beyond the irb: examining common but rarely explored ethical issues in psychosocial research

Monash Bioethics Review Vol. 26 No.3

ARTICLE

49 Ethics Committee Supplement

Beyond the IRB: Examining commonbut rarely explored ethical issues inpsychosocial researchROBIN K MATSUYAMAInstructor, Internal MedicineVirginia Commonwealth University (VCU) School of Medicine

LAURIE J LYCKHOLMAssociate Professor of MedicineInternal Medicine/Hematology/OncologyVCU Massey Cancer Center

M. ELIZABETH LoWEData Collection SpecialistVCU Massey Cancer Center

MICHAEL B EDMONDProfessor of Internal MedicineVCU School of Medicine

ABSTRACT

This article discusses common ethical and practical considerationsin psychosocial and behavioral research in healthcare. Issues suchas appropriate objectives and intent, risk-benefit ratios, researchdesign, and human subject protection are explored. The burden ofethical research design and implementation is placed on theinvestigator, rather than relying solely on institutional review boardsto judge individual projects. The benefit of acquisition of knowledgemust be balanced against the burdens of the research on society ingeneral and human subjects specifically. Scientific replication ofresearch is encouraged, unnecessary duplication defined anddiscouraged, and benefits of true collaboration outlined.Investigators are advised to consider the context, intent, purpose,implementation, and use of information when developing research.The concept of "researcher myopia" is defined as a commonstumbling block. It is suggested that academic researchers also lookto other disciplines, such as industry, for examples of research thatis concise, cost-effective, and reliable.

IntroductionThe best of psychosocial and behavioural research identifies

previously unknown information or clarifies the experiences ofindividuals. The goal is to contribute new understanding or makespecific improvements in programs, care , or the lives of others . Theworst of this research wastes the time of participants and researchersas well as institutional funding. Rather than contributing knowledge it

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instead causes potential distress to participants, fails to answer theresearch questions, defies effective analysis and dissemination, andcan result in erroneous assumptions by others.

Generally, researchers are a curious lot, wanting to know whypeople do what they do, what they think, or how they feel. If that didn'tfascinate us, we wouldn't be researchers. However, we sometimes fail torecognize that just because we can do a study or ask certain questionsit doesn't necessarily mean we should.

Weijer and Miller describe the purpose of clinical trials as that ofchanging clinical practice. The primary purposes of psychosocial andbehavioural research are more difficult to define, ranging fromintroducing therapeutic interventions to simply increasing knowledge. I

There are multiple reasons for psychosocial research and not all ofthem may be in the best interest of the subjects being studied. It is ourresponsibility as individuals, researchers, mentors and IRB members toevaluate carefully advantages and disadvantages, as well as thepurpose and meaning of the research in which we engage.

The purpose of this article is to identify common ethical andpractical considerations in psychosocial and behavioural research.These considerations may not be equally applicable to other types ofresearch and we do not directly address biomedical research or clinicaltrials in this discussion. We recommend factors to consider whenplanning and implementing psychosocial and behavioural research.

When using human subjects, we believe that knowledge forknowledge sake is a laudable goal provided that the research does notplace excessive burden on subjects and meets appropriate ethicalstandards. However, we are of mixed views with regards to theimportance of present utility in assessing the burden-benefit calculus.

Background and significanceThere is literature related to risks and benefits of clinical

research- but little describing similar issues specific to psychosocialand behavioural research.v Biomedical research has clearer guidelinesfor risk because the nature of the risk can include physical harm oreven death." It is unusual for behavioural research to reach that levelof risk, although there are cases of suicide subsequent to increaseddistress or depression triggered by insensitive studies." Because therisks and benefits of psychosocial research are more difficult to define,and because risk/benefit calculations are the essence of ethicaldecision making, they need to be further examined.

Feelings of embarrassment, anxiety, boredom and/ or annoyanceexperienced by subjects often are described as risks in behaviouralresearch and may be distressing. 6 Some researchers say that thesecommonly defined risks are better described as inconveniences." Truerisks, according to Levine are threats to psychological integrity.f It doesnot matter, however, whether they are called inconveniences or risks,they need to be considered in relation to the importance of anyresearch undertaken. 9


Risk is higher for participants in health research than in thegeneral population as subjects often are patients, a potentiallyvulnerable population. Feelings of obligation, dependence, gratitude,hope, or fear may prompt individuals to agree to participate in a study.Given their relationships with medical providers and the possibleeffects of illness, it is a challenge to do research withoutunintentionally constraining or excessively burdening participants.J?Research that emphasizes dignity and intentionally provides a valuableactivity reduces the risks for vulnerable populations. II

For participants, benefits of psychosocial research are notinconsiderable and include feelings of altruism and engagement. 12

Research participation may introduce a sense of personal legacy'<when participants feel that their contributions will outlive them.Participants also receive individual attention, feel they are helping withsomething important, and may enjoy the activity of participating.Researchers, however, tend to over-estimate the benefits andimportance of the research in which they engage!" and this may biaspresentation of the study during the consent process. As a result,investigator and participant needs may conflict. IS

The challenge is to carry out ethical research. In order to do that,researchers need to be attentive and remain focused on objectives andintent, as well as identify actual or potential burdens or risks tosubjects in relation to potential benefits.J> That is the crux of thisarticle.

