Report on CDC Article Analysis: Epidemiology and Research Ethics

This report analyzes several CDC articles focusing on public health issues. The first article examines the impact of pneumococcal conjugate vaccines (PCV13 and PCV7) on pneumococcal meningitis, revealing the effectiveness of PCV13 in reducing cases. The analysis includes a review of surveillance methods and the importance of prospective studies. The report also analyzes articles on descriptive and analytical epidemiology, comparing studies on gastric cancer and Parkinson's disease, highlighting the differences in approaches and their implications for disease prevention. Finally, the report provides a detailed overview of recommendations from the National Bioethics Advisory Commission for safeguarding the rights, welfare, and confidentiality of research participants, emphasizing informed consent, ethical review processes, and the need for continuous monitoring and education to ensure ethical research practices. The report underscores the significance of these recommendations in maintaining public trust and ensuring the ethical conduct of research involving human subjects.

CDC Article Analysis
The surveillance intervention by Oligbu et al. (2019) evaluated the potential of
pneumococcal conjugate vaccines to effectively control the epidemic of pneumococcal
meningitis. The selected pneumococcal conjugate vaccines were based on PCV13 (13 valent)
and PCV7 (7 valent). The study explored 4160 pneumococcal meningitis cases out of 84, 473
cases of pneumococcal complications between the duration of 1st July 2000 to 30th June
2016. The outcomes revealed the ineffectiveness of PCV7 vaccine in the treatment of
pneumococcal meningitis in 2006 due to an epidemic outbreak of meningitis associated with
PCV7 insensitive pathogen. However, the utilization of PCV13 potentially minimized the
occurrence of pneumococcal meningitis after 2010 (i.e. between the years 2015-2016).
Furthermore, 17.5% case fatality rate of pneumococcal meningitis patients was based on
31.9% elderly patients, 17.3% patients within the age group of 5-64 years, and 10.7% patients
with age of fewer than five years. The casualties or deaths based on pneumococcal meningitis
were reportedly caused by serotype-8. The study findings revealed a considerable reduction
in pneumococcal meningitis cases (in England) following the active implementation of the
PCV13 vaccine. The study findings also advocated the requirement of conducting prospective
studies in the context of evaluating potential serotypes that might increase the risk of
pneumococcal meningitis and related mortality.
The population-based surveillance questionnaires prove to be the most effective
methods to gather data related to disease conditions, medical histories, and vaccination
utilization (Riley et al., 2016). The repeated cross-sectional surveys help in acquiring health
details of the patients of various age groups and geographical regions. The national-level
surveys assist in recording health risk factors, physical exam findings, and laboratory data
warranted to evaluate the onset and progression of communication and non-communicable
diseases. The surveillance systems meaningfully assist in recording the communicable
disease factors for effectively minimizing the outbreaks of diseases based on the transmission
of drug-resistant pathogens (Dehcheshmeh, Arab, Foroushani, & Farzianpour, 2016).
Accordingly, the surveillance strategies adopted by Oligbu et al. (2019) helped in identifying
the significance of the PCV13 vaccine in controlling 48% pneumococcal meningitis cases
based on serotype 8. The selected disease surveillance approach also helped in identifying the
viewpoints of medical practitioners related to the causes, etiology, diagnostic outcomes, and
prevention approaches.

