User Manual - National Health and Medical Research Council
Contents
1. does not consider proposals for research involving humans the HREC is not required to complete the full annual report form Please complete Section 1 HREC composition and Section 21 Declaration then submit to NHMRC e If any of your HREC details have changed you will need to submit a Notification of Change of Details form found at http www nhmrc gov au health_ethics hrecs forms htm c e Sections 1 4 contain questions about meeting the requirements of the National Statement e Sections 5 9 contain questions relating to HREC compliance with the requirements of the Guidelines under Section 95 of the Privacy Act 1988 s95 Guidelines which relate to the privacy of information held by Commonwealth agencies The s95 Guidelines provide a framework for medical research to proceed using personal information held by Commonwealth agencies without obtaining consent The s95 Guidelines provide a process to resolve any conflict that may arise between the public interest in privacy and the public interest in medical research where this would otherwise involve a breach of privacy under the Privacy Act 1988 e Sections 10 14 contain questions relating to HREC compliance with the requirements of the Guidelines approved under Section 95A of the Privacy Act 1988 s95A Guidelines which relate to privacy information held by private sector organisations The s95A Guidelines establish a process for undertaking research statistical or health service manageme2. the word and add it to the dictionary so it won t repeatedly show as incorrect You can also check spelling by selecting the Edit then Check Spelling button This function will then go through the entire document checking for spelling mistakes To turn the spelling function off follow these steps 1 Select Edit from the Adobe main menu then preferences The preferences menu box will appear 2 In the Categories menu on the left hand side of the menu select spelling and 3 Un tick the check spelling while typing box Spelling Check spelling while typing Underline color O 15 Entering Dates Please enter the date in the format D M Y YYY for example 11 5 2011 Alternatively you can click on the arrow to the right hand side of the box to bring up a calendar You can scroll with arrow keys from month to month Click on the date to be added and it will automatically update in the correct format Date May 2010 Mon Tue Wed Thu 26 FF 28 3 3o 4 5 10 41 12 18 17 19 24 25 26 31 1 2 C Today 11 05 2010 IRF 16 Help with the HREC Annual Report Form If you have any general queries about reporting for the 2011 period please contact the NHMRC Program Assurance and Research Integrity Section by telephoning 1800 223 391 or 02 6217 9050 or by email at PA info nhmrc gov au 17 Printing the Report Form 11 of 12 To print a report select the Print all sections button on the top left hand co
3. 12 Annual Report form This includes assistance with completing the electronic form and lodging the report form with the NHMRC Program Assurance and Research Integrity team Help desk contact information Phone 1800 223 391 or 02 6217 9050 Email PA info nhmrc gov au 12 of 12
4. 9 13 Opening an existing Report FOr ccccceeeceee nce eneeeneeeeeeeeneeeneeenaeeeeeeeeeeeneeeneennes 10 Ceo of GDECKIN O A en an ee ee ee eee 10 15 Entenng DalOS sce iceciccs xe cocina euniseteesecaerseubodavesseeunbscnscasdeensacedemeuniues veucussivnscmnovadcieess 10 16 Help with the HREC Annual report form cccceeceeeeeeeeeeeceeneeeeeneeeeneeeeeeeenasennes 11 17 Punung the Report FOUN iis cescstsews scenes sowed cessasinmnnswedeesecaccesasinevined EREET 11 18 Submitting the Report Form to the NHMRC ccccceeeceee seen neeeneeeneeeeeeeeneeeneeees 11 19 Help Desk INTOFMAUON ve scccvennccctceccsentedeesessetavarctcnssenenntddvncseienetciseesesdectccentsetaseneontxs 12 2 of 12 1 Introduction The purpose of this document is to provide applicants with advice and instructions on how to use the NHMRC s HREC Annual Report Form efficiently This form is to be used to report on HREC activity for the 2012 period only 2 System Requirements In order to fill out the NHMRC s HREC Annual Report Form users are required to have version 8 1 1 or above of Adobe Reader Free downloads can be found at the Adobe website http www adobe com products acrobat readstep2_allversions html Note NHMRC s HREC Annual Report Form has been tested in the following versions of Adobe Reader e 8 1 3 e 92 0 e 9 4 7 e 10 1 3 23 Reader X e 11 0 01 Reader XI NB You may need administrator access to y
5. Australian Government National Health and Medical Research Council Aal al dax E 2012 ANNUAL REPORT FORM FOR INSTITUTIONS WITH A HUMAN RESEARCH ETHICS COMMITTEE HREC Report Period 1 January 2012 31 December 2012 User Manual Prepared by the National Health and Medical Research Council February 2013 Contents 1 BETO GUC HON sass r EAEE EEE E E EA 33 2 System PRO CUIFCIMONNS seirinin a EE 33 3 Use and Disclosure of INfOrmMatiONn 2c ccceeceeeeee en eeeeeeennneeeeeenneeeeenaaeeseesnaeeeeeeaaeeasens 3 4 Organisation Of this TROD ON ioe oie eccrine renee uraeeeuanemeumcnuesm EA 4 5 Getting Started how to start the report fOrm ccceee cece ee eeeeee ence eneeeneeeneeenneeeneeenes 5 6 Entering data and navigating Of the fOrm cccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneeeeneeeeneeeeneeneaees 5 PDG ENY DS racecars pacman nace saree clos nic screnoem E 7 8 Auto Complete Function aannnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn 7 9 Mandatory USSU OINS coca ara ees ctes esecce teers orene anemone ncevet moe sanecs nee sseoneueneinemeeusansaneets 8 10 Saving the HREC Annual Report Form cccccceeeeeeeeeeneeeeeeeeneeeeaeeeeeeeneeenessennnenes 9 TD CLOSING a PRC DOl COM Direc cccretctnoe gant cree ceiseemrenwee veces cantce E E 9 12 DEIGUNG Repon FON MN oiccsccsancenscceranaaunsscencesestcensesnssemneteciscsees acsesnceconneumascsmconncecces
