Handout #3Human subjects: Ethics andbureaucracyMad scientists• Over the years, researchers have subjectedhuman subjects to many harmful treatments:– leaving syphilis untreated to see how thedisease develops– inducing stuttering in children without a stutter– infecting healthy people with hepatitis, or virus-borne genetic material.Privacy issues• Researchers are often dealing with personalinformation about a human subject that thesubject would prefer to keep to themselves.• If the researchers publish the information insuch a way that the subject can beidentified, that subject’s privacy has beenviolated.Physical risks in speech research• There are few speech experiments thatreally risk physical harm to the subject.• X-ray motion pictures were an importantresearch tool up until the 1970’s.• Then the risks of cancer associated with X-ray exposure were made clear.• Currently, only microbeam X-ray is usedfor speech research, making use of very lowdosages of radiation.Physical risks in speech research• Some other articulatory phonetic techniquesrequire local anesthetic to minimizediscomfort, e.g. electromyography ornasography.• There can be minor physical discomfortfrom less invasive procedures, such aselectropalatography or airflowmeasurement.Privacy issues in speech research• But outside of articulatory phonetics,subjects in linguistic experiments aresubject to no real physical risks beyond theones they undergo every day.• The biggest risk for our subjects are risks totheir private information.• We frequently gather backgroundinformation on subjects.Privacy issues in speech research• In spontaneous speech, subjects will oftenreveal information about themselves thatthey would not like to see publicized.• It’s even conceivable that subjects couldreveal personal information in how theyreact to more controlled materials.Basic ethical principles• The basic ethics of the research situation arereally no different from everyday ethics.• You should treat people with respect, andhonor their right to make decisions forthemselves.• You should avoid doing people harm.• If you benefit from other people, you shouldshare that benefit with them.Informed consent• Informed consent: Every human subjecthas the right:– to know what will happen to them during theexperiment– to know what the risks are of the procedure– to know what will be done with the informationgathered– to withdraw from the study at any timeInformed consent• Most of the worst violations of humansubjects have occurred because they werenot told what they were getting into, or werenot allowed to get out when they wanted to.• Some gray areas:– Sometimes it’s hard to really adequatelyexplain the risks to a non-specialist.– Sometimes people (e.g. children) have to relyon someone else to make decisions for them.Privacy and confidentiality• Researchers must protect the subject’s privacy,i.e. the subject must have control over whatpersonal information he/she divulges.• The subject has has a right to confidentiality, i.e.the data obtained will be protected by the researchand not be passed on to any other party withoutwritten permission from the subject.Human subjects review• In an effort to enforce such ethicalstandards, all research with human subjectsat U.S. universities must be approved by anInstitutional Review Board (IRB).• The review process at UT is laid out at thewebsite of our IRB:http://www.utexas.edu/research/rsc/humanresearch/index.htmlHuman subjects research• Human subjects research involves systematicallygathering data from someone other than yourself.• Occasionally asking for judgements is notconsidered research in the relevant sense.• Nor is it human subjects research if you interviewsomeone about something they know about - theresearch has to be about the human subject.• The information obtained must be generalizable toother people beside the subject.Human subjects review• Full Board Review: This is a fuller reviewfor projects with a real risk.• Expedited Review: This is a quickerreview for projects with minimal risk.• Exempt: This is an even quicker review fora few kinds of minimal risk studies.• Projects with minimal risk involving soundrecording fall under expedited review.Training in the protection ofhuman subjects• As a researcher making an IRB application,you must certify that you have been trainedin the ethics of this area.• This involves doing the web-based trainingunder Training at the IRB website:http://www.utexas.edu/research/rsc/humanresearch/index.htmlAssignment: Due Tues., Jan. 30• (1) Complete the IRB training.• (2) At the IRB website, under Forms andTemplates, download the Required ProposalFormat [Word], and Consent Form 2 Only forMinimal Risk Studies [Word].• (3) Fill out these two forms for your proposedstudy. Delete the instructions in the forms.• (4) E-mail the completed forms to me by Tuesday(preferably earlier). Do not submit them to theIRB