About La Trobe University
The La Trobe University is situated in Victoria, Melbourne, Australia. It has a centrally operated unit known as the University Human Ethics Committee (UHEC) which is established as per the requirements framed by the National Statement (Rocchi, 2013). The members consist of minimum one person from the below mentioned categories: an experienced chairperson, a doctor, a minister of religion, a legal representative, at least two community representatives and minimum two members with the knowledge of current research (Tsang, 2015). Besides these, there happen to be five Faculty Human Ethics Committees (FHECs). They are basically the committees under the UHEC. The FHECs monitor their respective issues unless they are to be submitted to the parent body UHEC. The FHEC includes members from every discipline from the ethics reviews cases might arise (Gasper, 2013).
The ethical background
Every interaction by human beings, even those interactions which are parts of human research process consists of ethical aspects. But the ethical conduct is not just doing the correct thing. It encompasses many aspects of our life like acting in the right spirit (Arkin et al. 2015). It also includes concerning attitude for the fellow persons. Ethics is also about showing the due respect to the people around us. The National Statement on the ethical conduct in human research deals with something which in not just the ethical rights and wrongs. It is more fundamental in nature. The persons engaged in human research should be influenced by the ethical guidelines in every human research work they conduct. Human research covers a broad concept. Primarily it means to conduct research with or for the people. It may also include a research work on their data and tissue. (Sugarman, 2012). It is done with a view to doing well for the human race in general. However, in the past we come across certain examples where human research has failed to conduct its works ethically and it violated the basic norms of ethical human research. As for example, during the Second World War, a few experiments were carried on in the concentration and detention camps. After the Second World War, the scenario began to change slowly. The judgment made at the famous Nuremberg military tribunal suggested ten views about the experiments which are medical in nature that were to be made permissible. This came to be known as the Nuremberg Code (Manroop, 2015). Keeping these guidelines in mind the World Medical Assembly was formed in 1964. It adopted what is today known as the Helsinki Declaration.
Values and principles of ethical conduct
Humanitarian research is conducted on a ground where a relationship exists between the researchers and the research participants. There are certain criteria which seek to maintain a healthy relationship between the researchers and the participants. There are certain values and principles which need to be kept in mind while conducting such research works (Wassenaar et al. 2015). These are:
a) A sense of respect for human participants
b) Merit and integrity of the research
c) The prevailing justice concept
d) The concept of Beneficence
All of these seek to build mutual trust, responsibility and equality of ethics. That is why the National Statement refers to the people as participants and not subjects (Sparrow, 2013). These values are of very old origin. However they are not the only ones. The others comprise of altruism, contribution to goals of society and community and respecting the diversity of culture. These values are described in details in the text Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (NHMRC 2003). The above values have however become important with respect to ethical human research for the last sixty years. They help us to provide a vital framework for the designing, monitoring and proper conducting of the ethical research works. The primary value out of all of these is that of respect (DeWitte, 2015). It shows that every human being has his own set of values and these values shall be used during every interaction with other people. The order in which they are considered shows the order in which various ethical issues commonly arise in course of human research. Research merit and integrity are discussed with priority. Unless the proposed research has any merit involved and the researchers who are conducting the research have integrity, one cannot ethically justify the involvement of the human participants (Meneilly et al. 2015). Justice refers to the sameness of the human participants that they share with each other. The main focus of every human research work is to create something beneficial for the mankind which is achieved by fair means without being unfairly distributed and without the involvement of any unfair burdens. The researchers use the beneficence in various manners, while computing and accounting for the risks of malice and the potential benefits of the research works to the participants and to the rest of the community also. They also try to remain sensitive to the well being of the persons involved in the research work (DeWitte, 2015).
The objective of the research work
The La Trobe University wants to conduct a research on the following subject:
The aim is to conduct research work on the population consisting of adolescents and young adult patients with Type 1 Diabetes. It has been observed that in modern times, the attendance of the young adolescents in diabetes clinics have not been up to the mark. In order to receive a good care and lead a better life, the young adults, adolescents and the children with T1D should visit the clinics regularly for proper care and medication (Ethicist, 2015). The main aim is to determine the present attendance scenario in the diabetes clinics for the young adolescents and adults. The intended research work includes the following areas of focus:
Ascertaining the current health care scenario for the Type 1 Diabetes.
To develop and implement an efficient transition program for the adolescents to the young adults Type 1 Diabetes.
