Faculty of Health, Medicine, Nursing and Behavioural Sciences
Deakin University
Human Ethics Advisory Group - Health Medicine Nursing and Behavioural Sciences: Frequently Asked Questions
NEAF Question 5.5.1.1.8 asks me to provide the name and/or position of the contact person for any concerns in relation to the conduct of the research/ complaints process. Whose details should I include?
My project involves recruiting participants from an organization. How do I go about making contact with that organization to obtain their consent?
Participants from my study will be children/youth recruited from Catholic schools in my area. Does the Catholic Education office have any specific requirements for studies involving school children?
1. The Plain Language Statement (PLS) requires that I include the EC number in the complaints clause. What is this number and where do I get it from?
The EC number is the reference number that is assigned to “higher than low risk projects” that are submitted to DU-HREC for review. These numbers include the letters EC followed by the number of the submission, a hyphen and then the year in which the submission was made (eg: EC 52-2008 would refer to the 52nd project submitted to DU-HREC in the year 2008).
In the case of low risk projects that are reviewed by the HEAG-H, the HEAG-H reference number should be listed instead. This will be in the form of HEAG-H, followed by the number of the submission, a hyphen and then the year in which the submission was made” (eg: HEAG-H 3-08 would refer to the third project submitted to the HEAG-H in 2008).
Please note: all Ethics Committees are also assigned a reference number which also begins with “EC”. DU-HRECs reference number is EC00213 and this will appear automatically in the NEAF when you indicate that Deakin University’s HREC will be responsible for the review of your project. This is not the reference you should include in the PLS. This number does not relate to your project.
2. Several questions in NEAF ask if the data I’m collecting is identified, potentially identifiable or non-identifiable. How do I tell the difference?
Non-identifiable data: is that data which is completely anonymous. For example, a questionnaire returned by mail with no identifiers included (eg: name, address, date of birth etc), or a data set obtained from a third party which has been coded, where the data is supplied without the key to the code or any other information that could allow the data to be re-identified.
Potentially identifiable data: is data that has been coded and is stored separately from both the key to the code and any remaining identified data (eg: signed consent forms). This is data which can be re-identified using the key to the code.
Where data will be in the form of human tissue samples, this data is potentially identifiable data or re-identifiable data (due the advances in genetic knowledge, data linkage and the proliferation of tissue banks of identifiable material). (See NHMRC National Statement on Ethical Conduct in Human Research Chapter 3.2, p.29).
Identified data: is data that is stored with identifiers in place. It may include written data that includes participants’ name, address or other identifying information. Where the population(s) from which participants are recruited is/are particularly small, it may be that certain comments made by participants could allow them to be identified even where they are not specifically named or identified in other ways. Researchers should consider the likelihood of this occurring when reporting the results of their study and show respect for the confidentiality of participants. Where data will be either audio or video recorded, this data is identifiable data. The participants can be identified from either their image or the sound of their voice.
3. I want to code my data so that I can store it as ‘potentially identifiable’ data. What is the best method to use?
There are many different ways in which data can be coded. In order to select the best method of coding the data for a given project the researcher must first determine whether the code is something that potential participants need to know and remember/help to create, or whether the code will be used purely for their own reference.
Where a researcher is conducting a longitudinal study, they may wish to use a code devised by the participants to link anonymous data provided at different time periods. In this case the participant creates their own code according to predetermined criteria set by the researcher. (For example “the initials of your mother’s maiden name and the four digits of her birth date”). This code can then be recorded by participants when returning their responses at each stage of the project to allow for the analysis of linked data.
Where the data to be collected is not anonymous, (for example, data collected in an interview or focus group discussion) participants may be asked to select a code (pseudonym) that will not identify them but that they will remember (for example this may be any word that has specific meaning to that participant). This code can then be used by researchers to identify which participant made various comments when they transcribe the audio/video recorded discussion and allow participants to identify their own data in transcripts provided to them for approval prior to data analysis. This code may also be used in publications where direct quotes from participants will be included.
