Ethics In Research PDF
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Ruth Anne A. Valencia, RN, MN
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This document discusses ethics in research, particularly in nursing research. It covers various ethical principles like beneficence, respect for human dignity, and justice, alongside procedures for protecting participants such as informed consent, risk assessment, and confidentiality. It also touches on ethical dilemmas in research and government regulations.
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ETHICS IN RESEARCH (Continuation from Sampling PPT…) By: RUTH ANNE A. VALENCIA, RN, MN Topics to be Discussed: 1.Ethical Principles of Nursing Research a. Beneficence b. Respect of Human Dignity c. Justice 2.Procedures for Protecting Study Participants a. Informed Consent...
ETHICS IN RESEARCH (Continuation from Sampling PPT…) By: RUTH ANNE A. VALENCIA, RN, MN Topics to be Discussed: 1.Ethical Principles of Nursing Research a. Beneficence b. Respect of Human Dignity c. Justice 2.Procedures for Protecting Study Participants a. Informed Consent b. Risk/Benefit Assessment c. Confidentiality Procedures d. Debriefings and Referrals e. Treatment of Vulnerable Groups f. Institutional Reviews, Boards and External Reviews In any research with human beings or animals, researchers must address ethical issues. Ethical concerns are especially prominent in nursing research because the line between what constitutes the expected practice of nursing, and the collection of research data sometimes gets blurred. We might like to think that violations of moral principles among researchers occurred centuries ago rather than recently, but this is not the case. Why Research Needs Ethics Historical Background The Nazi medical experiments of the 1930s and 1940s are the most famous example of recent disregard for ethical conduct. The Nazi program of research involved using prisoners of war and “racial enemies” in medical experiments. There are more recent examples. For instance, between 1932 and 1972, the Tuskegee Syphilis Study, sponsored by the U.S. Public Health Service, investigated the effects of syphilis among 400 poor African American men. Medical treatment was deliberately withheld to study the course of the untreated disease. It was revealed in 1993 that U.S. federal agencies had sponsored radiation experiments since the 1940s on hundreds of people, many of them prisoners or elderly hospital patients. And, in 2010, it was revealed that a U.S. doctor who worked on the Tuskegee study inoculated prisoners in Guatemala with syphilis in the 1940s. Top 5 Disturbing Facts about Nazi Experiments Codes of Ethics In response to human rights violations, various codes of ethics have been developed: The ethical standards known as the Nuremberg Code were developed in 1949 in response to the Nazi atrocities. Several other international standards have been developed, including the Declaration of Helsinki, which was adopted in 1964 by the World Medical Association and was most recently revised in 2013. Most disciplines, such as medicine and nursing, have established their own code of ethics. In the United States, the American Nurses Association (ANA) issued Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research in 1995 (Silva, 1995). The ANA, which declared 2015 the Year of Ethics, published a revised Code of Ethics for Nurses with Interpretive Statements, a document that not only covers ethical issues for practicing nurses primarily but also includes principles that apply to nurse researchers. In Canada, the Canadian Nurses Association published the third edition of its Ethical Research Guidelines for Registered Nurses in 2002. And, the International Council of Nurses (ICN) developed the ICN Code of Ethics for Nurses, which was updated in 2012. Government Regulations for Protecting Study Participants Governments throughout the world fund research and establish rules for adhering to ethical principles. In the United States, an important code of ethics was adopted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission issued a report in 1978, known as the Belmont Report, which provided a model for many guidelines adopted by disciplinary organizations in the United States. The Belmont Report also served as the basis for regulations affecting research sponsored by the U.S. government, including studies supported by the National Institute of Nursing Research (NINR). The U.S. ethical regulations have been codified at Title 45 Part 46 of the Code of Federal Regulations and were revised most recently in 2005. Ethical Dilemmas in Conducting Research Research that violates ethical principles typically occurs because a researcher believes that knowledge is potentially beneficial in the long run. For research problems, participants’ rights and study quality are put in direct conflict, posing ethical dilemmas for researchers. Here are examples of research problems in which the desire for rigor conflicts with ethical considerations: 1. Research question: Does a new medication prolong life in patients with AIDS? Ethical dilemma: The best way to test the effectiveness of an intervention is to administer the intervention to some participants but withhold it from others to see if the groups have different outcomes. However, if the intervention is untested (e.g., a new drug), the group receiving the intervention may be exposed to potentially hazardous side effects. On the other hand, the group not receiving the drug may be denied a beneficial treatment. 