6. en a blank form using Adobe Reader if the form is not blank continuing with these steps will erase the data currently in the form 6 Select the Import data button on the top of the form and locate and select the XML data file that you wish to use 7 This will import the data into the form overwriting any existing data in the form and 8 You will now be able to continue working on the form and exporting as necessary to save the data 11 Closing a Report Form To close your document select File from the main Adobe Reader menu bar select Close from the drop down list or click the window s close box x at the top right hand corner of the form Make sure you save your document before closing the form 12 Deleting a Report Form To delete a document 1 Go to the location you saved your form 2 Locate your document and follow the normal file delete methods you use to delete files 13 Opening an existing Report Form To open an existing document 1 Open Adobe Reader 2 Select File then Open from the menu bar Find location of the HREC form you wish to open Highlight item and click Ok 14 Spell Checking The HREC Report form will underline in red anything it considers to be a spelling mistake You can right click on a misspelt word and a window showing alternative spellings or words is shown From there you can 10 of 12 make an alternative selection If the word is actually spelt correctly you can right click on
7. eral section of the form that you would like to complete The next drop down list titled question is to select the specific question within the section that you would like to navigate to Navigating through the form Once you are within the question pages there are several ways you can navigate through the Report Form 6 of 12 1 Use the previous next question buttons At the end of each question there are two buttons one to take you to the next question and the other to take you to the previous question Next Question 2 Use the drop down menus Choose the question you wish to complete by selecting the section drop down menu in the top left hand corner of the form and then the specific question you would like to navigate to Section 2 Human Research Proposals Question 3 Use the next mandatory question button The easiest way to navigate to the next question is to press the show next mandatory question button This will take you through the form in order to ensure you complete each mandatory question 2009 Annual Report Form for Institutions with a Human Research Ethics Committee HREC Print All Sections Export Data Import Data Submit To NHMRC Show Next Mandatory Question el 7 Data Entry Tips Please ensure you save your document frequently to avoid loss of data should the screen freeze or an unexpected shutdown occurs 7 of 12 8 Auto Complete Function This function is b
8. esearch proposals were considered Do you want to go to the question Once you have completed that question you will need to click again on the Show Next Mandatory Question button to check if all questions have been answered You will need to continue this process until the message all mandatory data for the HREC has been entered appears 10 Saving the HREC Annual Report Form Saving the whole document Once you have started an application it is recommended that you save the application straight away Click on File then Save As located in the top left hand side of the menu bar in Adobe Reader IMPORTANT Save your document frequently to avoid data loss You can use the save as function to save the form in a suitable format to email to colleagues for example the Head of Organisation or HREC Chair Saving data only export and import buttons 9 of 12 If you are low on memory or your computer is sluggish save your document as XML data by following these steps 1 Select the export data button on the top of the form Export Data 2 Select the location where you would like to save the data and save the data as the HREC code followed by a version number to eliminate confusion 3 Every time you wish to save your data follow steps 1 and 2 4 If you choose to save the data using the export data button and you exit the form please follow these steps to continue working on your form 5 Op
9. est turned off to complete this form To turn off Auto Complete select Edit from Adobe Reader menu bar then select Preferences The Preferences window will appear In the left hand Categories column select Forms You will then see the Auto Complete function towards the bottom of the window Click the arrow on the drop down box Select Off and then click Ok in the preference window to save your preference 9 Mandatory Questions To ensure you have not missed completing any mandatory questions click on the Show Next Mandatory Question button on the top of the HREC Annual Report Form This is the recommended method to complete the form to ensure you don t miss any mandatory questions A window will appear and if you have completed all mandatory questions the message will read All mandatory data for the HREC has been entered 8 of 12 i All mandatory data for the HREC has been entered Alternatively if not all mandatory questions have been answered the window will tell you which mandatory questions remain unanswered and will navigate you to each unanswered question xxNOTE All mandatory questions require a response You may need to put a zero 0 answer for some numerical questions Warning JavaScript Window Data Missing Section 2 Human Research Proposals Question 2 1 ry You need to indicate whether there was at least one member from each core membership category present at all meetings where r