To design a program that will increase the attendance of the young and adult Type 1 Diabetes patients in the health care providers.
Population and sample size selection
The population will be selected from that particular age band of 18-30 years with Type 1 Diabetes. For this study, the researcher has selected the simple probability random sampling method. Researcher will use both the online and offline interview process for this particular case study. The participants will be asked several questions relating to the treatment quality and the necessity to transform from pediatric to adult health care in Type 1 Diabetes. The sample size will be 150 people. This is done because it is believed in any research work that what holds true for the sample, can be construed to hold good for the rest of the population also. (Morar, 2014).
Data collection process
The university is going to conduct the research on patients with Type 1 Diabetes, after getting approval from the La Trobe University Ethics Committee (Tirosh, 2013). For data interpretation, the researcher will be using the descriptive method of data analysis and collection. Semi-structured interviews will be conducted in this particular study. The methods of statistical demographic information will be used by the researcher. Field notes will also be used. The researcher will not ask any personal questions which can hurt the patients emotionally. The replication of logic will be maintained by asking similar questions to all the participants.
The questionnaires will be stored in soft copy also within the system of the university, so that the data collection does not go in vain if the hard copies of the questionnaires are destroyed or lost somehow. This is done to ensure that the research work is not hampered at any stage. The data will be stored on systems having high degree of security, which will prevent any kind of data hacking or data storage (Sexton, 2014).
Data analysis technique
The analysis of the collected data will be done using the quantitative data analysis techniques. There will also be highly qualified and trained professionals who will be dealing with such data. The other software like Microsoft Excel will also be used whenever required (Posner, 2013).
Addressing the ethical issues.
The issues of ethical conduct are to be addressed. It should be pointed out by the university clearly to the Ethics Committee that in no way the project is going to harm the participants. The entire process should be scientific and shall involve a moral procedure. If at any moment the committee finds that the research has malicious intentions for the public, then they will not approve the project under any circumstances (Tsang et al. 2015). The researching committee should have very clear and transparent process oriented planning in mind, so that they can satisfy the ethics committee about the viability of such a research work. The committee cannot approve of something which might be a detriment to the society. So, it is of utmost importance that the researchers chalk out a realistic and beneficial project plan which is done with the intention of creating something good for the society (Jones, 2015).
Assessment of study risks and measures of mitigation
The university must be successful in proving to the ethical committee about the human welfare aspect of the project. In such a vast process of research work, it might well happen that an accident might happen during the process of the project. Plenty of risks are associated with any project work (Silaigwana et al. 2015). There should be estimation of the probable risks involved in the process of the research. This aspect cannot be overlooked under any circumstances as this decides the success and failure of a research proposal. It is imperative that the research department which will be conducting the work should understand the importance of making mitigation plans in case of any contingency. As for example, while collecting the blood sample from a particular participant, it may happen that the person’s vein gets ruptured and there is an excess leakage of blood. During such an emergency, the unit should make adequate arrangements with a health care organization, who will tackle such issues immediately and with care and empathy (Hosein, 2015). Unless the ethics committee is absolutely convinced that all the processes will have adequate contingency plans and supportive mitigation measures, it will not give the green signal. It happens many times that a number of research proposals fail to get the nod of the ethics committee since they have failed to follow the basic requirements of following the safety norms for the public and a very well thought out mitigation plan (Culbertson, 2012).
Drafting of data collection tools
In this section, the various tools and techniques involved in the data collection procedure are discussed.
Drafting of the participant information sheet
Participant Information Statement
TYPE 1 DIABETES - TRANSITIONING TO ADULT CARE THROUGH BETTER MANAGEMENT AND CONTROL
Invitation of Participation
The purpose is to attain good success in determining the current status of Type 1 Diabetes in adolescents and young adults. It will also discuss about the importance of transitional care in the health care providers for the Type 1 Diabetes.
Why the study is conducted
The basic purpose of the research work is to ascertain what the young adolescents of age 18-30 years who are suffering from Type 1 Diabetes feel about their quality of treatment. Whether they visit the clinics regularly or not? What is their impression about the transition from pediatric to adult care in Type 1 Diabetes? These questions will help to answer the necessary information which the research team is looking for. The main purpose is to reduce Type 1 Diabetes especially from the young population and what steps need to be taken to promote more use of health care to fight the disease. The real life experience of the patients will help to develop various remedies in this regard.
