Available online at www.sciencedirect.com

Arc

Developing Distress Protocols forResearch on Sensitive Topics

Claire Burke Draucker, Donna S. Martsolf, and Candice Poole

hives of Psyc

Two protocols thatwere developed to address risks related to emotional distressin an ongoing, qualitative, community-based study of adolescent dating vio-lence are presented.The first protocol is for use in telephone screening to iden-tify individuals at high risk of adverse emotional reactions.The second protocolguides interviewer’s responses to emotional distress expressed by participantsduring in-depth research interviews.The study is briefly described, and the pro-cess used to develop the protocols is discussed.The process of developing theprotocols caused the authors to reconsider some previously held assumptionsabout human subject protections in research on sensitive topics.© 2009 Elsevier Inc. All rights reserved.

ONDUCTING RESEARCH ON sensitive logical distress, (b) consistent monitoring of

From the College of Nursing, Kent State University,Kent, OH.

Corresponding Author: Claire Burke Draucker, RN,PhD, CS, Distinguished Professor, College of Nursing,Kent State University, Kent, OH 44242-0001.

E-mail addresses: cdraucke@kent.edu,dmartsol@kent.edu, clpoole@kent.edu

© 2009 Elsevier Inc. All rights reserved.0883-9417/1801-0005$34.00/0doi:10.1016/j.apnu.2008.10.008

C topics raises a number of ethical issues. Asensitive topic is “one that potentially poses for thoseinvolved a substantial threat, the emergence ofwhichrenders problematic for the researcher and/or theresearched the collection, holding, and/or dissemi-nation of research data” (Lee&Renzetti, 1993, p. 5).Topics are considered sensitive if identification ofparticipants would result in stigmatization, dissemi-nation of findings could harm a social group, or theresearch challenges values that people hold sacred(Lee & Renzetti, 1993). Another characteristic ofsuch research is the risk of inducing or exacerbatingemotional distress. Individuals who participate inresearch on traumatic or aversive events, forexample, may experience anxiety, depression,embarrassment, or acute stress reactions as theyrecall, reexamine, and reveal their experiences (Jorm,Kelly, &Morgan, 2007).

Professional organizations, governmental fund-ing and regulatory bodies, and institutional reviewboards require that researchers identify andminimize potential risks and ensure that thebenefits of the research outweigh these risks(Barnbaum&Byron, 2001). If, therefore, emotionaldistress is judged to be a risk, researchers mustdevelop strategies to minimize it. Several suchstrategies are identified in the literature: (a) employ-ing interviewers who are trained to handle psycho-

hiatric Nursing, Vol. 23, No. 5 (October), 200

participants' emotional reactions, (c) providingfrequent breaks during stressful data collectionprocedures, (d) debriefing, and (e) providing infor-mation on available psychological or social services(Griffin, Resick, Waldrop, & Mechanic, 2003;Hawton, Houston, Malmberg, & Simkin, 2003;Stanton & New, 1988).

Researchers conducting studies on emotionallycharged issues need to identify potential partici-pants who might be particularly vulnerable to harmand be prepared to respond to negative emotionalreactions that occur during the course of theresearch. Yet, the scientific and research ethicsliterature offers little practical guidance to assistresearchers in developing protocols to ensure theseprotections. We present two protocols that weredeveloped to address risks related to emotionaldistress in an ongoing, qualitative, community-

9: pp 343–350 343

344 DRAUCKER, MARTSOLF, AND POOLE

based study of adolescent dating violence. The firstprotocol is for telephone screening and can identifyindividuals at high risk of adverse emotionalreactions. The second protocol guides interviewer'sresponses to emotional distress expressed byparticipants during the research interviews. Thestudy is briefly described, and the process by whichthe protocols were developed is discussed.

