Research Methods
Institutional Review Boards and Peer-Reviewed Publication
Health Environments Research & Design Journal 2015, Vol. 8(2) 81-84 ª The Author(s) 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/1937586714567647 herd.sagepub.com
D. Kirk Hamilton1 and Jaynelle F. Stichler2
Health Environments Research & Design (HERD) requires authors to provide a copy of an approval letter from an Institutional Review Board (IRB) when the study involves human subjects. Some authors from countries outside of North America, or from nonacademic roles in practice, may have little or no experience with an IRB and wonder how to meet the journal’s requirements. The Code of Federal Regulations, Title 45, of the Department of Health and Human Services (DHHS) outlines the basic policy for the protection of human research subjects (http:// www.hhs.gov/ohrp/humansubjects/guidance/45cfr 46.html). Essentially, all research and evidencebased practice projects that are conducted in academic settings or in health care organizations are subject to this Code, requiring a review of the research proposal and its methods by an IRB, ethics board, or an administrative review board at the organization.
Abuses of Human Subjects in the Past Have Led to Formal Protections The sad history of research that tragically abused human subjects ultimately led to the imposition in the United States of IRBs and ethics boards. The 20th century included a number of prominent examples of abuse, as was the case in which Nazi and Japanese physicians conducted cruel and inhumane experiments on living persons during World War II. In the United States, the long running Tuskegee Syphilis Study (1932–1972)
conducted by the U.S. Public Health Service (Centers for Disease Control and Prevention, 2013) examined the natural progression of untreated syphilis among African American men without their knowledge. The subjects believed they were receiving free treatment. Radiation experiments on unsuspecting citizens were conducted by the U.S. government during the Cold War. The Soviets may have done the same thing. The Central Intelligence Association (CIA) is known to have been involved in mind control studies that included brainwashing and administration of experimental drugs without consent. Government-sanctioned abuses were not the only problems. Controversial projects were undertaken by faculty at universities. Prominent examples include the studies of obedience to authority by Yale psychologist Stanley Milgram involving the apparent administration of electric shocks by student subjects to other students to test the dangers of obedience to authority figures (Encina, 2004; Milgram, 1974). Professor Philip Zimbardo (Cherry, 2014) at Stanford studied behavior of students assigned to roles as prisoners or guards in a mock prison in the basement of the psychology building. This notorious experiment
1 2
Texas A&M University, College Station, TX, USA San Diego State University, San Diego, CA, USA
Corresponding Author: D. Kirk Hamilton, Texas A&M University, College Station, TX 77843, USA. Email: [email protected]
82
led to physical torture and psychological abuse of the student prisoners from the student ‘‘prison guards.’’
The National Research Act and Belmont Report The National Research Act of 1974 created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In response to outrage over the Tuskegee study that had ended in 1972, it proposed development of guidelines for human subject research and to regulate human medical experimentation. Four years later, the Commission issued the Belmont Report (Department of Health & Human Services, 1979) that summarized guidelines for research involving human subjects based on ethical principles. The following three core principles were identified by the Belmont Report: (1) respect for persons, meaning their respected autonomy and consent; (2) beneficence or not doing harm while maximizing benefits; and (3) justice, meaning fair administration of reasonable, nonexploitative, and well-considered procedures. The three primary areas of application are informed consent, assessment of risks and benefits, and selection of subjects. The Belmont Report has led to the formalization of ethics boards that may have existed, as well as the creation of new entities. Federal regulations now set out requirements for the membership and composition of IRBs, ethics boards, or administrative review boards, including provisions for diversity in experience, expertise, and institutional affiliation. The minimum number of members is five, which must include both men and women, at least one scientist, and at least one nonscientist.
Protection of Human Subjects in the Consenting Process The DHHS defines human subjects as any living individual about whom the researcher obtains data through observation, recordings, interaction (interviews, focus groups, or other types of interpersonal contact), or intervention such as a request for the individual to complete a questionnaire or survey.
