped the scruff and shoulders of the mouse to pull the front legs out to the side. The head will carefully be extended using the index finger. Insertion of the syringe will be performed with the supervision of a professional veterinary medical doctor. The syringe will be inserted along inner lateral side of the mouth. After placing the syringe properly, the concentrated solution of M. oleifera will be gently administered to the test subjects. The doses will be given straight for 15 days once a day. It will be given at 7am to ensure the solution is absorbed well by the mice after 24 hours and also for efficiency of results. Plastic feeding tubes for mice oral gavage are flexible to reduce the risk of trauma and disposable to eliminate the cost of cleaning and the chance of compound crossover. Flexible tubes are recommended as an animal welfare refinement over rigid metal tubes. Any significant changes of behaviors will be noted and reported immediately to the veterinarian.

Ionizing radiation source is the radiographic machine at the Radiology Department of Amai Pak Pak Medical Center. The test subjects will be exposed to ionzing radiation for 1 minute for study 1 and 2.5 minutes in Study 2 before and after initiating the MOAS.

Cytogenetic Technique for Isogenic MiceGregorio and Medina’s cytogenetic technique method will used to collect C-metaphase

from the test subjects’ testicular somatic cells. Test subjects will be given with 0.025% of colchicine solution at 0.25mk/kg body weight intraperitoneally. One hour after the administration of colchicine, test subjects will be sacrificed. Then testis will be dissected out form the sacrificed mice and will be flushed using isotonic solution (2.2% sodium citrate). The products will be centrifuged at 360 rpm for 5 minutes. Then samples are ready for hypotonic solution treatment. 5 minutes right after the centrifugation, the solution will be removed. Cells in pellets will be maintained for stocking and breaking for 12 minutes in the hypotonic solution (1% sodium citrate). If the samples will be used again, this will undergo centrifugation occurs at 1000 rpm for 5 minutes followed after the hypotonic treatment. Then, the supernatant will be removed and the pellet that contain chromosome will retained an added with fixative solution (3; 1 ethanol and glacial acetic acid). Fixation of somatic cells suspension will undergo four times. In the test tube,


Cells will be fixed with fixative solution. The cells suspension will be smeared using Pasteur pipette in a new glass slide air –dried for about 5 hours. The slides will be stained in the Coplin jar with 3% Giemsia -staining solution for 5 minutes.

Chromosome and Karyotype AnalysisSomatic cells will be examined using a binocular electric microscope. Each animal will be

assessed for chromosome aberrations. In oil immersion lens, chromosomal aberrations such as breaks, gaps, dicentric, polycentric, desperalized, complex sticky and ring (centric and acentric) will be analyzed. Chromosomal spreading will be examined under Low Power Objective and High Power Objective. Chromosomal aberrations will be counted according to types will be done during Karyotype analysis. The images in the microscope will be captured using a microscope with DSLR cam.Eligibility

This study will explore the radioprotective property of Moring oleifera leaves through cytogenetic studies. The Moringa oleifera will be gathered from the different barangays in Iligan City, Lanao del Norte. Plant authentication will be secured from the designated botanist of the Mindanao State University- Iligan Institute of Technology (MSU-IIT) at the Department of Biological Sciences (DBS). Leaves will include those from the branch of the pants. The last 2 twigs for each branch will be excluded from the study. The leaves will be processed to produce aqueous solution which will be done together with the designated chemist of MSU-IIT at the Department of Chemistry’s Tuklas Lunas Center. The study does not include the stem, roots, and flower of M. oleifera. Other properties of M. oleifera such as antihypertensive‚ antiulcer, antibacterial, antifungal, antispasmodic, diuretic and cholesterol lowering activities‚ and hepatoprotective activities are excluded in this research.

