Research and Development Unit

               Dr. Kwadwo Sarbeng
                      Head of Unit
ABOUT R & D UNIT

BACKGROUND INFORMATION

  • The mandate of Komfo Anokye Teaching Hospital as provided by Act 525 is to provide:
  • Advanced clinical care
  • Training, and
  • Research

In fulfilment of the hospital’s mandate to conduct Research, Research and Development Unit (RDU) was established in 2006.

MISSION

To develop a focused Research and Development strategy which prioritizes support for Research and Development in those areas which are consistent with the development of clinical and non-clinical services:

 

MANDATE

The R&D Unit was set up with the mandate to:

Develop and sustain the research capacity of the hospital.

  • Coordinate and monitor research activities going on in the hospital.
  • Provide evidence-based knowledge that will contribute to the improvement of clinical and non-clinical services at KATH.
  • Promote critical review and publication of research work.
  • Attract research partnerships to KATH.
RESEARCH POLICY

R&D REGISTRATION AND IRB APPLICATION GUIDELINES 

R&D REGISTRATION/ GUIDELINES

  1. Complete R&D registration application online at https://sites.google.com/site/infectiousprings2013/?
  1. Print out confirmatory submission email.
  1. Upload the electronic copy of the protocol/proposal at kathrdu@gmail.com.
  1. Send your confirmatory submission email print-out to the KATH’s main revenue office and collect payment voucher in return.
  1. Pay the non-refundable, one-time R&D registration/KATH IRB fees appropriate for the funding category at any of the Banks at the hospital; see item E for the appropriate fees.
  1. Note that all sponsored research studies to be conducted at KATH must budget Administrative charges/Indirect cost/Overheads cost/ Facilities and Administrative Rate in their budget. Consult R&D if you need further clarification(s).
  1. Submit one bound signed printed/hardcopy of the proposal, print-out of the confirmatory email and the official receipt of the R&D registration/KATH IRB fees to R&D for processing. Proposal/Protocol (see item C for sample format attached as a guide only), should have been signed and dated by the PI or Co-PI.
  1. All research studies to be conducted at KATH must have a collaborator (preferably a senior staff KATH employee) in the respective Directorate/Unit where the study is to be conducted.
  1. A Certificate of Registration (COR) being approval from KATH site will be issued by R&D for applicant to seek KATH IRB approval. See item D for KATH IRB submission requirements.

Note:

  • Applicants should no longer contact HODs/HOUs directly for their departmental approval).
  1. KATH IRB APPLICATION SUBMISSION GUIDELINES
  1. Complete KATH IRB Application form, obtainable from DOWNLOAD HERE
  1. The arrangement of the content should be in the same order as the KATH IRB form
  • The soft copy should be merged into one filename format
  • Soft copy should be uploaded to kathirb@kathhsp.org with copy to kathirb25@gmail.com
  • The same order should be on the pen drive or CD
  1. After KATH-IRB Review, Approval status, IRB verdicts and Recommendations will be communicated to applicants in a written form.
  1. Next, the principal investigator notifies KATH IRB the official start date of the study; and when the study closes.
  1. KATH-IRB meets the first Tuesday of every month except on National Holidays
  1. Submission of protocols to KATH-IRB for consideration could be done Monday to Friday except on public holidays. However, for a protocol to be considered for a scheduled Board meeting, it should be received by the KATH IRB office at least two weeks prior to a scheduled meeting date.
  1. All protocol amendment(s) for approved research studies conducted at the hospital should receive KATH IRB approval prior to implementation.
  1. The PI will ensure that all submitted application and supporting documents are in acceptable standard of English and that they have been proofread and edited before submission. It is not IRB’s duty to do “rough editing” of material submitted

 

  1. SAMPLE RESEARCH PROTOCOL/PROPOSAL GUIDELINES

The Protocol/proposal should at least contain the following details:

