How to complete a LNR application form online The online LNR can be found at: https://ethicsform.org/Au/SignIn.aspx For Detailed instructions please refer to the manual https://ethicsform.org/Au/Help/AU%20Online%20Forms%20for%20Research%20User%20Manual% 20v1.3.pdf 1. Create an account 2. Create new project Page 1 of 8 3. Fill out the form a) Start with section 1 and press next but you can also fill the different sections separately. Click on for more explanations. Page 2 of 8 b) Section 3: Our HREC is the South Eastern Sydney Local Health District (Northern Sector) c) • • • • • Section 5 “project detailed information” Clear aims and objectives Methodology - describe every step of the project Describe recruitment and consent process: who, where, when and by whom? Data collection: what, where, when and by whom? Include data collection sheet, questionnaires, interview questions etc Data analysis plan – relevant to study methods d) Section 6 “consent” There are 3 types of consents; • Informed consent : Patient Information Sheet (PIS) & Consent form (CF) , use standard where applicable • Implied consent: e.g. surveys, interviews. questionnaires • Waiver of consent : e.g. when undertaking a retrospective review of medical records (see section 7.2 to provide rationale for waiver of consent) e) section 7 “data, privacy, storage and confidentiality” It is essential to ensure that the privacy of persons participating in research projects is protected. Page 3 of 8 ! 7.1 Tick YES to “state department or agencies” if you use medical notes, SEALS database, radiology reports etc… ! 7.2 Please complete if you are asking for a waiver of consent to use personal information 7.3 Storage of data See examples below Page 4 of 8 f) Section 9 “Declaration by head of department” • • All projects must be signed of by the head of department – inked signature ONLY (after form has been locked and printed). A study investigator CANNOT sign off as Head of department A study investigator cannot sign off as Head of Department – inked signature must be sought from someone more senior – after form has been locked and printed Page 5 of 8 4. Authorisation Our HREC accepts electronic authorisation. Electronic authorisation is available as an alternative to ink signatures for investigators only. The user must have a valid Online Forms username and password, as this is used to authenticate the electronic authorisation. If you use the electronic authorisation option, the authorisation must take place BEFORE the form is locked and submitted For more information on electronic authorisation, refer to page 18 of the manual (4.4 authorisation tab) https://ethicsform.org/Au/Help/AU%20Online%20Forms%20for%20Research%20User%20Manual% 20v1.3.pdf 5. Submission tab Select generate submission code, a message appears, click OK. A submission code will be generated and the form will be ‘locked’ so no further changes can be made. Page 6 of 8 6. Generate a PDF by clicking the text ‘Generate PDF’. Make sure you select ‘PDF without text changes’ and save the file to your computer so it can be emailed. Page 7 of 8 7. Submission to the RSO process ! The online forms submission is an independent process. We don’t have any record of your submission online. For your application to be reviewed by the Executive committee, you have to submit it to the RSO • Please send one electronic copy of LNR in pdf format to RSOSESLHD@sesiahs.health.nsw.gov.au with: 1. a covering letter; and 2. documentation for review by the HREC, for example: o _ Protocol; o _ Curriculum vitae of the Co-ordinating Investigator and Principal Investigators; o _ Signed declaration & undertaking by the Data Custodian and Co-ordinatingInvestigator (if seeking access to a NSW Health owned or managed statewide data collection); o _ Participant Information Sheet and Consent Form; o _ Questionnaires/surveys; o _ Data collection forms; and o _ Recruitment materials (e.g. advertisements, letter to potential participants or others such as doctors) • A hard copy of LNR with original signatures is no longer required. We now accept scanned or faxed signatures. Page 8 of 8