Health Environments Research & Design Journal 8(2)
Additionally, any time that an individual is asked to provide any private information whereby they might be individually identified, their voluntary consent for participation is required. A waiver of written consent may be allowed if the data collection tools are anonymous and there is no identifying information requested, if the use or disclosure of information involves no more than minimal risk to the privacy of participants, or if the research activity cannot practically be carried out without such a waiver. In some instances, a letter of explanation about the purpose of the research and what is expected of participants can be provided indicating that their consent to participate is implied with the completion of any survey questionnaires or involvement in focus groups. It is imperative that the participants’ name, date of birth, address (physical and or e-mail), telephone numbers, Social Security numbers, or any other type of traceable information not be included or requested on any form or questionnaire. If a written consent is required, the IRB will expect that the participants are voluntarily consenting without any undue influence, coercion, or threats of any nature. The IRB will require some type of letter of the explanation or information that is written in a manner that will be understandable to the participants and will include the phone number of the IRB should the participant have any questions, concerns, or complaints related to the study process. NonEnglish participants must have a letter of information and their consent forms written in their first language. There are also specific rules for consenting participants who are incapable of comprehending or reading the consent form because of their age, health condition, or cognitive impairment. The readers should familiarize themselves with the rules related to observing or data collection involving minors or other individuals who may be vulnerable because of their inability to understand the intent of the research or data collection methods or to provide consent for their involvement. For architects and designers, this might include recorded observations of children involved in therapeutic healing gardens or other specifically design spaces that are under investigation for their effectiveness in improving human outcomes.
Hamilton and Stichler
Recruitment of Human Subjects for Research Studies IRBs are interested in how potential subjects will be identified and recruited for the study. Subjects can be recruited to participate in studies through personal contact with the researcher; referrals to the researcher from other individuals such as physicians, nurses, other care providers in health care settings or students or professors in academic settings; databases previously given to the researcher; advertising through recruitment letters, posters, or brochures; or other written or verbal screening materials such as web-based questionnaires or telephone calls. As an example, an IRB would be interested if an architect solicited intensive care unit nurses to participate in focus groups discussing their perceptions of design features that would promote patient safety. It would be important for the architect researcher to inform the IRB how the subjects would be specifically recruited, how their identities would be protected, how they might opt out of the study if they decided not to participate, and if they would be given any financial incentives to participate. The IRB would also want to be informed how the information collected would be de-identified to protect the subjects and how the data will be stored, analyzed, and disseminated to internal (feedback to the hospital) and external audiences (presentations at conferences). It should be noted that in this example, the IRB might be interested in how the identities of the nurses might be protected from internal feedback to hospital leaders who could sanction them for reported behavior or expression of opinion.
HERD’s Expectations for the IRB Process For all research studies, employing quantitative, qualitative, and observational or survey methods, HERD requires an approval from the institution where the subjects are located as the basic requirement for institutional review. A copy of the official approval letter from the institution’s IRB, ethics board, or administrative review board is to be provided to HERD and should be uploaded as a scanned document in the
83
electronic submission process. If the study is based at a university, a copy of the official approval letter from the academic institution whose faculty or students are involved is also to be provided to HERD. In addition to the uploaded approval form in the submittal process, HERD requires that the author indicate in the text in the beginning of the ‘‘Methods’’ section that the study was approved by an IRB, ethics board, or the organizational administrative review board. A sample sentence might be ‘‘IRB approval was received prior to the initiation of the study.’’ Researchers should be aware that IRB or ethics board approvals must always precede data collection. Experienced researchers know how unexpected waiting for approval to initiate data collection may disrupt planned research schedules, but initiating data collection without prior approval is a serious infraction. Studies that demonstrate minimal or no risk to subjects may be granted expedited review by an IRB, making the approval process faster. HERD does not require IRB approval for theory papers, opinion papers, systematic reviews of the literature, or secondary data analyses from a previously approved study, so long as there is no protected health information or identifying information in the data set.
