Research and Development Unit

Dr. Kwadwo Sarbeng
Head of 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 fulfillment 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.

PROCEDURE FOR CONDUCTING RESEARCH AT KATH

KATH is committed to supporting high quality research across all directorates and units.  Research and development is 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 process described below is to be followed if the research to be conducted meets any one or more of the following:

  1. The research will be conducted at KATH
  2. The researcher is a KATH employee (full or part-time)
  3. The researcher will in any way cite KATH before/during/after completion of the research
  4. 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.
  5. The investigator shall contact the R&D Unit to register his/her proposed study by completing an online Application Form at the hospital’s website, https://sites.google.com/site/infectiousprings2013/? under the Research & Development Unit section.
  6. The investigator, following submission of the application form, waits for a confirmatory submission email from KATH R&D, prints it, and then uploads an electronic copy of the research proposal/protocol at kathrdu@gmail.com. The protocol should be detailed according to the prescription of KATH R&D; please see item G below. It is critically important to note that ALL research studies to be conducted at KATH must have a Ghanaian collaborator (preferably a KATH employee) as a PI or co-PI in the respective directorate/unit where the study is to be conducted.
  7. The investigator then submits the printed confirmatory email to the KATH’s main revenue office behind Block A (close to Births & Deaths office), collects payment voucher in return and make a non-refundable R&D registration/KATH-IRB fees appropriate for the funding category, detailed below as appropriate, at any of the authorized Fidelity Banks at the hospital.,  and collect official receipt; the official receipt number will be quoted on the R&D Certificate of Registration (COA).
  8. The investigator submits 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. The protocol/proposal being submitted to the R&D for review should have been signed and dated by the PI or Co-PI.
  9. The R&D unit shall review all the pieces of information submitted to the unit including the research proposal for technical details and practical feasibility in the hospital, shall record it into a database and submits the proposal to the head of directorate(s)/unit(s) for comments/expression of any concerns/approval. The investigator will be notified within one week of application on progress of application.
  10. If, however the HOD(s) have concerns, the R&D Unit shall mediate by facilitating a discussion between the researcher and the HOD(s). Following resolution, the researcher will be notified and may now re-visit the R&D Unit to pick up his/her COA required for ethical clearance. If, however resolution is not achieved, the research cannot be conducted at KATH.
  11. Based on accepted ethical standards[1], the R&D unit shall determine if the researcher requires ethical clearance or otherwise to conduct the study.
  12. If on the other hand, it is determined that the researcher requires ethical clearance the researcher will be required to make the requisite submissions to the Komfo Anokye Teaching Hospital Institutional Review Board by completing KATH-IRB Application form, obtainable from http://www.kathhsp.org/?page_id=704, and send it with all the required documents to the KATH-IRB Office located at the R&D.
  13. KATH-IRB submission requirements including R&D registration/KATH-IRB fees are obtainable http://www.kathhsp.org/?page_id=704.
  14. The investigator submits soft copies of all KATH-IRB required documents to kathirb@kathhsp.org  with copy to kathirb25@gmail.com

After following the process laid down by the KATH-IRB, if ethical clearance is not granted, the research cannot take place at KATH.

  1. However, if clearance is granted, the researcher shall be be notified by either a phone call, email or text message to pick up their approved letters from the KATH-IRB office.
  1. Next, the principal investigator notifies KATH-IRB the official start date of the study; and when the study closes.
  2. The R&D Unit, based on the regulatory approval (s) received from the investigator, shall write to the relevant HOD(s) for a date to commence the work. Official notification of commencement date shall be by either minute on the ethical clearance letter, a memo or a letter.
  1. All protocol amendment(s) for approved research studies conducted at the hospital should receive KATH-IRB approval prior to its implementation.
  2. The principal investigators of all approved research projects are required to submit quarterly report to the R&D Unit.
  3. Once the research is approved, the investigator shall maintain their studies in good standing throughout the study period at KATH. The researcher is also required to abide by these guidelines as well as any specific directives that may have come from R&D Unit or KATH’s management.

[1] A study shall require ethical clearance before commencement if personal data (information about living people which in isolation or in combination with other data which may be available, may lead to the identification of the patient) is to be collected and/or the study requires that results or conclusions of the study are intended to be extended beyond a single individual or an internal program. E.g. activities where there is an intent to publish the results in a peer-reviewed journal or to present at a regional or national meeting, as well as, theses or dissertation projects conducted to meet the requirements of a graduate degree.