  • Title page (This page should have the title of the Protocol and the names, addresses, e-mail, departments and affiliations of Investigators).
  • Structured abstract (Maximum of 300)
  1. Background
  2. General Aim

iii. Methodology

  1. Expected Outcome
  • Background
    • Problem Statement
    • Hypothesis (if applicable)
    • Aim(s)
    • Specific objectives
    • Literature review
  • Methodology
    • Study design:
    • Study sites (Please indicate if it’s a multicentre study and indicate the other centre)
    • Subjects/study population
  • Inclusion/exclusion criteria
    • Provide inclusion and exclusion criteria appropriately
  • Sample size
    • Procedures to be used
    • Data collection methods and instruments
  • Data handling
    • Data security and confidentiality 
  • Statistical analysis
    • Descriptive statistics (frequency, central tendencies, associations)
    • Inferential statistics (test of means, correlation coefficient, etc.)
  • Dissemination of results
    • To Project sponsors, policy makers and study participants (where applicable)
  • At workshops, seminars and conferences
  • In different types of publications
  • Ethical issues
    • Recruitment and sampling procedures, Potential risks and benefits,
    • Confidentiality
    • For vulnerable subjects (children, pregnant women, institutionalized
    • Subjects), state how subjects’ protection will be ensured.
    • Consent Form with simple and clear language.
  • Timelines/work schedule
    • This may be in the form of a Gantt chart.
  • Personnel of the study team
    • Please state all personnel involved in your study including the role of each member of the team
  • Budget & logistics
    • To be detailed even if there is no external funding
    • This should include funding agency, total funds available to the project and the institution administering funds.
    • If it’s a multicentre study, please give details of site-specific budget with reference to KATH.
  • References 
  • Appendix
    • Copy(ies) of all regulatory approvals already acquired elsewhere (e.g., GHS-ERC, CHRPE, FDA etc).
    • Questionnaire (if any)
    • Any other attachments
    • CV for the PI (maximum 2 pages)

 

  1. KATH IRB SUBMISSION REQUIREMENTS
Section Description General Research Student Research Please Check
A.       All Research Protocols Other Than Clinical Trials Copies Copies
 

Signed cover letter from investigator

addressed to KATH IRB chairman

6 4
  Any other document relevant for the conduct of the study 6 4
 

R&D certificate of registration if site is KATH /written

approval from the site/facility where study is to be conducted

6 4
  Proof of payment of KATH IRB fees 6 4
  Evidence of sponsorship from study sponsor (if applicable) 6 4
  Completed Application Form 6 4
  Participant Information Leaflet and Consent form(s) 6 4
 

Case report form (s)/data capturing sheet(s)/questionnaires

/Interview guide

6 4
  CV of PI (Abridged) 6 4
  Budget/Financial declaration for the study 6 4
  Sample Material/Data Transfer Agreement (if applicable) 6 4
 

Full Research Protocol with Executive summary

(Executive summary should not be more than 3 pages)

6 4
  Soft copies of all documents on pen drive/CD 1 1
 
B.      

Students’ Research Protocol

(Further requirements in addition to Section A)

  Cover letter from supervisor 4
  Abridged CV of supervisor (s) 4
  Cover letter from school/college (if available) 4
   
C.      

All Clinical Trials

(Further requirements in addition to Section A)

Copies Copies
 

Profile of previous study/studies, if applicable

(i.e., Phase 1 & Phase II studies)

6 6
  Investigational Product Brochure 6 6
  DSMB membership, Charter of work & current CVs of members 6 6
  Sample Material Transfer Agreement (if applicable) 6 6
  Data sharing agreement (If applicable) 6 6
  CV of Co-Investigator(s) 6 6
  Current GCP certificate of PI 6 6
  Statement of Investigator / Form 1572 (if applicable) 6 6
  Clinical Trial Agreement (CTA) (If applicable) 6 6
  Financial disclosure agreement (if applicable) 6 6
  Insurance Certificate for study participants (If applicable) 6 6
  FDA Approval (if applicable) /evidence of FDA application 6 6

 

NOTE:                                 

(a).  Please note that all documents in submission to KATH IRB shall be versioned and dated.

(b).  For all clinical trials (including students’ research which are clinical trials), the total number of protocols

       in submission to KATH IRB shall be six (6)

(c).  For All Research Protocols Other Than Clinical Trials, arrangement order is as listed in Section A

(d).  The arrangement order for Clinical Trials are all documents as listed in Section A and documents as listed in Section C

 

 

POLICY ON RESEARCH FUNDS, GRANTS AND INDIRECT COST

PROJECT FUNDS, GRANTS, AND INDIRECT COST POLICY AT KOMFO ANOKYE TEACHING HOSPITAL

Funded projects (research and outreaches) refers to all projects being funded from external, internal (KATH, Government of Ghana) and other sources (including personal and not third-party).