Certification Courses in the Protection of Human Subjects Many organizations require that researchers provide certification of their knowledge and competence of federal guidelines in protecting human subjects. There are several bodies where individuals can take an online tutorial and test resulting in a certificate that can be sent to the IRB or ethics board, along with their proposal and application for approval to conduct the research in that organization. Such certification indicates that the researcher has received formal training related to protection of human subjects. Certification of competency is a requirement for all academic settings and most health care organizations that participate in clinical research. Certification courses for the protection of human subjects may be obtained from the National Institutes of Health at https://phrp.nihtraining.com/users/
84
login.php. Another website providing similar online tutorials and certification is from the Collaborative Institutional Training Initiative (CITI) at the University of Miami for courses that can be accessed at https://www.citiprogram.org/. One need not be associated with the University of Miami to acquire their certification.
Situations When an IRB Is Not Available In some situations, especially for international research, there may not be an IRB to approve the study. Some countries offer an equivalent model. In the case of professional firms, individual design practitioners, corporate entities, nonacademic institutions, research organizations, or nations without a tradition requiring institutional review to protect human subjects, HERD asks the researchers to seek other methods of independent review. These independent reviews should come from an external source that might include research councils; ethics boards; or independent, freestanding, nonaffiliated IRBs. There are independent, commercial services provided by organizations like the New England Institutional Review Board in Newton, Massachusetts (http:// www.neirb.com/), the Copernicus Independent Review Board in Durham, North Carolina (http:// www.cgirb.com/), the Quorum Review IRB of Seattle, Washington (http://www.quorumreview. com/), or the IntegReview organization of Austin, Texas (http://www.integreview.com/). No endorsement is intended; these are simply examples to show that one can pay for an independent review if there is no IRB associated with the study site or institution of the researcher. At the absolute minimum, the researcher should have written administrative approval from the institution whose staff or patients might be involved. Such an approval should make it clear that the organization has carefully considered all the potential risks to human subjects that may be part of the study. The readers are referred to the International Section of the Office for Human Research Protections of the DHHS to review the International Compilation of
Health Environments Research & Design Journal 8(2)
Human Research Standards (Department of Health & Human Services, 2014) for detailed information for research ethics websites listed by country and topic.
Conclusion As initially indicated, HERD requires authors to provide a copy of an approval letter from an IRB, ethics board, or administrative review board when the study involves human subjects. There are standardized ways in which North American academic institutions and health care organizations require IRB approvals to be acquired. For international researchers, nonacademic practitioners, and study authors, alternate forms of ethical review can ensure that research subjects are provided the maximum protection through review of the proposed study’s methods and protocols by an independent entity composed of persons qualified to consider the ethical and scientific issues of each unique study. HERD subscribes to this noble goal. References Centers for Disease Control and Prevention. (2013, December 10). U.S. Public health service Syphilis study at Tuskegee. Retrieved November 21, 2014, from http://www.cdc.gov/tuskegee/timeline.htm Cherry, K. (2014). The Stanford prison experiment: An experiment in the psychology of imprisonment. Retrieved November 22, 2014, from http://psychology.about.com/od/classicpsychologystudies/a/stanford-prison-experiment.htm Department of Health & Human Services. (1979). The Belmont report. Retrieved November 21, 2014, from http://www.hhs.gov/ohrp/policy/belmont.html Department of Health & Human Services. (2014). International compilation of human research standards. Retrieved November 21, 2014, from http:// www.hhs.gov/ohrp/international/index.html Encina, G. B. (2004). Milgram’s experiment on obedience to authority. University of California. Retrieved November 21, 2014, from http://nature.berkeley.edu/ ucce50/ag-labor/7article/article35.htm Milgram, S. (1974). Obedience to authority: An experimental view. New York, NY: Harper and Row.