THE STUDY

The research project is a qualitative study fundedby the Centers for Disease Control and Prevention(CDC). The aim of the study was to develop atheoretical framework that describes, explains, andpredicts how dating violence unfolds duringadolescence. The project is being conducted by acollaborative team of university- and community-based researchers. The research team includes fiveinvestigators (three university-based nurse re-searchers, the executive director of a domesticviolence/rape crisis agency, and a hospital-basedtrauma psychologist), two research associates(master's-level mental health clinicians), and aproject manager. Women and men between the agesof 18 and 21 years who are living in northeast Ohioand have experienced dating violence as adoles-cents are being recruited by fliers placed at publicsites in 12 socioeconomically diverse communities.In addition, the researchers are networking withsocial-service professionals and religious and com-munity leaders, many of whom are promoting thestudy to young adults with whom they work.

Young adults who are eligible and interested inthe study are invited to call a toll-free number. Theyare connected to a voice mailbox with a messagethat reviews the requirements, benefits, and risks ofparticipation. Callers are asked to leave theirtelephone numbers if they wish to participate. Aresearch associate contacts the callers, providesadditional study information, and conducts a briefscreening interview. If a person meets study criteria,an interview is scheduled in his or her community.During in-depth interviews, participants are askedto reflect back on their adolescence and describe thedating violence they experienced. Qualitative dataanalytical techniques are being used to develop thetheoretical framework.

In the grant application submitted to the fundingagency, the researchers indicated an intent toscreen out individuals for whom the interviewsmight be harmful:

The research associates…will conduct a brief telephonescreening interview with potential participants prior toscheduling an interview to rule out individuals who are…experiencing acute emotional distress that would makeparticipation risky (e.g., suicidality/homicidality, serioussubstance abuse, psychosis, or acute post-traumaticdistress). If individuals are excluded from the study, theywill be offered an appropriate psychological or socialservice referral. There are no other exclusion criteria.

The telephone screening guide included a briefscript advising individuals experiencing “significantstress or severe emotional distress” not to participatebecause the topic of dating violence was sensitiveand might bring up “tough” feelings. We then askedfour loosely structured questions to determinewhether individuals were experiencing significantstress, severe emotional problems, abuse in a currentrelationship, or thoughts of harming themselves. Inaddition, we inquired about prescribed psychiatricmedications and recent psychiatric hospitalizations.We also included a general question: “Are there anyreasons you can think of that might make participat-ing in interviews about your adolescent partnerviolence/mistreatment too stressful for you?” Weassumed that these questions would provide enoughinformation for the telephone screeners to determinewhether participants “were experiencing acute emo-tional distress that would make participation risky.”

We indicated in the grant application thatmaster's-level clinicians would conduct the inter-views and have a list community referralsavailable in the event that a participant becamedistressed or indicated a desire to pursue counsel-ing. In addition, one of the coinvestigators, who isa licensed psychologist at a hospital-based traumaprogram, was designated to assist participants whoneeded emergency treatment or requested ongoingcounseling. We did not have a detailed protocol toguide the interviewers in assessing and respondingto emotional distress that became apparent duringthe interviews.

Because it was possible that the research wouldproduce data related to illegal activities, such asperpetration of violence, the research applicationalso included a plan to secure a Certificate ofConfidentiality from the CDC. A Certificate ofConfidentiality is a legal document issued by federalagencies that exempts researchers from releasingidentifiable and sensitive information about partici-pants of a research (Barnbaum & Byron, 2001). Toobtain the certificate, we were required to provide

345DEVELOPING DISTRESS PROTOCOLS

detailed protocols that outlined specific proceduresto be used to manage emotional distress.

Because we could not find suitable models ortemplates of such protocols in the literature, weconstructed them by explicating and expanding onthe procedures outlined in the grant application. Inour beginning discussions about the content and theformat of the protocols, the research team raisedissues related to inclusion and exclusion ofvulnerable persons, how best to ascertain whethera person was to be enrolled or excluded, andappropriate strategies to manage participant dis-tress. We also examined the literature on emotionaldistress and research participation, consideredethical issues related to protecting participantsfrom emotional harm, and used team meetings toconstruct and refine the protocols.

