Is the following declaration provided, dated and signed?
I, - name of principal investigator- have read the MRC Guidelines on Ethics for Medical Research and have prepared this proposal with due cognisance of its content. Furthermore I will adhere to the principles expressed when conducting this proposed research project.

Did you have any difficulty with any specific provision in the guidelines concerning your proposal?   If so, please provide details - this will be very helpful to the MRC Ethics Committee.

____________________________________________________

____________________________________________________

____________________________________________________

Please give a statement of the research problem.

____________________________________________________

Has the application been approved by the MRC Research Committee?

____________________________________________________

Has the application been checked for content, grammar and spelling?
If yes, by whom?

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7

Are the ethics issues identified, and is it stated how they will be addressed?

___________________________________________________

Yes

N/A

Are the copies of the following attached?[N/A = not applicable]

• An Executive Summary, stating the AIM, METHODS, OUTCOME and INTENDED FEEDBACK of the study.

Yes

N/A

• Subject information sheet

• Informed consent form

Are the technical terms in the above forms explained in lay terms?

Are the contact details of the MRC Ethics Committee given with a statement that participants can contact the Chairperson when they have queries or problems?
(Prof Danie du Toit, tel. (021) 938 0341; e-mail: adri.labuschagne@mrc.ac.za)

Translations into languages relevant to the study area.  If yes, which language(s)?

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If consent will be verbal or informed consent is not necessary, please explain why not

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9

Are questions that are going to be posed to participants provided?

10

Is confidentiality clarified?

11 

Has consent from minors been explained?
If subjects are under age (less than 14 years) from whom will consent be obtained?

____________________________________________________

12

Have the following protocol details been provided?

Table of Contents

Number the pages in the proposal and include page numbers in the contents.

Methodology details

1

Overall aim and specific objectives.

2

Background and rationale: This must be substantial and include references to or details of similar studies, and allow for thorough technical peer review by experts in your field.

3

Research work plan: Describe in considerable detail your overall research protocols. Discuss research alternatives if your original assumptions prove incorrect.

4

Data-analysis: purposive sampling, data saturation, method of analysis, independent coder.

5

Time chart: Critical path analysis identifying when each activity is to take place. Identify points at which timing is critical (e.g. a season when a particular field study would need to be done).

6

References cited.

7

Description of methods applied.

8

Has this study been approved by the research group you operate in, or by any other peer group, for scientific validity? 

If yes, name the group. ____________________________________________________

Management details

1

Management approach: Discuss the overall management of the project. Where is managerial responsibility? Consider specific functions such as reporting, financial management, procurement of equipment and research supplies, and management of field activities.

2

Staff and scientific collaboration: Who will do what, when and where? (one page).

3

Facilities: Describe the facilities and resources available for the proposed research.

Budget details

1

Budget: full detailed budget for each year. The following headings can act as a guide:
Salaries, equipment, its repair and maintenance, materials and supplies, training, consultation, travel, other, indirect costs/overheads.

2

Budget justification: Explain how the individual items of the budget were calculated. Justify major or unusual expenses.

3

Budget summary.

4

Has your research group reviewed and accepted the budget?

5

Do you believe the budget is fully sufficient to conduct the study ethically and scientifically?

6

Has the name of the sponsor of the study (if applicable) been indicated on the subject information sheet?

Details of researchers

CVs and publication lists of all senior personnel involved in the project.

NOTE: Only provide qualifications and scientific experience, e.g. publications, projects, presentations. A one-page biosketch with the ten most important references will suffice.

Other details

1

Ethical considerations: This must address all relevant ethical issues including: details of possible negative consequences to the study animals/subjects, information to be given to subjects, reporting back procedures to the community/authorities and an example of the consent form to be used.

2

Additional Review Bodies: does this protocol need to be reviewed by another institution or review board? If so, has it been submitted and what was the outcome? Please provide copies of relevant documentation.

3

Similar studies: Please list titles of any similar studies previously approved.

4

Please declare which of the following interests you may have in the study, such as:

• resources paid directly to you or your research account;

• potential financial benefits from the outcome of the study;

• direct financial interest in the company;

• any others;

• any gains to your family;

• travel sponsorship.

5

Name the possible (both positive and negative) short- and long-term consequences of the study.