The reason for your invitation
We have chosen the sample participants from the young age group of 18-30 years. The research is mainly on the young adults and adolescents with Type 1 Diabetes. It is conducted in order to collect information relating to the disease at this young age and what could be the various methods of improvement in the health care system for Type 1 Diabetes.
What is expected of you?
The participant needs to answer the questions put forward by the research team. The interview process will take hardly 15-20 minutes to complete. The participant should voluntarily try to answer all the questions that are being asked to him. He should give fair answers to the questions as the results of his answers will be used to determine the real life situation of Type 1 Diabetes. If the participant wishes not to answer a particular question, he might do so. There is no pressure on him under any circumstances.
What the advantages and disadvantages are?
This research is conducted for the welfare of the society. Today the modern world is getting affected by the Type 1 Diabetes at a very early age. The sedentary lifestyle, lack of physical work, stressful life, food habits are to be blamed for all of these. Through this research we will be able to find out the critical areas of improvement in the transition to adult health care in Type 1 Diabetes. So, the participant is doing something which is good for the society. He is making a significant contribution to the welfare of the society at large. Anyone who is affected with the disease from the age band of 18-30 years can take part. Only, the pregnant ladies who are pregnant, persons with asthma, children under the age of 18 years are restricted from participating in the research. There are no visible disadvantages as such in participating in the survey. There is no chance of any financial or loss in health due to this research.
If at any point of time, you decide to withdraw from the research or not to participate at all, you may do so. There will be no bindings whatsoever on this. You just need to mention that you are not able to continue your participation on purely personal grounds. There will be no fines or penalties charged to you for this.
How will your privacy be protected?
The research team will take the utmost care in order to protect your personal data. Extreme caution will be taken to ensure that your personal information and identity is not disclosed or misused. This will be maintained, except in cases where the disclosure of personal information is mandatory in view of public health and safety. All the interview questionnaires will be preserved in hard copy as well as in soft copy. This data will be used for various reporting and publications. Likewise, the interview transcripts and the written narratives by the participants will also be stored in hard copies and soft copies in order to back up the data in case of any loss or damage. The participant can request for a copy of his or her personal data during the course of the research work. But, he will have to show valid reasons for the request. The copy will reach him within a period of seven working days. The participants can also request for a final review of their interview transcripts before submission of the thesis or the publication of the reports. After publication of the final results of the research, the participants will be provided with the summary of the same. The university has the sole right to preserve the data collected through research with itself, for a period of 5 years. The data might be used for future research work by the university without requesting further permission from the participants. The authorized research personnel of the university will have the sole access to the data for re-use in any research work in future. The data gets removed after five years from the date of collection.
What will happen to the outcome of the research?
The research will reveal all the areas of concern in the field of transition from pediatrics to the adult care in Type 1 Diabetes. It will create more awareness in the society about the ill effects of Type 1 Diabetes and how it can be cured with the help of proper care at the health care providers and also by maintaining a good and healthy lifestyle.
Downloading and forwarding the UHEC application form
Filling up the application form
The application or proposal form should be downloaded from the website of the La Trobe University. It should be duly filled up, with signatures from all the members of the research committee, who will undertake the research work. The most recent version should be downloaded from the website. The UHEC / FHEC will accept the application form for approval of ethics, which should be completed with the DHS Core Application Form and the Checklist. It should be kept in mind that the DHS Core Application Form does not contain the required data and it is the duty of the investigator to ask for all the relevant information to the concerned person or team. Information regarding this is mentioned in the document named UHEC Guidelines for DHS Applicants.
Forwarding the application form
The process of review related to the individual research proposals which involve the human subjects depends on the associated risks which the subjects may face and that is regulated by the National Statement on Ethical Conduct in Human Research, 2007.
The process of review designed by La Trobe conforms to the norms laid down by the National Statement. Here is the list of committees who are involved in the review and approval of the applications.
The appropriate FHEC needs to monitor the following cases:
There is no need for any ethical review in this case. However the researchers should submit a brief summary about their intended research proposal. It is done according to the guidelines of the National Statement. There should be proper audited records also of the negligible risk studies. The FHECs should provide summary along with the checklists for risk assessment for the researches which involve negligible risk to the UHEC (Borenstein et al. 2015).
According to the National Statement, if the risk is of low category, the application must be submitted to the relevant FHEC. The application will be forwarded by the FHEC to the UHEC if the research involves more risk than perceived by the chief investigator of the research team.