The study will be conducted in MSU-IIT College of Nursing’s (CON) Laboratory. Test subjects are male isogenic mice (Mus musculus) with an average weight of 20 -25 gm. Uniformity of weight and gender can avoid extraneous variable in yielding varied results (Gracilla and Bagunu, 2011). The study will segregate the 18 mice into 2 treatment groups and 2 control groups. Each group will comprise 6 mice wherein 3 mice will be used before irradiation and the remaining 3 mice after irradiation. Segregation will be done through complete randomized sampling design. Non-radiated mice and without the treatment will serve as the negative control group, while irradiated mice without the treatment will serve as the positive control. Ionizing radiation will be produced by radiographic machine from the Diagnostic Unit of Amai-Pakpak Medical Center in Marawi City. Isogenic mice in study 1 will be exposed for 1 minute; whereas, 2.5 minutes in study 2.How many subjects will be screened? How many subjects are likely to be enrolled?

There will be 18 mice to be screened and likely to be included.

Describe benefits to the subject/ participant in this study. Also describe the benefits, if any, to the society. Describe possible harm to the subject/participant in the study, if any.The result of the study will serve as an avenue in exploring the utilization of Moringa oleifera Aqueous Solution as an adjunct radioprotective agent for patients who do not comply to radiation therapy due to the adverse effects secondary to destruction of both the normal cells and those


with abberations.

Variables to be estimated

Independent: Varied concentrations of Moringa oleifera aqueous solution

Dependent: Mean difference of chromosomal aberration

Analysis of the variables

Describe how the variables obtained during the study will be statistically analyzed.

The following variables will be statistically analyzed using Average weighted mean and ANOVA1. To determine the mean number of specific chromosomal abnormalities in the treatment

groups with Moringa oleifera aqueous solution before and after exposure to ionizing radiation.

2. To determine the mean number of specific chromosomal abnormalities in the control groups without Moringa oleifera aqueous solution before and after exposure to ionizing radiation.

3. To determine the significant difference on the mean number of chromosomal abnormalities in the treatment groups and control groups before and after exposure to ionizing radiation.

While Pearson’s Correlation will be used to establish relationship between the mean number of chromosomal aberrations and the varied concentrations of Moringa oleifera aqueous solution.

How is it intended the results of the study will be reported and disseminated?

__/____ Peer reviewed scientific journals

__/___ Other publication

__/___ Conference presentation

Name of Primary Investigator: _Princess Marie Grace Gutierrez

Signature: __________________________

Date: __________________________



PROJECT FACT SHEET

Project No.(To be filled up by the Secretariat)

Date of receipt by IERC:

Project Title:

FORMULATION OF Moringa oleifera AQUEOUS SOLUTION AS ADJUNCT RADIOPROTECTIVE AGENT IN IRRADIATED SOMATIC TESTICULAR CELLS OF BALB/C ISOGENIC MICE USING CYTOGENETIC STUDIES

Key Words (5 words): formulation, adjunct, radioprotective, agent, cytogenetic

Principal Investigators/Researchers: Gutierrez, Princess Marie Grace E., Dableo, Mara Queena P. and Maurin, Mariza C.Department/College: College of NursingCo – investigators/Researchers: Prof. John Paul Ben T. Silang, Prof. Neil Martin, Prof. Gloria Shiela Coyoca and Prof. Elizalde BanaDepartment/College: College of NursingCo – investigators/Researcher/ Consultant: Prof. Olive S. AniesDepartment/College: College of Science and MathematicsContact number of Principal Investigator/ResearcherLandline number________None__________ Mobile number __09365699441_____________

Site / sites where study is to be conducted:

Amai Pakpak Medical Center , Wawalayan Calocan , 9700 Marawi City , Lanao Del Sur

Mindanao State University-Iligan Institute of Technology, College of Nursing

Mindanao State University-Iligan Institute of Technology, College of Science and Mathematics

Number of ongoing studies, Principal Investigator is involved:

Agency or Sponsor

Primary :

Collaborating :

Total estimated budget: Php 14,000.00

Conflict of interest, if any:

Duration of the Project (months): 8 months

Suggested date of starting the study (mm/dd/yyyy): August 15, 2015


Signature of Principal Investigator/Researcher:

Date of submission to IERC:

Received by:



COLLEGE ETHICS REVIEW COMMITTEE (CREC) APPROVAL

The members of the CREC met on___________________ at ________________________________ and reviewed the project / proposal entitled FORMULATION OF Moringa oleifera AQUEOUS SOLUTION AS ADJUNCT RADIOPROTECTIVE AGENT IN IRRADIATED SOMATIC TESTICULAR CELLS OF BALB/C ISOGENIC MICE USING CYTOGENETIC STUDIES with all the accompanying documents. The committee has granted approval on the scientific content of the project. The proposal may now be reviewed by the Institute Ethics Review Committee (IERC) for granting of final approval.

