Who Reviews the Potential Harm of a Proposed Study in Light of Ethical Guidelines?
Iran J Nurs Midwifery Res. 2018 May-Jun; 23(3): 157–166.
Ethical Considerations in Sexual Health Research: A Narrative Review
Maryam Shirmohammadi
1 Student Enquiry Committee, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Islamic republic of iran
Shahnaz Kohan
2 Department of Midwifery and Reproductive Health, Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Isfahan Academy of Medical Sciences, Isfahan, Iran
Ehsan Shamsi-Gooshki
3 Department of Medical Ideals, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Islamic republic of iran
Mohsen Shahriari
4 Department of Medical Surgical Care Nursing, Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
Received 2017 April; Accepted 2018 February.
Abstract
Groundwork:
There is an supposition that sexual health research has cracking influence on the quality of homo life through elevating sexual wellness standards, and their results will eliminate the brunt of sexual wellness challenges on family relationships. The aim of this study was to review upstanding considerations in sexual health inquiry.
Materials and Methods:
This narrative review was conducted betwixt January 1990 and December 2017 based on the five-footstep approach of York University. The keywords used to search for the studies included ethical issues, research, sexual health, reproductive health, and sensitive topics. The language of the literatures was English and the search process was performed on PubMed, Elsevier, Ovid, Springer, Google Scholar, ResearchGate, SAGE Publishing, ProQuest, WHO website, Kinsey Confidential, and Worldsexology.
Results:
After assessing the quality and eligibility of 94 articles, 13 were selected. The results of the nowadays study showed that the well-nigh important upstanding considerations were protecting the confidentiality and privacy of participants, obtaining informed consent, and paying attention to vulnerable people.
Conclusions:
The review of literature exhibited several considerations that sexual health researchers are faced with. In lodge to manage these considerations, the researcher should take sufficient understanding of them. The important matter is that strategies to manage these challenges should be completely rational and practical co-ordinate to each context. These strategies can also be practical in other societies with neat similarities in their context.
Keywords: Ethics, inquiry, sexual wellness
Introduction
Ethical considerations in research refer to a set up of rules and guidelines that should be considered in society to avert possible damage to participants and researchers.[one,ii,3] There is no general clarification of the characteristics of a sensitive research, except for topics that have been accepted as sensitive equally a result of experiences. Some examples of sensitive topics include sexual behaviors, drug abuse, topics that arouse emotions, and other topics tagged as a taboo.[4,five] The level of sensitivity tin vary according to some characteristics of participants, such as historic period (for example, adolescents nether xv years of historic period or elderly people), gender identity (for example, homosexuals), and mental health retardation.[five] Some other topics, such as corruption and violence, are also considered sensitive every bit they can remind participants, who have been victims of past traumatic memories. For example, in some cases such as sexual violence, ethical complexities emerge because using methods such as in-depth interviews and questioning can arouse painful emotions and memories in victims.[6]
Researchers have different views on sensitivity of sexual topics. Many merits that sexual topics are not more sensitive than other inquiry areas,[4,seven] whereas others believe that these studies are highly sensitive.[eight,ix] It should exist noted that sensitivity affects all details of research, from designing the arroyo to implementing and publishing the results.[10]
In countries with a traditional and religious context such every bit Iran, some of the traditional beliefs and social structures make it difficult to acquit sexual health and sensitive research.[eleven] Studies on sexual wellness and sensitive topics become important in the case of the widespread occurrence of some high-risk sexual conditions, such every bit HIV, sexually transmitted diseases (STDs), unwanted pregnancy and unsafe abortion due to some hazard factors such as very young age at the time of start sexual relationship, multiple sex partners, extramarital relationship, and higher up all, the lack of any education and information provision particularly amidst adolescents. The mutual linguistic communication of sex in Islamic republic of iran is the language of silence, because sex and related issues are considered a taboo and talking about them freely in most settings is forbidden.[11] Therefore, this study was conducted to place upstanding considerations in research related to sexual health and sensitive research.
