Informed+Consent

=__**Informed Consent**__=

The protection of human subjects who are participating in research, is a key component in any type of research (Patton, 2002), especially in health and sexuality research. Insuring that potential participants understand the research, risks, benefits, alternatives, confidentiality, compensation, contacts, and voluntary particpation/withdrawal are a part of informed consent (Family Health International, 2004).

According to Callahan and and Hobbs (1998): The first ethical principle cited by the influential Belmont Report is autonomy, which refers to the obligation on the part of the investigator to respect ea ch participant as a person capable of making an informed decision regarding participation in the research study. __The investigator must ensure that the participant has received a full disclosure of the nature of the study, the risks, benefits and alternatives, with an extended opportunity to ask questions__.

[|BELMONT REPORT]

The selection of voluntary research participants involves the careful avoidance of two significant ethical issues: 1) Coercion- threats or use of force to get research participants 2) Undue influence- inappropriate rewards to get research participants (Cottrell & McKenzie, 2011).

While coercion and undue influence may seem like tools of unethical researchers in that past, Rennie (2011) discussed the viewpoint that participating in health research is a moral obligation. When some researchers believe that others have an obligation to participate, that viewpoint seems contrary to the protections provided by the Belmont Report.

Another consideration for research proposals is the specific population that will be studied. There should be specific protections mentioned when proposing research for vulnerable populations (those at risk for exploitation) such as the elderly, minors, prisoners, etc. In the examination of mental health consumers as research participants, Davies (2005) notes specific safeguards that can help participants feel empowered to participate, rather than feeling coerced or tricked.

Researchers of sexuality-related studies must ensure that the principles of informed consent, namely anonymity of participants and of the research data, are secure for several reasons: Some sexuality-related behaviors (such as homosexual acts, oral-genital contacts, and extramarital intercourse) are illegal in some states and are considered socially undesirable by some people. Additionally, sexuality-related research focuses on topics that are emotionally distressing for some people (such as childhood homosexual fantasies and experiences)(Griffitt and Hatfield, 1985).

Technology provides a range of benefits and risks to participants, researchers, and to research projects. While multimedia approaches have had limited success toward improving the participants' understanding of informed consent information, Flory and Emanuel (2004) suggest that the best approach is to engage qualified individuals and participants in face to face meetings to review information regarding informed consent. Researchers must procure additional procedures and electronic safeguards in order to ensure that all aspects of informed consent are electronically maintained (Barchard & Williams, 2008). A few examples of electronic safeguards are: Researchers must not maintain research data or participant data on computers that they do not own. The security and confidentiality of research/data maintained on computers that are owned by institutions or organizations may be compromised, as this information may be accessible by other employees, such as technology employees. When researchers electronically maintain sensitive data and records relating to sexuality research, special electronic safeguards and procedures must be implemented to sustain confidentiality and security (Pittenger, 2003).

Naturalistic observation is defined as a study method that involves observing organisms’ behaviors in their natural environment, without intervention (Fournier, 2010). Naturalistic observation of most online virtual communities do not require informed consent since they exist within the Internet's public forum. However, Pittenger (2003) recommends that naturalistic observers of virtual communities **not**deceptively join these online groups, but instead, ethically maintain the trust of participants by identifying themselves and the purpose(s) of their online observations to participants. Researchers should also secure informed consent as a courtesy, especially if the focused discussions of the online groups are controversial (Pittenger, 2003). Researchers must be cognizant of threats to data integrity and potential biases of electronic responses by participants, since the observer is never quite sure who the electronic participant may be (Binik, Mah, & Kiesler, 1999).







[|INFORMED CONSENT EXAMPLE VIDEO]

EXAMPLE OF ADULT CONSENT FOR MINOR PARTICIPANTS FORM AND MINORS ASSENT FORM



References

Barchard, K. A., & Williams, J. (2008). Practical advice for conducting ethical online experiments and questionnaires for United States psychologists. //Behavior Research Methods//, 40(4), 1111-1128. doi:10.3758/BRM.40.4.1111.

Binik, Y., Mah, K., and Kiesler, S. (1999). Ethical issues in conducting sex research on the internet. The Journal of Sex Research, 36 (1), 82-90.

Callahan, T. C. & Hobbs, R. (1998). Ethics in Medicine. Retrieved from University of Washington website: http://depts.washington.edu/bioethx/topics/resrch.html

Cottrell, R. & McKenzie, J. (2011). Health Promotion & Education Research Methods Using the Five-Chapter Thesis/Dissertation Model. 2ndEd. Salisbury, MA. Jones & Bartlett.

Davies, B. (2005). Coercion or collaboration? nurses doing research with people who have severe mental health problems. //Journal of Psychiatric & Mental Health Nursing//,//12//(1), 106.

Family Health International. (2004). //Research Ethics Training Curriculum for Community Representatives//. Retrieved from http://www.fhi.org/en/RH/Training/trainmat/ethicscurr/RETCCREn/ss/Contents/SectionV/b5sl54.htm

Flory, J., & Emanuel, E. (2004). Interventions to improve research participants' understanding in informed consent for research. //JAMA, 292//(13), pp. 1593-1601. doi:10.1001/jama.292.13.1593.

Fournier, G. (2010). Naturalistic Observation. PsychCentral website: http://psychcentral.com/encyclopedia/2009/naturalistic-observation/

Griffit, W., & Hatfield, E. (1985). Human sexual behavior. Glenview, IL: Pearson.

Patton, M.Q. (2002). Qualitative research and evaluation methods (3rd Ed.). Thousand Oaks, CA: Sage.

Pittenger, D. (2003). Internet research: An opportunity to revisit classic ethical problems in behaviroal research. Ethics & Behavior, 13 (1), 45-60, retrieved from http://ceres.imt.uwm.edu/cipr/image/5.pdf.

Rennie, S. (2011). Viewing research participation as a moral obligation: In whose interests?. //Hastings Center Report//, //41//(2), 40.