INTERNET RESEARCH AND ETHICS: TRANSFORMATIVE ISSUES IN NURSING EDUCATION RESEARCH PAMELA YOUNG MAHON, PHD, RN, ANEF, CNE, NEA-BC⁎ As practice in the educational and clinical settings seeks to be evidence based, faculty are increasingly required to conduct research and publish the results to advance the science of our profession. The purpose of this article is to discuss transformative research ethics because Internet use is an increasing component of current research studies. How nurse educators can engage in research-utilizing methodologies inclusive of technology while adhering to ethical standards developed before the advance of the Internet is reviewed. Recommendations are cited to address the new questions that arise at institutional review board meetings resulting from potential ethical implications of using students or research participants in cyber space. (Index words: Internet research ethics; Nurse researchers; Nurse educators) J Prof Nurs 30:124–129, 2014. © 2014 Elsevier Inc. All rights reserved.

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S NURSING FACULTY, we assume many roles: teacher, clinician, researcher, school citizen, and affiliate liaison. Because practice in the educational and clinical settings seeks to be evidence based, faculty are increasingly required to conduct research and publish the results to advance the science of our profession. How do nurse educators engage in research utilizing methodologies inclusive of technology while adhering to ethical standards developed before the advance of the Internet? The purpose of this article is to discuss transformative research ethics because Internet use is an increasing component of current research studies. New questions arise at institutional review board (IRB) meetings resulting from potential ethical implications of recruiting and using research participants in cyber space.

Conducting survey research and asking questions, however seemingly benign, constitute human participant interaction. The history of research is replete with instances of abuse and atrocity. Prompted by the grave wrongdoings of the Tuskegee Syphilis Study (1932– 1972), the Stanford Prison Experiment (1971), and the Milgram Study (1974), IRBs were given federal regulatory status in 1974 and revised in 1981 by the Department of Health and Human Services. The resulting CFR: Title 45 (Public Welfare) Part 46 (Protection of Human Subjects) is today referred to as 45 CFR Part 46 or the “Common Rule.” The CFR primarily addresses biomedical and behavioral research and applies directly to all federally conducted or funded research. The CFR is concerned with six major areas of research that address risk reduction and safety:

Human participant research is defined by the Code of Federal Regulations (CFR) as that which involves any intervention or interaction with another person for gathering information or in which information is recorded by researchers in a manner that holds the potential for a person to be identified (CFR, 2001).

▪ Minimize participant risks through sound research methodology [46.111a(1)] ▪ Risks appropriate to benefits [46.111a(2)] ▪ Equitable subject recruitment [46.111a(3)] ▪ Informed consent [46.111a(4) and (5)] ▪ Monitor data for participant safety [46.111a(6)] ▪ Appropriately protect privacy and confidentiality of participants [46.111a(7)]

∗Associate Professor, Hunter-Bellevue School of Nursing, Hunter College, CUNY, New York, NY. Address correspondence to Dr. Mahon: 215 – 93rd Street, Brooklyn, NY 11209–6805. E-mail: [email protected] 8755-7223/13/$ - see front matter

The most recent revision to the Common Rule was in 2005, and the Office of Human Research Protections is collecting comments as part of the plan to overhaul research regulations.

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124 http://dx.doi.org/10.1016/j.profnurs.2013.06.007

Journal of Professional Nursing, Vol 30, No. 2 (March/April), 2014: pp 124–129 © 2014 Elsevier Inc. All rights reserved.

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Along with the development of IRBs, the National Commission for the Protection of Human Subjects issued the Belmont Report in 1978 to ensure that the rights and welfare of human participants of biomedical and behavioral research are protected. The document outlines that research on humans must take care to respect autonomy—free will, beneficence—minimizing harm and preserving privacy and justice toward human participants. Boundaries must be established between the practice of accepted therapies and those deemed research. Belmont Principles of respect, beneficence, and justice are to be applied when conducting informed consent, risk/benefit assessment, and the selection of research subjects (Lewis, Gonzalez, & Kaufman, 2011). Both the Belmont Report and the CFR recognize limitations and offer rationales for exceptions from general requirements, for example, when it is understandable and allowable not to seek informed consent. Both documents were created prior to the Internet and offer general principles and practices rather than instructions about specific media. Individual IRBs can go overboard with them as applied to Internet research and contribute to the view of university IRBs as a major obstacle to research progress (Stark, 2012). Guiding documents for Internet research ethics include Ethical and Legal Aspects of Human Subjects Research on the Internet (American Association for the Advancement of Science, 1999), Ethical and Policy Issues in Research Involving Human Participants (Frankel & Siang, 1999; National Bioethics Advisory Board, 2001), and Ethical Decision Making and Internet Research (Ess & AoIR Ethics Working Group, 2002).