There are several things to consider when developing apsychosocial and behavioural study. Let us examine one hypotheticalquestion: Do victims of assault consider suicide on a regular basis?There is a risk of significant psychological trauma if a study withassault victims is not conducted properly. Do the investigators andstudy staff have the necessary competencies and expertise?Investigators should not do studies that exceed their areas of expertise.What kinds of outreach or support are planned for the participants ofthe study? Researchers need to think carefully about the impact of thestudy itself on the participants. In this study, it is necessary to haveadequate safeguards and the study should be implemented by thoseadequately trained in suicide prevention.

It may be difficult to recruit subjects without possiblecompromise of highly private and confidential information.Confidentiality, a prima facie principle, should not be compromisedunless the benefits of research clearly outweigh the risk of violatingconfidentiality.

Participants may reveal psychological distress, such asdepression or anxiety, and might benefit from timely treatment.Intervening may negatively affect the study. Research is never moreimportant than the individual participants.


Table 1. Ethical Implications and Practical ConsiderationsExample of research Ethical Practicalquestion implications considerations1. What do people

think about whenthey are about tohave a limbamputation?

2 . Do victims ofassault considersuicide on a regularbasis?

3. Are red cars stoppedmore frequently bypolice and whatdeciding factors areinvolved?

4. Researcher choosesto study anxiety insiblings with BRCA1 gene mutationbecause there aresignificant fundingopportunities.

5. Physician, who isalso a researcher,interviews ownpatients in study ondecision makingrelated to patients'medical care.

6. Would nurses washtheir hands more ifsubliminal cueswere added to musicin the ICU?

Risk/benefitratioSensitive topic

Risk ofpsychologicaltraumaProtection ofconfidentiality

Distributivejustice

Potentiallyopportunistic ordishonestmotivationQuestionableintegrity

VulnerablesubjectsPotentialconflict ofinterestPossible bias

Deception

Determine utilityTraining in lossand bereavement

Protection ofhuman subjectsNeed adequatelytrained personnelCare inrecruitment andimplementation

Misuse ofresources ifduplication ofprevious research

Research questionchosen based onpotential forfunding ratherthan true interestin topic

Patients may feelobliged to engagein the researchInformationprovided may becensored toprotect self orphysician.

When is deceptionacceptable?


Do we already know the answer? It is time to find out whatinformation already exists about this topic. Perhaps joining forces withothers could enrich both research process and research results, orperhaps the study already has been done and does not need to berepeated.

If the study objective is to determine frequency of suicideideation, it is not necessarily relevant to inquire into what models ofcars participants drive . Researchers should be aware of the potentialfor over-burdening subjects and carefully prioritize inquiries so as tonot waste resources .

As researchers we wonder about motivations, thoughts, feelings,and experiences of others, and probably could corne up with pages ofquestions for which we would like answers. While there are no stupidquestions there may be external circumstances that make itinappropriate or even unethical to investigate those questions. It is notthe question itself but the context, intent, purpose, implementation,and use of information that define ethical research

When good research turns badNo one deliberately sets out to do bad or unethical research, but

there are many examples of both. A study may sound good or may bewell-written but it may still lack the capacity for implementation.Research that tries to cover too much can end up scattered, withinformation that skims the surface. Study implementation and dataanalysis phases that go for too long a period risk loss of focus , attritionfor both researchers and participants, and aged data at the conclusionof the study. Studies that require excessive time commitments, areexceptionally intrusive, and ask questions that can not be effectivelyevaluated, burden participants, waste valuable time and goodwill, anddetract from the purpose of the research.

Researchers may fail to have clearly identified goals, mayintroduce ambiguous concepts and questions, may gather too muchdisparate information, and may be unable to distil the data.!? All ofthese problems can result in useless data that defy analysis, inconclusions that are incorrect, or in reports that may not answerintended questions .t" Ethical implications include benefit/risk ratiosskewed towards risk, potential harm to human subjects, and misuse ofresources .