R&D REGISTRATION/KATH-IRB APPLICATION FEES

 

Funding Category

Registration/

Full Committee Review

IRB Amendments

Review

Studies Sponsored by KATH /Unit Budgets

(US$100.00)

or Cedi Equivalent

(US$30.00)

or Cedi Equivalent

Studies Sponsored by Local Ghanaian Organizations

(US$500.00)

or Cedi Equivalent

(US$50.00)

or Cedi Equivalent

Studies with International Funding

(US$15,000.00 – 500,000.00)

(US$1000.00)

or Cedi Equivalent

(US$100.00)

or Cedi Equivalent

Studies with International Funding

(<US$15,000.00)

(US$500.00)

or Cedi Equivalent

(US$50.00)

or Cedi Equivalent

Studies with Substantial International Grants/Contracts Research

(>US$500,000.00)

(US$ 2000.00)

or Cedi Equivalent

(US$200.00)

or Cedi Equivalent

Non-Ghanaian Investigators with no External Support

(US$100.00)

or Cedi Equivalent

(US$10.00)

or Cedi Equivalent

Ghanaian Lecturers/Professionals

(Non-KATH Employees Without Funding)

Gh¢500.00 Free

Ghanaian Lecturers/Professionals

(KATH Employees Without Funding)

Gh¢200.00 Free
Post Graduate Students with International Funding

(US$100.00)

or Cedi Equivalent

(US$10.00)

or Cedi Equivalent

Post Graduate Students with Local Funding

(US$50.00)

or Cedi Equivalent

Free

Post Graduate Students

(Without Funding)

Gh¢100.00 Free
Undergraduate Students Gh¢25.00 Free
Non-Ghanaian Students with no External Support

(US$50.00)

or Cedi Equivalent

Free
Continuing Review Application Free

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

 

  1. SPONSORED RESEARCH PROJECTS CONDUCTED AT KATH

In this document, sponsored/funded research refers to all research being funded from external, internal (KATH, KNUST, Government of Ghana) and other sources (including personal and not third-party).

Where externally funded research involves KATH in relation to employer’s time, resources and infrastructure the following are to be noted:

  1. Aside the agreement signed between the PI and the sponsor; there must also be an agreement with KATH that clearly defines the relationship between KATH and the PI and/or the sponsor. This may take the form of the sponsor signing an agreement directly with KATH or the PI signing an agreement with KATH covering the project. No externally funded project shall commence without a signed agreement as per the above.
  2. Funded research must clearly describe KATH’s time, resources and infrastructure required by the project. When available, all funds for research must be fully disclosed in detail in the agreement signed between KATH and sponsor as per point 1. This includes remuneration to the PI, project staff, cost of equipment etc.
  3. Where funds for research 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 and prevailing institutional requirements without any disadvantage to the PI.
  4. Per the hospital policy any sponsored research work conducted on KATH premises is subject to an administrative charge of 10% of all direct costs incurred for the study. The administrative charge covers things such as electricity, water, office space, bank charges and other administrative support from the central hospital’s management. KATH reserves the right to review these charges from time to time
  5. Where research funds are lodged and managed by institutions other than KATH and the research study site is KATH the administrative charges shall be 50% of the indirect cost. It is the responsibility of the PI of the sponsored research to ensure the release of the funds to KATH in a timely fashion in the course of the project; at least not later than five months to the end of the project.
  6. Projects involving collaborating partners[1] and others not specified in this section shall be considered on their individual merit.
  7. The following shall be exempted from paying administrative charges:
    1. Hospital projects
    2. Grant-in-aid[2] sponsored projects
    3. Local student projects.
  8. PI’s of all research projects conducted at KATH are required to formally notify R&D Unit about the commencement of their project and its expected duration. The PI shall provide a quarterly report of the project including any amendment(s) to the R&D Unit following commencement of the study; and a final close up report when the study ends.
  1. PROTOCOL/PROPOSAL FORMAT

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, 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 (e.g. CHRPE, FDA etc)
    • Questionnaire (if any)
    • Any other attachments
    • CV for the PI (maximum 2 pages)
  1. CONTACT DETAILS

If you require further information or assistance you may contact the R&D unit on phone at:

+233 3220 22301-4 Ext.2112 or direct line at 233 322 000 617

[1] Research involving collaborating partners can be characterized as follows:

  • Research to be conducted is defined jointly by the sponsor and KATH (often by MOU)
  • A specific result or development is expected
  • Ownership of inventions, software, biological materials, know-how, trade secrets or other intellectual property vests in KATH
  • Sponsors can be granted an option for a royalty-bearing license to such property
  • Resulting publications may be temporarily restricted (within clearly defined limits) to protect commercial interests
  • Confidential information provided by the sponsor will be protected by KATH to the best of its ability

[2] Grant-in-Aid can be characterized follows:

  • Often in support of the general research activities of an individual researcher or group of researchers
  • Has no specific result required or expected by the sponsor?
  • Has no rights in inventions or other intellectual property accrue to the sponsor?
  • Has no restriction on publication of results, no restriction on use of funds and no information being confidential to the sponsor
  • Has substantial advance funding with no requirement for invoicing or detailed administrative reporting