Secretary____________________________ Chairperson__________________________

Name :______________________________ Name : ______________________________

Date: _______________________________ Date: _______________________________



CONSENT OF HEAD/ DEAN OF THE PRIMARY INVESTIGATOR’S DEPARTMENT / COLLEGE

I have reviewed the above project/proposal submitted by _Gutierrez, Princess Marie Grace E., Dableo, Mara Queena P. & Maurin, Mariza C._

(Researcher(s)) for the study entitled FORMULATION OF Moringa oleifera AQUEOUS SOLUTION AS ADJUNCT RADIOPROTECTIVE AGENT IN IRRADIATED SOMATIC TESTICULAR CELLS OF BALB/C ISOGENIC MICE USING CYTOGENETIC STUDIES

from my Department / College. I endorse the project and have ‘no objection‘ for submission for consideration by Institute Ethics Review Committee.

I concur with the researchers / investigators included in the study.

_________________________________ ____________________________Name of Chairperson and Signature Name of Dean and SignatureDate_____________________________ Date ________________________



CONFIDENTIALITY AGREEMENT FORM FOR INDEPENDENT CONSULTANTS

I, _________________________________________________ (Name and Designation) as a non – member of Institute Ethics Review Committee (IERC) understand that the copy (ies) given to me by the Institute Ethics Review Committee is (are) confidential. I shall use the information only for the indicated purpose as described to the IERC and shall not duplicate, give or distribute these documents to any person(s) without permission from the said committee.

Upon signing this form, I agree to take reasonable measures and full responsibility to keep the information as confidential.

_______________________ _______________________Chairperson of IERC Name and Signature Date

I , ____________________________________(Name of Consultant) acknowledge that I have received a copy of this Agreement signed by the Chairperson of the IERC.

Conforme:

_______________________ ________________________ Signature Date



CONSENT FORM FOR RESEARCH PARTICIPANTS

Part I: Information Sheet

Title of Study ______________________________________________________________________________Main Purpose of the Study: ___________________________________________________________________________________________________________________________________________________________

Duration/Period: From ___________________________ to ___________________________ (Month and Year) (Month and Year)

Place: ____________________________________________________________________________________(Barangay/ Municipality/ City/ Province/ Region)

Name of Researcher/Investigators: ________________________________________________________ ________________________________________________________

Contact number of Researcher/Investigators: ____________________________________________________Cooperating Agencies/Institutions: ________________________________________________________

Part II: Certificate of ConsentWritten Consent Form for Research Participants/Informants or Parents/Guardians of Children (below 18 years old who are respondents) * To be signed at the beginning of the interview/survey.

Direction: Please read the following statements carefully and put a check (/) in the corresponding box if you agree:

I fully understand the nature and purpose of this research activity/study.

I give my voluntary consent to participate in this research/study.

I give my consent for the researchers to record the related activities.

I give my consent for the researcher to record the conduct of the activities (video, audio, photos)

I can stop participating in the study at any time, for any reason if I so decide.

If I have questions about the research in general or about my role in the study, I can freely ask the researcher about my concerns.

___________________________________________________ _________________Name and Signature of Participant/Respondent Date (Day/Month/Year)

Oral Consent:When written consent is inappropriate for cultural/political reasons or if a participant cannot read/write, researchers will verbally explain the nature and purpose of the research and request him/her to affix his/her thumb mark in the space indicated below as a sign of voluntary consent as well the signature of a witness.