Human Participant Research in a Digital Age In their research on U.S. IRBs, Buchanan and Hvizdak (2009) found that the overwhelming majority (94%) of respondents stated that the most frequently reviewed type of research was on-line survey research. This is understandable in light of the many advantages of on-line survey research, which readily and conveniently opens access to large numbers of potential participants while still maintaining low cost regardless of numbers of participants. On-line surveys are flexible when compared with traditional mail surveys, yet similar to CATI telephone surveys where the researcher can pose different questions to people depending on their response to previous questions. On-line survey administration is less error prone because data are compiled automatically, so there is no need for human keying or transcription of data. Furthermore, study data are compiled in real time, so the researcher can begin to see results almost instantaneously. On-line survey research also has numerous disadvantages. On-line surveys are characterized by low response rates. There is also response bias when the same individual answers the same on-line survey multiple times. These problems may be mitigated when a previously identified sample of individuals is invited to

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participate in an on-line survey, for example, a textbook publisher surveying nursing faculty can issue passwords for accessing a site, and Internet protocol (IP) addresses can be tracked. Perhaps, the greatest disadvantage is external validity and the generalizability of the findings from an Internet sample. There is a lack of control over the research environment: using on-line surveys means that there is no face-to-face communication, and so, obtaining informed consent presents different kinds of challenges. What do we do if someone assumes a different on-line identity, for example, how do we identify underage participants? “At present there are no reliable methods for determining the age of internet users” (CITI, 2009). There is also no way to prevent someone else signing on to another's Facebook page. Yet, the CFR stipulates that human participants' research must provide benefit either to participants or to scientific understanding, and there can be no benefit unless data are valid and reliable. Despite these serious issues, over one third of respondents in the Buchanan and Hvizdak (2009) did not regard the privacy and security policies of commercial tools as part of their protocol review process. Security is poor in commercial products, and data are not safe. Even Apple has been breached: within days of the 2010 launch of the first iPads, AT&T servers were hacked, and personal data belonging to 120,000 iPad users were stolen. To address security problems, institutions such as Georgia Tech (http://www.cc.gatech.edu/~asb/ethics/) and Marian University, Wisconsin (http://www. marianuniversity.edu/interior.aspx?id=13714), have developed guidelines for Internet research. Loyola University has an on-line survey research policy and has created a checklist to screen survey software systems for approved use (http://www.luc.edu/irb/irbonlinesurveys2.shtml). A few institutions are attempting to create their own on-line survey software, but this remains uncommon. It has been recommended that an open source tool collaboratively developed by an academic consortium would be better than commercial products to stop the “outsourcing of research” (Buchanan & Hvizdak, 2009). It is critical that the researcher realize that research methods are research ethics and be able to articulate why using the Internet is required in meeting the research aims. Ease and convenience of data collection are insufficient reasons for using the Internet. The CFR and the Belmont Report were developed pre-Internet, and so, the ethics of on-line surveys are different from traditional research ethics to the extent that they are not comparable, much like “apples and oranges.” Instead, researchers and IRBs must consider how best to translate ethics from one environment to another (Buchanan & Hvizdak, 2009). Regulations that do not strictly translate must be applied metaphorically. Spirit and intent, not letter, often must be used to interpret digital equivalents, for example, locked file cabinet and signed consent. IRB panels make individualized, case-by-case decisions often based on local institutional history (Stark, 2012). Panels are not always equipped to understand nuances of Internet data

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security issues, which is why IRBs typically have information technology (IT) consultants (Buchanan & Ess, 2009). Researchers benefit from university policies informed by best practices in ITs, as guidance in conducting studies.