Oligbu et al. (2019) did not utilize secondary or primary meta-analysis for the
statistical assessment of invasive pneumococcal disease outcomes and vaccine-related data.
However, the serotype-based analysis was undertaken through multivariable logistic
regression in the context of comparing the findings with pneumococcal meningitis age-
adjusted annual incidence rates. The assessment of meningitis odds of mortality helped to
track the deaths of patients under the impact of specific serotypes. The multivariable logistic
regression assessment also helped in comparatively analyzing the prognostic outcomes of the
vaccinated and unvaccinated pneumococcal meningitis patients. Most importantly,
multivariable regression analysis helped in generating multiple categorical predictors and
consistent outcomes based on independent variables/risk factors (Hidalgo & Goodman,
2013). The utilization of odds ratio by the researchers substantially assisted in evaluating the
risk of the selected episode (i.e. pneumococcal meningitis) based on the reported risk factor
or exposure (i.e. serotype) (Tenny & Hoffman, 2019). For example, the study outcomes
revealed an elevated mortality predisposition of meningitis serotype 8 patients across the
selected age groups (Oligbu et al., 2019).
Analysis of Articles Based on Descriptive Versus Analytic Epidemiology
The study by Karimi, Islami, Anandasabapathy, Freedman, and Kamangar (2015)
effectively evaluated prevention strategies, screening approaches, and descriptive
epidemiology of gastric cancer. The researchers, accordingly discussed the time-based trend,
mortality, survival rate, and incidence of gastric cancer cases. They also evaluated gastric
cancer’s genetic and environmental risk factors with the pattern of histological precursor
lesions and serological markers. The study outcomes revealed age, male gender, tobacco
smoking, race, family history, physical activity, fibre intake, radiation, obesity, H. pylori
infection, reduced socioeconomic status, elevated consumption of smoked, salty food,
reduced intake of vegetables/fruits, and gastroesophageal reflux disease as the predisposing
attributes for gastric carcinoma. The descriptive epidemiology effectively deals with disease
determinants and distributions in the context of assessing the frequency of various disorders
based on time, place, and person (i.e. the geographical distribution of populations) (Liu,
2018). Descriptive epidemiology in this manner helps in determining the etiological research
framework in the context of evaluating a range of chronic and life-threatening disease
conditions. Accordingly, the descriptive epidemiology assessment by Karimi et al. (2015)
evaluated the overall trend and burden of gastric cancer based on a detailed narrative review.

The study by Abbas, Xu, and Tan (2018) predominantly deployed an analytical
epidemiology approach in the context of studying the non-genetic attributes of PD
(Parkinson’s disease). The authors also utilized a descriptive epidemiological approach to
evaluate the Parkinson’s disease distribution based on geographical variations, ethnicity, and
demographic alterations of the selected populations. The authors, however, considered
analytical epidemiology strategy in the context of using meta-analysis, case-control studies,
and cohort interventions for effectively evaluating the relationship between exposure and the
burden of selected health complication (i.e. Parkinson’s disease). The utilization of analytical
epidemiology approach was also undertaken to identify regional variations, differences, and
similarities between non-genetic predisposition factors for Parkinson’s disease. Contrarily,
the descriptive epidemiological assessment by Karimi et al. (2015) primarily focused on
evaluating genetic and environmental attributes and their impact on the histological
presentation of gastric cancer. However, the analytical epidemiology intervention by Abbas
et al., (2018) considered and comparatively analysed the variable impact of smoking,
caffeine, tea, pesticides, dairy products, urate, cholesterol, dietary fat, brain trauma, physical
activity, body mass index, alcohol, and hepatic C on the overall incidence of PD. The authors
accordingly analyzed the preventible causes or risk factor profile of PD. The analytical
epidemiology design also helped the authors to understand the regional variations in PD
occurrence based on the variable influence of the reported risk factors. Contrarily, the
descriptive assessment by Karimi et al. (2015) followed a wider approach by evaluating the
non-preventable and preventable risk factors of the selected disease (i.e. gastric factors). The
descriptive assessment by Karimi et al. (2015) provided a thorough insight of both genetic
and non-genetic causes of the selected disease. However, analytical assessment by Abbas et
al., (2018) solely focused on studying the relationship between disease exposure and
incidence. Accordingly, the analytical assessment provided more effective evidence for
customizing disease prevention approaches as compared to the descriptive analysis. The
greatest similarity between both approaches was based on the assessment of preventable risk
attributes for the selected disease conditions.
Recommendations for Safeguarding the Study Participants
The report by the National Bioethics Advisory Commission (2016) presents a range of
significant recommendations to effectively protect the welfare, rights, integrity,
confidentiality/privacy of the research participants. The recommendation 2.1 advocates the