  1. Administrative charge may also be referred as Indirect costs or overheads costs or facilities and administrative cost (F&A) costs
  2. Projects Leads applying to register a project at Komfo Anokye Teaching hospital (KATH) should give the full funding declaration involved.
  3. This should include the full financial amount involved in the currency of the sponsor agency. This should be graduated per year where necessary.
  4. In the case of anonymous donors, this should be indicated and appropriately incorporated into the research budget.

 PROJECTS AND KATH RESOURCES (EMPLOYEES AND INFRASTRUCTURE)

This refers to externally funded projects involving KATH in relation to employee’s time resource and infrastructure, the following are to be noted:

  1. Apart from the agreement signed between the project lead and the sponsor, there must also be an agreement with KATH that clearly defines the relationship between KATH and the Project Lead and /or the sponsor.
  2. This may take the form of the sponsor signing an agreement directly with KATH or the Project lead signing an agreement as per the above.
  3. Funded Projects must clearly describe KATH’s staff time, resources and infrastructure required by the project.
  4. projects can engage KATH employees in various capacities. This may be up to 25% of their full regular working schedule. In the event of a higher percentage, there should be authorization from the KATH CEO or Director of Class through the Head of Directorate or Unit of the employee.
  5. When available, all funds for projects must be fully disclosed in detail in the agreement signed between KATH and sponsor. This includes remuneration to the Principal investigator, project staff, cost of equipment etc.
  6. Hired project staff who are not KATH employees should have their work schedule, rules of engagement etc. made available to hospital management through the Research and Development unit.
  7. Where funds for projects are lodged with KATH, they shall be managed (including purchase of equipment and materials) by KATH (directorate/unit accountant or central accounts) in accordance with the contract /MOU in line with prevailing institutional requirements without any disadvantage to the Project Lead.
  8. Komfo Anokye Teaching Hospital charges 10% of the total sponsorship amount as administrative fee.
  9. For projects where the sponsor has a fixed, capped or lower percentage for administrative fee, investigators shall provide documentation to that effect. This will be considered on their individual merit.
  10. The following may be exempted from paying administrative charges
  11. Hospital projects
  12. Grant-in-aid sponsored projects
  13. Local student project.
  14. Projects involving collaborating partners and others not specified in this section shall be

               considered on their individual merit

  1. Where project funds are lodged with another institution and the project site is KATH, the administrative charges shall be split evenly between the two institutions i.e. 50% of this sum will be paid to KATH.
  2. The administrative charge levied by the other institution will be disclosed in full with supporting documentation.
  3. The portion of the indirect cost to be paid to KATH should be incorporated into the project/ budget at the time of registration

 

  1. The project lead has the responsibility of making sure that funds are promptly delivered to KATH before the project is halfway to completion.

 

 

SAMPLE RESEARCH PROTOCOL/PROPOSAL GUIDELINES

KATH is committed to supporting high-quality research across all directorates and units.  Research and development are regarded as integral to the provision of high-quality evidence-based care.  Further information on this process is available from the R&D Unit.

The R&D registration procedure is to be followed if the research to be conducted meets any one or more of the following:

  • The research will be conducted at KATH
  • The researcher is a KATH employee (full or part-time)
  • The researcher will in any way cite KATH before/during/after completion of the research
  • Every research to be conducted at the Komfo Anokye Teaching Hospital (KATH), Kumasi, Ghana, requires KATH R&D registration, and an approval from the Komfo Anokye Teaching Hospital Institutional Review Board (KATH-IRB) as detailed below.
  1. Complete R&D registration application online at https://sites.google.com/site/infectiousprings2013/?
  2. Print out confirmatory submission email.
  3. Upload the electronic copy of the protocol/proposal at kathrdu@gmail.com.
  4. Send your confirmatory submission email print-out to the KATH’s main revenue office behind Block A (close to Births & Deaths office) and collect payment voucher in return.
  5. Pay the non-refundable R&D registration/KATH-IRB fees appropriate for the funding category at any of the Fidelity Banks at the hospital.
  6. Note that all sponsored research studies to be conducted at KATH must budget Administrative charges/Indirect cost/Overheads cost/ Facilities and Administrative Rate in their budget. KATH overheads cost is 10%. Consult R&D if you need further clarification(s).
  7. Submit one bound signed printed/hardcopy of the proposal, printout the confirmatory email and the official receipt of the R&D registration/KATH-IRB fees to R&D for processing. Proposal/Protocol (sample

format attached as a guide only), should have been signed and dated by the PI or Co-PI.

