CUREC Application - Face to Face

8/14/2019 CUREC Application - Face to Face

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Form CUREC/2University of Oxford

CENTRAL UNIVERSITY RESEARCH ETHICS COMMITTEE (CUREC)

Not all research project leaders need to fill in this form. Before starting work on this form,please fill in CURECs checklist (CUREC/1) which will show if you need to complete thisform. Please also ensure you have consulted the following CUREC guidance documents

available on the CUREC website (http://www.admin.ox.ac.uk/curec/resrchapp/index.shtml):

Guidance on approval process Glossary FAQs

Definitions of terms marked with an asterisk are to be found in CURECs glossary andguidance.

SECTION 1: PROJECT TITLE, RESEARCHERS, AND CONTACT DETAILS

1. Person to whom IDREC/CUREC should direct correspondence.

*Principal investigator/supervisor/student researcher

Title and name: Mr. William DeJanes, M.Sc.

Appointment:

Department: Department of Social Policy and Social Work

Institution: University of Oxford

Address: Barnett House, 32 Wellington Square, Oxford OX1 2ER, UK

Phone: +44 1865 270325

Fax: +44 1865 270324

e-mail: [email protected]

Will you need training to participate in this project?Yes No

FOR STUDENT RESEARCH PROJECTS ONLY

Name of Supervisor: Dr. Paul Montgomery

2. Full project title and proposed starting date:A Test of the Validity and Transportability of a Revised Information Motivation Behavioral Skills (IMB) Model of HIV Prevention Incorporating Culturally-RelevantExtra-Individual Factors to Predict and Understand Risky Sexual Behavior among Youthin a Large South African Township

On or about March 01, 2010

Office use only: IDREC Ref. No.______________Date of Approval: / /

Application date: / /Approval Period: from / / to / /

Signature of IDREC approver: ________________________________________

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FAQs14-19 FAQs14-19

FAQ12 FAQ12

FAQs13&28 FAQs13&28
http://www.admin.ox.ac.uk/curec/resrchapp/index.shtmlhttp://www.admin.ox.ac.uk/curec/resrchapp/index.shtmlhttp://www.admin.ox.ac.uk/curec/glossary/glossary.shtmlhttp://www.admin.ox.ac.uk/curec/resrchapp/faqethapp.shtmlhttp://www.admin.ox.ac.uk/curec/resrchapp/index.shtmlhttp://www.admin.ox.ac.uk/curec/glossary/glossary.shtmlhttp://www.admin.ox.ac.uk/curec/resrchapp/faqethapp.shtmlhttp://www.admin.ox.ac.uk/curec/resrchapp/index.shtml


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Form CUREC/2

Name (printed) and position of approver: _______________________________

Date applicant informed of approval: / /

3. Are you submitting this project to another ethics committee or has it been

previously submitted to an ethics committee?

Yes - provide details.

No

This project will also be submitted to the Cape Peninsula University ofTechnology for review and approval.

Please supply one completed copy of this box for each researcher.

*Associate researcher/student researcher

Title and name:

Appointment:

Department:

Institution:

Address:

Phone:

Fax:

e-mail:

Role in this project:Qualifications and relevant experience for this project:Degree course (if relevant):

Will this researcher be approved by the principal researcher as competent to obtain*informed consent from participants?

Will this researcher need training to participate in this project?Yes No

For each researcher who requires training to participate in this project, describe training onaseparate page and include the name of the trainer(s).

SECTION 2: PROJECT DESCRIPTION

5. Description of project

Please give a description (500-1000 words) of your project including a lay summary (about200 words), briefdescription of research design, aims and methods, detailing those aspects

of the project which involve *human participants, particularly any aspect which is beyondalready established and accepted techniques. Please attach all other documents (e.g.

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Form CUREC/2questionnaire, recruitment advertisements, participant information, and consent forms) thatyou plan to use in the study. Please note that detailed scientific background is notrequired unless directly relevant to ethical issues.