2. Research question: Are nurses equally empathic in their treatment of male and female patients in the intensive care unit (ICU)? Ethical dilemma: Ethics require that participants be aware of their role in a study. Yet, if the researcher informs nurse participants that their empathy in treating male and female ICU patients will be scrutinized, will their behavior be “normal”? If the nurses’ usual behavior is altered because of the known presence of research observers, then the findings will be inaccurate. 3. Research question: How do parents cope when their children have a terminal illness? Ethical dilemma: To answer this question, the researcher may need to probe into parents’ psychological state at a vulnerable time, yet knowledge of the parents’ coping mechanisms might help to design effective ways of addressing parents’ grief and stress. 4. Research question: What is the process by which adult children adapt to the day-today stress of caring for a parent with Alzheimer’s disease? Ethical dilemma: Sometimes, especially in qualitative studies, a researcher may get so close to participants that they become willing to share “secrets”and privileged information. Interviews can become confessions—sometimes of unseemly or illegal behavior. In this example, suppose a woman admitted to physically abusing her mother— how does the researcher respond to that information without undermining a pledge of confidentiality? And, if the researcher divulges the information to authorities, how can a pledge of confidentiality be given in good faith to other participants? As these examples suggest, researchers are sometimes in a bind. Their goal is to develop high-quality evidence for practice, but they must also adhere to rules for protecting human rights. 1. Ethical Principles of Nursing Research The Belmont Report articulated three primary ethical principles on which standards of ethical research conduct are based: beneficence, respect for human dignity, and justice. a. Beneficence Beneficence imposes a duty on researchers to minimize harm and maximize benefits. This principle covers multiple aspects. The Right to Freedom from Harm and Discomfort Researchers have an obligation to prevent or minimize harm in studies with humans. Participants must not be subjected to unnecessary risks of harm or discomfort, and their participation in research must be necessary for achieving societally important aims. In research with humans, harm and discomfort can be physical (e.g., injury), emotional (e.g., stress), social (e.g., loss of social support), or financial (e.g., loss of wages). Ethical researchers must use strategies to minimize all types of harms and discomforts, even ones that are temporary. Protecting human beings from physical harm is often straightforward, but it may be more difficult to address psychological issues. For example, participants may be asked questions about their personal lives. Such queries might lead people to reveal deeply personal information. The need for sensitivity may be greater in qualitative studies, which often involve in-depth exploration into highly personal areas. Researchers need to be aware of the nature of the intrusion on people’s psyches. On the other hand, qualitative researchers often are in a better position than quantitative researchers to do good, rather than just to avoid doing harm, because of the close relationships they develop with participants. Example of therapeutic research experiences Beck et al. (2015) found that some participants in their study on secondary traumatic stress among certified nurse-midwives told the researchers that writing about the traumatic births they had attended was therapeutic for them. One participant wrote, “I think it is fascinating how little respect our patients and coworkers give to the traumatic experiences we suffer. It is healing to be able to write out my experiences in this study and actually have researchers interested in studying this topic.” The Right to Protection from Exploitation Involvement in a study should not place participants at a disadvantage. Participants need to be assured that their participation, or information they provide, will not be used against them. For example, people describing their economic situation should not risk loss of public health benefits; people reporting drug abuse should not fear being reported for a crime. Study participants enter into a special relationship with researchers, and this relationship should not be exploited. Because nurse researchers may have a nurse–patient (in addition to a researcher–participant) relationship, special care may be needed to avoid exploiting that bond. Patients’ consent to participate in a study may result from their understanding of the researcher’s role as nurse, not as researcher. In qualitative research, psychological distance between researchers and participants often declines as the study progresses. The emergence of a pseudotherapeutic relationship