Key Issues Informed Consent Informed consent, forced choice/required answers, and data security are ongoing issues for the conduct of Internet research. The CFR defines informed consent as documented by the use of a written consent form approved by the IRB and signed by the participant or the participant's legally authorized representative. A copy shall be given to the person signing the form. Signature collection is not practical in most of the on-line research settings. Digital signatures are a way to verify that an email message is really from the person who supposedly sent it and that it has not been changed (US-CERT, 2009). However, the vast majority of the population is not set up for federally recognized digital signatures, to the extent that at this writing not even the IRS uses them. So how can we overcome these obstacles to obtaining written consent when conducting on-line research? Make the digital requirements for the consent form identical to paper requirements: the consent form is the first page of the on-line survey, and all the required elements of consent must be presented before the participant enters the survey page. In place of the traditional signature line, a check box selection for “agree/disagree” or “yes/no” states, “I have read the above consent form. I am at least 18 years of age. I have asked any questions I may have and have received answers. I consent to participate in this study.” An affirmative answer is required to move forward in the survey. For an IRB application, this procedure must be explicitly explained for every project. While technically the IRB can waive consent or elements of the consent, ethical consent should never be waived.

Forced Choice IRB regulations tightly restrict a researcher's right to require a participant to answer a question. Face-to-face “required answers” are different from on-line “forced choice.” Participants cannot really be forced to answer a question on-line—respondents usually just stop answering the survey. With advances in software, forced choice/ required answers are becoming more infrequent. Consent to participate in research is an ongoing process; therefore, participants should be allowed to skip questions or choose “no response” or “NA.” Informed consent requires that the researcher explicitly state in the consent document that a participant may leave the survey at any time without penalty.

Privacy State institutions are subject to open records/open access law in state e-mails. Public institutions and their e-mails are public, and this needs to be made clear in the written

consent form. The first duty of a researcher is to honor the promise of confidentiality. In an age of rapidly improving hacking and security bypasses and backdoors, there is no guarantee of a truly secure on-line interaction. Anonymity cannot be assured with an on-line survey, but every effort must be made to keep confidentiality. For the clinical researcher, if “e-betty” is portrayed on an electronic support group for a medical condition, will “she” be identifiable and at what risk (Buchanan, 2010)? How should on-line participants be identified in research reports given the “track-back-ability” of on-line data? Screen names do not solve all problems—if the researcher changes the participant's original screen name, does that name change detract from the reality of the participant? Text searches can reveal more context than a researcher may in her reporting. Tracking IP addresses, third party access, auto fill-ins, public Internet terminals, and ownership of data contribute to a situation where research participants can be easily identified. “Even if the researcher deletes all personal information, powerful search engines can index Web pages so that the original message, including the email address of the sender, could be retrieved by anyone using the direct quote as a query” (Cohen, 2006). The following statement on an informed consent alerts the participant to actual or potential breach of confidentiality: “As an online participant in this research, there is always the risk of intrusion by outside agents, i.e. hacking, and therefore the possibility of being identified.” Listservs, blogs, and chat rooms are viewed as public spaces and present problems especially when exploring sensitive issues such as medical conditions. The role of researcher in the space must be clearly demarcated as observer, participant, or member. A complication of using these public on-line spaces is that, in traditional research, the researcher assumes responsibility for protecting the participant identities, but in on-line research, the researcher may not be solely responsible. The researcher using a listserv must consider how best to protect the privacy of those who do not consent to participate in the study. Those who do not consent and do not participate are still in contact with those who do consent, thereby making their communications accessible to the researcher. A properly executed informed consent must plainly state the inherent “shared” condition of the listserv. Common, public Internet spaces need greater protection, and amplifying community decision making may lead to communal consent as the new norm. Work surveillance issues arise in the administration of on-line competency surveys—which level of workers and how many workers know the respondents' scores? Does right to privacy outweigh the need to assess competence? The right for an employer to measure competence usually outweighs the right to worker privacy in the on-line work “setting.”

Data Security The traditional gold standard of data security consists of data stored in a locked file cabinet, housed in a locked