See attached:

Description of Research

Lay Summary

Study Design and Methods

The IMB Model

Questionnaires

Informed Consent Forms

Interviewer Sheet

CV of Project Manager

Protocol for Conduct of Research

Child Welfare Referral Form

6. *Sites where project will be conducted

(a) List all sites where the project will be conducted

Residences of secondary school students in Khayelitsha, Western Cape, South Africa

(b) If other relevant approvals for this research are required (e.g. from otheruniversities ethics committees) please attach them.

I am still awaiting approval from the Western Cape Education Department and theUniversity of the Western Cape and will submit documentation of approval once received.

7. Anticipated duration of project:__2__ months

8. Anticipated start date: 01/03/2010

9. Anticipated end date: 01/05/2010

10. Literature searchIf the research involves significant risk to the human participants please describe whatliterature searches have been undertaken to obtain information to aid riskreduction/management.

Based on prior experience, no significant risks are foreseen. However, please refer toattached document regarding risk reduction measures should any distress be experienced by

participants due to the sensitive nature of the data being collected.

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Form CUREC/2

SECTION 3: RESEARCH INVOLVING CONTACT WITH *HUMAN

PARTICIPANTS

If the project does NOT involve contact with*human participants, but only use of data aboutthem, do NOT complete this section, but go to Section 4. If you are not completing Section 3

please delete it from your application to save paper.

11. Description of participants(a) How many participants will be involved in the project?

Approximately 140-160

12. Details of participants

(a) What types of people will be recruited e.g. students,* children, people with learningdisabilities?

Students

(b) What will be the age range of participants?

14-19

(c) How will the competence of participants to give *informed consent be determined?

Parental consent will be required for participation in this study

(d) What are the *defining criteria for participation in the study?

Participants must attend secondary school located in the township of Khayelitsha, South

Africa.

13. Recruitment of participants

(a) Describe how, where, and by whom participants will be identified, approached, andrecruited.

Participants will be visited at their household by a Xhosa-speaking graduate studentassistant. A description of the study will be given verbally in (Xhosa) and potential

participants will be given separate informed consent (IC) form for them and their parents toread, sign, and date. Only students who, along with their parent/guardian, sign IC forms will

be eligible to participate.

(b) If your research involves any use of *personal data obtained from a *third party,describe the steps you have taken to ensure that the *third party has arrangements in

place to permit disclosure.

N/A

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Form CUREC/2

(c) Will any *unequal relationships exist between anyone involved in the recruitment andthe potential participants?

Yes

No

If yes:

(i) Describe the nature of the unequal relationship.

(ii) Explain how ethical problems arising from the unequal relationship will beresolved.

(d) Describe any financial or other rewards which will be offered to participants.

14. *Participant information

It is essential that written information is easily understandable by participants.Inadequate information sheets are the most frequent reason for delays in ethicalapproval.

(a) Will participants receive written information about the project before giving theirconsent?

Yes - please attach.

No - give reasons.

See attached informed consent forms.

(b) Who will give the participants the information and how?

A social work or psychology graduate student assistant will provide information about the

study both verbally and in writing (see attached IC form) after school hours at the studentsresidence. Parents will be provided with a separate IC form describing the study, andparticipation in the study will be contingent upon the signing of the student andparental/guardian IC forms.

(c) Does the research involve deliberate *deception of participants?

Yes- explain why the real purpose of the research needs to be concealed and howand when participants will be told of the deception.

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Form CUREC/2No

(d) Please describe the basis on which you have decided how long participants will have tothink about the information provided before giving consent.

Students will be given a minimum of 48 hours for themselves and their parent or guardian toreview the provided IC forms as this is deemed sufficient time to make a fully informeddecision regarding proposed participation in the study.

15. *Informed consent

(a) Will you obtain written consent?

Yes - please attach *consent form.

No - explain how consent will be obtained and recorded and why this method isused.

(b) If participants are unable to give valid consent, how and from whom will you obtainconsent?

An IC form will be provided to the students and a separate form for their parents, both ofwhich will be required for participation in the study.

(c) List those researchers who will, with the authorisation of the principal researcher (orsupervisor in the case of student researchers), secure the consent of participants.

Xhosa-speaking assistants with graduate training in social work or psychology.