In situations where the code is only for the reference of the researcher and is to be used solely for the purpose of protecting participant confidentiality, the researcher would ordinarily select a numeric code or other non-decipherable code. The key to this code may be stored electronically in a password protected document or in hard copy in a locked filing cabinet (coded data should be stored in a separate locked filing cabinet where the code is stored in hard copy).
4. NEAF (Version 1) Question 1.4.1 requires me to tick one of the boxes even if it’s not applicable and doing so requires the completion of unnecessary sections.
The previous version of NEAF (available for editing existing applications till 31 Dec 2008) does not provide a box indicating that none of the options apply and requires that at least one box be ticked to complete the question. The new version of NEAF (NEAF 2) released mid 2008 has corrected this error and a “none apply” box is included.
When using NEAF 1, choosing one of the boxes under “design specifically excludes” will minimize unnecessary sections which appear as a result.
It is usual in most projects that at least one group listed here would be excluded as part of the normal study design.
OR In instances where this is not the case, researchers may choose to answer any additional questions which arise as a consequence of having been required to tick a box erroneously by indicating “this question is irrelevant to the project and arose as a consequence of an error in question 1.4.1 of the NEAF”.
Where this is the case, researchers should take care to ensure that questions answered in this way did in fact arise as a consequence of this particular error. Where questions which do not arise as a consequence of this error are answered in this way, reviewers will require that these questions be appropriately addressed before ethics approval can be granted.
5. I am a student completing the NEAF and am not sure who to list as the applicant, the principal researcher and the associate researchers in section 2.
In a student project the student may be listed as both the applicant and an associate researcher but the supervisor ultimately takes responsibility for the project so they must be the principal researcher (event though someone else may carry out the bulk of the research). NEAF 2 also includes the option of listing chief researchers. This addition reflects the management structure of many large multi-centre projects where a single researcher may be assigned to oversee all of the different sites involved. Where this structure is absent researchers are advised to answer section 2.1.0 “How many chief researchers/investigators are there?” as 0.
Please note: chief investigators cannot be listed as being responsible for any particular site as it is assumed they are responsible for all sites involved in the project. (See NEAF V.2 section 4.1.1.1.1.2.1.1)
6. I am a member of staff and am working jointly on a project with another Deakin employee. In Section 2 of the NEAF who should be listed as the principal researcher?
The principal researcher is responsible for the project. Ordinarily there is only one principal researcher, however, in situations where it is unclear who has this responsibility and researchers are reluctant to nominate of the researchers to take this role, the NEAF does allow for more than one principal researcher to be listed. This should be the exception rather than the rule. A student must not be listed as the principle researcher.
7 Questions 3.7 and 3.9 of the NEAF V.1 (available for editing existing applications till 31 Dec 2008) and Section 8.3 of NEAF V.2 discuss the storage and disposal of information. How long am I required to store the data I collect as part of my research?
Deakin University policy requires that data be retained for minimum of six years from the date of publication, but for specific types of research, such as clinical research, 15 years may be more appropriate.
8. Question 3.7.7 of the NEAF V.1 (available for editing existing applications till 31 Dec 2008) and Question 8.3.7 of NEAF V.2, discuss the arrangements made regarding the storage of data collected for, used in or generated by this project in the event that the principal researcher ceases to be engaged at the current organization. What would be an appropriate arrangement?
All data should be stored at Deakin University and be maintained by the Principal Researcher or one of the associate researchers. In the event that the nominated researcher ceases to be engaged at Deakin University, data storage should be transferred to one of the other researchers initially involved with the project. Where all members of the researcher team cease to be engaged at Deakin University, the storage of this data becomes the responsibility of the head of school.
9. NEAF V.1 (available for editing existing applications till 31 Dec 2008) Question 3.8 and NEAF V.2 Question 8.4.2 asks about ownership of information collected for the research project and information resulting from the research. Who owns this information?
In such cases, it is the University’s responsibility to ensure that the student has assigned their IP to Deakin or the external funding body. In the absence of such an agreement, research outcomes remain the IP of the student.