Review of Research on the Risk of EmotionalDistress in Research on Sensitive Topics

Before constructing the protocols, we reviewedresearch on emotional distress and participation instudies on sensitive topics. A number of studieshave been conducted to determine the incidence ofemotional distress reported by participants inresearch on emotionally charged topics, such aspsychiatric illness, suicide, and trauma (e.g., Boot-hroyd, 2000; Boothroyd & Best, 2003; Dean, Stein,Jaycox, Kataoka, & Wong, 2004; Griffin et al.,2003; Hawton et al., 2003; Newman, Walker, &Gefland, 1999). Most studies queried individualsabout their reactions to the research at theconclusion of their involvement. Several compre-hensive reviews of these studies have beenconducted to guide researchers and regulatorybodies in decision making about risk protection.

A review of 46 studies that examined distressafter participation in psychiatric research waspublished recently (Jorm et al., 2007). The reviewrevealed that only a small minority of participants(b10%) in community and clinical samplesreported distress immediately after participation,and positive reactions were more common thanwere negative ones. Individuals most likely toreport distress were those who had mentaldisorders or were experiencing psychiatric symp-toms before their participation in the research.Although few long-term follow-up studies hadbeen conducted, available evidence indicated thatthere is little risk of lasting emotional harm fromparticipation in psychiatric research. A wide range

of perceived positive benefits were reported.These benefits included catharsis, an increase inself-awareness, a feeling of empowerment, a senseof purpose, and an opportunity to help others(Jorm et al., 2007).

A review of 12 studies of participants' appraisalsof their experiences in trauma-related research alsorevealed that most participants perceived benefitsfrom their involvement, and only a small subsetindicated some degree of marked or unexpectedupset (Newman & Kaloupek, 2004). Some parti-cipant characteristics associated with upsetincluded distress before participation, youngerand older age, multiple trauma exposure, socialvulnerability (e.g., minority status), and greaterphysical injury. Only a small subset of those whoexperienced distress regretted their participation orrated the overall experience as negative (Newman& Kaloupek, 2004).

In constructing the distress protocols, therefore,we were guided by findings that (a) mostparticipants tolerate research on sensitive topicswell; (b) most participants find benefit in participat-ing in research on sensitive topics; (c) a small groupof participants will experience marked or unex-pected distress; (d) responses that indicate distressdo not necessarily imply harm; and (e) although it israre, there are some participants, especially thosewho are distressed before participation, who reportnegative effects from participation.

RELEVANT ETHICAL ISSUES

The research team deliberated on several ethicalissues that were raised during the development ofthe protocol. The three broad principles of ethicalresearch identified in the Belmont Report of theNational Commission for the Protection of HumanSubjects of Biomedical and Behavioral Research(Department of Health, Education, & Welfare,1979) served as a basis for these deliberations.The three principles are autonomy, beneficence(and nonmaleficence), and justice (Barnbaum &Byron, 2001). Autonomy is the right to determineone's own life course. Researchers honor theprinciple of autonomy by providing sufficientinformation regarding the risks and benefits of theresearch so that individuals may freely accept ordecline participation. Beneficence is the promotionof the welfare of individuals; this principle alsoincludes nonmaleficence, the mandate to do noharm. To ensure beneficence and nonmaleficence,

346 DRAUCKER, MARTSOLF, AND POOLE

researchers are called upon to seek the greatestbenefit for research participants while minimizingharm. The ethical principle of justice requiresresearchers to equitably allocate the benefits andthe burdens of research.

Because the aim of the protocols is to protectparticipants from the harm, nonmaleficence was theprimary ethical principle involved in their devel-opment. To minimize the risk of negative emotionaleffects, the protocols needed to guide researchers in(a) identifying those who were particularly vulner-able to harm, (b) screening out those at high riskbased on exclusion criteria, and (c) intervening ifresearch participants became distressed during thecourse of the research.

As several researchers have pointed out, how-ever, efforts to protect participants from harm mayviolate the principles of autonomy and justice(Becker-Blease & Freyd, 2006; Newman & Kalou-pek, 2004; Newman et al., 1999; Stanton & New,1988). Exclusion criteria that are overly rigid orconservative or procedures that call for cessation ofa participant's participation at the first sign ofdistress, for example, may violate the principleof autonomy (Newman & Kaloupek, 2004). Byensuring that vulnerable persons are not exposed toharm, a researcher runs the risk of denying them theright to participate in a research study. Proceduresthat impose interventions on participants who areexperiencing distress, such as a “follow-up” call bya mental health professional made without theparticipants' request or consent, would also violatethe principle of autonomy (Stanton & New, 1988).

