Request for Ethical Review and Research Approval

Transcription

1 Request for Ethical Review and Research Approval Background Research provides a significant benefit to the delivery of effective health promotion and services. ACON seeks to encourage researchers to participate in a process of peer-review regarding ethical issues to promote ethical conduct in human research in the lesbian, gay, bisexual, and transgender (LGBT) community; among people with and affected by HIV; and among sex workers. This process helps to improve the quality of research related to these groups, which, in turn, makes the research more useful for health providers such as ACON. The ACON Research Ethics Review Committee exists to provide advice to ACON on ethical issues relating to research and to provide ethical guidance to researchers and research participants. Research projects seeking ACON s endorsement, or access to ACON s support and resources, are required to attain approval from the RERC. Approval is a prerequisite for the consideration of assistance or support for the research by ACON. Who should seek ACON ethics approval? Projects that seek to use ACON or SWOP staff, mailing lists, or other material resources, Projects that specifically target LGBT populations, either as their sole sample group or as an identified sub-sample, Projects that specifically target people with HIV or those who provide their care and support, Projects that specifically target people who work in the sex industry, and Projects that concern issues relating to the health of people with HIV/AIDS, LGBT people, or sex workers. ACON support for, or involvement in, research projects ACON RERC approval does not imply any formal assistance from ACON. The provision of any assistance, including resource allocation, is a management decision to be made by ACON. However, ACON will generally only provide formal assistance to research projects that have RERC approval. Procedure for consideration and assessment of research proposals 1. A Request for Ethical Review and Research Approval form should be completed and submitted to research@acon.org.au, along with other relevant forms (a checklist is attached at the end of this application form). All forms should be submitted electronically. Please carefully check the meeting date and its cut-off date for submission (provided on ACON Ethics Committee website). 2. In the event that the proposal is to be submitted to a granting agency, these relevant forms should also be included. The RERC requires a clearance/approval statement from the project

2 investigators relevant Human Research Ethics Committee (HREC). If ethical approval from the relevant IEC has not yet been received, the investigators must identify an appropriate IEC and demonstrate their intention to seek ethical approval. 3. The Committee may invite the applicant to attend the meeting of the Committee at which the application will be considered. If the applicant is unable to or does not wish to attend, the Committee shall review the application in their absence. 4. After an open discussion of the proposal, the Chair of the Committee will formulate a consensus recommendation concerning the proposal as follows: Approval Approval after amendments or clarifications Deferment Declined The proposal is approved as submitted. The proposal is approved subject to the incorporation of the amendments or clarifications into the proposal. The proposal is not approved as submitted, but it can be reassessed after revision to address the reasons for deferment. The proposal is not approved as submitted. 5. Applicants will be advised of the decision of the Committee in writing within two weeks of a recommendation of the Committee. Sex Worker Related research seeking SWOP support: 1. If you are a researcher interested in engaging in sex worker related research and you are seeking SWOP support, you must contact SWOP directly ( 2. Sex worker related proposals that are seeking SWOP support can only be reviewed by the ACON RERC if they are submitted by SWOP staff Applications are evaluated on the following criteria: Threshold Criteria Applications that do not meet these will not be considered. Consideration of and adherence to NHMRC s National Statement on Ethical Conduct in Human Research Informed consent process/privacy/confidentiality Evidence of considered risk assessment Clearance/approval of Human Research Ethics Committee, or evidence of approval being sought* Page 2 of 8

3 Essential Criteria Cultural relevance Appropriate research methodology and procedures Benefit to community/research participants Evidence of community consultation in the development of the research proposal Feedback to community tes *This does not apply to projects where ACON s RERC is the sole form of ethical review. Page 3 of 8

4 Request for Ethical Review and Research (RERC) Approval Project Details Title of Research Project Proposed Start Date Proposed End Date Principal Researcher Highest Academic Qualification: Co-Researcher Co-Researcher Co-Researcher Insert additional boxes if necessary. Contact Person (Please include job title, if different from above.) Address: Phone: Fax: Identify any research partners and funding relationships Provide a brief summary of the project in lay language (approximately 100 words) Page 4 of 8

5 Criteria for Approval 1. Threshold Criteria Proposals which do not meet these criteria will not be considered 1a. Consideration of and adherence to NHMRC s National Statement on Ethical Conduct in Human Research What are the ethical implications of this research? Think about the risks and benefits of undertaking the research. 1b. Informed consent process/privacy/confidentiality Are participants provided with sufficient information about the study? Is consent obtained? Are the participants legally able to give consent (i.e. over 18 years old)? Who will have access to the research data? How will confidentiality be assured? 1c. Evidence of considered risk assessment What potential risks are there to participants/researchers of the study and to LGBT communities? 1d. Clearance/approval of Human Research Ethics Committee, or evidence of approval being sought Has approval been sought/granted from another ethics committee? Page 5 of 8

6 Essential Criteria 2a. Relevance to the community being researched How is this research relevant to the community being researched (i.e. LGBT, HIV/AIDS, Sex Workers, IDU)? 2b. Appropriate research methodology and procedures Provide a detailed summary of the research methodology and procedures. Please include the number of participants who you expect to recruit and how you plan to recruit them. 2c. Benefit to community/research participants Outline the benefit to community of this study. 2d. Evidence of community consultation in the development of the research proposal How have you/do you plan to consult with the community in the development of the study? 2e. Contribution to body of knowledge How do you plan to provide feedback of the results of the research to ACON, research subjects, and the broader affected community? 3. Is this research being conducted as part of the completion requirements of a degree? Page 6 of 8

7 What assistance are you requesting from ACON? Endorse the project Use premises Provide advice on recruitment Assist with distribution & promotion Provide input into methodology Act as a formal partner in research Other (please specify) Page 7 of 8

8 Research Ethics Application Checklist Please ensure that you satisfy each of the following before submitting the application. Omission of any information below will delay the process of your application. 1. Included application form with all the questions clearly answered (Please avoid using the terms, refer to attachment or other document in your answers) 2. Included the letter of ethics approval from other institutes 2a. If ACON RERC is the sole Ethics Review Committee, has your project complied with NSW Privacy Act AND National Statement of Ethical Conduct on Human Research by National Health and Medical Research Council and Australian Research Council? 3. Included the copy of participant information sheet 4. Included the copy of participant consent form 5. Included the copy of all questionnaires/surveys/interview questions to be used 6. Included the copy of all recruitment documents (posters/ads/notices) 7. Included the copy of protocol (if applicable) 8. Included letter of support from SWOP (Only for Sex Worker Related proposals) For ease of distribution to Committee members, please merge all files into one PDF document with this application form being the first document, omitting the first three pages. Page 8 of 8