human research ethics approval – an introduction

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Human Research Ethics Approval –

an introduction

By

Professor Dan Remenyi [email protected]

It is now well established that ethics is an important research issue. Researchers

have to be cognisant of the different ways their research can impact a wide range

of individuals if they are to be regarded as responsible in today’s complex society.

This has not always been the case. Ethics first raised its head in the medical field

at the end of the Second World War, but even then it was not taken all that

seriously and it only became a real issue when Henry Beecher’s whistle blowing

paper was published New England Journal of Medicine in 1966. Beecher’s paper

drew attention to 22 cases in the USA where human subjects of research were

abused in ways that are difficult to imagine doctors doing today. In the USA this

triggered federal rules on human experimentation and informed consent. This

concern spread and ethics finally became part of the general academic mind set

or consciousness when David Rothman had his widely read book, Stranger at the

Bedside published. Of course, science had been taking advantage of vulnerable

people for decades, if not for centuries, but by the third quarter of the 20th

century it was finally realised that this had to stop. All medical research

institutions ranging from hospitals to universities were required to apply for ethics

clearance before research on humans and animal could begin.

It took another 2 to 3 decades for it to be realised that the principle of ethics

clearance should be applied to any research which involved human participants.

Today ethics approval should be obtained before any research involving even

minor contact with humans begins. This applies to all fields of study including

Information Systems and all branches of management. Of course, were the

research does not involve human participants, as in topics to do with pure

computer science such as algorithm optimisation or computer language

performance or new designs for integrated circuits for example, then there is no

need for ethical approval. It is sometimes comforting for researchers in IS to know

that they are not unique in being required to apply for ethics approval, which has

become standard practice for all researchers who have even minimal contact with

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human participants such as that required when an informant completes a

questionnaire or when any personal information about people is involved.

The ethics of research is a wide ranging topic and it has implications for all aspects

of the research process as well as for the relationships between the researcher

and the institution or the company for that matter, in which the research takes

place. In the University or research institution environment there are a number of

issues related to the researcher and the supervisor as well as concerns related to

relationships between different researchers themselves. This note focuses on how

a researcher obtains ethics approval for a proposed research project, this is

sometimes referred to as procedural ethics, and therefore the issues mentioned

here are highly specific to satisfying that group having oversight for the research

in the School/Department or organisation. There are many other ethics issue

which are not raised by this process such as plagiarism and deceit about the

nature and source of data, this may be referred to as ethics in practice, and it is

assumed by the ethics procedural process that these issues will not be

transgressed by the researcher.

It is worth keeping in mind that the institution uses the research approval process

to achieve two outcomes. The first of these is to focus the attention of the

research in such a way that the researcher will not be open to any criticism on the

grounds of misconduct. The second reason is that researchers or the organisation

in which the researchers work wishes to protect itself against any actions which

could arise from an accusation of research misconduct.

Where ethics approval is required a form normally has to be completed. The form

will contain a number of questions related to the topic of the research, the

research question, what type of participants are required, how data will be

collected and so on. This means that the researcher needs to have given quite a

lot of thought as to how the research will be conducted and if there is any

potential for ethics problems to arise. It is a normal requirement that this form

should be accompanied by at least two separate documents. The first of these

documents is what is generally referred to as a Research Participant’s Information

Document. This document should address all the major issues which the

informant should be made aware and in so doing it should explain all the major

features of the research project to the prospective informant. The form of this

document, which can be seen in Figure 1, is that of a series of questions which

may occur to the informant together with the answers which the researcher

considers to be appropriate. It is realised that all institutions will have their own

approach to the issues outlined in Figure 1, but nonetheless it is a useful indicator

of the type of matters the researcher needs to think about.