___________________________________________________Name and Signature of Witness Right Thumb

of Participant__________________________Date (Day/Month/Year)



Mindanao State University-Iligan Institute of TechnologyAndres Bonifacio Avenue, 9200 Iligan City, Philippines

Telephone No. (+63) 2210744

INFORMED ASSENT FORM FOR CHILDREN/MINORS AS PARTICIPANTS/PARENTAL PERMISSION FORM

Part I: Information Sheet

Title of Study ______________________________________________________________________________Main Purpose of the Study: ___________________________________________________________________________________________________________________________________________________________

Duration/Period: From ___________________________ to ___________________________ (Month and Year) (Month and Year)Place: ____________________________________________________________________________________

(Barangay/ Municipality/ City/ Province/ Region)

Name of Researcher/Investigators: ________________________________________________________Contact number of Researcher/Investigators: ____________________________________________________Cooperating Agencies/Institutions: ________________________________________________________

Part II: Certificate of AssentThe Informed Assent Form/Parental Permission Form is for children/minors signal for willingness to cooperate in the study. The Informed Assent Form should be signed by the child/minor and the Parental Permission Form signed by the parents/guardian. The Parental Permission Form is in addition to the Informed Assent Form.

Direction: Please read the following statements carefully and put a check (/) in the corresponding box if you agree:

I fully understand the nature and purpose of this research activity/study.

I give my voluntary consent to participate in this research/study.

I give my consent for the researchers to record the related activities.

I give my consent for the researcher to record the conduct of the activities (video, audio, photos)

I can stop participating in the study at any time, for any reason if I so decide.

If I have questions about the research in general or about my role in the study, I can freely ask the researcher about my concerns.

___________________________________________________ _________________Name and Signature of Child/Minor/Parent/Guardian Date

Oral Consent:When written consent is inappropriate for cultural/political reasons or if a participant cannot read/write, researchers will verbally explain the nature and purpose of the research and request him/her to affix his/her thumb mark in the space indicated below as a sign of voluntary consent as well the signature of a witness.

___________________________________________________Name and Signature of Witness Right Thumb

of Participant__________________________Date (Day/Month/Year)



DOCUMENT RECEIPT FORM

IERC Study Number :

Submitted date:

Type of Submission :

II Initial Review

C Continuing Review of Approved Protocols

Protocol Title :

Principal Investigator:

Type of document:

Date Received:

Received by:



STUDY ASSESSMENT FORM

(Study Assessment Form to be used during the IERC meeting)

Protocol Number: Date (DD/MM/ YY):

Protocol Title :

Principal Investigator(s)/Researcher (s)

Institution: Contact No.

Principal Investigator/Researcher Contact No.

Co – investigator(s) Contact No.

Delineation of responsibilities of investigators:

Total No. of Participants:

No. of Study site s:

Funding Agency: Contact No.

Duration of the Study: (months /years)

Status: New Revised Amended

Reviewer’s name: Contact No.

Type of the Study (place a check mark (/):

Descriptive Qualitative Intervention

Descriptive Quantitative Document based

Correlational/Regression analysis Social Survey

Quasi-Experimental Epidemiology

Experimental Individual based

Meta-Analysis Genetic

Others, specify _____________________


Review Status:

Regular Expedited Emergency

Description of the Study in brief: (Mark whatever applies to the study)

Stratified Randomized Use of Blood samples

Screening Descriptive

Randomized Treatment controlled

Brief the study design and the statistic used:

Study Objectives:

Mark and comment whatever item(s) is/are applicable to the study:

1 Objectives of the Study

Clear Unclear

What should be improved?

2 Need for Human Participants

Yes No

Comment:

3 Methodology:

Clear Unclear

What should be improved?