Hence, where a both a staff member(s) and student(s) are involved in a research project (as in the case of a staff member acting as the supervisor of the student(s)), the research outcomes remain the joint IP of both the university and the student(s).
Thus, when completing Section 3.8 of the NEAF (V.1) or Section 8.4.2 of NEAF (V.2) which refers to ownership, please insert the following:
(V.1) 3.8.1 Who owns the information collected for the research project?
Deakin University(V.1) 3.8.2 or (V.2) 8.4.2 Who is understood to own the information resulting from the research, eg. the final report or published form of the results?
Deakin University
(V.1) 3.8.1 Who owns the information collected for the research project?
Deakin University and [insert the student’s name](V.1) 3.8.2 or (V.2) 8.4.2 Who is understood to own the information resulting from the research, eg. the final report or published form of the results?
Deakin University and [insert the student’s name]
(V.1) 3.8.1 Who owns the information collected for the research project?
As per the contractual agreement.(V.1) 3.8.2 or (V.2) 8.4.2 Who is understood to own the information resulting from the research, eg. the final report or published form of the results?
As per the contractual agreement.
10 NEAF (V.2) Question 5.4.2 asks me to "Please detail your DSMB and its nominee for this trial".What is a DSMB and is this relevant to my project?
A DSMB is a Data & Safety Monitoring Board. Large multi-centre clinical trials employ the use of DSMBs which have “a mechanism for informing the Human Research Ethics Committee of any relevant emerging data from the DSMB” (National Statement, 2007, 3.3.20c). Other projects do not require the use of DSMBs but must have appropriate monitoring mechanisms in place (See National Statement Chapter 5.5 for monitoring requirements).
11. NEAF Question 5.5.1.1.8 asks me to provide the name and/or position of the contact person for any concerns in relation to the conduct of the research/ complaints process. Whose details should I include?
For all low risk applications to be submitted to the Faculty HEAG-H please insert:
Secretary HEAG-H
Dean's Office
Faculty of Health, Medicine, Nursing and Behavioural Sciences
Level 3, Building J
221 Burwood Hwy
Burwood VIC 3125
Enquiries should be directed to:
Telephone: (03) 9251 7174
Email hbs.research@deakin.edu.au.
This information should additionally be inserted into the relevant complaints clause of the plain language statement.
12. My project involves recruiting participants from an organization. How do I go about making contact with that organization to obtain their consent?
It is ethically permissible for researchers to contact an organization informally (prior to ethics approval being granted) and after informing an appropriately authorized individual about the project, ask for an expression of interest as to whether they would be willing to have members of their organization recruited and/or the study conducted at their premises. Should they agree in principle to this involvement, the researcher may at this time request a letter from the organization (on letter head) expressing their interest in being formally approached, which letter may later be included in the ethics application. Alternatively, researchers may simply include an organizational Plain Language Statement (PLS) and Consent form in their application, which may then be forwarded to the organization after ethics approval has been granted.
13. Participants from my study will be children/youth recruited from public schools in my area. Are there any specific Department of Education requirements for studies involving school children?
The Department of Education has specific requirements for projects that are conducted within public schools in Victoria. These requirements are stated in a document titled “Application procedures for research in Victorian government schools”, the link for which can be found on the web site below:
http://www.education.vic.gov.au/studentlearning/research/conductresearch.htm
In brief, this document outlines the need for researchers to:
Ms Chris Warne
Project Officer (Research)
Education Policy and Research Division
Department of Education and Early Childhood Development
Level 2, 33 St Andrews Place
GPO Box 4367 Melbourne 3001
The document titled “Application procedures for research in Victorian government schools” noted above also provides valuable information regarding the types of projects most likely to be approved/rejected and other important information researchers should make themselves aware of.
14. Participants for my study will be recruited from early childhood services in my area (maternal and child health, childcare centers and kindergartens). Are there any government requirements for the recruitment of children from these services?