Procedures that decrease the risk of emotionalharm may also breach the principle of justice(Becker-Blease & Freyd, 2006). For example, if allindividuals who have a psychiatric disorder arescreened out because they are deemed vulnerable,they would not enjoy the rewards of the researcheither as individuals or as a group. As individuals,they would be denied the personal benefits ofresearch participation, which, according to theempirical findings discussed earlier, may be con-siderable. As a group, they would be denied thebenefits of scientific knowledge gleaned from theirexperiences. If no trauma studies are conductedwith those who are mentally ill, for example, littleknowledge would be gained about the effects oftrauma on mental health, thereby impeding thedevelopment of treatments that might improve thequality of their lives.

In constructing the protocols, therefore, wesought to balance autonomy, beneficence (nonma-leficence), and justice. We specified exclusioncriteria that promoted inclusiveness and excludedonly those at highest risk, designed screeningquestions that involved participants in risk assess-ment whenever possible, and identified minimallyintrusive strategies to reduce the risk of harm.

THE PROTOCOLS

Screening Interview and Distress Protocol

The screening interview and distress protocol ispresented in Figure 1. This protocol is being usedby research associates who conduct telephonescreening interviews.

The aim of the telephone screening is to screenout individuals for whom participation in theresearch interview would be too risky. Becausethe funding agency asked for a detailed protocol forthis screening, we sought to clarify our originalexclusion criteria and provide a clearer plan forassessing these criteria. We rejected the use ofpublished instruments, such as standardized psy-chiatric screening tools, as they did not offer theflexibility we needed to conduct the screening.

We deliberated about which indices wouldsuggest that participation in the study would be illadvised for an individual. We knew that a smallportion of individuals who participate in researchon sensitive topics would experience negativeemotional effects. Guided by the ethical principleof nonmaleficence, we aimed to develop criteria toidentify those callers at high risk of adversereactions. We also knew that most participants insuch research will not experience adverse reactions.Mindful of the ethical principles of autonomy andjustice, therefore, we aimed to develop criteria thatwould not exclude those who could safely partici-pate. On the basis of empirical evidence that thosemost likely to experience adverse reactions arethose in distress before participation, we deter-mined that individuals who were experiencingacute distress (regardless of past history) and/or ahigh level of stress at the time of the telephoneinterview would be screened out because theirdistress would likely be exacerbated if they foundthe interview upsetting. Individuals who hadrecently experienced a life crisis and were dis-traught would be excluded, for example, whereasindividuals who had a history of emotional

Fig 1. The screening interview and distress protocol.

347DEVELOPING DISTRESS PROTOCOLS

problems or who endured ongoing life stresses thatthey managed on a day-to-day basis would beincluded. Thus, Screening Question 1 prompts thescreener to ask individuals if they are experiencinga high level of stress or emotional distress. If anindividual answers “yes,” a series of follow-upquestions are used to determine whether the distressis currently interfering with the person's life in asignificant way. The participants' responses arerecorded on the protocol.

The second and third screening questions concernthoughts about suicidality or homicidality, whichare important indices of acute emotional distress andcould signal imminent danger. If an individualanswers “yes” to either of these questions, follow-upquestions are included to assess the acuity andseverity of these thoughts. Because the studyconcerns dating violence, the protocol includes afourth screening question to determine whether anindividual would be in danger if another person

348 DRAUCKER, MARTSOLF, AND POOLE

(e.g., the perpetrator) were to find out that he or shewas participating in the study. Follow-up questionsare provided for this issue as well.

The protocol requires the screener to makedeterminations about each potential participant'slevels of emotional distress and intervene accord-ingly. Interventions are based on the ethicalprinciples of nonmaleficence and autonomy; exceptin the event of imminent danger, potential partici-pants in distress determine which, if any, follow-uprecommendations they wish to pursue.