Copyright of Health Environments Research & Design Journal (HERD) is the property of Vendome Group LLC and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Copyright of Health Environments Research & Design Journal (HERD) (Sage Publications, Ltd.) is the property of Sage Publications, Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Institutional Review Boards and Peer-Reviewed Publication
Health Environments Research & Design Journal 2015, Vol. 8(2) 81-84 ª The Author(s) 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/1937586714567647 herd.sagepub.com
D. Kirk Hamilton1 and Jaynelle F. Stichler2
Health Environments Research & Design (HERD) requires authors to provide a copy of an approval letter from an Institutional Review Board (IRB) when the study involves human subjects. Some authors from countries outside of North America, or from nonacademic roles in practice, may have little or no experience with an IRB and wonder how to meet the journal’s requirements. The Code of Federal Regulations, Title 45, of the Department of Health and Human Services (DHHS) outlines the basic policy for the protection of human research subjects (http:// www.hhs.gov/ohrp/humansubjects/guidance/45cfr 46.html). Essentially, all research and evidencebased practice projects that are conducted in academic settings or in health care organizations are subject to this Code, requiring a review of the research proposal and its methods by an IRB, ethics board, or an administrative review board at the organization.
Abuses of Human Subjects in the Past Have Led to Formal Protections The sad history of research that tragically abused human subjects ultimately led to the imposition in the United States of IRBs and ethics boards. The 20th century included a number of prominent examples of abuse, as was the case in which Nazi and Japanese physicians conducted cruel and inhumane experiments on living persons during World War II. In the United States, the long running Tuskegee Syphilis Study (1932–1972)
conducted by the U.S. Public Health Service (Centers for Disease Control and Prevention, 2013) examined the natural progression of untreated syphilis among African American men without their knowledge. The subjects believed they were receiving free treatment. Radiation experiments on unsuspecting citizens were conducted by the U.S. government during the Cold War. The Soviets may have done the same thing. The Central Intelligence Association (CIA) is known to have been involved in mind control studies that included brainwashing and administration of experimental drugs without consent. Government-sanctioned abuses were not the only problems. Controversial projects were undertaken by faculty at universities. Prominent examples include the studies of obedience to authority by Yale psychologist Stanley Milgram involving the apparent administration of electric shocks by student subjects to other students to test the dangers of obedience to authority figures (Encina, 2004; Milgram, 1974). Professor Philip Zimbardo (Cherry, 2014) at Stanford studied behavior of students assigned to roles as prisoners or guards in a mock prison in the basement of the psychology building. This notorious experiment
1 2
Texas A&M University, College Station, TX, USA San Diego State University, San Diego, CA, USA
Corresponding Author: D. Kirk Hamilton, Texas A&M University, College Station, TX 77843, USA. Email: [email protected]
82
led to physical torture and psychological abuse of the student prisoners from the student ‘‘prison guards.’’
The National Research Act and Belmont Report The National Research Act of 1974 created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In response to outrage over the Tuskegee study that had ended in 1972, it proposed development of guidelines for human subject research and to regulate human medical experimentation. Four years later, the Commission issued the Belmont Report (Department of Health & Human Services, 1979) that summarized guidelines for research involving human subjects based on ethical principles. The following three core principles were identified by the Belmont Report: (1) respect for persons, meaning their respected autonomy and consent; (2) beneficence or not doing harm while maximizing benefits; and (3) justice, meaning fair administration of reasonable, nonexploitative, and well-considered procedures. The three primary areas of application are informed consent, assessment of risks and benefits, and selection of subjects. The Belmont Report has led to the formalization of ethics boards that may have existed, as well as the creation of new entities. Federal regulations now set out requirements for the membership and composition of IRBs, ethics boards, or administrative review boards, including provisions for diversity in experience, expertise, and institutional affiliation. The minimum number of members is five, which must include both men and women, at least one scientist, and at least one nonscientist.
Protection of Human Subjects in the Consenting Process The DHHS defines human subjects as any living individual about whom the researcher obtains data through observation, recordings, interaction (interviews, focus groups, or other types of interpersonal contact), or intervention such as a request for the individual to complete a questionnaire or survey.
