SOUTH WEST REGIONAL HEALTH AUTHORITY BIOETHICS COMMITTEE Guidelines for Research Protocols Submitted for Review "die following information should be included in Research Protocols being submitted to the Bioethics Committcc of the SWRI IA: COVERING NOTE: Briefly introduce your request to conduct research at the SWRHA and specify any institutions to which you are affiliated, tor example whethcr you are an employee / student at a University, employee of an RHA, etc. List the documents included in your application, for example 1. Research Protocol, 2. University’s Ethics Approval / Employer’s Approval, 3. Informed Consent Form, 4. Questionnaires, etc (100 words limit). 1. TITLE OF THE PROPOSED RESEARCH 2. DATF. (and Version - it’there has been a prcvious submission) 3. NAME, ADDRESS, TELEPHONE NUMBER AND EMAIL 1or ALL THE INVESTIGATORS, COLI.ABORA4 ORS, AND/OR SUP ERVISORS (starting with the Principal Investigator). 4. SITE/S (LOCATION) OF RESEARCH 5. NUMBER OF RESEARCH PARTICIPANTS TO BE ENROLLEI3 6. PROPOSED DURATION OF THE STUDY 7. A SUMMARY OF THE PROPOSED STUDY — not more than 250 words and should include: a. The hypothesis and scientific basis or justification for the study b. The usefulness and significance of the study c. An outline of the study design d. An indication of steps taken to ensure and maintain confidentiality e. An assessment of the bcnefits to participants (and/or groups in the communlty or the entire community) and the risks Page 1 of 4 8. THE PROJECT PltOPOSAL A. An introduction and background information on the research topic. This should also include the justification for the research (review of the current knowledge from the literature on the topic, with an explanation why this project is necessary, and how it will contribute to the overall knowledge in this area) B. A clear statement of the objectives of the research proposal C. Design and Methodology: i. Study design ii. Data collection methods: • Details of procedures to be performed (e. g. volume of blood, the frequency, timing, and possible site of the blood-taking; any drug administration, physiological measures, etc.). • Which procedures may cause pain and/or discomfort for research participants. • Details of the intervention (where appropriate) • Copy of the data collection tool in the Appendix iii. Study population and sampling methods • Choice of participants, inclusion exclusion criteria, any controls, etc. • A statement that participants were selected only because of the specific pr‹›blem under investigation, and not because of their easy availability, diminished autonomy, or any social bias. • Sampling methods iv. Statistical issues • Number of research participants and its justification • Planned data analysis D. A statement confirming that reasonable time will be given for the participant to consider his/her involvement E. Procedures for obtaining informed consent, including statements that the researcher/s will read the informed consent form to the participant or his/her legal guardian and will provide that person with a copy of the form, that questions from the person will be invited, and that all efforts will be made to ensure that s/he understands its content before the seeking of consent Page 2 of 4 F. A copy of the informed consent form and recruitment posters (see details below) G. Data privacy/confidentiality: Mcthods to protect the confidentiality of participants, and methods to ensure that a participant who opts out of a research endeavour is well protected as far as hcalth care delivery is concerned and not disadvantaged in any way. Plans for the secure storage of the data. H. Assumptions made I. Relevant references (i.c. literature citation) J. Conflicts of intcrest K. Dissemination plan L. The name, address, telephone and fax numbers, as well as email address of a contact person 9. THE INFonM«D CONSENT FORM should include the following: a. Statements in language written for comprehension by the lay person outlining the purpose of the research, what will be done in the research study, and indicating that this has been explained orally and in writing to the participant (or the participant’s parent or legal guardian — if a child or mcntally challenged individual) who understands what will be done. These will be countersigned by the participant or his/her legally authorized representative; b. Explicit statements about risk or discomfort to the participant, with an assessment of the degrec of risk, and viable alternatives; c. A statement that the participant’s involvement is voluntary, and that refusal to participate or (if after having agreed to participate) withdrawal from the study at any timc will not affcct the participant’s access to or thc type of care to which s/he is entitled; d. The name, address, telephone numbcr, as well as email addrcss of a contact person for any queries; e. A statement confirming that reasonable time will be given for the participant to consider her/his involvement; f. Statements that the participant or her/his legal guardian has read the informed consent document, or that it has been read to her/him, and that s/he understands its contents; that a copy will be given to the participant; and that the signature of the participant or the legal guardian indicates that s/he has frccly agrccd to participate; Page 3 of 4 g. The signature: of a witness to the consent procedure who is not connected to the research undr'rtaking (i.e. a relative, caretaker, friend) FORMATTING: Font: Times New Roman Font Size: 12 Line spacing: 1.5 Limit: 4 to 6 pages (approximately 2000 words). IN STRUCTI ONS: Researchers must submi one (1) soft copy o1 their Rcscarch 1'rotoco1 and any other supporting documcnts to: Mrs. Kathyann Thomas-Elbourne General Manager-Nursing / Secretary, S WItflA 13io‹•thics Committee Levcl 8, San Fernando 4 caching 1lospital Chanccry Lane, San Fernando Email: i u1It iii iii c1 l›‹ ›i n n ‹ « i ha .c‹› i I : ii c I It i i c - la url‹c rf s \› i 1 ‹i. c t› . II CONFIlIMATION : Upon receipt o1’ an application, a confirmation email will bc sent to the researcher. Should researchers wish to also follow-up via telephone, thcy may contact 868-225-1763 ext 1763. Pace 4 of 4