Materials and Methods
This narrative review written report was conducted in 2017 to determine the ethical considerations in inquiry related to sexual wellness and sensitive topics (such as, trafficked women, unwanted pregnancy and illegal abortion specially in adolescents, sexual violence, etc.) based on the five-step approach of York University. This approach includes evolution of the research question, identification of relevant studies, assessment of the quality of the studies, summarization of the prove, and analysis and synthesis of data.[12,xiii]
The databases used included PubMed, Elsevier, Ovid, Springer, Google Scholar, ResearchGate, SAGE Publishing, and ProQuest. Moreover, websites, including who.org, kinseyconfidential.org, and worldsexology.org, were searched to find relevant studies using keywords such as "Ethical problems, Enquiry, Sexual Health, Reproductive health, and Sensitive Topics". In the offset stage, the keywords were searched separately, so, they were combined with "and" or "or" to make some new keywords or phrases. The search process was conducted on articles published from Jan 1990 until Dec 2017. At start, 94 texts, including E-books and articles were obtained; 36 articles gained from PubMed, 7 from Elsevier, 7 from Scopus, 14 from ResearchGate, 16 from Google Scholar, 9 from ProQuest, and v from Ovid. After inspecting the inclusion criteria, including year of publication, language, and consisting of clear and precise description of upstanding considerations related to the research question and suitable method of information gathering and analysis, 33 articles were selected. Finally, thirteen articles were identified as eligible for the study after the thorough review of the texts. The quality of the selected articles was assessed based on a checklist consisting of the standard components of qualitative, descriptive, and review studies. The most of import criteria were: Has the question of the written report been adult conspicuously?; Is the approach of the study advisable for answering the question of the study?; Has the groundwork of the study been described well?; Has the sampling procedure of the study been fully described?; Has the information drove method been described well?; and Is the data analysis method appropriate for this study?.[xiv] In addition, to ensure the reliability of the selected studies, each article was reviewed past at least two members of the research team. Finally, concepts in different categories were separately identified and studied; there were no considerable differences among the opinions of the members. So, all the content was analyzed and categorized, and ethical challenges were fully described. The process of article selection is described in Figure i.
The process of finding resources
Ethical considerations
Research ethics confirmation was received from the Isfahan University of Medical Sciences.
Results
In this study, thirteen studies were reviewed, which were conducted in vii different countries including Canada, Commonwealth of australia, Britain (3 articles each), Nigeria, Africa, United mexican states, and America (one article each). In the review, unfortunately, no Iranian or fifty-fifty Persian articles were establish in this regard. In full, 1,275 individuals have participated in quantitative and qualitative studies. The information collection methods used in these articles were unlike; individual and group interviews with purposive sampling in qualitative studies and convenience sampling in quantitative studies, examining a instance report, and review of articles.
The results showed some similar and mutual upstanding considerations related to sexual health and sensitive research in all of the reviewed studies. In 2007, Gune and Manuel stated that performing any enquiry on sexual bug tin cause embarrassment in participants, because sexual health research oftentimes interferes with individual's privacy, and the ethical concepts of studies besides as the publication of their findings may crusade many problems. This study sheds more light on the importance of the confidentiality and anonymity of participants and results.[15]
In 1999, Binik et al. in Canada studied ethical issues regarding conducting sexual inquiry on the Net.[16] They stated that the Internet provides the virtual space for conducting innovative research in sexual topics, but this new world is associated with new ethical complications similar ethical issues related to participants' registration in the research, informed consent, and collecting and storing information. Special methods and circumspection are required in guild to collect information from children in social club to protect privacy and preserve and record sensitive data. Finally, the researchers stated that the research related to sexual issues on the Internet is associated with a few risks; they considered common ethical standards to be sufficient for ordinary research in this field. Information technology seems that risks on the Cyberspace are non and so extreme as to require the use of strict standards in this respect.[16]
