Ministry of Health  
	   
  Republic of Botswana
Application for Social Behavioral - Human Research

Section A: Instructions
1.	For research/academic institutions or PHD students attach:
a)	14 copies of the Research Application form Version 8
b)	4 copies of the following:
(i)	Study proposal. The full proposal should include the following: Title, objectives, background and literature review, methodology (to include research design, subjects and methods, ethical considerations, timetables etc. references, budget etc. Investigators may submit the full proposal in the funding agency format as long as it covers the above headings.
(ii)	 Consent/authorization form or a request for waiver of consent/authorization- Setswana, English and back translation where applicable.
(iii)	Questionnaires to be used. Setswana, English and back translation where applicable.
(iv)	Curriculum vitae/ resume: Principal Investigators and all Co- investigators.
(v)	Approval letter from other  IRBs
(vi)	Grant approval letter 
(vii)	Any other supporting materials i.e. recruitment scripts, flyers etc
(viii)	Drug brochures
(ix)	For drugs, attach Clearance from the Drug Regulatory Unit
2.	For undergraduates and graduates attach four copies of the above listed items/ documents. 
3.	All submissions should be made 5 weeks before the scheduled date of the HRDC meeting

Section B: Application Details

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

2. Date of submission:

3. Principal Investigator( Name & Qualifications):

	 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):

4. Other Investigators /Co-Principal Investigators
	
Name:	Organization:	Email:	Telephone Number:	

				

5. Key Personnel working with data that may be linked to human subjects:
	
Name:	Organization:	Email:	Telephone Number:	

				

6. Conflict of interest (real or apparent)	
• Other than the normal scholarly gains, are there any other gains you might receive from taking part in this study?

	

7. Sponsor information	
Do you have a sponsor?                         Yes (     )          No (     )	
Name the funding source: 
	
Sponsor Contact Details	
Type of funding	

8. Multi Centre Studies	
a) Is this a multi-center study?     (   )Yes     (   )No
	
b) List all sites that are expected to participate in the proposed study.	
Site (City, Country)	Approval Status	Study recruiting?	Expected total enrolment                	

NB: Attach IRB clearance letters from all participating sites.	

Section C: Description of Research

1. Brief Summary of the  Study (In your summary include the following Background Information, aim, objectives, methods, expected outcome and study duration)

	
2. Research question to be addressed by this proposal (if applicable)
	
3.  Rationale/Justification (Why the need to carry out this study in Botswana):

	

4. Study Objectives ( Both General and Specific):

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

Outcome measurements/variables: 
[These should be clearly stated and justified]

Section D. Methodology

1. Study Design
 [These should be clearly described.]

2.Local Study sites (Districts, Towns, Villages, Health facilities, Schools etc :
	
3. Subject Population(s)  Gender, age, and other relevant Characteristics):

i)Would you be involving any of the following groups? Please tick the applicable group of your subjects:
 
(   )Children (Under 18 years of age) :                                         (   )Pregnant women
(   )Foetuses                                                                                  (   )Elderly (over 65 years)
(   )Prisoners :                                                                               (   )Cognitively impaired
(   )Hospital inpatients :                                                                (   ) mentally retarded
 (   ) mentally disabled                                                                  (   ) Other (Specify)

ii) Explain the necessity for including any of the above population(s). 

iii)What plans will the research team put in place to provide extra protection to the vulnerable groups

iv) Please tick the appropriate subject's state of physical health; 
(   ) healthy  
(   ) ill  
(   ) terminally ill.

NOTE: If you plan to advertise for participants, the advertisements MUST be submitted to the HRDC for review and approval prior to its publication and/or posting.

6. Sample size(Provide a clear and justified description of how the sample size was determined)

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

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

Sources of Data
i.	Focus Group(s)		(  )
ii.	Interviews		(  )
iii.	Questionnaires/Surveys	(  )
iv.	Census/Public Records	(  )
v.	 Human Biological Specimen                                                                                                                  (  )   Archive   	(  )   Prospectively Collected	(  )   Discharged        (   )   Stored Samples     
vi.	Medical Records		(  )
vii.	Registers (e.g. TB register and Cancer register)		(  )
Other ___________________________________________________________
	
9. Data Analysis (Briefly explain how data will be analyzed)

Statistical measures:
[Provide a clear and justified description of the following:]
Statistical method(s) and analysis of quantitative and qualitative  measures 
Data processing (e.g. how, where, when, who) 
	