4 Background Information & Data

Sufficient Insufficient

Comment:

5 Risks and Benefits Assessment

Acceptable Unacceptable

Comment:

6 Inclusion Criteria

Appropriate Inappropriate

Comment:

7 Exclusion Criteria


Comment:

8 Discontinuation & Withdrawal Criteria Comment:



9 Involvement of Vulnerable Participants

Yes No

Comment:

10 Voluntary, Non – Coercive Recruitment

Yes No

Comment:

11 Sufficient number of Participants

Yes No

Comment:

12 Are qualification & experience of the Participating Investigators appropriate?

Yes No

Comment:

13 Disclosure or Declaration of Potential Conflicts of Interest

Yes No

Comment:

14 Facilities & infrastructure of Participating Sites


Comment:

15 Community Consultation

Yes No

Comment:

16 Involvement of Local Researchers & Institution in the Protocol Design, Analysis & Publication of Results

Yes No

Comment:

17 Contribution to Development of Local Capacity for Research & Treatment

Yes No

Comment:

18 Benefit to Local Communities

Yes No

Comment:

19 Availability of similar Study / Results

Yes No

Comment:

20 Are procedures for obtaining Informed Consent appropriate?

Yes No

Comment:


21 Contents of the Informed Consent Document

Clear Unclear

Comment:

22 Language of the Informed Consent Document

Clear Unclear

Comment:

23 Contact Persons for Participants

Yes No

Comment:

24 Privacy & Confidentiality

Yes No

Comment:

25 Inducement for Participation

Unlikely Likely

Comment:

26 Provision for Medical /Psychosocial Support


Comment:

27 Provision for Treatment of Study – Related Injuries


Comment :

28 Provision for Compensation


Comment :



ASSESSMENT REPORT

Review Date (dd/mm/yyyy): Protocol number :

Protocol Title:

Elements Reviewed:

Attached Not attached

Review of Revised Application:

Yes No

Date of Previous Review:

Decision :

Approved Approved with Recommendation

Resubmission Disapproved

Comment :

Name and Signature of IERC Chairperson



REQUEST FOR FORMULATION OF NEW SOP / REVISION OF SOP

This form is to be completed by any member whenever a problem or a deficiency in an SOP is identified and maintained with the SOP until an authorized replacement is in place.

SOP No.

Title:

Details of problems or deficiency in the existing SOP

Need to formulate an entirely new SOP ( i.e. SOP not existing previously)

Identified by: Date (DD/MM/YYYY):

Discussed in IERC Meeting held on:

SOP revision required; Yes No

New SOP to be formulated: Yes No

If yes, to be carried out by whom?

If no, why not?

Date SOP revised:

Date SOP approved:

Date SOP becomes effective:



ETHICAL CLEARANCE FORM

Proposal Title:

Name of Researchers:

Reviewer’s Recommendation (/):

Accept With recommendations

Reject

Reviewers’ Comments/Recommendations:

Committee Members:

Signature (Chair of the Institute Ethics Review Committee)

Date:



INSTITUTE ETHICS REVIEW COMMITTEE (IERC) APPROVAL

The members of the IERC met on ______________________at ____________________, and reviewed the proposal entitled ______________________________________________________

_____________________________________________________________ with all the documents submitted. The ethics committee after careful deliberations has granted final approval to the project. The above mentioned project / study may now be undertaken at ___________________ in accordance with the study protocol submitted by the investigators, subject to fulfilling other institutional regulations.

Secretary____________________________ Chairperson__________________________

Name :______________________________ Name : ______________________________

Date: _______________________________ Date: _______________________________


LIST OF FORMS

Name of Form Form NumberLog of the Institute Ethics Review Committee Members Receiving SOPs

01

Project Submission Overview 02Project Fact Sheet 03College Ethics Review Committee (CREC) Approval

O4

Consent of Head/Dean of the Primary Investigator’s Department/College

O5

Confidentiality Agreement Form for Independent Consultants

06

Consent Form for Research Participants 07Informed Assent for Children/Minors as Participants/Parental Permission Form

08

Document Receipt Form 09Study Assessment Form 10Assessment Report 11Request for Formulation of New SOP/Revision of SOP

12

Ethical Clearance Form 13Institute Ethics Review Committee(IERC) Approval

14

Documents

Dableo...IERC