In 2008, Flicker and Guta conducted a study to evaluate the necessity of obtaining parental consent for participation of adolescents in these types of studies.[17] Their hypothesis was that the procedure of parental intervention may accept no place in this blazon of research because it is in contrast to the principal of participants' autonomy.[17]
In a qualitative research conducted by Dickson-Swift in 2007, the upstanding considerations in studies with sensitive topics included advice between researchers and participants, relationship with isolated person, the creation of a sense of guilt in the researcher, vulnerability due to leaving the research relationship, and fatigue acquired by the written report.[18]
In a review article, Benbow and Haddad examined the ethical considerations in research on elderly patients with dementia, who were sexually abused, in 1993.[19] The results showed that in near cases the rapist had a history of psychological disorders, which indicates that both rapist and rape victim tin can be victims of their psychiatric disease. The most of import challenges in this blazon of study have been the problem of connecting with participants and the perilous state of affairs of the study that could endanger the researcher due to the presence of both offenders and victims.[xix] Cowburn in 2005 evaluated the ethical complexities in studies where the participants were sex activity offenders.[twenty] In interviewing this group of people, the principle of confidentiality should exist repeated by the investigator at the showtime of each new section of the report. The result indicated that observing the principle of confidentiality could legally cause serious challenges, peculiarly when the researcher is informed of an unpleasant imminent incident.[20]
In a study conducted by Marshall and Crossbar in 2003 on groups with different cultures, the results showed that the research process must be based on the culture of each group of participants, respect for the values of each community, and devoting enough fourth dimension to familiarization with the culture of each grouping of participants.[21] In 1999, James and Platzer conducted a report to evaluate the ethical considerations of research on minority groups, and the marginalized and stigmatized population. The results indicated some challenges such as the vulnerability of researchers and participants, the need for partnership of the researcher and his/her coworkers to support him/her in case of stress, the participants' potential for remembering emotionally painful experiences, using advisable policies to deliver the results of these studies without negative influence on the cultural temper of the community.[22]
Cwikel and Hoban, in another written report in 2005, explored the upstanding issues in studies on trafficked women.[23] They pointed out that the ethical considerations in enquiry on this group in the nearly important cases included the complexities associated with obtaining informed consent, legal penalisation for researchers who get involved in illegal actions for the benefits of their study, and protection of the rights of vulnerable participants by the researcher.[23] The results of the written report on ethical considerations of research on runaway and homeless immature people as vulnerable populations, which was performed past Meade and Slesnick in 2002, revealed that maintaining beneficence and justice, ensuring the autonomy of the teenager, obtaining informed consent from the teenager, reporting any corruption regarding runaway and homeless teenagers, and providing access to useful services as the near of import ethical necessities.[24]
In a study by Seal et al. in 2000 on qualitative studies with the field of study of sexual health, the most important upstanding considerations included obtaining informed consent, maintaining privacy and confidentiality, and observing the principles of establishing communication in such qualitative studies.[25] Gledhill et al. in 2008 studied the culturally taboo and forbidden topics in various communities; indeed they wanted to disclose the importance of sex research as a socially prohibited and culturally taboo topic. Furthermore, they indicated obtaining informed written consent and confidentiality as the most important upstanding considerations.[26] A comparison of the feature of all 13 studies is presented in Table ane. In Tabular array 2, near all ethical considerations found during this study accept been listed.
Tabular array 1
Outline of the studies included in the review
Table 2
Upstanding considerations and challenges in sexual and sensitive research
Word
Based on the results of the study, the nearly important attained ethical considerations were protecting the confidentiality and privacy of participants, various aspects of informed consent, informed consent in vulnerable participants (particularly adolescents), the necessity of standard ethical protocols for sexual wellness and sensitive research, and ethical problems in publishing sexual health or sensitive research results. The summary of results is provided in Table 2.