need for voluntary informed consent and independent assessment of potential benefits and
risks of the selected study. The recommendation 2.2 emphasizes the need for an autonomous
federal office for the implementation of research ethics, monitoring, review processes, and
regulatory reforms. The recommendation 2.3 emphasizes the need for standardized federal
regulations for the systematic monitoring of research subjects. The recommendation 2.4
provides the research participants’ selection criteria based on their exposure to investigator
interventions and manipulations. The recommendation 2.4 also advocates systematic
identification of research subjects through medical records and biological materials. The
recommendation supports the need for including robust research monitoring mechanisms in
the federal oversight system to effectively streamline the execution of research activities. The
recommendation 2.5 advocates the need for ethical assessment to effectively identify
potential harms and risks associated with the proposed research intervention. The
recommendation 2.5 also supports the need for protecting the rights and dignity of human
participants through consistent review and monitoring of the study procedures.
The recommendation 3.1 emphasizes the need for initiating educational sessions by
the study sponsors in the context of improving research-related ethical awareness of IRBs
(Institutional Review Boards), investigators, and institutional officers. The recommendation
3.2 advocates the engagement of professional societies with the federal government in the
context of improving the worth and quality of comprehensive educational interventions based
on safeguarding the wellness of the research participants. The recommendation 3.3 is based
on the systematic accomplishment of research-related certification requirements for
researchers and other staff members. The recommendation 3.4 is based on the organization of
accreditation programs for effectively improving the autonomy of IRBs and investigators in
the context of reviewing the study processes related to the human subjects. The
recommendation 3.5 is based on minimizing the undesired burden of research organizations.
The recommendation 3.6 enforces the compliance of IRBs, investigators, sponsors, and
CROs (contract research organizations) with regulatory conventions. The recommendation
3.7 is based on elaborating COIs (conflict of interests) of study investigators and IRBs. The
recommendation 3.8 is based on COI disclosure to the study subjects in concordance with
regulatory policies. The recommendation 3.9 effectively establishes norms and conventions
for the shortlisting of IRB candidates. The recommendation 3.10 advocates the inclusion of
non-scientific members in IRBs.

The recommendation 4.1 advocates the wide implementation of research benefits and
risks assessment across all sectors of the recommended study. The recommendation 4.2
advocates the overall risk identification of the research studies. The recommendation 4.3
advocates equitable and unbiased inclusion of all communities without the intent of creating
harm to the vulnerable sector.
The recommendation 5.1 advocates delineation of the informed consent process in a
voluntary manner for the selected human subjects. The recommendation 5.2 specifies
selected criteria to write-off the need for informed consent in rare situations. The
recommendation 5.3 advocates the need for documenting voluntary informed consent. The
recommendation 5.4 advocates the requirement of minimizing confidentiality breaches
through the development of robust mechanisms and federal conventions.
The recommendation 6.1 provides regulatory methods for the assessment of research
activities. The recommendation 6.2 advocates the need for consistent IRB assessment of
study data and outcomes. The recommendation 6.3 presents norms and conventions related to
the redesigning of research interventions and their approval from IRB. The recommendation
6.4 guides the development of provisions for the systematic reporting of safety events across
multiple research locations. The recommendation 6.6 advocates the need for developing an
appropriate mechanism to effectively compensate research participants against their reported
injuries (related to the study procedures).
The recommendation 7.1 advocates the development of a robust and efficient
oversight mechanism for the enhancement of research activities and protection of enrolled
subjects. The recommendation 7.2 advocates the development of a dynamic research agenda
for mitigating the human studies’ protection complications through the systematic
coordination between professional societies, academic institutions, and the federal
government. The adoption of these recommendations is paramount to the enhancement of
public trust in various research activities involving human participants.

References
Abbas, M. M., Xu, Z., & Tan, L. C. (2018). Epidemiology of Parkinson's Disease—East
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Dehcheshmeh, N. F., Arab, M., Foroushani, A. R., & Farzianpour, F. (2016). Survey of
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Hidalgo, B., & Goodman, M. (2013). Multivariate or Multivariable Regression? American
Journal of Public Health, 103(1), 39-40. doi:10.2105/AJPH.2012.300897
Karimi, P., Islami, F., Anandasabapathy, S., Freedman, N. D., & Kamangar, F. (2015).
Gastric Cancer: Descriptive Epidemiology, Risk Factors, Screening, and Prevention.
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Tenny, S., & Hoffman, M. R. (2019). Odds Ratio (OR). In StatPearls. Treasure Island
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