Where research beginsIdeally, research is an iterative process. It begins with a research

question and continues through literature and fact review, studydesign, implementation, analysis, and dissemination. Much ofpsychosocial and behavioural research is hypothesis driven based onthe idea that if you do not know what you are looking for, you won'tknow what you have found . This can result in bias if proving that thehypothesis is true becomes the focus of the study. An exception to thisis qualitative research. Qualitative research tends to put less emphasison specific hypotheses and is exploratory in nature. The purpose is to

Monash Bioethics Review Vol. 26 No. 3 54 Ethics Committee Supplement

understand, explain, or identify phenomena and associations ratherthan to prove any particular points.

It is essential that research objectives drive study design,implementation, and analysis. At each step a firs t -rate research plan isevaluated and re fined in relation to the original goals and objectives. Incontrast, most "bad" research results from losing track of the purposeand/or the intent. Th is leaves the process unguided and unfocusedand that can weaken or even taint the entire study.

Let us start a t the beginning. Evaluating intent is complex andchallenging but a necessary part of quality research. While researchplans can be adjusted without compromising integrity, research that isdesigned primarily for it s ability to be funded is an example of flawedresearch. Developing purely opportunistic research and fitting studiesto current trends also present ethical issues. Without passion orsincere commitment, the integrity of a study is compromised before iteven begins . An approach that emphasizes popular topics rather thanpersonal conviction hinders execution and is likely to result in studiesthat lack depth, commitment and/or significance. Trends and fundingopportunities may fade just as quickly as they appear and goodresearch needs to stand the test of time.

Sometimes routine practice or interventions overlap withresearch. Federal regulations define research as "sys tematicinvestigation designed to develop or contribute to generalizableknowledge."19 The Belmont Report describes practice as activities thatimprove (or seek to improve) the well-being of an individual patient orgroups of patients.s? While research and non-research activit ies mayco-exist, investigators need to know tha t there are distinctions. Thiscan sometimes be complicated.

Consider this example. A pilot program that has a hospitalemployee gathering information on patient satisfaction immediatelyafter surgery may actually have been fu nd ed as research ondepression. There is nothing wrong with doing res earch on a pilotprogram but, in this case, data collected on depression does notmeasure the feasibility of an intervention. It also does not necessarilymeasure patient satisfaction. The opposite problem is when ongoinginterventions provide research data without patient awareness. Anemployee meeting with patients after surgery could gather informationon anxiety. That data might later be accessible through IRB approvedresearch reviewing patients' records. Both situations have goodintentions and may provide valuable services or data. However, neitherstrictly meets an ethical standard.

Researcher myopiaResearchers sometimes can develop what we call "resea rcher

myopia." This happens when investigators become too attached to theirown id ea s , lose objectivity , and forget th e world outside their research.They may fail to see potential defects in their projects, overestimate theimportance of a study, underestimate the im pact on participants, andign ore previous con tribu tion s of others . Unaware and unchecked, an

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investigator's project can take on a life of its own. Many months (oryears) and dollars later, the research contributes little or nothing ofimportance. Because of these tendencies, the wisest researchers useongoing systems of informal checks and balances. New investigatorsbenefit from having mentors while experienced investigators benefitfrom input from peers . If we want to be good researchers , we activelyseek cooperative partnerships and generously mentor others.

Duplication, replication, and collaborationDuplicating existing studies, a common pitfall, happens for

several reasons. Researchers may repeat a study because it is easy, willbe funded, and is likely to produce a published article. Withoutcontributing something new, this is a waste of time and resources.Another possibility is that a researcher may duplicate a study withoutbeing aware of doing so . It can be difficult to know when others aredoing or have done similar research because there is no establishedclearinghouse for psychosocial and behavioural studies. In publishing,duplication can be observed when the same dataset is usedredundantly in more than one journal article.v' This is not to say thatit is bad to reduce large datasets to more manageable proportions andproduce several articles that report on distinct subsets of data.

Although seemingly similar, replication is not the same asduplication. Purposive replication of studies is a scientifically soundand effective way to test reliability or validity. Consistency of findingsacross different groups of study subjects using different measurementtools is one of the criteria that epidemiologists use to determinewhether an observed association between a predictor (independent)variable and an outcome (dependent) variable represents a causalrelationship.

Professional partnerships between institutions, departments,disciplines, and researchers should be a priority. In-depth literaturesearches may fail to produce relevant studies and sometimes it is onlya serendipitous comment from a colleague that introduces theinvestigator to important related research. Even within the sameinstitutions there may be studies that overlap unbeknownst to theinvestigators.