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office. The office key is given only to those who need it, and the file cabinet key is given only to the researcher(s) who absolutely must have access (Lindsay, 2008). The physical security of such traditional methods is characterized by multiple layers of protection from outsiders and strict control of who has access. Yet, locks can be broken, and file cabinets can be moved. There is always a need for stronger security. Digital equivalents to the locked room/file include multiple layers of protection, most importantly, encryption of all data. Secure Socket Layer protocols and Secure File Transfer protocols are essential to keep data secure over the Internet. The survey must use https encryption, not just http. Regarding the server, there should be a dedicated database server for on-line research that has no unnecessary services or jobs. The dedicated server only accepts connection from the dedicated Web survey server. Identifiable data should be collected on a separate server. Cost, however, is often an obstacle to this ideal use of a separate server. Firewall and password protection are all part of industry standards and institutional regulations (Geller, Boyce, Ford, Sugarman, 2010). All identifiers must be removed and segregated from survey data, for example, if using a personal computer, the IP address essentially identifies the participant— under HIPAA, an IP address is an identifier. The IP address must be removed and stored on a separate server. This can be done with dynamic IP addressing systems that “anonymize” the data because it is pulled from the Web site and stored in a database (Lindsay, 2008). Claims that survey participation is anonymous cannot be made because there is no completely secure interaction on-line. A text within Google can often point to a source and thus a person. The following disclaimer is offered as part of all Internet research participants' protection: “As an online participant in this research, there is always the risk of intrusion by outside agents, i.e., hacking, and therefore the possibility of being identified” (Buchanan & Hvizdak, 2009).

Ownership of the Surveys and Data Survey Monkey is the dominant purveyor of on-line survey instruments and is the owner of the tools used to build surveys and analyze the data. On their Web site, Survey Monkey states that “You are the sole owner of, and are accountable for, the information created and collected using our system…NOTE: We will not use your survey, or the information collected from your surveys, in any way other than as described in our Privacy Policy. We will make every effort to ensure that whatever information you provide will be maintained in a secure environment” (Survey Monkey, 2011). In an age of ever-sophisticated on-line hacking and theft, there are no guarantees of absolute security. Alternatives to on-line research must remain an option when research presents special risks (Garrick, 2009). Methodological issues, including use of the Internet to collect data, are ethical issues (Walther, 2002). Research involving highly personal or sensitive topics that may cause adverse

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emotional or psychological reactions should not be subject to Internet transmittal, nor should research that presents more than minimal risk, or involve vulnerable populations. Research that involves deception and, therefore, increased risk to participants, requires debriefing and is not appropriate for Internet research. The use of Internet research cannot be approved when waiver of documentation is sought (Garrick, 2009).

Educational Research In 2008, researchers publicly released data from Facebook accounts of a study exploring how race and cultural tastes affect relationships of college students (Lewis, Kaufman, Gonzalez, Wimmer, & Christakis, 2008). The data set was composed of machine-readable files of virtually all the information posted on 1,700 Facebook profiles by an entire cohort of students at a northeastern American university. Profiles were sampled at 1-year intervals, beginning in 2006. The source of the data, that is, the college, was quickly identified, as was the student cohort itself—every member of the freshman class (Parry, 2011). The numerous conceptual gaps in the researchers' understanding of privacy risks quickly emerged: the nature of consent, properly identifying and respecting expectations of privacy on social network sites, developing sufficient strategies for data anonymization prior to the public release of personal data, and the relative expertise of IRBs when confronted with research projects on social media. Anonymity was breached immediately because the Facebook friend network is like a fingerprint. No two networks will be similar. Favorites were also collected, allowing their identification. Further identification was possible from the listing of student nationalities and majors. Within days of its public release, the source of the data set was identified as Harvard, and the identification of the source did not require access to the full data set—only Harvard offered the specific variety of majors listed in the codebook and its unique method for assigning undergraduate housing. All data were cleaned and de-identified, and the study had received IRB approval because, in part, the roster of names and ID numbers were maintained on a secure local server accessible only by authors. However, it was easy to piece together random bits of information to deduce a participant's identity simply by gender, race, ethnicity, hometown, and major. The codebook revealed that a number of states had only a single student in the data set. To add to the confidentiality breach, the IRB did not recognize that using an innetwork research assistant to pull data could circumvent privacy settings intended to keep that data visible only to other Harvard students. It seems that the Harvard IRB failed to recognize that individuals with unique characteristics could easily be extracted from the data set and be identified. Again, Facebook is a public space, and the data on it are considered public (Zimmer in Parry, 2010).

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In another well-publicized Facebook study breach of privacy, two students in a course on Internet ethics and law at MIT designed a computer program to look at profile information including gender and sexuality of a person's Facebook friends and analyzed the information to predict the person's sexuality (Terris, 2009). The students called the program “Gaydar” and admitted that the experiment highlighted the risk of how information can be inadvertently shared. The University of California at Berkeley initiated a “Bring Your Genes to Cal” program, where students can voluntarily submit deoxyribonucleic acid (DNA) samples to be screened for three genetic markers (Jabr, 2010). The state Department of Public Health has ruled that because students would have been granted access to their own DNA test results, the program was subject to regulations regarding clinical diagnostic tests. Berkeley biology professors argued that their DNA project should be exempt from the diagnostic-testing ruling because it served an educational rather than a medical purpose: “Who has the authority to tell people what they have the right to know about themselves?” (Kowarski in Jabr, 2010).