Confidentiality and privacy
Among the xiii reviewed studies, 6 indicated that, based on the principles of the Declaration of Helsinki, all precautions to protect the privacy and confidentiality of participants' personal information should exist considered.[19] The violation of the confidentiality and privacy of participants are circumstances in which they lose their control over personal information that has been provided during the written report.[26] The most important role of these concerns is related to preserving the dignity and individual command of participants and establishing rapport with them in society to guarantee the validity and integrity of the report. These concerns are particularly amongst vulnerable groups such equally immature people, drug abusers, prostitutes, people with dementia, etc. The concerns of scientists and researchers about ethical standards have guided them to feel the necessity for creating ethical guidelines and solutions in order to protect the participants from risks and maintaining their privacy past establishing confidentiality. In improver, scientists are looking for guidelines that can protect novice researchers from potentially dangerous conditions.[27] Regarding vulnerable people, although some bug in studies are usual, there are some cases that should be considered as uniquely and independently sensitive problems. For instance, observing privacy in studies on adolescents, especially in dealing with high-take a chance behaviors, can be performed with the conditional or unconditional consent of the adolescent.[28] The principle of privacy is not only a topic in the context of ethics, simply also is an private correct regarding privacy and freedom from danger.[29] Preserving privacy and confidentiality is i of the principal concerns of adolescents who have part in research. They are normally and potentially prone to self-harm or abuse by relatives. For case, in example of domestic violence, if the adolescent feels that there is the risk of the offender becoming aware of the presented information, he/she will be frightened and this may result in cocky-censorship. In add-on, there is the hazard of each fellow member of the research squad disclosing information related to the adolescent participants and the results of the enquiry.[30]
Parental intervention and interference mainly with adolescents above 15–18 years of age regarding the enquiry atmosphere, especially in sensitive topics, may outcome in a kind of self-censorship past the adolescents. The confusion of the adolescents can finally result in silence, because of the fear of exposing their individual matters; however, in sexual health research, the accuracy of the adolescents' speech is crucial.[17]
At that place are some exceptions related to preserving privacy during inquiry. If researchers understand that there is some risky behavior or condition that can potentially endanger the adolescent's health, they should pause their silence and inform the parents or law. Please notice that in any situation related to risky behavior, the health and well-being of children and adolescents are more of import than confidentiality.[31]
Informed consent
The participation of people qualified to provide informed consent equally written report subjects or participants in health and medical studies must be voluntary. An informed consent in research tin can only exist obtained when participants are fully informed of the objectives, methods, sources of data, the possibility of whatever disharmonize of interest, organizational affiliation of the researcher, potential benefits and risks of the study, the requirements after the study, other aspects related to the study, and their right to withdraw from the study at whatever time, freely, and without any take chances of retaliation.[19] Obtaining informed consent in cases such as vulnerable population, such as adolescents, has special importance and it may challenge researchers. In 2014, Folayan et al. stated that deciding on the adequacy of informed consent in adolescents was mostly based on birth document age rather than on a direct cess of adolescents' capacity to empathise the issues and ability to offer informed consent for participation in the report.[32] Moreover, Folayan et al. are of the stance that the participation of adolescents in research is compulsory, and therefore, adolescents do non accept a comprehensive understanding of damage related to participating in those studies.[32] Based on the Islamic Republic of Islamic republic of iran research ethical guide on vulnerable people, children and adolescents are amongst vulnerable groups, and regarding the power to give informed consent, children are categorized into three groups. The first grouping consists of children of less than 7 years of age, in which written informed consent should be obtained from both parents, or if they are absent-minded, from their legal guardian, peculiarly in clinical research. The 2nd group consists of 7- to 15-year-old children, in which written informed consent should be obtained from the children'due south legal guardians and as well as the children according to their understanding and cognitive power. Children of in a higher place 15 years of age constitute the third grouping, in which written informed consent should be obtained from both the legal guardian and kid.[33] In addition, participants of over 18 years of age are authorized to participate in research without parental consent or even awareness.[33]
Vulnerable people
Sexual health and sensitive research on vulnerable people (adolescents, sexual minorities, prostitutes, sexual violence victims, etc.) should be conducted with the maximum protection specific to each group. Studies on such participants are justified just in the case of paying attending to their special wellness needs and only when it is not possible to perform the study on ordinary people. In addition, these people should exist aware of the results of the enquiry and types of interventions. Moreover, there should be sufficient rational support for all the interventions performed and actions taken in these kinds of research.[19] For example, careful attention and special adolescent-friendly protocols are the basic requirements for inquiry on this age group. The Convention on the Rights of the Child includes the near basic human rights for children.[31] This protocol has been the nearly widely accustomed human rights certificate in history and includes 54 articles and 2 optional protocols with iv basic principles. These principles include no kid should suffer from discrimination; when a decision is made regarding children, their highest interests must be taken into account, children should have the right to live and develop,[ten] children take the right to express their ideas freely, and these ideas should be considered in all issues related to them.[34] In order to observe the rights of adolescents nether the form of the Convention on the Rights of the Kid, although these models have been defined as the standards in the world, a more than specialized protocol should be developed in each context and in each inquiry according to the study objectives and characteristics of the target group, using the four mentioned principles.
