are a critical component in advancing research. Ethical and legal issues have
caused laws to be put in to place to protect human rights. Informed consent
must be in place prior to the participants accepting the right to be able to
participate in a study. The informed consent contains a clear statement of what
the study consist of, the risk and benefits, what their rights are, expected duration
of the study, if the study consist of any procedures, and any personal identifiers
that may be used (Nijhawan, Janodia, Muddukrishna, Bhat, Bairy, Udupa &
Musmade, 2013). The informed consent allows the participant to be well educated
prior to making a voluntary decision.
Human subjects are a must in improving evidence based data. A good example is
the need for drugs that are FDA approved. The drugs have to be safe and effective
and the only way to prove that would be with human subjects that have the
comorbidities that the drug could potentially treat (Kapp, 2006).
In the article,
Intention to use mHealth in older adults with heart failure, the subjects gave
their consent to be a part of the study prior to approaching them with the details.
This study used an inclusion and exclusion criteria for the determination of the
subjects prior to presenting them with the informed consent. The inclusion criteria
were that the subject had to have a history of heart failure and were at least
65 years of age. The exclusion criteria were if the subject was unable to read
English, had any cognitive impairment such as dementia, if they were
hospitalized with an acute MI, or had any emergency cardiac issues (Cajita,
Hodgson, Budkathoki, & Han, 2017). This
allowed their subjects to be fairly chosen with the chance for the most
accurate data. The beneficence of the study was fully addressed to the subject,
and informed consent was taken. I believe this lengthy approach allowed for the
most ethical, autonomy, fidelity, and secure study for these subjects.
also offered a fair amount of, $10, compensation for their participation,
allowing the subjects to not be blinded by components of the study (Cajita et
M.K., Hodgson, N.A., Budhathoki, C., & Han, H. (2017). Intention to use
mHealth in older adults with heart failure. Journal of Cardiovascular Nursing,
00(00), 00-00. Doi: 10.1097/JCN.0000000000000401.
B. (2006). Ethical and legal issues in research involving human subject: do you
want a piece of me? Journal of Clinical Pathology, 59(4). doi:
L. P., Janodia, M. D., Muddukrishna, B. S., Bhat, K. M., Bairy, K. L., Udupa,
N., & Musmade, P. B. (2013). Informed Consent: Issues and challenges.
Journal of Advanced Pharmaceutical Technology & Research, 4(3). Retrieved