Lecture 6 Human Research Ethics

Lecture 6Human Research Ethics COMPSCI 345/SOFTENG 350 (not in textbook)

Human research ethics • So, we want to ‘experiment’ on humans to assess usability • Unfortunately (from the perspective of convenience), experimenting on humans is a very formally constrained undertaking, with a Code and associated procedures • At least in the University and Medical (e.g., hospital) environments of the West, where the code is just about uniform • In the corporate environment, I guess anything is OK as long as you don’t get sued – many of the same principles are still helpful from that perspective (then again, telemarketers seem to just ignore this)

Nuremberg Code • In 1947, the judgmentby the war crimestribunal at Nuremberglaid down 10 standardsto which physiciansmust conform whencarrying outexperiments on humansubjects • See http://www.cirp.org/library/ethics/nuremberg/ • This Code now underlies all university and medical human research ethics approval procedures

Nuremberg Code (contd.) • 1. The voluntary consent of the human subject is absolutely essential… The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. • This has lots of implications for what we do in front of the main part of an experiment

Nuremberg Code (contd) • 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature • This is somewhat problematic for doing studies just for the sake of research training • 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury • 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment • So it can be risky and painful as long as it’s worth it

Nuremberg Code (contd.) • 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible • And this is usually softened to be whenever they wish and with absolutely no penalty (e.g., no bias in their subsequent treatment as an employee, patient or student)

Nuremburg Code (contd) 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. • So, you need to watch out for the safety of the human subjects • You’ll need to describe precautions, staff and procedures you have in place to deal with any threat to the subjects that exists beyond those of ‘everyday life’ • This may include what you’ll do if they fall while doing a demanding physical task in your protocol, or referral to counselling if you’re asking probing questions (but doesn’t need to include shielding against meteor strikes)

Code also says 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. • Can’t just hire flunkies to run the experiment 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results justify the performance of the experiment. 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. • We don’t usually need these in HCI!

HREC approval • What’s needed? • Fill out the forms (see http://www.auckland.ac.nz/uoa/re-uahpec or http://www.fmhs.auckland.ac.nz/faculty/research/humaneth.aspx) • Your response is reviewed by a University of Auckland Human Participants Ethics Committee (UAHPEC) that may approve, or tell you why not (often they have a few questions which are easily answered) • UAHPEC is staffed by a variety of disciplines, a lawyer, a ‘moral philosopher’, clinical input, etc • Particulars of the pro forma • Consent Form • Project Information Sheet • Motivation • Description of the protocol • Lots of other stuff

Major ethics approval issues • Informed Consent and Project Information • That Nuremberg Code principle #1 (and also #9) leads to a specific format for these two forms • Project Information sheet explains what you’re doing, identifies the researchers, and names ethics committee (independent) contacts • Consent Form is like a contract that says they understand what they’re in for (explicitly agreeing to any audio or video taping and use of direct quotations), can stop at any time without penalty, etc. • Signed by investigator and participant (hence investigator is attesting that participant understands) • These forms (as a contract) must be perfect in terms of grammar and overall clarity of expression

Ethics approval issues (contd.) • Motivation • Need to justify that the experiment is not arbitrary • Usually a literature review and a defensible statistical method to address well-defined hypotheses • Protocol • HREC wants to know just what you’re going to do to the participants • Each and every step • How long will it take? • Copies of all questionnaires (phrasing of questions must be perfect) • Good description of the software (and esp. of any unusual hardware)

Other ethics stuff • Safety • Is it safe? (to degree of ‘everyday life’) • What will you do if participant has a problem? • Recruiting and coercion • How will participants be sought? • Putting up posters (sending emails, etc.)? Do you have approval? • Will the population feel pressured to participate (or think they should bias their responses)? • E.g., if they are employed by the investigator • Intellectual Property (IP) and data storage • Who owns the data? • Where will it be kept? (expectation of keeping for 7+ years in case of data fraud challenge) • Need to be clear on management of confidentiality and anonymity (these are not the same thing!)

UAHSEC timing • At UA the committee meets once a month • If your timing is poor, might take 7 weeks to get the protocol seen (then some time for a response, which asks questions to be taken up at next meeting, often with a tight turnaround…) • Meetings are monthly – find the schedule on the Web. They don’t give extensions (not even a little) and they mean it has to be with them by the due time (too bad if the post was slow) • For an honours dissertation, UAHPEC approval must be integral to project plan (i.e., gotten into early) or you’ll run out of time • In fact, a one-semester project involving human research ethics is almost impossible to organise unless you know exactly what you’re going to do BEFORE the semester begins! • Must have final approval or you’re not covered by Uni’s insurance • Technically, your thesis can’t be marked (or the degree awarded) without approval • Of course this is only for thesis work that involves human subjects

Summary • The code of research ethics grew out of cruel and forced experimentation by the Nazis in World War II • Provides a basis for people to know what they are in for and to be free from inappropriate coercion to participate in, or stay in, any ‘scientific’ experiment • With the rise of usability studies, Computer Science comes into contact with this largely Medical tradition even though our experiments are mostly quite non-invasive

Lecture 6 Human Research Ethics