is not uncommon, which could create additional risks that exploitation could inadvertently occur. b. Respect of Human Dignity Respect for human dignity is the second ethical principle in the Belmont Report. This principle includes the right to self-determination and the right to full disclosure. The Right to Self-Determination The principle of self-determination means that prospective participants have the right to decide voluntarily whether to participate in a study, without risking prejudicial treatment. It also means that people have the right to ask questions, refuse answering questions, and drop out of the study. A person’s right to self-determination includes freedom from coercion. Coercion involves explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate. The issue of coercion requires careful thought when researchers are in a position of authority or influence over potential participants, as might be the case in a nurse–patient relationship. Coercion can be subtle. For example, a generous monetary incentive (or stipend) to encourage the participation of a low-income group (e.g., the homeless) might be considered mildly coercive because such incentives may be seen as a form of pressure. The Right to Full Disclosure Respect for human dignity encompasses people’s right to make informed decisions about study participation, which requires full disclosure. Full disclosure means that the researcher has fully described the study, the person’s right to refuse participation, and potential risks and benefits. The right to self-determination and the right to full disclosure are the two elements on which informed consent is based. Full disclosure is not always straight forward because it can create biases and sample recruitment problems. Suppose we were testing the hypothesis that high school students with a high absentee rate are more likely to be substance abusers than students with good attendance. If we approached potential participants and fully explained the study’s purpose, some students might refuse to participate, and nonparticipation would be selective; students who are substance abusers—the group of primary interest—might be least likely to participate. Moreover, by knowing the study purpose, those who participate might not give candid responses. In such a situation, full disclosure could undermine the study. In such situations, researchers sometimes use covert data collection (concealment), which is collecting data without participants’ knowledge and thus without their consent. This might happen if a researcher wanted to observe people’s behavior and was worried that doing so openly would change the behavior of interest. Researchers might choose to obtain needed information through concealed methods, such as observing while pretending to be engaged in other activities. A more controversial technique is the use of deception, which can involve deliberately withholding information about the study or providing participants with false information. For example, in studying high school students’ use of drugs, we might describe the research as a study of students’ health practices, which is a mild form of misinformation. Deception and concealment are problematic ethically because they interfere with people’s right to make truly informed decisions about personal costs and benefits of participation. Some people think that deception is never justified, but others believe that if the study involves minimal risk yet offers benefits to society, then deception may be acceptable. Full disclosure has emerged as a concern in connection with data collected over the Internet (e.g., analyzing the content of messages posted to blogs or social media sites). The issue is whether such messages can be used as data without the authors’ consent. Some researchers believe that anything posted electronically is in the public domain, but others feel that the same ethical standards must apply in cyberspace research and that researchers must carefully protect the rights of individuals who are participants in “virtual” communities. c. Justice The third principle articulated in the Belmont Report concerns justice, which includes participants’ right to fair treatment and their right to privacy. The Right to Fair Treatment One aspect of justice concerns the equitable distribution of benefits and burdens of research. The selection of participants should be based on research requirements and not on people’s vulnerabilities. For example, groups with lower social standing (e.g., prisoners) have sometimes been selected as study participants, raising ethical concerns. Potential discrimination is another aspect of distributive justice. During the 1990s, it was found that women and minorities were being excluded from many clinical studies. In the United States, this led to regulations requiring that researchers who seek funding from the National Institutes of Health (including NINR) include women and minorities as study participants. The right to fair treatment encompasses other obligations. For example, researchers must treat people who decline to participate in a study in a nonprejudicial manner, they must honor all agreements made with participants, they must show respect for the beliefs of people from