Health Environments Research & Design Journal 8(2)
Additionally, any time that an individual is asked to provide any private information whereby they might be individually identified, their voluntary consent for participation is required. A waiver of written consent may be allowed if the data collection tools are anonymous and there is no identifying information requested, if the use or disclosure of information involves no more than minimal risk to the privacy of participants, or if the research activity cannot practically be carried out without such a waiver. In some instances, a letter of explanation about the purpose of the research and what is expected of participants can be provided indicating that their consent to participate is implied with the completion of any survey questionnaires or involvement in focus groups. It is imperative that the participants’ name, date of birth, address (physical and or e-mail), telephone numbers, Social Security numbers, or any other type of traceable information not be included or requested on any form or questionnaire. If a written consent is required, the IRB will expect that the participants are voluntarily consenting without any undue influence, coercion, or threats of any nature. The IRB will require some type of letter of the explanation or information that is written in a manner that will be understandable to the participants and will include the phone number of the IRB should the participant have any questions, concerns, or complaints related to the study process. NonEnglish participants must have a letter of information and their consent forms written in their first language. There are also specific rules for consenting participants who are incapable of comprehending or reading the consent form because of their age, health condition, or cognitive impairment. The readers should familiarize themselves with the rules related to observing or data collection involving minors or other individuals who may be vulnerable because of their inability to understand the intent of the research or data collection methods or to provide consent for their involvement. For architects and designers, this might include recorded observations of children involved in therapeutic healing gardens or other specifically design spaces that are under investigation for their effectiveness in improving human outcomes.
Hamilton and Stichler
Recruitment of Human Subjects for Research Studies IRBs are interested in how potential subjects will be identified and recruited for the study. Subjects can be recruited to participate in studies through personal contact with the researcher; referrals to the researcher from other individuals such as physicians, nurses, other care providers in health care settings or students or professors in academic settings; databases previously given to the researcher; advertising through recruitment letters, posters, or brochures; or other written or verbal screening materials such as web-based questionnaires or telephone calls. As an example, an IRB would be interested if an architect solicited intensive care unit nurses to participate in focus groups discussing their perceptions of design features that would promote patient safety. It would be important for the architect researcher to inform the IRB how the subjects would be specifically recruited, how their identities would be protected, how they might opt out of the study if they decided not to participate, and if they would be given any financial incentives to participate. The IRB would also want to be informed how the information collected would be de-identified to protect the subjects and how the data will be stored, analyzed, and disseminated to internal (feedback to the hospital) and external audiences (presentations at conferences). It should be noted that in this example, the IRB might be interested in how the identities of the nurses might be protected from internal feedback to hospital leaders who could sanction them for reported behavior or expression of opinion.
HERD’s Expectations for the IRB Process For all research studies, employing quantitative, qualitative, and observational or survey methods, HERD requires an approval from the institution where the subjects are located as the basic requirement for institutional review. A copy of the official approval letter from the institution’s IRB, ethics board, or administrative review board is to be provided to HERD and should be uploaded as a scanned document in the
83
electronic submission process. If the study is based at a university, a copy of the official approval letter from the academic institution whose faculty or students are involved is also to be provided to HERD. In addition to the uploaded approval form in the submittal process, HERD requires that the author indicate in the text in the beginning of the ‘‘Methods’’ section that the study was approved by an IRB, ethics board, or the organizational administrative review board. A sample sentence might be ‘‘IRB approval was received prior to the initiation of the study.’’ Researchers should be aware that IRB or ethics board approvals must always precede data collection. Experienced researchers know how unexpected waiting for approval to initiate data collection may disrupt planned research schedules, but initiating data collection without prior approval is a serious infraction. Studies that demonstrate minimal or no risk to subjects may be granted expedited review by an IRB, making the approval process faster. HERD does not require IRB approval for theory papers, opinion papers, systematic reviews of the literature, or secondary data analyses from a previously approved study, so long as there is no protected health information or identifying information in the data set.