The Department of Education and Early Childhood Development (DEECD) requires that any research “that relates to, or involves, early childhood clients (children, young people and their families), staff, information or services provided by, or funded by, DEECD, must be submitted to the ECRC [Early Childhood Research Committee] for approval”(DEECD web site “Making an application:, http://www.education.vic.gov.au/ocecd/statewide-outcomes/monitoring/making-an-application.html)
An application form can be found on the DEECD web site (see link above) and can be submitted either via email or in hard copy (see contact details below) according to the published deadlines (http://www.education.vic.gov.au/ocecd/statewide-outcomes/monitoring/meeting_and_submission_dates.html).
The ECRC performs a review based on the relevance of the project to early childhood and the proposed methodology. It does not conduct an ethics review of the project. Researchers are therefore required to submit an ethics application to either the Faculty Human Ethics Advisory Group (HEAG-H) (if they believe their project meets the criteria for low risk), or to the Deakin University-Human Research Ethics Committee (DU-HREC) (if they believe their project is higher than low risk).
Applications to the ECRC can be made prior to ethics approval being granted but it is a condition of ECRC approval that ethics approval be obtained prior to the commencing the research.
Once approval has been granted by the ECRC, researchers are required to obtain approval from each the services from which participants are to be recruited.
Researchers are permitted to commence their project only after approval has been granted from the HREC/HEAG, the ECRC and the services involved in the project.
Researchers are additionally required by DEECD to:
For more information, please refer to the ECRC web site (see link above) or contact:
Early Childhood Research Committee
Statewide Outcomes for Children Division
Department of Education and Early Childhood Development
Level 1, 2 Treasury Place
EAST MELBOURNE VIC 3002
Enquiries:
Tel: (61 3) 9947 1849
Fax: (61 3) 9637 3913
Email:gabriel.stacey.s@edumail.vic.gov.au
15. Participants for my study will be recruited from both public schools and early childhood services (maternal and child health, childcare centers and kindergartens) in my area.Am I required to submit two applications to EECD in order to recruit from both schools and early childhood services? (see Questions 12 & 13)
Researchers should only submit one application to DEECD per project. In the event that participants will be recruited both from public schools and early childhood services, an application should be made based on the requirements for recruitment in public schools (see question 12).
16. Participants from my study will be children/youth recruited from Catholic schools in my area. Does the Catholic Education office have any specific requirements for studies involving school children?
The Catholic Education Office of Melbourne (CEOM) have specific guidelines which apply to researchers wanting to recruit students from their schools and/or conduct research on school grounds.
Generally, only research where study findings are likely to improve student outcomes or increase school effectiveness are approved. In the absence of such potential, research may be approved in Catholic Schools where researchers can show that findings may directly benefit study participants.
There are a number of steps involved. Initially, researchers should submit an ethics application to the University Human Research Ethics Committee (HREC), after which they can submit an application to the CEOM for consideration. (Please note applications may be submitted to the CEOM before final approval is obtained from DU-HREC but this notification of approval must be forwarded to CEOM before schools can be approached). After approval has been granted by the CEOM, researchers can then approach schools and request their participation.
When submitting an application to the CEOM researchers will need to complete:
To access additional information on the types of research that can be approved at Catholic schools, please see appendix 1 on the web site listed below.
Applications can be submitted to:
Director of Catholic Education
Attention: Knowledge Management Unit (PG9)
Catholic Education Office
PO Box 3
EAST MELBOURNE VIC 8002
Or email: km@ceo.melb.catholic.edu.au
Or fax: 03) 9415 9325, Attention Knowledge Management Unit (PG9)
Once the CEOM has provided researchers with approval they can then contact the school(s) in question. When doing so, they should provide the principal with:
To access further information please see the following web site, select policies from the menu and then policy 2.8 “Researchers in Catholic Schools and Access to Data on Catholic Schools” http://www.ceo.melb.catholic.edu.au/
17. My project design includes limited disclosure (not fully disclosing the aims or methods of research to research participants). How can I best respect their autonomy and ensure that they are able to give informed consent?
