Research application procedures

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Please note that Research Applications should be directed to the Research Permit Officer in the Ministry most relevant to your research.

Guidelines for Research in Botswana were originally laid down by the Ad Hoc Research Coordinating Committee, meeting at Gaborone in May 1981, which devised the form attached below as Document 1. Until recently research applications were routed through the Office of the President, which referred them to individual government ministries. Now applications must be sent direct to Research Permits Officer in the appropriate government ministry.

Most human research, other than health-related research, is handled through the Ministry of Labour and Home Affairs (MLHA). See its application form Document 1 below. Most other Ministries follow the same format: just substitute their names for MLHA's. (For a list of Ministries and their addresses go to http://www.gov.bw/ and scroll down on the left to GOVERNMENT LIST "Organs of State".) Following precedents in health-related research elsewhere in the world, the Ministry of Health demands a much more complex form of application. See Document 2 below.

Many government ministries outlined their research priorities in chapters of a 1987 publication, still worth consulting, titled Research for Development in Botswana: Proceedings of a Symposium held by the Botswana Society at the Gaborone Sun Conference Centre Gaborone August 19-21, 1985, Edited by Robert Hitchcock, Neil Parsons, & John Taylor (Gaborone: The Botswana Society. 453pp. ISBN: 99912-60-1). The current state of research is best gauged by the contents of academic journals such as Botswana Notes and Records (Botswana Society, Gaborone) and Pula: Botswana Journal of African Studies (University of Botswana, Gaborone).

For the full Subject & Title Index by discipline of Botswana Notes and Records, go to http://www.botsoc.org.bw/bnr/bnr01.htm.

For Pula: Botswana Journal of African Studies, go to its title index at http://digital.lib.msu.edu/projects/africanjournals/html/search.cfm

with electronic copies of back-volumes available at http://digital.lib.msu.edu/projects/africanjournals/html/browse.cfm?colid=12


For affiliation at the University of Botswana go to its Office of Research & Development (ORD) in Gaborone at http://www.ub.bw/ord/ord_detail.cfm?pid=165&m3=88 (email maletel@mopipi.ub.bw). and/or to its Harry Oppenheimer Okavango Research Centre (HOORC) in Maun at http://www.orc.ub.bw/.


Document 1:

Ministry of Labour & Home AffairsResearch Application Form

Document 2:

Ministry of HealthResearch Application Form



Document 1: Ministry of Labour & Home Affairs Research Application Form

REPUBLIC OF BOTSWANA

Research Application Form

Five copies to be completed and signed and sent to:

Research Permits Officer,

Ministry of Labour and Home Affairs,

Private Bag 002,

Gaborone, Botswana

fax +267-381-3584

Description of the Proposal

1 (a) Title of Research:

(b) Disciplines Involved:

2. Name and Address of Applicant:

3. Name and Address of Home Institution (if any):

4. Name and Address of Supervisor in Home Institution and/or Responsible

Referee (Letters of Endorsement Enclosed):

5. Research Plans:

(a) Main Aims:

(b) Objectives:

6. Recurrent Budget Costs (including subsistence, interpreters,

secretarial, etc.):

7. Name and Address of Financial Sponsor:

8. Funding Payment Details:

9. Previous Residence and Research in Botswana:

10. Name and Address of Institution in Botswana to which Affiliated:

11. Botswana-based Personnel to be Involved:

12. Places in Botswana where Research is to be Conducted:

13. Proposed Time-Table for Research:

14. Plans for Dissemination of (Interim and Final) Research Findings in Botswana:

15. Plans for Dissemination of Research Findings in Home Country:

16. Other Relevant Information (Please Attach Curriculum Vitae)

17. Signature of Applicant:

18. Date:

Enclosures:

(i) Letter(s) of Endorsement

(ii) Curriculum Vitae

 

Document 2: Ministry of Health Research Application Form

 

                      Ministry of Health 

 

  Republic of Botswana

Application for Approval of Human Research

 