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The second document is a draft a Letter of Informed Consent. See Figure 2 for an

example of such a document. This letter confirms that the informant has received

and has read and understood the Research Participant’s Information Document

and that any questions which he or she may have had have been answered to

their satisfaction. A very important aspect of this letter is the recognition that the

informant is aware that he or she is not obliged to complete or answer every

question asked of them and that he or she may withdraw from the research at

any time.

Where interviews are involved the researcher should have a signed Letter of

Informed Consent for each informant. Where questionnaires are involved then

the questionnaire itself should have a section which requires the informant to

indicate that he or she has given informed consent. If the questionnaire is

completely anonymous then the submission of the questionnaire to the

researcher is normally accepted as an indication of Informed Consent.

In addition to these documents it will be necessary to supply a copy of any

measuring instrument to the ethics approval group which will be used. Research

studies based on a questionnaire will need to have approval of the specific

questionnaire and research based on interviews will have to show the interview

schedule to the ethics committee. Where case studies or action research is

involved a detailed plan of who exactly will supply data and how the data will be

used is normally necessary.

If the research involves vulnerable people such as children, patients, the elderly to

mention only a few such groups then additional approval may be needed for the

research. If the researcher wish to enter a school for example additional police

clearance will normally be required.

The body that awards ethical approval will consider these documents and decide

whether the proposed research will comply with the ethics standard of the

research institution or the University. It is not common for an ethics application to

be approved immediately. Often the researcher or researchers will have to

answer questions which are raised by the consideration of their documents.

Sometimes additional clarification is called for and the researcher may have to

attend and provide explanations to the committee.

As may be seen from the above, ethics approval is a serious matter and some

research institutions and universities are very strict about to whom they will give

approval. Some Universities state that if a project is started without approval it

has to be discontinued and the people involved must not pursue that topic. Here

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no retrospective approval will be entertained. This is obviously a very extreme

attitude to take.

Thus the best advice which can be given to researchers is to take ethics approval

very seriously and to apply for it as early as they possibly can. It is important to

expect that approval will not be given immediately and that the application may

have to be resubmitted.

For a full account of this subject see http://academic‐

bookshop.com/ourshop/prod_1439563‐Ethics‐Protocols‐and‐Research‐Ethics‐

Committees.html

Figure 1 Research Participants’ Information Document

The purpose of this Document is to explain to potential research participants the

nature of the research which is proposed and the role which he or she is being

invited to play in that research.

Issue Detail (the following is a fictitious example)

1 Name of researcher

& contact details

Jamie Cassidy

e‐mail and telephone number

Affiliation of

researcher

School of Business Studies (Part‐time) and The Hi‐

Tech Corporation

2 Title of Research

Project

Cloud Computing, What is in it for us?

3 Purpose of the Study The purpose of this research is to find out if Cloud

Computing can advance the following:

‐ In Business; to sell and supply products or

services into the cloud and the considerations of

business strategies and processes to do this

‐ In IT; acquiring, and using IT/IS services provided

by the cloud to do business – will it be good for ICT

strategy, the IT Organisation, and the company as a

whole?

‐ In the Hi‐Tech sector we operate in; can the

sector overall benefit by supplying to, and/or using

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the services of the cloud?

4 Description of the

Study

The research will take the form of Interviews

(external participants) and Interviews &

Questionnaires (internal participants).

5 Duration of the Study 30 months

6 What is involved? Send participants an overview of the areas they

will be asked questions on when partaking in the

interview.

7 Why you have been

asked to participate?

You have been asked to partake in this study due

to your experience in conventional and Cloud

Computing, and have worked in an environment

where they have been used.

8 What will happen to

the information which

will be given for the

study?

The information will be held in a confidential

manner while the work is being collated. Following

the successful completion of the project all

material collected as a result of the interviews and

questionnaires will be destroyed.

Data will be traceable back to you until it is

anonymised.

Can you review the

data after it has been

written up by the

researcher?

The data may be reviewed at any time before it is

anonymised after which it will not be easy to

identify which data came from whom.

9 What will be done with

the results of the

study?