The protocol outlines three sets of interventionsfor the screener. If individuals do not answer any ofthe screening questions affirmatively, they areconsidered not to be in acute emotional distress orimminent danger. In this case, the protocol directs

Fig 2. The research interv

the screener to read a confidentiality statement andschedule an interview. If individuals answer any ofthe screening questions affirmatively and theiranswers to the follow-up questions indicate acutedistress or a safety concern but no imminent danger,the screener is directed to (a) not schedule aninterview, (b) recommend that the individual contacthis or her mental health care provider or the studypsychologist for follow-up, (c) offer a follow-up callfrom the study psychologist the next day, and (d)inform the study psychologist and principal inves-tigator. In the rare event that individuals respond tothe screening questions affirmatively and provideinformation in the follow-up questions that suggestsimminent danger, the protocol dictates that thescreener (a) contact local law authorities, (b) offer a

iew distress protocol.

349DEVELOPING DISTRESS PROTOCOLS

follow-up call from the study psychologist the nextday, and (c) notify the study psychologist and theprincipal investigator.

Research Interview Distress Protocol

The research interview distress protocol ispresented in Figure 2. This protocol is beingused by the research associates who conductresearch interviews.

In specifying procedures to be used if aparticipant experienced an adverse reaction duringthe interviews, we were guided by research findingsthat suggested that such reactions were rare butpossible and by the ethical principle of nonmalefi-cence. We anticipated that discussing experiencesof dating violence could be distressing for manyparticipants. Thus, we sought to design a protocolthat would help interviewers determine when suchdistress exceeded what would be normally expectedduring the course of an interview on a sensitivetopic and might signal an adverse reaction.Research findings suggested that participants whoexperience distress rarely regret participation orreport lasting harm. On the basis of that finding andthe ethical principles of autonomy and justice, weaimed to develop a protocol that would not hinderthe participation of individuals who are distressedbut unlikely to experience adverse reactions.

The research interview distress protocol requiresinterviewers to be aware of four indications ofacute emotional distress beyond what would beexpected in an interview on a sensitive topic: (a)statements or behaviors that suggest that theinterview is too stressful, (b) statements that reveala participant is considering hurting himself orherself, (c) statements that reveal that a participantis considering hurting someone else, or (d)statements that reveal a participant might be indanger if another person found out about theinterview. The protocol contains follow-up ques-tions that promote dialogue to reveal acuteemotional distress or imminent danger.

As with the screening interview and distressprotocol, three determinations can be made. If theinterviewer determines that a participant's distressreflects what would be expected in an interview ona sensitive topic, support is offered and theparticipant is provided an opportunity to stop,regroup, or continue. If a participant is in acuteemotional distress or imminent danger, the proce-dures are similar to those outlined in the screening

protocol, with two variations. For those participantswho are experiencing acute distress but are not atrisk of imminent danger, a call to the studypsychologist or mental health provider is suggestedif they feel that their distress worsens after theinterview. Because interviews are conducted inperson, the interviewer can have a participant whois in imminent danger contact a family member totake him or her to the emergency room, therebyavoiding having to contact the police.

DISCUSSION

We found the task of developing detailed distressprotocols time consuming and, at times, trying. Wediscovered, as did Newman and Kaloupek (2004),that “all researchers must accommodate individualdifferences in risk-benefit perspectives when con-structing study procedures…but they often lack areliable point of reference for decisions about howto do so” (p. 383). We had to operationalize somedecisions that had been previously based on theresearch associate's unarticulated clinical judg-ments. The challenge was to develop protocolsthat had enough specificity and detail for ourfunding agencies and regulatory bodies but did notprevent our clinically trained research associatesfrom making sound judgments based on eachunique situation.

The two protocols presented here, therefore,might serve as templates for those who researchsensitive topics and seek to outline procedures formanaging emotional distress. The delineation of theprocess by which we constructed the protocols,including a review of the empirical literature and adetermination of relevant ethical principles, mayalso inform researchers. We recognize that theprotocols will need to be empirically examined. Inthe course of the 3-year study, we will gather dataon their feasibility and utility.