A final key issue is that of integrity in professional collaboration.This affects every aspect of research from inception through topublication. In some cases, titular investigators are used to ensurefunding or publication but are completely absent or offer only nominalcontributions to the work. In other situations, there may becollaborators who devote time and effort in important ways to a projectwithout receiving any public recognition. Real collaboration emphasizesjoint efforts and authentic contributions to the tasks at hand. Whilenot everyone may do the same amount of work, all are equallycommitted and add considerable value to the project.

Researchers seeking to produce quality research benefit fromenvironments that emphasize the need for conscientious mentoring andtrue collaboration.


RecommendationsOverall, these issues are not simple. It is not possible to establish

a series of unambiguous steps to follow to create perfect research.Instead we must think objectively and clearly about the research thatwe do and , each step along the way, carefully weigh risks and benefits.

Table 2. Five major questions1. Is the research being done for the right reasons?II. Does the research framework support the objectives?III. Do potential benefits outweigh risks and/ or burdens?IV. Is it worth the investment?V. Can research interests be combined?

We recommend a series of questions to ask before developing aresearch project and to reflect on during study design andimplementation.

1. Is the research being done for the right reasons?

1. Why do you want to know? Research that places undue burdenon participants while primarily satisfying the curiosity of theresearcher should be avoided.

2. For what will the information be used? Quality researchcontributes to new knowledge or present utility (e.g.,educational materials or outreach efforts; symptom relief;quality improvements; better care) .

3. Does it pass the so-what test? If the objective is to investigateknowledge that has been sufficiently replicated and validated, orif it is so obvious it is ridiculous, then you do not need to do theresearch.

4. Is it research? Know the difference between research andpractice.

II. Does the research framework support the objectives?

1. What do you need to know in order to accomplish the identifiedobjectives? Identify what already is known and what remains tobe learned. Allow these to drive study design, implementation,and analysis.

2. Is the methodology correctly designed? Choose your methodologybased on the goals of the study.

3. Is the study measuring what it is meant to measure?

a. Are these the right questions? Know what you want tomeasure and choose or design appropriate tools tomeasure that. If a validated scale is used, make surethat it has measurements that actually meet theresearch objectives. Sometimes you need to just ask aquestion directly.

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b . What do you think you are asking? Ask yourself andothers the questions at different times . If you getdifferent answers, your questions lack clarity or maydepend on external circumstances. Test variables and doconfirmatory factor analyses.

c. In a survey, are you asking more than one question at atime? Asking one question at a time produces data thatcan be tracked and measured. If you are including morethan one variable in a single question, a single answermeasures nothing.

4 . Where are the original goals of the research? It is important tokeep checking on the study's objectives to ensure that you arestill on track. Tailor implementation to the goals, not the otherway around.

III. Do the benefits outweigh the risks? This needs to be carefullyweighed when working with human subjects.

IV. Is it worth the investment?

A study should be worth the money and time spent on it . Be theparticipant for a little while and really think about what thestudy will be asking of you. Think about the study as thoughsomeone else wanted to do it and challenge your valueassumptions . If you were paying for it out of your own savingsdecide whether you would spend the money.

V. Can research interests be combined?

Constructive partnerships between disciplines, individuals, andsites can enrich research. This is not the same as adding tokeninvestigators for the purpose of getting funding or studyapproval. True collaborative efforts create opportunities toimplement multi-dimensional research, expand learning, reach awider audience, and save both money and time.

ConclusionAttention to specific design issues, consideration of social utility,

pursuit of knowledge, and burdens on participants is essential. In theend, however, it is the character and integrity of the individual thatguarantees ethical behaviour. IRB approvals and signed consent formsare not enough. Those requirements establish minimum standards andprovide oversight and correction to ensure that these standards aremet. Commitment to doing what is right, rather than what is required,is necessary. We must consider the moral aspects of every study inwhich we or others engage. An ethical individual does not rely solelyon others to define what is right; does not consider that the ends justifythe means; and questions always his or her actions and experiences inan attempt to act with integrity. Ethical behaviour must be aninstitutional imperative and each of us needs to promote this.


It is possible to meet the basic requirements for funding, protocoldevelopment, IRB submissions , or study design, and still makemistakes. It is better to err on the side of being overly rigorous in ourdefinitions, expectations, and guidelines than not rigorous enough.

The inherent value of a research study is not always clear.Information that enhances knowledge can be considered a laudablegoal if the costs (financial and personal) are not higher than potentialbenefits. In psychosocial and behavioural research the need to knownever eclipses the need to protect the rights of human subjects. Often itis a judgment call. We may more easily see the flaws in others' researchbefore we are able to see the flaws in ours. It is only through judiciousquestioning and rigorous self-examination, in conjunction withteamwork and sound research methodology, that we will be able to docost-effective, ethical, and valuable research.