The results of the interviews and questionnaires

will be reported in the findings section of the

research dissertation. This will be done in a

completely anonymous manner.

10 What are the possible

disadvantages?

I foresee no negative consequences for

participants in this research.

11 In what way will the

study be beneficial and

This study will provide a useful basis for companies

to understand Cloud Computing (private, hybrid, or

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to whom? public) as an option for business initiatives, IT

Service delivery (part or whole), and any associated

application in the ICT sector. The study will

investigate, conclude and recommend what’s

required (or not) to achieve this.

12 Who has reviewed this

Study to ensure that it

complies with all the

requirements and

ethical standards of

the university?

The Ethics Committee of Trinity College Dublin

have approved this research proposal and granted

permission for this research.

13 Can permission be

withdrawn having

previously being

granted?

Yes all contributors shall retain the right to have

their contributions to the research withdrawn at

any time. In addition the contributor has the right

to refuse to answer any question asked during the

interview. They may also ask to end the interview

at any time.

14 Can you refuse to

answer any question?

Yes. The contributor has the right to refuse to

answer any question on either the questionnaire or

as part of the interview and you may terminate the

interview at any time.

Figure 2: An example of Letter of Informed Consent

I, <informant>, agree voluntarily to take part in the research project being conducted by Joe Blogs as part of the requirements for his Degree Research at <XYZ>. I have read the Research Participants’ Information Document and I understand the contents thereof. Any questions which I have asked have been answered to my satisfaction. I understand that the information which I will supply is confidential and that it will be anonymised and will only be used in the findings of the research. I agree that the data may be used both in a masters/doctoral dissertation and also in papers arising from this research which may be published in peer reviewed journals.

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I understand that I do not have to answer all the questions which may be put to me. The information which I provide will be held securely until the research has been completed (published) after which it will be destroyed.

The information which I provide will not be used for any other purpose.

I understand that I am entitled to ask for a de-briefing session or a copy of the research at the end of the project.

I have been informed that I may withdraw from this study at any time and that any information which I have supplied will not be used and any records held relating to my contribution will be destroyed. I do realise that this is only possible before my data has been anonymised.

Informant

Date

Researcher

Date

References

Comstock G, 2012, Research Ethics : A Philosophical Guide to the Responsible

Conduct of Research, Cambridge University press, Cambridge

Guillemin M and L Gillam, Ethics, Reflexivity, and “Ethically Important Moments”

in Research Qualitative Inquiry April 2004 10: 261‐280

Rothman David J, 1991, Strangers at the Bedside ‐ A History of How Law and Bioethics Transformed Medical Decision Making A History of How Law and

Bioethics Transformed Medical Decision Making, Basic Books, Pereus Book Group,

NY

Remenyi D N Swan and B van den Assem, 2012, Ethics Protocols and Research

Ethics Committees – Successfully Obtaining Approval for your Academic Research,

Academic Conferencing and Publishing International Limited, Reading

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The Menlo Report: Ethical Principles Guiding. Information and Communication

Technology Research, by M. Bailey, D. Dittrich, E. Kenneally, and D. Maughan,

“The Menlo Report'', IEEE Security & Privacy, vol. 10, no. 2, pp. 71—75,

September 15, 2011.

Useful Websites

http://www.niehs.nih.gov/research/resources/bioethics/whatis/

http://www.socialresearchmethods.net/kb/ethics.php

http://www.who.int/ethics/research/en/

http://www.ethicsguidebook.ac.uk/

http://www.ethicsweb.eu/ere/

http://www.onlineethics.org/

http://www.esrc.ac.uk/about‐esrc/information/research‐ethics.aspx

http://the‐sra.org.uk/sra_resources/research‐ethics/ethics‐guidelines/

http://www.reading.ac.uk/internal/res/ResearchEthics/reas‐

REethicshomepage.aspx

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1118625/

human research ethics approval – an introduction

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