While some projects require that participants are subject to limited disclosure as part of the project design, the following suggestion enhances researchers’ ability to protect the autonomy of the participant and maximize their ability to give informed consent.
According to the NHMRC National Statement on Ethical Conduct in Human Research (NS), researchers should, “whenever possible and appropriate, after the participation has ended, provide …information about the aims of the research and an explanation of why the omission or alteration was necessary” (NS 2.3.1.e.i., p.23).
Where possible, when informing participants of the aims of the research (by providing them with a Plain Language Statement (PLS) including the previously omitted information), researchers are encouraged to include a new consent form which invites participants to include their data in the final data set. Where participants choose not to sign this additional consent form, their data should be destroyed and should not be used in the project.
Where appropriate, once researchers have had the opportunity to explain the study (including giving an explanation of why the omission or alteration was necessary) participants should be provided with option to take the PLS away and decide in their own time whether to return the signed consent form.
18. I’ve been told that if my project involves active deception of participants it’s ineligible for expedited review but I’m not sure whether my project involves active deception or just limited disclosure. How can I tell the difference?
According to the NHMRC National Statement on Ethical Conduct in Human Research (NS) (2007), limited disclosure is defined as “not disclosing to research participants all of the aims and/or methods of the research”, while active deception is defined as “where relevant material is withheld from research participants, and/or they are intentionally misled about procedures and/or purposes of research”.
While projects involving limited disclosure may be eligible for expedited review, those involving the active deception of participants are ineligible and must be reviewed by DU-HREC (NS. 2.3.4a, p. 24).
To determine which of the two your project involves, consider the following:
Hence, when designing a project, researchers are encouraged to consider ways in which they can avoid the need to practice the planned deception of participants. This can be done through both the avoidance of making specific, untrue statements and ensuring that the stated aims are broad enough to encompass both what it is desirable for participants to know initially, as well as those facts which will only later be disclosed after the participant’s involvement has ended. Researchers should only omit facts, the disclosure of which would otherwise prevent the aims of the research from being achieved.
19. As part of my research project I intend to use a questionnaire developed as a diagnostic tool. As my questionnaire will be anonymous I am unable to notify participants should their results indicate they may suffer from this condition. What should I do?
According to the NHMRC National Statement on Ethical Conduct in Human Research (NS), where “re-identifiable data reveals information that bears on the well being of participants, researchers have an obligation to consider how to make that information available…[and] where individual notification is warranted, …[researchers] need to take all reasonable steps to re-identify those data” (NS 3.2.6).
Hence, while in the case of re-identifiable data all reasonable steps should be taken, an anonymous questionnaire is non-identifiable data and cannot be re-identified. Hence, researchers cannot therefore have a responsibility to notify any potential participants of results that may affect their well being.
20. My study will only involve accessing publicly available data (for example: review of previously published peer review journals; statistics or other data published online, in freely available reports or in books; manuscripts or other archival materials that are available to the general public), do I need to obtain ethics approval prior to commencing my research?
Where the only data to be analysed for a research project is publicly available data ethics approval is not required. However, where data may be individually identifiable or otherwise sensitive in nature, researchers should consider the possible impact of their study on the individuals/communities examined in the research and if necessary seek advice from the HEAG-H or DU-HREC.
21. My study involves the analysis of a non-identifiable data set (for example: data purchased from another institution, data obtained from an external research group or from another Deakin researcher where all identifiers have been removed) do I need to complete a full ethics application?
Currently, Deakin University is trialing the ethics exemption of negligible risk research projects where the project “involves the use of existing collections of data or records that contain only non-identifiable data about human beings (NS 5.1.2.2b, p.79).
Negligible risk research is defined as research “…where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk” (NS 2.1.7, p.18).
If a researcher believes that their project meets the criteria for negligible risk research, they should: contact the main ethics office for further information:
Human Ethics Office
Research Services Division
Deakin University
221 Burwood Hwy
Burwood Vic 3125
Research-ethics@deakin.edu.au
Sally Fornaro 03 9224 6090
Vicky Bates 03 9241 7052