In the process of designing the protocol, werevisited some of our assumptions about the risk ofemotional harm in research. As trauma researchersand clinicians, we had been particularly concernedabout the “Pandora's box phenomenon”—that is,that in-depth interviews about abuse may “unleashpainful emotions and memories” (Draucker, 1999.p. 162). Although this remains a legitimate concern,our literature search revealed that research onsensitive topics, including that on trauma, is welltolerated by most participants and that adversereactions are rare. Becker-Blease and Freyd (2006),

350 DRAUCKER, MARTSOLF, AND POOLE

for example, challenged the common assumptionthat research questions about abuse trigger trau-matic memories. They argued that it is more likelythat such memories are triggered by violenceportrayed in the media or sensory or sexualexperiences that mimic abuse experiences. Theyalso suggested that distressing questions are notnecessarily overwhelming or undesired and chal-lenged the notion that negative feelings are dangersfrom which participants need protection. Theyargued the following:

Even when the negative feelings evoked by researchare more closely associated with the experience oftrauma or abuse (e.g., feelings of betrayal or grief), thisis not necessarily an indication of psychological harm.Feelings like grief, anger, and fear in response toremembering a trauma may be a transitory negativestate that is understandable and not harmful. (p. 222)

The process of developing the protocols forcedus to balance consideration of the benefits ofresearch on sensitive topics against the risks; theethical principles of autonomy, justice, and non-maleficence; and the strengths, resiliency, andvulnerability of participants.

ACKNOWLEDGMENT

Researchwas fundedby theCDC,NationalCenterfor Injury Prevention and Control (Donna Martsolf,principal investigator, 1RO1CE001183-01).

REFERENCES

Barnbaum, D. R. & Byron, M. (2001). Research ethics: Text andreadings. Upper Saddle River, NJ: Prentice Hall.

Becker-Blease, K. A. & Freyd, J. J. (2006). Research participantstelling the truth about their lives: The ethics of asking and

not asking about abuse. American Psychologist, 61(3),218–226.

Boothroyd, R. A. (2000). The impact of research participation onadults with severe mental illness.Mental Health ServicesResearch, 2(4), 213–221.

Boothroyd, R. A. & Best, K. A. (2003). Emotional reactions toresearch participation and the relationship to under-standing informed consent disclosure. Social WorkResearch, 27(4), 242–251.

Dean, K. L., Stein, B. D., Jaycox, L. H., Kataoka, S. H.8&Wong,M. (2004). Acceptability of asking parents about theirchildren's traumatic symptoms. Psychiatric Services, 55(8), 866.

Department of Health, Education, and Welfare. (1979). TheNational Commission for the Protection of HumanSubjects of Biomedical and Behavioral Research: TheBelmont Report. Retrieved on July 21, 2008, from http://ohsr.od.nih.gov/guidelines/belmont.html.

Draucker, C. B. (1999). The emotional impact of sexual violenceresearch on participants. Archives of Psychiatric Nursing,13(4), 161–169.

Griffin, M. G., Resick, P. A., Waldrop, A. E.8&Mechanic, M. B.(2003). Participation in trauma research: Is there evidenceof harm? Journal of Traumatic Stress, 16(3), 221–227.

Hawton, K., Houston, K., Malmberg, A.8 & Simkin, S. (2003).Psychological autopsy interviews in suicide research: Thereactions of informants. Archives of Suicide Research, 7,73–82.

Jorm, A. F., Kelly, C. M.8 & Morgan, A. J. (2007). Participantdistress in psychiatric research: A systematic review.Psychological Medicine, 37, 917–926.

Lee, R. M. & Renzetti, C. M. (1993). The problems ofresearching sensitive topics: An overview and introduc-tion. In C. M. Renzetti & R. M. Lee (Eds.), Researchingsensitive topics (pp. 3–13). Newbury Park, CA: Sage.

Newman, E. & Kaloupek, D. G. (2004). The risks and benefits ofparticipating in trauma-focused research studies. Journalof Traumatic Stress, 17(5), 383–394.

Newman, E., Walker, E. A.8&Gefland, A. (1999). Assessing theethical costs and benefits of trauma-focused research.General Hospital Psychiatry, 21, 187–196.

Stanton, A. L. & New, M. J. (1988). Ethical responsibilities todepressed research participants. Professional Psychol-ogy, Research, and Practice, 19(3), 279–285.