Section A: Instructions

  1. For research/academic institutions or PhD students attach:

a)       14 copies of the Research Application form

b)       4 copies of the following:

    1. Study proposal.
    2.  Consent/authorization form or a request for waiver of consent/authorization- Setswana, English and back translation where applicable.
    3. Questionnaires to be used. Setswana, English and back translation where applicable.
    4. Curriculum vitae/ resume of each member of the Research team
    5. Approval letter from other  IRBs
    6. Grant approval letter
    7. Any other supporting materials i.e. recruitment scripts, brochures, flyers etc

      2. For undergraduates and graduates attach one copy of the above listed items/ documents.

 

Section B: Application Details

 

1. Study Title: (Include Version number and date)

2. Date of submission:

 

3. Type of Research:

  1. Basic Science              (  )     
  2. Public Health              (  )
  3. Clinical Research       (  )
  4. Human Biology          (  )
  5. Other________________________

 

 

4. Principal Investigator( Name & Qualifications):

 

 

4(i). Local Contact Details

        Name:

 

Postal

Address:

 

Postal

Address:

Phone

Number:

Phone

Number:

E mail

Address:

 

E mail

Address:

Name of affiliate

Institution/Organization:

Name of

Institution/Organization:

Department (If Government):

 

Department (If Government):

 

 

 

 

5. Other Investigators /Co-Principal Investigators

 

Name:

Organization:

Email:

Telephone Number:

 

 

 

 

 

 

6. Key Personnel working with data that may be linked to human subjects:

 

Name:

Organization:

Email:

Telephone Number:

 

 

 

 

 

 

Section C: Description of Research

 

1. Brief Description of Study

 

 

2. Rationale/Justification (Why the need to carry out this study in Botswana):

 

3. Study Objectives ( Both General and Specific):

 

4. Expected Results (Both Primary and Secondary endpoints):

 

Section D. Methodology

 

1. Study Design

2. Study sites (Districts, Towns, Villages, Health facilities, Schools etc :

3. Subject Population(s) (Clinical condition, Gender, age, and other relevant Characteristics):

 

4. Sample size(The number of subjects to be involved in the study and how these subjects will be selected from the population):

 

 

 

 

 

 

5. Subject Recruitment/Sampling Methods (Explain all procedures in detail):

 

 

 

 

 

6. Data Collection Methods (Explain all procedures in detail)

7. Data Analysis (Briefly explain how data will be analyzed)

8. Piloting/Pretesting (Explain all procedures in details)

 

9. Protection of Subjects (Describe measures to protect subjects from and minimize possible risk of harm, discomfort, or inconvenience):

 

 

 

 

 

 

 

 

 

 

 

 

10. Approximate Date Study Recruitment will begin:______________________________________

11. Estimated Duration of entire study: _________________________________________________

 

 

Section E: Subject Information

 

1. Inclusion Criteria

 

2. Exclusion Criteria:

3. Does the study involve Vulnerable Groups? (Tick all that Apply)?     

Elderly                                                                                                                               (  )

Children                                                                                                                 (  )

Pregnant women, fetuses, or neonates of uncertain viability or nonviable     (  )

Prisoners                                                                                                                (  )

Decisionally impaired Persons                                                                             (  )

Minority and indigenous groups                                                                          (  )

Low Literacy                                                                                                          (  )

Economically Disadvantaged                                                                                (  )

Other__________________________________________________________

N/A                                                                                                                          (  )

4. Does this study involve any use of a drug?  No (  )  Yes (  ). If yes, is the drug registered or given exemption status (IND studies) by the Drug Regulatory Unit in Botswana? If yes attach proof)_________________________

 

5. Reasonably foreseeable risk or discomforts to the subjects (list in detail):

 

6. Who will cover Subject Injury-Related Costs?

    1. Sponsor                          (  )
    2. Third-Party Payers       (  )
    3. Subjects                          (  )
    4. N/A                                  (  )
    5. Other                                 __________________________

 

7. Potential benefits to society and to subjects (do not include compensation):

 