More than low risk
If the research is of more than low risk category, then the UHEC should review it.
It is of utmost importance that the members of the UHEC and FHECs are absolutely used to with all the rules and regulations of the National Statement on Ethical Conduct in Human Research.
The chair review
A review is conducted by the FHEC/UHEC and it is not circulated to the other members of the committee. This process is followed in few of the cases as mentioned below:
Modifications to projects
There may be certain requests for modifying the said project like, extending the duration of the approval, minor changes to the process and other details of study.
Projects which are already approved
It includes the projects which are already approved by the HREC of any external agency where any of the La Trobe staffs bears a joint appointment or are required to acquire approvals externally, when the study is located centrally in any other agency from where the project will recruit the subjects. But there should not be any La Trobe University students who are involved as participants.
Externally approved studies
The studies which are approved externally and are conducted by the students of La Trobe and which are of low risk category, may ask for review which is expedited, by the concerned FHEC Chair except when the La Trobe students are selected as the participants of the research. In such cases the study which is approved externally, must come to the hands of the chair of the UHEC for consideration (Ethicist, 2015).
The institution maintains a register which consists of all the human ethics applications. It is not a document which is confidential. The register contains the following details such as: Names of the investigating persons, affiliated institutes, the title of the research project and a small objective of the project (Sexton, 2015). The electronic copies of the research proposals and all the documents relevant to the project are stored in the Research Services files. They may also be kept in the office of the relevant faculty. The applications are generally confidential in nature and are not accessible to the persons who do not belong to the ethics committee. However, in some special cases such applications can be made available to the outsiders. As for example, in case of an application being subjected to a court subpoena or a special request to information, under the Freedom of Information Act. If any application is a part of any funded research project, there may be some contractual obligations on the part of the University and in those cases the investigators should maintain confidentiality (Wassenaar et al. 2015). Any information relating to patentable or commercial nature is to be marked with Commercial-in-Confidence while submitting.
Advice to applicants
It is a general suggestion to all the applicants to follow these rules in order to get fast approval. These steps are to be kept in mind:
The application form needs to be fully completed.
Language should not be too complicated to understand.
The role of the research and what exactly the participants should be doing in the project should be explained clearly (Arkin et al. 2015).
The process of receiving informed consent should be clearly mentioned.
There should be a clear mention of how the research data will be used and stored.
The application should be duly signed in all the required places, by all the investigators.
All the documents necessary for the purpose should be included with the application before final submission.
Process of approval
The applications need to be lodged 30 days before the date of data collection. Unless there is written approval from the UHEC or the relevant FHECs, the process of data collection should not begin. It is to be noted that the applications are taken for evaluation by the UHEC/FHECs within ten or twelve days of receiving and they are considered in order of their date of receipt. The required information on how to fill the form is mentioned on the cover page of the application. The websites of the faculty also contain the additional information for the successful submission to the respective FHEC.
Procedure of appeal
If an application has been rejected by an FHEC, it is possible for the investigator to file a complaint against the decision of the UHEC. If any application has not been approved by the committee, the applicant may request the committee to review its decision in this regard. In this situation, the committee may seek an expert advice. If the result is still not satisfactory, it is possible to approach the Office of the University Ombudsman. The University Ombudsman will review the process by which the decision was taken by the ethics committee.
It might be said that the process of any research work, conducted by any institution or health care providers is an extensive one. There are plenty of regulations and guidelines to be followed while carrying out research on the human subjects. As this sort of research work involves the human beings, hence it becomes an extremely sensitive issue (Muller et al. 2015). Thus, a university should be extremely diligent in structuring all the research objectives and should chalk out a course of project in such a way that, it does not cause any harm to the society at large. It should also be kept in mind that there should be a definite contingency or risk tackling plan in mind in case any emergency arrives. This article reflects how the La Trobe University has followed all the basic steps from setting up the research objective to the final submission of the project application form to the ethics committee. The process has been meticulously followed by the university and it has followed all the steps mentioned in the National Statement (Whiteman et al. 2015). The La Trobe University has successfully lodged the application process for receiving the approval from the Ethics Committee. Now, it is up to the committee to decide whether it will approve the project or not. If accepted, the research will prove to be extremely beneficial to the society. It will help to create more awareness among the general public and help to develop proper solutions (Jones et al. 2015).