16. Consequences of participation

(a) What are the potential risks or actual ill effects of participation (if any) e.g. invasiveprocedures, distress, deception etc, and what will be done to minimise these risks

(i) to the participants?

Although similar research conducted in the past among school-attending adolescents in thiscommunity has not produced any ill effects among participants, it is possible that thesensitive nature of the questionnaire may cause unease or embarrassment among

participants. In order to account for this, participants will be individually interviewed so asto allow for questions and clear communication regarding the optional nature of the

interview as well as the need to answer any particularly sensitive questions. Interviews willbe conducted by same-gender assistants to avoid any gender bias or unease. It will also be

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Form CUREC/2repeatedly stressed that participation is entirely voluntary, and participants are free todiscontinue participation at any time without cost or penalty. If any participants feeldistressed secondary to completion of the survey, a member of the study team will beavailable for immediate transport to the nearest youth clinic and possible follow-up referralto Cape Town Child Welfare.

See attached description of risks of harm for additional information.

(ii) to the researchers?

None

(iii) to others (e.g. the university, family)?

None

(b) Is there a need for support or counselling?

Yes - describe the form of support or counselling and how, when, and by whom itwill be conducted.

No

It is not foreseen that counselling will be required as a result of participation in this study.However, all participants will be provided with the location of the nearest VCT clinicshould any distress arise. Participants will be informed that they neednt answer any itemsthat make them feel uncomfortable and that they are free to discontinue participation at any

time without penalty. Additionally, a member of the study team will be available totransport by automobile any participant experiencing acute distress to the nearest youthclinic with possible follow-up referral to Cape Town Child Welfare.

(c) Is there a need for debriefing or follow-up discussion?

Yes - describe the form of debriefing or follow-up discussion and how, when,and by whom it will be conducted.

No

Participants will be thanked for their participation in the study and a verbal description ofthe aims of the study will again be provided to the students.

(c) Are there any potential benefits to the participants?

Yes - describe them below

No

No IMB-related model has been tested among school-attending youth in any South African

township areas with one of the highest concentrations of HIV, making the validity of thismodel in this population unknown. If this model is capable of being adapted to the above

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Form CUREC/2No

(b) collection of personal information?

Yes go to Question 21

No go to Question 23

21 Collection of information directly from individuals(a) Does the project involve collection of information directly from individuals about

themselves?

No go to Question 22.

Yes answer the following questions:

(b) Do the *participant information and the *consent form include the following:

the name of the study? Yes No

the name and status (e.g. doctoral student) of the researchercollecting the information and how to contact him/her?

Yes No

the purpose of the study? Yes No

Declarations that the participanthas read the participant information sheet?

Yes No

has had the opportunity to ask questions about the study andhas received satisfactory answers to questions, and any

additional details requested?

Yes No

understands that s/he may withdraw from the study without penalty at any time by advising the researchers of thisdecision?

Yes No

understands that this project has been reviewed by, andreceived ethics clearance through, the University of OxfordCentral University Research Ethics Committee?

Yes No

understands who will have access to personal data provided,how the data will be stored; and what will happen to the dataat the end of the project?

Yes No

agrees to participate in this study ? Yes No

If you answered no to any of these questions, explain why this information has not beenincluded in the participant information and the consent form.

(c) Are the consent form and participant information on headed letter paper which bears thename of the University and the name and address of the department to which the principalresearcher is attached?

Yes

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Form CUREC/2No -explain why not.

(d) Are the participant and the researcher who secures the consent required to sign, print and

date their names?

Yes

No -explain why not.

22 Collection of information from a third party

(a) Does the project involve collection of information about an individual from a sourceother than the individual?

No Go to Question 23.

Yes complete the following sections.

(b) List the individuals or organisations from which information will be collected. Ifinformation will be collected from more than one source, state which information orrecords will be collected from each source.

(c) Have all organisations from which the information is to be collected agreed to providethe information or to allow access to the information?

Yes - attach a copy of each letter of agreement. Provide details of any conditionsimposed by the organisation(s) concerning the release of the information.

No - explain how and when the agreement of the disclosing organisation will beobtained.

(d) Will the information be potentially or actually ascribable to an individual when it is

received?