Certification Courses in the Protection of Human Subjects Many organizations require that researchers provide certification of their knowledge and competence of federal guidelines in protecting human subjects. There are several bodies where individuals can take an online tutorial and test resulting in a certificate that can be sent to the IRB or ethics board, along with their proposal and application for approval to conduct the research in that organization. Such certification indicates that the researcher has received formal training related to protection of human subjects. Certification of competency is a requirement for all academic settings and most health care organizations that participate in clinical research. Certification courses for the protection of human subjects may be obtained from the National Institutes of Health at https://phrp.nihtraining.com/users/
84
login.php. Another website providing similar online tutorials and certification is from the Collaborative Institutional Training Initiative (CITI) at the University of Miami for courses that can be accessed at https://www.citiprogram.org/. One need not be associated with the University of Miami to acquire their certification.
Situations When an IRB Is Not Available In some situations, especially for international research, there may not be an IRB to approve the study. Some countries offer an equivalent model. In the case of professional firms, individual design practitioners, corporate entities, nonacademic institutions, research organizations, or nations without a tradition requiring institutional review to protect human subjects, HERD asks the researchers to seek other methods of independent review. These independent reviews should come from an external source that might include research councils; ethics boards; or independent, freestanding, nonaffiliated IRBs. There are independent, commercial services provided by organizations like the New England Institutional Review Board in Newton, Massachusetts (http:// www.neirb.com/), the Copernicus Independent Review Board in Durham, North Carolina (http:// www.cgirb.com/), the Quorum Review IRB of Seattle, Washington (http://www.quorumreview. com/), or the IntegReview organization of Austin, Texas (http://www.integreview.com/). No endorsement is intended; these are simply examples to show that one can pay for an independent review if there is no IRB associated with the study site or institution of the researcher. At the absolute minimum, the researcher should have written administrative approval from the institution whose staff or patients might be involved. Such an approval should make it clear that the organization has carefully considered all the potential risks to human subjects that may be part of the study. The readers are referred to the International Section of the Office for Human Research Protections of the DHHS to review the International Compilation of
Health Environments Research & Design Journal 8(2)
Human Research Standards (Department of Health & Human Services, 2014) for detailed information for research ethics websites listed by country and topic.
Conclusion As initially indicated, HERD requires authors to provide a copy of an approval letter from an IRB, ethics board, or administrative review board when the study involves human subjects. There are standardized ways in which North American academic institutions and health care organizations require IRB approvals to be acquired. For international researchers, nonacademic practitioners, and study authors, alternate forms of ethical review can ensure that research subjects are provided the maximum protection through review of the proposed study’s methods and protocols by an independent entity composed of persons qualified to consider the ethical and scientific issues of each unique study. HERD subscribes to this noble goal. References Centers for Disease Control and Prevention. (2013, December 10). U.S. Public health service Syphilis study at Tuskegee. Retrieved November 21, 2014, from http://www.cdc.gov/tuskegee/timeline.htm Cherry, K. (2014). The Stanford prison experiment: An experiment in the psychology of imprisonment. Retrieved November 22, 2014, from http://psychology.about.com/od/classicpsychologystudies/a/stanford-prison-experiment.htm Department of Health & Human Services. (1979). The Belmont report. Retrieved November 21, 2014, from http://www.hhs.gov/ohrp/policy/belmont.html Department of Health & Human Services. (2014). International compilation of human research standards. Retrieved November 21, 2014, from http:// www.hhs.gov/ohrp/international/index.html Encina, G. B. (2004). Milgram’s experiment on obedience to authority. University of California. Retrieved November 21, 2014, from http://nature.berkeley.edu/ ucce50/ag-labor/7article/article35.htm Milgram, S. (1974). Obedience to authority: An experimental view. New York, NY: Harper and Row.
Copyright of Health Environments Research & Design Journal (HERD) is the property of Vendome Group LLC and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Copyright of Health Environments Research & Design Journal (HERD) (Sage Publications, Ltd.) is the property of Sage Publications, Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