ENDNOTES

1 Weijer C, Miller PB, When are research risks reasonable in relation to anticipatedenefits? ' Nature Medicine, vol. 10, no. 6,2004, pp. 570-573.

2 Brody JL, Scherer DG, Annett RD, Pearson-Bish M, 'Voluntary assent in biomedicalresearch with adolescents : a comparison of parent and adolescent views', Ethics andBehavior, vol. 13, no . I , 2003, pp. 79-95; Macrina F. Scientific integrity, 2nd edition,Washington, DC: ASM Pre ss ; 2000; Van Ness PH, 'The concept of risk in biomedicalresearch involving human subjects ', Bioethics, vol. 15, no. 4, 2001, pp.364-370.

3 Labott SM, Johnson TP, 'Psychological and social risks of behavioral research ', IRB:Ethics and Human Research, vol. 26, no. 3, 2004, pp .II-15.

4 National Commission for the Protection of Human Subjects of Biomedical andBehavioral Research, The Belmont report: ethical principles and guidelines for theprotection of human subjects of research. Washington DC 1979, DHEW Publication No.(OS) 78-0012, US Government Printing Office .

5 Levine RJ, Ethics and regulation of clinical research, 2nd edition. New Haven, CT: YaleUniversity Press, 1986.

6 Weijer and Miller, op . cit .; Labott and Johnson, op . cit. ; Adair JG, 'Ethics ofpsychological research: new policies; continuing issues; new concerns', CanadianPsychology, vol. 42 , no . 1,2000, pp. 25-37.

7 Levine, op . cit.8 Ibid.

9 Ibid .

10 Chochinov HM, 'Palliative care : an opportunity for mental health professionals', TheCanadian Journal ofPsychiatry, vol. 49 , no . 6 , 2004, pp . 347-349.

11 Hack TF, Chochinov HM, Hassard T, Kristjanson W , McClement, S , Harlos M,'Defining dignity in terminally ill cancer patients: a factor-analytic approach', Psychooncology, vol. 13 , 2004, pp. 700-708. McClement SE , Chochinov HM, Hack TF,Kristjanson W, Harlos M, 'Dignity-conserving care: application of research findings topractice', International Journal ofPalliative Nursing, vol. 10, no . 4 , 2004, pp.173-179.

12 Labott and Johnson, op . cit. ; Levine, op . cit.; Ritchie J, Lewis J , Qualitative researchpractice: a guide for social science students and researchers, London: Sage Publications,2003.

13 McClement et al ., op . cit .

14 Levine , op . cit.

15 Miller FG, 'Ethical s ign ificance of ethics-related empirical research', Journal of theNational Cancer Institute, vol. 94, no . 24, 2002, pp. 1821 -1822; Joffe S, Weeks JC,


'Views of American oncologists about the purposes of clinical trials ', Journal of theNational Cancer Institute, vol. 94 , no. 24, 2002, pp.1847-1853.

16 Lo B, 'Addressing ethical issu es,' In SB Hulley, SR Cummings , WS Browner, D Grady,N Hearst and TB Newman, Designing clinical research, 2nd edition: Philadelphia, PA:Lippincott , Williams and Wilkins, 2001 , pp. 215-229; McMillan J , Sheehan M,'Commen tary: ethical review and ethical behaviour', British Med ical Journal, vol. 330,2005, p.473; Wade DT, 'Ethics, audit , and research: all shades of grey', British MedicalJournal, vol. 330, 2005, p:468-471.

17 Creswell JW. Research design: qualitative and quantitat ive approaches . ThousandOaks, CA: Sage,1994; Miles M, Huberman A, Qualitative data analysis : an expandedsourcebook, 2nd edition , Thousand Oaks, CA: Sage Publications ; 1994.

18 Fowler FJ , 'How unclear terms affect survey data', Public Opinion Quarterly, vol. 56, no.2,1992, pp.218-231.

19 United States Department of Health & Human Services, 45 CFR 46: Federal Policy forthe Protection of Human Subjects, 2007, available at http://hhs.gov/ohrp/ humansubjects/ guidance/ 45cfr46.htm (accessed January 18, 2007J.

20 National Commission for the Protection of Human Subjects of Biomedical andBehavioral Research, The Belmont report, op. cit.

2 1 Jerrells TR, 'Du plica tive publication of data and other ethical issues in publishing ofscientific findings ', Journal of Substance Abuse Treatment, vol. 20 , 2001 , pp.111-113.

beyond the irb: examining common but rarely explored ethical issues in psychosocial research

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