(e) Does the project involve collection of information without the consent of the individualto whom it relates?



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Form CUREC/2(f) Give reasons why information will not be collected in a way which prevents its

ascription to an individual.

(g) Why will consent not be obtained from the individual(s) whom the informationdescribes?

23 Form in which data are to be stored

Are the data to be kept

(a) with an open identifier i.e. in non-anonymised form Yes No

(b) as anonymised but potentially identifiable data Yes No

(c) as anonymised, non identifiable data Yes No

24 Use or disclosure of information about individuals

(a) Does the project involve the use or disclosure of information potentially or actuallyascribed to an individual?


Yes answer the following questions(b) Does the project involve use or disclosure of information without the consent of the

individual whom the information describes?



(c) What are the specific purposes for which the information will be used?

(d) Is the purpose for which the information will be used related to the purpose for whichthe information was originally collected?

Yes give details.

No give details.

(e) Describe in detail which information or records will be disclosed to whichorganisations.

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Form CUREC/2

(f) Give reasons why information will not be used or disclosed in a way which prevents itsascription to an individual. (If the answer is the same as for question 22 (f), write asabove.)

(g) Why will consent not be obtained from the individual(s) whom the informationdescribes? (If the answer is the same as for question 22 (g), write as above.)

(h) Explain why the proposed use or disclosure of information is in the public interest.Tthe public interest in the proposed research must substantially outweigh the publicinterest in respecting individual privacy.

25 Data collection, storage, and disposal

(a) How many records will be collected, used or disclosed? Specify the information thatwill be collected, used, or disclosed e.g. date of birth, medical history, number of

convictions.

Number of records: approx. 140-160

Type of information: Date of birth yielding a 10-digit number for coding purposes to assist inidentifying individual surveys to rectify any potential inconsistencies in response patterns (nonames will be asked or recorded), sexual history, drug use history, HIV-related knowledge,attitudes, behaviours, poverty-related stressors, gender differences in sexual power anddecision-making. Additionally, addresses of participants will be obtained for the purposes ofvisiting households for the conduct of the interview.

(b) How, where, and under what security arrangements will electronic and paper data bestored? Who will have and control access to the information?

All surveys will be stored in a locked filing cabinet. The Project Manager will ship completedsurveys on a weekly basis to the PI in Oxford using a reliable international parcel deliveryservice. Data will be entered into SPSS during and immediately after the study period untilcomplete. Data will be encrypted and stored in a password protected computer. Data will also

be stored in a portable storage device for backup. After completion of the study, all data willbe archived for a period of up to 5 years.

(c) When, how and by whom will the information be disposed of?

Hard copy data will be shredded by the primary investigator once it is converted to electronic

form. Electronic data will be maintained for a period of up to 5 years.

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Form CUREC/2(d) How will the privacy of individuals be respected in any publication arising from this

project?

No personal or identifying information will be referred to in any presentation, report, orpublication.

(e) Have you explained in the *participant information and *consent form that

maintenance of confidentiality of information is subject to normal legal requirements?

Yes

No explain why not.

26 Adverse and unforeseen events

How will adverse and unforeseen events relating to the collection, use, or disclosure of

information be managed, monitored and reported?

Report of any distress or psychological trauma will be reported according to a hierarchy of command,

including 1) PI, 2) parent/guardian, 3) supervisor of researcher, 4) head of department and, if necessary, 4)

further referral or transport to nearest youth clinic or Cape Town Child Welfare. A member of the study

team will be available during to transport by vehicle any individual experiencing potential acute distress

arising from the conduct of the study.

SECTION 5: MISCELLANEOUS ISSUES

27 *Conflict of interest

(a) Do researchers on this project have a financial or other interest in its conduct or

outcomes?

Yes give details.

No

(b) If there is a conflict of interest, have you declared it in your *participant informationand *consent form?

Yes

No explain why not.

(c) Are there any other potential conflicts of interest e.g. research findings that couldcompromise the researchers relationship with the university?

No

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Form CUREC/2

28. *Peer review

Has this project been peer reviewed?

Yes explain by whom (e.g. by a, tutor, supervisor, funding body etc) and withwhat outcome

No explain why not.

