OxTREC minimal risk form, version 1.0, 19 February 2015

University of Oxford

OXFORD TROPICAL RESEARCH ETHICS COMMITTEE (OxTREC)

APPLICATION FORM FOR MINIMAL RISK STUDIES

The University of Oxford aims to ensure that all research is subject to appropriate ethical scrutiny. This form is designed for minimal risk research that will be conductedoutside the European Union. Please visit the OxTREC homepage to view the full set of criteria for minimal risk applications. Applicants planning research that carries more than minimal risk should complete the full OxTREC application form.

ONLY TYPEWRITTENAPPLICATIONS THAT ARE SENT BY EMAILWILL BE ACCEPTED.
PLEASE ENSURE THAT YOUR FORM BEARS THE NECESSARY SIGNATURES.
PLEASE INCLUDE ALL SUPPORTING DOCUMENTATION WITH YOUR APPLICATION FORM: PROTOCOL, PARTICIPANT INFORMATION SHEET, CONSENT FORM, AND ANY OTHER RELEVANT DOCUMENTS.

Before completing this application form, please consult the following guidance documents available on the OxTREC and Central University Research Ethics Committee(CUREC) websites:

  • OxTREC minimal risk criteria and approval process
  • Glossary (which defines the words marked with asterisks*)
  • Frequently Asked Questions (FAQs)

This form does not cover research governance, satisfactory methodology, or the health and safety of employees and students. As principal investigator, it is your responsibility to ensure that requirements in these areas are met.

1. Investigators

*Principal investigator (PI) name and status:
Name of Supervisor (for student research projects only):
Department or institute:
Address of PI for correspondence:
E-mail and telephone contact of PI:
Names and status of other investigatorstaking part in the project:

2. Description of study

Title
Brief description of *research (about 150 words), plus description (about 200 words) of the nature of participants (including the criteria for inclusion/exclusion, method of recruitment), purpose of the research, methods to be used, and use to which the results/data will be put.
List all *sites where project will be conducted:
Anticipated duration of project: / ____ months
Anticipated start date: / / /
Anticipated end date: / / /

3. Checks

3.1) Does the study fit the definition of audit in the CUREC glossary? / YES / NO
3.2) Are all the data about people to be used in the study previously collected anonymised data which neither you nor anyone else involved in the study cantrace back to the individuals who provided them (e.g. census data, administrative data, secondary analysis)? Please refer to the definition of *personal data in the CUREC glossary and FAQ A.3 for further guidance. / YES / NO

If you have answered ‘yes’ to questions 3.1 or 3.2, it is likely that you do not need to submit your proposal for ethical scrutiny. If you have answered ‘no’ to both questions please proceed to the next question (4).

4. Methods to be used in the study

Tick as many as apply. This information will help the committee understand the nature of your research and may be used for audit.

METHOD USED / PLEASE TICK
Unstructured interview
Structured interview
Questionnaire
Analysis of existing records
Participant performs verbal/paper and pencil/computer based task
Measurement/recording of motor behaviour
Audio recording of participant
Video recording or phtotography of participant
Physiological recording from participant
Participant observation
Systematic observation
Observation of specific organisational practices
Other (please specify in box below)
Please specify other procedures here

5. Informed consent and risk assessment

(Please put a tick in the yes/no column as appropriate to indicate your response).

5.1) Have you made arrangements to obtain written *informed consent fromparticipants? If yes, please attach copies of the information sheet and consent form. / YES / NO
5.2) Have you made arrangements to ensure that *personal datacollected from participants will be held in compliance with therequirements of the DataProtection Act? / YES / NO
5.3) If your research involves any use of *personal data obtained from a *thirdparty, have you checked to ensure that the *third party has arrangements in place to permit disclosure? / YES / NO
5.4) Does the research involve as participants *people whose ability togive free and informed consent is in question? / YES / NO
5.5) Does the research involve any alteration of participants’ normalpatterns of sleeping, eating, or drinking? / YES / NO
5.6) Is there a significant risk that the research will expose participantsto visual, auditory, or other environmental stimuli of a level or typethat could have short- or long-term harmful physical effects? / YES / NO
5.7) Is there a significant risk that that the research will induce anxiety,stress or other harmful psychological states in participants that mightpersist beyond the duration of the test/interview? / YES / NO
5.8) Does the research involve exposing participants to any physical orpsychological hazard, beyond those of their usual everyday life, notcoveredby questions 5.9 and 5.10? / YES / NO
5.9) Does the research involve any *invasive procedure? / YES / NO
5.10) Will the research elicit information from participants that mightrender them liable to criminal proceedings (e.g. information on drugabuse or childabuse)? / YES / NO
5.11) Does the research involve the *deception of participants? / YES / NO
5.12) Will the research require a participant to spend more than 2 hoursin any single session on activities designed by the researcher (NB: this timerestriction does not refer to situations where participants are observed goingabout activities not devised by the researchers, e.g. observation of lessons inschools)? / YES / NO
5.13) Will the research involve a significant risk of any harm of anykind to any participant not covered above? / YES / NO
5.14) Do you intend to follow any professional/CUREC guidelines (please provide details) / YES / NO

If any of your answers in question 5 are in a shaded box, please answer question 6. If all your answers in question 5 are in the unshaded boxes, go to question 7.

6. Use of approved protocols

One or more aspect(s) of your research project suggest(s) that it may pose risks to participants (see shaded box(es) ticked in question 5).

Are all the aspects of your project which caused you to tick a shaded box in question 5 fully covered by CUREC-approved research protocol(s)? / YES / NO
Please give CUREC protocol number(s).
Please proceed to question 7. / Please complete a full OxTREC form and submit it to the Oxford Tropical Research Ethics Committee.

7. Have you sought approval from the local research ethics committee(s) in the place(s) where your research will be conducted?

If yes, please give the name(s) of the committee(s)………………………………………..…………..

Final Section

Complete this section only if you do not need to submit a full OxTREC application form.

I understand my responsibilities as principal investigator as outlined on p.1 of this form and in the CUREC glossary and guidance.

I declare that the answers above accurately describe my research as presently designed and that I will submit a new application should the design of my research change in a way which would alter any of the above responses so as to require full scrutiny by OxTREC. I will inform OxTREC if I cease to be the principal investigator on this project and I will supply the name and contact details of my successor if appropriate.

Signed by principal investigator:…………………………………………………………………………….

Date:…………………

Print name (block capitals)………………………………………………………………………………………

FOR STUDENT RESEARCH PROJECTS ONLY

I have read the research project application named above. On the basis of the information available to me, I:

(i)consider the principal investigator (student researcher) to be aware of her/his ethical responsibilities in regard to this research;

(ii)consider that any ethical issues raised have been satisfactorily resolved or are covered by CUREC approved protocols, and that it is appropriate for the research to proceed without further formal ethical scrutiny at this stage (noting the principal researcher’s obligation to report should the design of the research change in a way which would alter any of the above responses);

(iii)am satisfied that the proposed project has been/will be subject to appropriate *peer review and is likely to contribute something useful to existing knowledge and/or to the education and training of the researcher(s) and that it is in the *public interest.

Signed by supervisor:…………………………………………………………………………………………..

Date:…………………

Print name (block capitals)………………………………………………………………………………………

Please send your signed application form by email to .
Please ensure that you include all supporting documentation with your application form (protocol/participant information sheet/consent form, etc.).

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