During work with vulnerable people, in that location is the chance of evoking terrifying memories in the participants, for example, in a victim of sexual violence. In these cases, the researcher or interviewer should be equipped with consulting skills and in the least time begin counseling the participant to minimize the maleficent effects of the enquiry.[18]
Standard ethical protocols for sexual and sensitive inquiry
Research with human being subjects must be conducted based on scientific and more often than not accepted principles. The blueprint and method of such studies should exist clearly explained and justifiable based on a research protocol. The inquiry protocol should include information such as the inquiry funding, institutional affiliations of the researcher, potential conflicts of interest, and motivation of the participants, information on the rules of the treatment or inquiry, and the ways to compensate possible losses due to research.[19] For example, if the data gathering method in a sensitive written report is through the use of the Internet, researchers should be aware of possible threats that place data and information at risk as well as potential biases of participants in responding to questions through a computer and report them conspicuously.[16] There are several phenomena that are considered as sensitive co-ordinate to specific cultural and social contexts. For case, topics with a dominant private nature, stressful topics, and topics related to expiry, fears of stigma, and sexual problems that tin can evoke the feelings of people are considered sensitive. The experiences and review of studies have revealed that not only are the participants exposed to the influence of the sensitive nature of the written report process, but besides the researchers are susceptible to the furnishings of these studies. Researchers and participants involved in the study, observers, and readers of published results could besides be considered as susceptible. In order to protect the physical and psychological wellness of all people, developing the protocols and guidelines at the beginning of each report is essential in order to identify and reduce risks or loss during the research.[35] Clear and precise protocol and strategies to minimize the potential risk and loss during the research should be included in the proposed pattern of research with sensitive topics. They should also be provided for the ideals committee in order to forbid whatsoever misconception and subtract the chance of the rejection of the proposed topic. In studies conducted through interview or when interview is a part of them, the manner to reduce the threats from the start step of meeting the interviewee, arranging interviews, protecting the concrete and psychological health of the interviewer and interviewee, predicting the approach to end the interview, and the last study should be included in the proposed protocol. Another benefit of a standard protocol is to prevent the creation of unrealistic or unnecessary obstacles especially in sensitive research by the ethics committee.[36]
Disseminating the issue of the studies
Researchers, authors, sponsors, editors, and publishers are required to observe all upstanding problems related to the publication of the inquiry results. Researchers are responsible for human subjects and the accuracy of the reports. When publishing the results, the source of funding, institutional affiliations, and whatever conflicts of involvement must be clearly expressed. If there is whatever conflict between regional ethical guidelines and principles and the international statements of ethical principles, such as the Helsinki argument, the results should not be accepted for publishing.[19] Sociocultural and religious sensitivity are some of the virtually of import specialized characteristics in most studies with sensitive topics and on sexual health, which mainly induce the researcher to use unclear words and concepts at the stage of publishing the results. At the stop of this spectrum, sometimes we are faced with self-censorship by researchers, due to the consequences of results publication or the absence of project approval past research ideals committees that, in turn, causes uncertainty regarding the accuracy of the findings. Another course of self-censorship is created by the participants often due to the private nature of data and feeling of shame due to the taboo nature of the information. Finally, in some cases, in order to prevent anxiety, tension, and disturbance in the atmosphere of the community, the whole or a office of the results of some studies with sensitive topics are provided just to groups of decision-makers, officials, and related experts, and publishing the results for the community is prohibited.
Nonetheless, this topic is one of the priorities of our society in order to promote sexual science. A limited number of studies have been conducted on sexual problems in Iran, which caused limitation in results generalization and native suggestions. The importance of sexual health and issues around the world and Islamic republic of iran is due to several causes including high-risk sexual behaviors, for example, the onset of high-take chances sexual relationships at a immature age.
Decision
Based on the results of this study, upstanding considerations in sexual health and many other sensitive topics have swell similarities in terms of moral principles and standards. Information technology should be noted that these common ethical principles in biomedical studies, based on the special nature of sexual health and sensitive topic research, not only tin can be interpreted in one study differently from some other report but besides are afflicted differently past the dominant civilisation of each club.
Fiscal back up and sponsorship
Isfahan University of Medical Sciences.
Conflicting Interest
Nothing to declare.
Acknowledgement
We are thankful for the support provided by the Isfahan University of Medical Sciences in approving this project with the number 393866 and the National Commission of Ethics in Inquiry of the Ministry of Health and Medical Education for scientific grant. Also, nosotros appreciate all the people who contributed in this research kindly.
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