  1. All research studies to be conducted at KATH must have a Ghanaian collaborator (preferably a senior staff KATH employee) in the respective directorate/unit where the study is to be conducted.
  2. R&D reviews the protocol/proposal and sends a copy of it to the HODs/Unit for comments/approval (Applicants should no longer contact HODs/HOUs directly for their departmental approval).
  3. Based on comments from HODs/HOUs and R&D internal review, a Certificate of Registration (COR) will be issued for the applicant to seek KATH-IRB approval (See KATH-IRB application guidelines).
  4. Collect your COR from R&D and proceed to make your submission to KATH-IRB.

 

KATH IRB APPLICATION SUBMISSION GUIDELINES

  1.  After obtaining your certificate of registration (COR-see R&D registration guidelines), complete KATH-IRB Application form, obtainable from http://www.kathhsp.org/wp-content/uploads/2019/10/KATH-IRB-Application-form.doc
  2. Submit all the required set of documents (see checklist of attachments of KATH-IRB Application) in soft and hard copy to the KATH-IRB Office located at the R&D
  3. All soft copies should be:
  • exactly the same in content and arrangement order as the signed printed bound hardcopies (see arrangement order below).
  • merged into one file with filename format as “PI’s Name plus the study title”. e.g., Prof. Kofi Nti_UTI Study in Ghana
  • submitted via email to kathirb@kathhsp.org with copy to kathirb25@gmail.com
  • on either a pen drive or CD to be collected at the IRB office.
  1. The required number of signed printed hard copies should be:
    § bound in one document
  • submitted with soft copies on a pen drive or CD.
  • submitted to the KATH IRB Office
  1. The arrangement order of both the soft (merged into one file) and all required hard printed copies (bound in one document) should be as detailed below:
  2. Once KATH-IRB approval is granted, applicants are notified by either a phone call, email or text message to pick up their approved letters from the KATH-IRB office.
  3. Next, the principal investigator notifies KATH-IRB the official start date of the study; and when the study closes.
  4. The principal investigators of all approved research projects are required to submit quarterly report to the R&D Unit.
  5. All protocol amendment(s) for approved research studies conducted at the hospital should receive KATH-IRB approval prior to implementation

 

All Research Protocols Other Than Clinical Trials

Signed cover letter from investigator

addressed to KATH IRB chairman

Any other document relevant for the conduct of the study

R&D certificate of registration if site is KATH /written

approval from the site/facility where study is to be conducted

Proof of payment of KATH IRB fees
Evidence of sponsorship from study sponsor (if applicable)
Completed Application Form
Participant Information Leaflet and Consent form(s)

Case report form (s)/data capturing sheet(s)/questionnaires

/Interview guide

CV of PI (Abridged)
Budget/Financial declaration for the study
Sample Material/Data Transfer Agreement (if applicable)

Full Research Protocol with Executive summary

(Executive summary should not be more than 3 pages)

Soft copies of all documents on pen drive/CD

Students’ Research Protocol

(Further requirements in addition to Section A)

Cover letter from supervisor
Abridged CV of supervisor (s)
Cover letter from school/college (if available)
 

All Clinical Trials

(Further requirements in addition to Section A)

Profile of previous study/studies, if applicable

(i.e., Phase 1 & Phase II studies)

Investigational Product Brochure
DSMB membership, Charter of work & current CVs of members
Sample Material Transfer Agreement (if applicable)
Data sharing agreement (If applicable)
CV of Co-Investigator(s)
Current GCP certificate of PI
Statement of Investigator / Form 1572 (if applicable)
Clinical Trial Agreement (CTA) (If applicable)
Financial disclosure agreement (if applicable)
Insurance Certificate for study participants (If applicable)
FDA Approval (if applicable) /evidence of FDA application

 

The Protocol/proposal should at least contain the following details:

  • Title page(This page should have the title of the Protocol and the names, addresses, e-mail, departments and affiliations of Investigators).
  • Structured abstract (Maximum of 300)
  1. Background
  2. General Aim

iii. Methodology

  1. Expected Outcome
  • Background
    • Problem Statement
    • Hypothesis (if applicable)
    • Aim(s)
    • Specific objectives
    • Literature review
  • Methodology
    • Study design:
    • Study sites (Please indicate if it’s a multicentre study and indicate the other centres)
    • Subjects/study population
  • Inclusion/exclusion criteria
    • Provide inclusion and exclusion criteria appropriately
  • Sample size
    • Procedures to be used
    • Data collection methods and instruments
  • Data handling
    • Data security and confidentiality
  • Statistical analysis
    • Descriptive statistics (frequency, central tendencies, associations)
    • Inferential statistics (test of means, correlation coefficient, etc.)
  • Dissemination of results
    • To Project sponsors, policymakers and study participants (where applicable)
    • At workshops, seminars and conferences
    • In different types of publications
  • Ethical issues
    • Recruitment and sampling procedures, Potential risks and benefits,
    • Confidentiality
    • For vulnerable subjects (children, pregnant women, institutionalized
    • Subjects), state how subjects’ protection will be ensured.
    • Consent Form with simple and clear language.
  • Timelines/work schedule
    • This may be in the form of a Gantt chart.
  • Personnel of the study team
    • Please state all personnel involved in your study including the role of each member of the team
  • Budget & logistics
    • To be detailed even if there is no external funding
    • This should include funding agency, total funds available to the project and the institution administering funds.
    • If it’s a multicentre study, please give details of the site-specific budget with reference to KATH.
  • References
  • Appendix
    • Copy(ies) of all regulatory approvals already acquired (e.g. CHRPE, FDA etc)
    • Questionnaire (if any)
    • Any other attachments
    • CV for the PI (maximum 2 pages)
FEES AND PAYMENTS

R&D REGISTRATION/KATH IRB APPLICATION FEES 

 

Funding Category

 

                      Fees

Amendments/Continuing Review/Renewal
Studies Sponsored by KATH /Unit Budgets

(US$100.00)

or Cedi Equivalent

US$10 or Cedi Equivalent
Studies Sponsored by Local Ghanaian Organisations

(US$500.00)

or Cedi Equivalent

US$50 or Cedi Equivalent

Studies with Substantial International Grants/Contracts Research

(>US$500,000.00)

(US$ 2000.00) or Cedi Equivalent US$200 or Cedi Equivalent

Studies with International Funding

(US$15,000.00 – 500,000.00)

(US$1000.00)

or Cedi Equivalent

US$100 or Cedi Equivalent

Studies with International Funding

(US$5,000.00 – US$15,000.00)

(US$500.00)

or Cedi Equivalent

US$50 or Cedi Equivalent
Non-Ghanaian Investigators with no External Support

(US$100.00)

or Cedi Equivalent

US$10 or Cedi Equivalent

Ghanaian Lecturers/Professionals

(With Funding <US$5000.00)

(US$100.00)

or Cedi Equivalent

US$10 or Cedi Equivalent

Ghanaian Lecturers/Professionals

(Non-KATH Employees Without Funding)

Gh¢500.00 Gh₵50.00

Ghanaian Lecturers/Professionals

(KATH Employees Without Funding)

Gh¢350.00 Gh₵50.00
Post Graduate Students with International Funding

(US$150.00)

or Cedi Equivalent

US$20 or Cedi Equivalent
Post Graduate Students with Local Funding

(US$100.00)

or Cedi Equivalent

US$10 or Cedi Equivalent

Post Graduate Students

(Without Funding)

Gh¢250.00 GH₵30.00
Undergraduate Students Gh¢150.00 GH₵20.00
Non-Ghanaian Students with no External Support

(US$70.00)

or Cedi Equivalent

US$10 or Cedi Equivalent

 

BANK DETAILS

Account Name:                                 Komfo Anokye Teaching Hospital Service Account

Bank:                                                  Fidelity Bank

Account Number:                             1070031981539

Branch:                                               Ridge Tower

Currency:                                            Ghana Cedis 

Bank Name:                                      Societie Generale, Ghana

Branch:                                               Kumasi Central

Branch Code:                                     90602

Account Name:                                 Komfo Anokye Teaching Hospital

Account Number:                             332510003094

IBAN:                                                 GH2880000990602332510003094

Swift Code:                                         SSEBGHAC

SWIFT No.                                        SSEBGHAC

Currency:                                            US DOLLAR

 

 

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