This study has been reviewed and approved by the PIs supervisor and is subject to approvalfrom the Cape Peninsula University of Technology.

29. Funding

List all bodies and individuals from whom funding has been or will be sought.

Source Amount in Status of FundsAvailable Applied for

John Fell Fund 7,500 Yes No Yes No

Yes No Yes No

30. Reporting of results

(a) Will the project outcomes be made public at the end of the project?

Yes describe the intended report and how and to whom it will be madeavailable.

No explain why not

We will disseminate pooled findings to local universities, NGOs, schools, and inthe form of publication in peer-reviewed journals.

(b) Will a report(s) of the project outcomes (for example, individual or group data) bemade available to participants at the end of the project?

Yes describe report and how it will be made available.

No explain why not.N/A

A report of results of group data with no identifying information relating toindividual participants or individual schools will be provided to school life skillscoordinators.

31. Declaration by researchers

Full project title:

A Test of the Validity and Transportability of a Revised Information Motivation Behavioral Skills (IMB) Model of HIV Prevention Incorporating Culturally-Relevant Extra-

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Form CUREC/2Individual Factors to Predict and Understand Risky Sexual Behavior among Youth in a LargeSouth African Township

I/We, the researcher(s) agree:

To start this research project only after obtaining approval from IDREC/CUREC;

To carry out this research project only if funding is adequate to enable it to becarried out according to good research practice and in an ethical manner;

To provide additional information as requested by IDREC/CUREC before approvalis secured and as research progresses;

To maintain the confidentiality of all data collected from or about projectparticipants;

To notify IDREC in writing immediately of any proposed change which wouldincrease the risks that any participant is exposed to and await approval before

proceeding with the proposed change;

To notify IDREC if the principal researcher on the project changes and supply thename of the successor;

To notify IDREC in writing within seven days if any serious *adverse event occursin the course of research;

To use data collected only for the study for which approval has been given;

To grant access to data only to authorised persons; and

To maintain security procedures for the protection of personal data, including (butnot restricted to): removal of identifying information from data collection forms andcomputer files, storage of linkage codes in a locked cabinet and password control foraccess to identified data on computer files.

Signed by principal researcher/supervisor/student researcher:

Date: 01.12.09

Print name (block capitals)WILLIAM DEJANES

Signed by supervisor:(for student projects)

Date: .

Print name (block capitals)DR PAUL MONTGOMERY

Signed by associate/other researcher:

Print name (block capitals)

Date

32. Certification by *principal researcher/supervisor/student researcher and head of

department

Full project title: A Test of the Validity and Transportability of a Revised Information Motivation Behavioral Skills (IMB) Model of HIV Prevention Incorporating Culturally-

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s27&31 s27&31

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Form CUREC/2Relevant Extra-Individual Factors to Predict and Understand Risky Sexual Behavior amongYouth in a Large South African Township

Certification by *principal researcher/supervisor/student researcher

I accept responsibility for the conduct of this research project.

I certify that all researchers and other personnel involved in this project are appropriatelyqualified and experienced or will undergo appropriate training to fulfil their role in this

project.

Signed by principal researcher/supervisor/student researcher:

Date: 01.12.09

Print name (block capitals)WILLIAM DEJANES

Acceptance by head of department/other senior member of the department if theprincipal researcher is the head of department

I have read the research project application named above.

On the basis of the information available to me, I support this research project as meetingappropriate ethical standards.

Name of head of department/other senior member of the department(e.g Chair of DREC,Director of Graduate Studies for student projects):

Signature Date.

FINAL CHECK

To prevent delay please check each of the following before submitting the application.

Have you answered all relevant questions in Sections 1-5?

Have you defined all technical terms and abbreviations used?

Have you included all questionnaires and participant information, consent forms,advertisements, and surveys to be used?

Have you included all relevant approvals and supporting letters?

Have you declared all potential conflicts of interest?

Are all pages (including appendices and attachments) numbered?

Have you completed the declaration by researcher(s)?

Have you completed the certification by principal researcher and headof department?

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Form CUREC/2February 07

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Documents

CUREC Application - Face to Face