10. nt activities using health information held by a private sector organisation It is a condition of using the s95A Guidelines that it must be necessary to use identifying information and that it is impracticable to seek consent from the individual to whom the information relates e Sections 15 19 contain questions about the operations of the HREC during the reporting period These questions do not relate to meeting the requirements of the National Statement or compliance with other NHMRC guidelines These questions have been included to inform AHEC and the Office of NHMRC about the operations of HRECs and to provide feedback to HRECs about ethical review of research in Australia 4 of 12 e Section 20 provides free text space for any additional comments that could not fit into the prescribed text boxes throughout the form e Section 21 contains the Statutory Declarations to be completed by the HREC Chair and the Head of Organisation with primary responsibility for the HREC 5 Getting Started how to start an application Once you have the required Adobe Reader application the next step is to download the HREC Annual Report Form from our website at http www nhmrc gov au health_ethics hrecs report htm To start the HREC Annual Report Form Once you have the required software you can then open and start to complete the form To open the form 1 Open the Adobe Reader application 2 Select File then open to open a new file 3 Go
11. our computer for downloading software If you do not have administrator access you may need to contact your IT department for assistance For more information For more information about System requirements see http www adobe com products acrobat acrrsystemreqs html 80win 3 Use and Disclosure of Information The information provided by institutions and their HRECs through their Annual Reports is used and disclosed by NHMRC in a number of ways namely to update the operational profile and status of each HREC assist in the development of policy and initiatives to support HRECs and research institutions report to AHEC a principal committee of NHMRC s 35 NHMRC Act 1992 report to the Federal Privacy Commissioner on the use of information which may be subject to the requirements of the Privacy Act 1988 and related Guidelines and e monitor compliance with the National Statement on Ethical Conduct in Human Research 2007 the National Statement 3 of 12 Accuracy of Information e The information provided in this Annual report must be certified as true and accurate by the Chair of the HREC and the Head of the Organisation with primary responsibility for the HREC 4 Organisation of this Report e The set up page of the HREC Annual report form asks you to enter your HREC Code ECOO In addition it asks if your HREC considers proposals for research involving humans If your ethics committee is a non research committee 1 e it
12. rner of the form This button will compact the questions so they print next to each other rather than on single pages You will be able to modify your print settings i e landscape or portrait duplex options and number of copies etc once you have selected the button 18 Submitting the Report Form to the NHMRC To submit the form to the NHMRC ensure you have filled out the Mandatory Questions Once all data has been filled in select the Submit to NHMRC button located on top of the form Submit To NHMRC Pressing this button will check that all mandatory fields have been entered and will package the information in the form into a data file This button will then open your email client e g MS Outlook or Lotus Notes and will attach the file to a blank email ready for you to submit to HREC reports nhmrc gov au If you do not use a standard email client 1 e if you use Gmail Yahoo etc firstly please use the submit to NHMRC button to check all mandatory data has been filled then use the export data button to export the data to a location of your choice You can then attach the exported data file and send it to HREC reports nhmrc gov au Please use this email for sending of reports only any queries please send to PA info nhmrc gov au Export Data 19 Help Desk information The Program Assurance and Research Integrity team will be the first point of contact for all respondents requiring assistance with the NHMRC 20
13. to location where you saved the HREC Annual report form from the NHMRC website Select the form by clicking on it and then hit the open button and 6 Entering data and navigation of form To start entering data complete the HREC code on the front page and answer the question Does your ethics committee consider proposals for research involving humans If the answer is yes then press the start entering data button and begin to complete the form If the answer is no and your committee does not consider proposals for research involving humans the HREC is not required to demonstrate that it meets the requirements of the National Statement Please complete Section HREC constitution and submit this with the declaration at Section 21 5 of 12 2012 Amsal Report Form for lustitubous with a Human Research Ethics Coumuttee HREC HREC Code BOOOL00 fies Australian Government National Health and Medical Research Council 2012 ANNUAL REPORT FORM FOR INSTITUTIONS WITH A HUMAN RESEARCH ETHICS COMMITTEE HREC REPORTING PERIOD 1 JANUARY 2012 31 DECEMBER 2012 SUBMISSION DATE 20 APRIL 2013 HREC Code EC00100 ACT Health Human Research Ethics Committee Dunng the reporting penod did your ethics commuttee consider any proposals seeking cucal approval for research involving humans Yes Nof On the next screen there are two drop down menus The top drop down menu titled section is to select the gen
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