8. Give details of Botswana based personnel that will be involved (Name, functions and qualifications):

 

9. Any renumeration given to subjects?   Yes   (   )   No   (   ). If yes, specify:

 

10. Will the participant incur any financial cost in this study?   Yes   (   )   No   (   ). If yes, specify:

 

 

Section F: Data Sources

 

1. Sources of Data

  1. Focus Group(s)                   (  )
  2. Interviews                            (  )
  3. Questionnaires/Surveys   (  )
  4. Census/Public Records     (  )
  5.  Human Biological Specimen                                                                                                                  (  )   Archive                 (  )   Prospectively Collected    (  )   Discharged        (   )   Stored Samples    
  6. Medical Records                                (  )
  7. Registers (e.g. TB register and Cancer register)                                (  )
  8. Other ___________________________________________________________

 

Section G. Study Details

 

1. Capacity Building (how will the study build capacity in the country)  

2. Dissemination (How will the study findings be disseminated)

3. Other Ethical Body(ies) Involved in the review of the study

 

 

 

 

Section H: Sponsor Information

 

1. Name of             Sponsor:________________________________________________________________________________

 

2. Type of Sponsor:

         i.            Government                           (  )

        ii.            Private Foundation               (  )

      iii.            Industry                                 (  )

      iv.            Internal                                  (  )

        v.            Other                                      (  )

 

3. Sponsor Contact         Person:_________________________________________________________________________________________

 

4. Sponsor Contact

Telephone: _______________________________________________________________________

 

Section I: Contact Information:

 

PI or other researchers for answers to questions about the study or research-related injuries(You must offer at least two contacts):

The HRDC representative who can answer questions about their rights as research subjects

 

i).

 

 

 

ii).

 

 

 

Name___________________________

Head of Health Research Unit

Ministry of Health

Private Bag 0038

Botswana

Tel: (+267)  3914467    

Fax: (+267) 3914697

 

 

 

Section J: Investigator’s Statement

 

 

INVESTIGATOR’S STATEMENT OF ASSURANCE

 

I promise to abide with existing relevant International Declarations and National procedures and guidelines when undertaking research involving human subjects within the Republic of Botswana and agree to:

1. Ensure that all studies conducted on human participants are designed and conducted according to sound scientific and ethical standards within the framework of good clinical practice.

2. Report to the Health Research and Development Committee any information requested, serious or unexpected adverse events and any information related to national programs.

3. Unless if an emergency treatment for patient care, obtain prior approval from the HRDC before amending or altering the scope of the project or implementing changes in the approved consent form(s).

4. Submit progress reports as required by the HRDC.

5. Maintain all documentation including consent forms and progress reports.

6. Ensure that all members of the research team are aware of their roles and responsibilities in this study.

7. Ensuring, in accordance with the duties outlined for each member, that all members of the team are fully utilized for tasks assigned to them.

 

Principal Investigator’s Name:

 

Principal investigator’s Signature:                                                    Date:

 

Principal Investigator’s Position:

 

 

Local Investigator’s Name:

 

Local investigator’s Signature:                                                          Date:

 

Local  Investigator’s Position:

 

 

After Completion

 

1.                              An electronic and hard copy of the report should be submitted to the Health Research Unit, Ministry of Health as well as other relevant Botswana Government Institutions/Organizations within 3 months of producing a bound report.

 

2.                              All continuing renewals should be submitted at least 6 weeks before the expiration.

 

Section K. For Health Research Unit use ONLY.

 

  1. Date Received

 

6.  Review Body     [  ]  Health Research Unit

                                  [  ] HRDC
  1. Final Outcome

 
  1. Ref No:
  1. Expiration Date:

       7. Continuing renewals extension

 

                                Date 1 ______________________________________

 

                                Date 2  ______________________________________

 

                                Date 3 ______________________________________

 

       8. Final Report Submission

 

                                (   ) Yes                      Date  ______________________

                                (   ) No

                     

          

 

 

Last updated 12 May 2008

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