Nursing Education Research Nursing education is characterized by the use of rapidly evolving technologies including simulation, virtual worlds, on-line education, and electronic charting. The benefits of these technologies must be supported by evidence acquired through research. Nursing pedagogical research, of course, involves research with students. There must be avoidance of coercion, protection of participants, and the assurance of student rights. However, the dual roles of educator and researcher create role conflict during the data collection process (Ferguson, Yonge, & Myrick, 2004). Faculty researchers hold power over students in the teaching relationship, especially in a preprofessional licensure program. To uphold their fiduciary relationship, faculty cannot collect data from their own students. In this relationship, students are not able to give voluntary consent because they are considered vulnerable, even captive, and thus protected by the Nuremberg Code (Ferguson, Yonge, & Myrick, 2006). To ethically involve students, research teams can be used, and a nonteaching faulty or research assistant can mitigate potential conflict. Incentives should be used with caution. Offering money is questionable because of student need. The option to earn extra credit should be offered to all students, not just those participating in the research (Ridley, 2009). If possible or practical, newly graduated students can be surveyed after final grades are submitted, posted, and students officially awarded the terminal degree. Informed consent cannot be “backed in” or obtained “post-hoc” for journals, blogs, or other confidential sources. When the study is longitudinal, use large samples and “continuing consent” at each data collection point to obtain students continued willingness to participate (Ferguson et al., 2006).

Recommendations for Nursing Research in Education and Practice IRBs and nurse researchers should use the Belmont Principles to model the ethical conduct of research. Im and Chee (2004) aligned five specific aspects of the Belmont model to guide the protection of individuals participating in Internet research: anonymity or confidentiality, security, self-determination and authenticity, full disclosure, and fair treatment. Longo (2010) recommends that studies be conducted, which compared traditional pen and paper instruments with an on-line format to see what issues arise in participant response rates and the equivalence of the instrument format. Watson, Jones, and Burns (2007) have developed an eight-step decision tree when researchers are using archived e-mails, discussions, or blogs. Perhaps, the most useful set of recommendations for researchers and IRBs is the compilation of the following questions to use as a protocol when reviewing a research proposal's informed consent (Easter, Davis, & Henderson, 2004) and Internet considerations (Cohen, 2006): ▪ Assess sensitivity of information, length of time information is being held, usefulness of the information collected, and ability to protect information. ▪ Do not collect, hold, or disclose information in identifiable form unless identifiers are essential to the purpose of the research. “It is worth the saving in anguish, recrimination, and liability to make the effort to remove identifiers, or limit their availability, to prevent an accidental, malicious, or legally compelled disclosure” (Fischbach & Klitzman, 2006). ▪ When research is conducted across multiple sites, review how information is being protected. Identify and limit number of people having access to the data, particularly when data are being transferred across locations, and be aware of when data are reproduced in other formats, such as faxes or computer files. Make sure that duplicated information is properly destroyed when transferring data. ▪ If a protocol is up for a continuing review, ensure confidentiality procedures by reexamining the protection of sensitive information and the success of the protection efforts. ▪ Assess the risks of exposure of the research participant's identity during data gathering, data dissemination, and publication. ▪ Because Internet users often use pseudonyms, guard against the possibility of recruiting vulnerable populations such as children into your study. ▪ Be cautious when you quote directly from on-line conversations and stories. Informed consent is always needed when using verbatim quotes. ▪ Security procedures should be standard practice whenever conducting research using databases that include identifiers. Protections should include the encryption of the data, authentication, and authorization of passwords for those who have access to the

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data, software security, firewalls, and electronic and physical security of data storage devices and networks. When nurse researchers navigate the complexities of regulations and protections, it is best to remember that respect for the dignity of research participants, professional ethics, good judgment, and common sense remain principal strategies for protecting privacy and maintaining confidentiality (Fischbach & Klitzman, 2006.

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Internet research and ethics: transformative issues in nursing education research.

As practice in the educational and clinical settings seeks to be evidence based, faculty are increasingly required to conduct research and publish the...
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