10. Piloting/Pretesting (Explain all procedures in details)	

11. Ethical Issues: 
b) Protection of Subjects (Describe measures to protect subjects from and minimize possible risk of harm, discomfort, or inconvenience):
 [The following additional information, in respect of the proposed trial, is required:]
a) Describe how you will deal with the following ethical issues:
•	Choice of investigators
•	training / updating / for staff involved in this study on ethical issues
•	Capacity building element of study
•	Informed Consent .
•	Will any of the following identifiers be recorded with or linked by code to the data?   Check all that apply:

        (  )Names
(  )Date of Birth, Admission, Discharge or Death
(  )Biometric identifiers, including fingerprints
(  )Full face photographic images and any comparable images
(  )Postal address information, 
        (  )Telephone numbers
        (  )Fax numbers
        (  )Electronic mail addresses
        (  )Medical Aid numbers
        (  )Medical record numbers
        (  )Account numbers
        (  )Certificate/license numbers
•	
•	Privacy 
-	Gathering sensitive information 
-	Data storage (location and duration)
-	Who will have access to the data
-	Plans for disposal of the data upon completion of the study
•	Confidentiality

d) Methods for dealing with illegal, reportable activities (e.g child abuse, rape)

12. Consent Process (Check all that applies)
(    )Written : (   ) Oral : (   )English : (   )Local Language : (   )None :

• If subjects are minors or mentally disabled, describe how and by whom permission will be granted.

Reading level of consent document (Check all that applies): 
(    ) Below Standard 7 
(    ) Below Form 3
(    ) Below Form 5
(    ) Tertiary Level
(    ) Graduate level

13. Approximate Date Study Recruitment will begin:______________________________________	
14. Estimated Duration of entire study: _________________________________________________

15. Determination of Risk (Check all that applies)	
	Does the research involve any of the following    ( √ ) YES    ( X ) NO	
	Existing data available via public archives/sources	
	Existing data not available via public archives	
	Observation of public behavior	
	Is the information going to be recorded in such a way that subjects can be identified	
	Does the research deal with sensitive aspects of the subjects behavior, sexual behavior, alcohol use or illegal conduct such as drug use	
	Could the information recorded about the individual if it became known outside of the research, place the subject at risk of criminal prosecution or civil liability	
	Could the information recorded about the individual if it became known outside of the research, damage the subjects financial standing, reputation and employability	

16. Do you consider the proposed research	

A) greater than minimal risk
B) minimal risk
C) no risk

Minimal risk is a risk where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical, psychological examinations or tests. For example the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examinations.	

Section E: Subject Information

1. Inclusion Criteria
Outline criteria for selection of subjects, gender, ethnic group, and performance sites (provide justification for single gender or group).

	
2. Exclusion Criteria:
Outline criteria for exclusion of subjects, gender, ethnic group, and performance sites (provide justification for single gender or group).

	
3. Who will cover Subject Injury-Related Costs?
i.	Sponsor                          (  )
ii.	Third-Party Payers       (  )
iii.	Subjects                          (  )
iv.	N/A                                  (  )
v.	Other		            __________________________
	
4. Potential benefits to society and to subjects (do not include compensation):
Assess potential benefits to be gained by the individual subject and explain why the benefits outweigh the risks.
Assess benefits which may accrue to society in general as a result of the planned work

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

	

Section E: 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

Declaration by Principal Investigator

Name:

Site:

1.	I have notified the regulatory authority of any aspects of the above with which I do not / am unable to, comply. (If applicable, this may be attached to this declaration.)

2.	I have thoroughly read, understood, and critically analyzed the protocol and all applicable accompanying documentation, including the investigator’s brochure, patient information leaflet(s) and informed consent form(s). 

3.	I will conduct the study as specified in the protocol. 

4.	To the best of my knowledge, I have the potential at the site(s) I am responsible for, to recruit the required number of suitable participants within the stipulated time period.

5.	I will not commence with the trial before written authorizations from the HRDC and other relevant Research Ethics Committee(s).

6.	I will obtain informed consent from all participants or if they are not legally competent, from their legal representatives. 

7.	I will ensure that every participant (or other involved persons), shall at all times be treated in a dignified manner and with respect. 

8.	I will ensure, in accordance with the duties outlined for each member, that all members of the team are fully utilized for tasks assigned to them.

9.	I will submit all required reports within the stipulated time-frames.

Signature: 						Date: 

Witness:						Date:	

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	
2.	New Applications/ Resubmissions/ Continuing review/Amendments		
3.	Final Outcome		
4.	Ref No:
		
5.	Expiration Date:		
       7. Continuing renewals extension

                                Date 1 ______________________________________

                                Date 2  ______________________________________

                                Date 3 ______________________________________

       8. Final Report Submission

                                (   ) Yes                      Date  ______________________
                                (   ) No