Research Methodology

Research--A systematic investigation including development, testing and evaluation, designed to contribute to the general knowledge of the mankind. In common usage it is mankinds quest for upgradation of existing knowledge. It can be in natural, behavioral or social sciences. Research involves gathering certain information in certain ways for certain purpose. It is systematic attempt to gather information in a very methodical process about a particular subject area and then to disseminate it in the world for general good.

Data & Conclusions

Every stage of research including conception of project, gathering and analysis of data & dissemination of conclusions is meant to be shared with other researchers who have helped in compiling data and general public. Data must stand scientific scrutiny (scientific contents), moral scrutiny (ethical issues) and support research conclusions. Research reports can be very significant and may lead to clinical or policy decisions. Researchers have a responsibility to make sure their claims are accurate before they report their findings to public. There are some scientific standards or methods which have to be followed while doing research.

Systematic Investigation
Scientific and Ethical Requirements of a research study? Are there scientific standards of study? Are the methods appropriate to study? Are the questions relevant to study? Has the hypothesis been rigorously tested? Are the results duplicable? Have proper ethics been followed? Has gathering and analysis been done properly? Has the data been documented correctly? Have the conclusions been reached logically? Were all contributors given proper acknowledgements? Were the conclusions shared with other researchers & passed the scientific and moral scrutinies?

Ethical Implications
Researchers have to be ethically responsible. Whom do researchers have moral responsibility? Themselves, other researchers, research subjects whether human or animals, institution, community, fund providers, society and humanity as a whole. Moral obligation to respect others, protect others, no harm to subjects, benefit to them, just and fair approach. Informed consent, ability to give consent voluntarily, precautions, humane treatment. Factual reporting, no falsifying or fabricating data, cooking, trimming or forging statistics. Can lead to study failures. Funding institutions who make study possible may expect some benefits in return. Research can change public policy or clinical options, so can benefit or harm society.

Disadvantages of ethical approach

Fewer regulations, less paper work. All federally funded research involving human beings must be reviewed by IRB--Institutional Review Board with ethical oversight. If involving animals, must be reviewed by Institutional Animal Care and Use Committee. Some projects involve annual reviews. All this involves a lot of cumbersome paper work. Without oversight, some decisions would be reached more quickly. New drugs or clinical products would come in the market more quickly. Get paper published more quickly. But short cuts can have more legal repercussions and dangerous ramifications in the long run. Hastily tested drugs could be harmful & erode public confidence.

Laws & Ethics

Laws and regulations govern peoples behavior e.g prohibit something and then punish for violations as copy right infringement and patent laws, treatment of human subjects. But many questions can not be settled by law alone. Ethics provide some perspective from which we can judge others beliefs and attitudes e.g. kind or mean, polite or rude, just or unjust, responsible or not, moral or immoral.

Ethical Theories
Utilitarianism (Jeremy, John, James)--Our actions have consequences for ourselves and for others. So the consequences should be beneficial, promote pleasure and diminish pain. Greatest good of the greatest number creates greatest balance.e.g. Tetanus and Small pox vaccines. Ignores personal considerations and maximizing the number of lives saved. Act Utilitarianism--Always assess actions one at a time. Should do more good and less harm. Rule Utilitarianism--Justify a rule..always tell the truth..even it causes more harm and less good. De-ontology(Duty)--Ethics of duty--Immanuel Kant...our duty is to simply perform those actions that follow from universal rules which everybody can follow. Do unto others as you would have them to do unto you.

Rights based ethics

Rights to be the fundamental basis upon which ethical judgments are made. Action is right if it respects the rights of others to life, liberty, and property & wrong if it does not.(John Locke).e.g. plagiarism. takes away what others own. Virtue Ethics--Aristotle..based on use of human intellect, reasoning, abilities and capabilities...good person uses these traits...whatever action is wise and is performed by virtuous person. Offers no hard and fast rules..depends upon the situation. Ethics of Care--Carol and Nel--Feminine traits of care, receptivity and nurturing, feelings and responsiveness. Natural caring like parent and child, makes the needs of others paramount.

Normative Principles
Autonomy--(Respect for person)--principle that protects the capacity of individual human beings to chose for themselves and determine their own course of life. Choices made voluntarily, with sufficient information to make a rational choice. Informed consent, minimize infringement of autonomy, no experiments without permission; or by fraud or force. Beneficence--promote the welfare of all those affected by research to the greatest degree possible...maximize benefit. Non-maleficence--to do no harm. protection of human subjects. Maximization of ratio of expected benefit to risk involved, minimization of harm. Justice--Retributive--deals with punishment and reward. Distributive--fair and equitable distribution of benefits and burdens. Like cases be treated alike.e.g. dispute of authorship.

Summary
Nuremberg code--voluntary consent, absolutely essential, legal capacity to give consent, free power of choice, without any intervention of force, fraud, deceit, duress or coercion with sufficient information of risks involved to make an enlightened decision. Personal duty of researcher, may not be delegated. Experiment should be necessary, fruitful and good for society. World Medical Association Declaration(Helsinki)--Mission of physician to safe guard the health of people. Scientific research involving human subjects be clearly assessed, legitimately formulated, accepted and conducted by only qualified scientists with due precautions and following all rules and regulations.

Medical Research
Duty of physician to remain protector of life. Subjects should purely be volunteers. Should stop research if harmful to individual. Interest of science and society should never take precedence over well being of individual. Physician must be use a new diagnostic and therapeutic measure, if as per his judgment it offers the hope of saving a life, reestablishing health or alleviating suffering. Potential benefits, hazards and discomforts of new method should be weighed against the advantages of best current methods. Patient should be free to walk out of study without affecting the relationship. Belmont Report--respect,beneficence, justice, consent, information, comprehension, risks and benefits, selection of subjects.

Study Design & Review

Methodology and Samples--Be objective--Sampling Errors-Biased samples produce biased results...convenience samples..students and patients easy to recruit. It may not be a voluntary audience..just captives. Stratified samples--draw representative populations from larger population may yield more accurate data. Randomized--considered gold standard of clinical research... chance placement of subjects in one of groups of study...either control or treated. Drawback is uncertainty. No one knows where a person will be placed. Subjects may secretly harbor fear that researches are making some choices. Subjects may wish to get treatment benefits of study. Cross-over methodology--just switch both sides.

Randomized Trials
Single blinded--one of the parties, either researcher or subject blind...who is where. Double blinded. Equipoise--two groups are in equipoise if one group is not preferred as a treatment option. Placebos--control groups are given placebos...controversial.... critics say no treatment given at all. Placebos surgeries also performed in Parkinsonism for brain implants....not desirable (Critics) IRB..Institutional Review Boards & Oversight Federal law and National Research Act in 1974. In 1981, both FDA...Food and Drug Administration & DHHS-Department of Health and Human Services revised the regulations for protection of human subjects.

Some Case Studies

Oncologist trial Osteoporosis trial HIV trials