**4. Concept of medical research**

#### **4.1. Value of medical research**

Research is explained by Health Insurance Portability and Accountability Act (HIPAA) including the Privacy Rule and the Common Rule as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge" [70, 71].

Data analysis collected for either diagnostic or treatment purposes can be used for secondary research purposes. These purposes could be health services or public health research that include analysis of occurrences' patterns, determinants, natural history of disease, drug safety surveillance, and some genetic and/or social studies [72–74].

#### **4.2. The importance of medical research**

Medical research serves as sources of important information about disease outcomes, drift and risk factors, functional abilities, patterns of care, and health care costs. Clinical trials are sources of important notification about the efficacy and adverse effects of medical interventions by controlling the variables that could influence the study results [73, 74].

Food and Drug Administration (FDA) approval of a drug for a particular indication relies upon a series of controlled clinical trials. Guidelines for best practices with high-quality patient care can be achieved by recording and assessing experience in clinical practice [75]. Economists notice that medical research has a positive effect on human health and life span which in turn increase productivity that will be reflected on the national economy [76].

#### **4.3. The globalization of medical research**

Medical research goes globalization is a familiar term. Globalization has brought on economic benefits such as higher production rates, more efficiency, industrialization, and faster growing knowledge and innovation for those countries that are a part of it. We hear about poor working environment and low salaries in developing countries, a situation that Western companies have taken advantage of, which makes us think that everything that follows is not always morally justifiable [77].

The pharmaceutical industry is not exempted from globalization and has embraced it is as a core component of their business models, especially in the realm of clinical trials. Industry and government sponsors in wealthier countries move their research trials to less wealthy countries. The majority of medical research is currently sponsored and conducted by private pharmaceutical companies [78].

Medical research proved the fact that globalization of commerce, trade, industry, and travel means that diseases can spread easily across the globe. For example, HIV spread from Africa and around the world and each year a new strain of the influenza virus emerges in Southeast Asia and spreads throughout the globe. As diseases have become international, medical research should also become international [77].

#### **4.4. The value and importance of medical information privacy**

Medical privacy and confidentiality are vital to improving human health and health care. Protecting patients involved in research from harm or abuse and preserving their rights is essential to ethical research. Privacy has a value at the societal level as it permits complex activities, including research and public health activities to be carried out in ways that protect individuals' dignity without violating their rights [79].

### *4.4.1. Value of privacy*

**4. Concept of medical research**

**4.2. The importance of medical research**

**4.3. The globalization of medical research**

always morally justifiable [77].

pharmaceutical companies [78].

research should also become international [77].

surveillance, and some genetic and/or social studies [72–74].

Research is explained by Health Insurance Portability and Accountability Act (HIPAA) including the Privacy Rule and the Common Rule as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general-

Data analysis collected for either diagnostic or treatment purposes can be used for secondary research purposes. These purposes could be health services or public health research that include analysis of occurrences' patterns, determinants, natural history of disease, drug safety

Medical research serves as sources of important information about disease outcomes, drift and risk factors, functional abilities, patterns of care, and health care costs. Clinical trials are sources of important notification about the efficacy and adverse effects of medical interven-

Food and Drug Administration (FDA) approval of a drug for a particular indication relies upon a series of controlled clinical trials. Guidelines for best practices with high-quality patient care can be achieved by recording and assessing experience in clinical practice [75]. Economists notice that medical research has a positive effect on human health and life span which in turn increase productivity that will be reflected on the national economy [76].

Medical research goes globalization is a familiar term. Globalization has brought on economic benefits such as higher production rates, more efficiency, industrialization, and faster growing knowledge and innovation for those countries that are a part of it. We hear about poor working environment and low salaries in developing countries, a situation that Western companies have taken advantage of, which makes us think that everything that follows is not

The pharmaceutical industry is not exempted from globalization and has embraced it is as a core component of their business models, especially in the realm of clinical trials. Industry and government sponsors in wealthier countries move their research trials to less wealthy countries. The majority of medical research is currently sponsored and conducted by private

Medical research proved the fact that globalization of commerce, trade, industry, and travel means that diseases can spread easily across the globe. For example, HIV spread from Africa and around the world and each year a new strain of the influenza virus emerges in Southeast Asia and spreads throughout the globe. As diseases have become international, medical

tions by controlling the variables that could influence the study results [73, 74].

**4.1. Value of medical research**

50 International Development

ized knowledge" [70, 71].

Privacy is simply used to designate different concepts as the right to body safety or to be free from supervision. All information being gathered, the intentions of the parties involved, as well as the politics and cultural probability [80, 81]. Privacy denotes those concerned with personal information collection, storage, and examine whether data can be collected either for primary or secondary purposes [82].

#### *4.4.2. The importance of privacy*

There are a variety of reasons for placing a high value on protecting the privacy, confidentiality, and security of health information [83]. Some theorists believe that respecting privacy (and autonomy) is a form of recognition of the attributes that give humans their moral uniqueness and part of human rights [84, 85].

Privacy facilitates and promotes other *fundamental values*, including ideals of personhood [86, 87] such as:


Perceptions of privacy vary among individuals and various groups. Data that are considered intensely private by one person may not be by others [74].

#### **4.5. Distinguish medical research from practice**

Privacy rule can differentiate between medical research and similar health care practices as public health practice, quality improvement activities, and program evaluations [88] and writing reviews [76]. However, specifying which activities meet the definition of "research" is a major challenge for privacy boards [89]. Neither the regulations of investigators and health care practitioners nor their interpretations by HHS denote clear guidelines on how to distinguish research from activities that use similar techniques to analyze health information [90]. Unfortunately, failure to correctly denote an activity as research could potentially allow improper disclosure of personally identifiable health information without sufficient oversight [91].

#### **4.6. Genetic information and the privacy rule**

Research involving genetic information presents perhaps some of the most challenging areas for protecting the privacy of health information [92–94]. Recently, development makes it possible to learn a great deal about disease processes and individual variations in treatment effectiveness or susceptibility to disease from genetic analyses as the DNA sequences comprising a person's genome strongly influence a person's health.

Human genome knowledge, combined with advances in computing capabilities, can help decipher the roles that genetics and the environment play in the origins of complex but common human diseases as cancer. Patient samples stored in bio-specimen banks can provide a wealth of information for addressing long-standing questions about health and disease, and efforts are underway to create large genomic databases for that purpose [74, 94]. These data are of paramount importance for any community that could affect the national security. Based on the strict privacy rules inside the European Union than the United States, DNA is not direct identifier in Europe [95].

Genetic information does not itself identify an individual in the absence of other identifying information. Person's genetic code could be interpreted as a unique identifier and used to match a sequence in another databank, which includes identifiers [96, 97].

The NIH starts requiring data from the Genome-Wide Association Study in January 2008. That database became publicly accessible until August 2008 then NIH removed the database from the public Website regarding patient privacy [95, 98]. Those concerns stemmed from a study showing that a new type of DNA analysis could confirm the identity of an individual in a pool of similarly masked data if that person's genetic profile was already known [99]. NIH intends to move the aggregate genotype data to a secure, controlled-access database with policies for review and approval of data access requests in very strict manner [98].