different backgrounds, and they must treat participants courteously and tactfully at all times. The Right to Privacy Research with humans involves intrusions into people’s lives. Researchers should ensure that their research is not more intrusive than it needs to be and that privacy is maintained. Participants have the right to expect that any data they provide will be kept in strict confidence. Privacy issues have become even more salient in the U.S. health care community since the passage of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which articulates federal standards to protect patients’ medical records and health information. For health care providers who transmit health information electronically, compliance with HIPAA regulations (the Privacy Rule) has been required since 2003. 2. Procedures for Protecting Study Participants Now that you are familiar with ethical principles for conducting research, you need to understand the procedures researchers use to adhere to them. It is these procedures that should be evaluated in critiquing the ethical aspects of a study. TIP Information about ethical considerations is usually presented in the method section of a research report, often in a subsection labeled “Procedures.” a. Informed Consent An important procedure for safeguarding participants involves obtaining their informed consent. Informed consent means that participants have adequate information about the study, comprehend the information, and have the power of free choice, enabling them to consent to or decline participation voluntarily. Researchers usually document informed consent by having participants sign a consent form. This form includes information about the study purpose, specific expectations regarding participation (e.g., how much time will be required), the voluntary nature of participation, and potential costs and benefits. Example of informed consent Kelley and coresearchers (2015) studied the evolution of case management services for U.S. service members injured in Iraq and Afghanistan. A total of 235 nurses were interviewed on patient care experiences. Written informed consent was obtained from study participants. The consent form outlined information pertaining to the divulgence of illegal activities. Prior to each interview, investigators reminded participants not to divulge information that might be interpreted as sensitive or classified. Researchers may not obtain written informed consent when data collection is through self-administered questionnaires. Researchers often assume implied consent (i.e., the return of a completed questionnaire implies the person’s consent to participate). In qualitative studies that involve repeated data collection, it may be difficult to obtain meaningful consent at the outset. Because the design emerges during the study, researchers may not know what the risks and benefits will be. In such situations, consent may be an ongoing process, called process consent, in which consent is continuously renegotiated. b. Risk/Benefit Assessment One strategy that researchers use to protect participants is to conduct a risk/benefit assessment. Such an assessment is designed to evaluate whether the benefits of participating in a study are in line with the costs—i.e., whether the risk/benefit ratio is acceptable. Benefits to society and to nursing should also be taken into account. The selection of a significant topic that has the potential to improve patient care is the first step in ensuring that research is ethical. Major Potential Benefits to Participants Access to a potentially beneficial intervention that might otherwise be unavailable Reassurance in being able to discuss their situation or problem with a friendly, objective person Increased knowledge about themselves or their conditions Escape from normal routine Satisfaction that information they provide may help others with similar problems Direct gains through stipends or other incentives Major Potential Risks to Participants Physical harm, including unanticipated side effects Physical discomfort, fatigue, or boredom Emotional distress from self-disclosure, discomfort with strangers, embarrassment relating to questions being asked Social risks, such as the risk of stigma, negative effects on personal relationships Loss of privacy Loss of time Monetary costs (e.g., for transportation, childcare, time lost from work) In some cases, risks may be negligible. Minimal risk is a risk expected to be no greater than those ordinarily encountered in daily life or during routine procedures. When the risks are not minimal, researchers must proceed with caution, taking every step possible to reduce risks and maximize benefits. c. Confidentiality Procedures Study participants have the right to expect that the data they provide will be kept in strict confidence. Participants’ right to privacy is protected through confidentiality procedures. Anonymity Anonymity, the most secure means of protecting confidentiality, occurs when the researcher cannot link participants to their data. For example, if questionnaires were distributed to a group of nursing home residents and were returned without any identifying information, responses would be anonymous. Example of anonymity Melnyk and colleagues (2016) conducted a study to identify key factors that influenced healthy lifestyle behaviors in 3,959 faculty and staff at one large university. Participants completed an anonymous online survey that asked questions about participants’ healthy lifestyle beliefs and behaviors and perceptions about the wellness culture. Confidentiality in the Absence of Anonymity When anonymity is not possible, other confidentiality procedures need to be implemented. A promise of confidentiality is a pledge that any information participants provide will not be publicly reported in a manner that identifies them and will not be made accessible to others. Researchers can take a number of steps to ensure that a breach of confidentiality does not occur. These include maintaining identifying information in locked files, substituting identification (ID) numbers for participants’ names on records, and reporting only aggregate data for groups of participants. Confidentiality is especially salient in qualitative studies because of their in-depth nature, yet anonymity is rarely possible. Qualitative researchers also face the challenge of adequately disguising participants in their reports. Because the number of respondents is small and because rich descriptive information is presented, qualitative researchers must be especially vigilant in safeguarding participants’ identity. TIP As a means of enhancing individual and institutional privacy, research articles frequently avoid giving information about the locale of the study. For example, a report might say that data were collected in a 200-bed, private nursing home, without mentioning its name or location. Confidentiality sometimes creates tension between researchers and legal authorities, especially if participants engage in criminal activity like substance abuse. To avoid the forced disclosure of information (e.g., through a court order), researchers in the United States can apply for a Certificate of Confidentiality from the National Institutes of Health. The certificate allows researchers to refuse to disclose information on study participants in any legal proceeding. Example of confidentiality procedures Hayes (2015) studied the life patterns of incarcerated women. The 18 women who participated selected pseudonyms for themselves. The interviews were conducted in private rooms in the prison. The researcher made certain that the rooms did not have cameras or microphones in them and that no correctional staff were nearby. d. Debriefings and Referrals Researchers should show respect for participants during the interactions they have with them. For example, researchers should be polite and should make evident their tolerance of cultural, linguistic, and lifestyle diversity. Formal strategies for communicating respect for participants’ well- being are also available. For example, it is sometimes advisable to offer debriefing sessions following data collection so that participants can ask questions or share concerns. Researchers can also demonstrate their interest in participants by offering to share study findings with them after the data have been analyzed. Finally, researchers may need to assist participants by making referrals to appropriate health, social, or psychological services. Example of referrals Holmes and colleagues (2015) studied the experience of seclusion in a forensic psychiatric setting. The study involved in-depth interviews with 13 psychiatric inpatients who had experienced a period of seclusion in the 6 months before the interview. The researchers, aware of the sensitive nature of the research, made arrangements to refer any distressed patients to the head nurse on the unit. e. Treatment of Vulnerable Groups Adherence to ethical standards is often straightforward. The rights of special vulnerable groups, however, may need extra protections. Vulnerable populations may be incapable of giving fully informed consent (e.g., cognitively impaired people) or may be at high risk for unintended side effects (e.g., pregnant women). You should pay particular attention to the ethical dimensions of a study when people who are vulnerable are involved. Among the groups that should be considered as being vulnerable are the following: Children. Legally and ethically, children do not have the competence to give informed consent, and so the consent of children’s parents or guardians should be obtained. However, it is appropriate—especially if the child is at least 7 years of age—to obtain the child’s assent as well. Assent refers to the child’s affirmative agreement to participate. Mentally or emotionally disabled people. Individuals whose disability makes it impossible for them to make informed decisions (e.g., people in a coma) also cannot legally provide informed consent. In such cases, researchers should obtain the consent of a legal guardian. Severely ill or physically disabled people. For patients who are very ill or undergoing certain treatments (e.g., mechanical ventilation), it might be necessary to assess their ability to make reasoned decisions about study participation. The terminally ill. Terminally ill people can seldom expect to benefit personally from research, and thus the risk/benefit ratio needs to be carefully assessed. Institutionalized people. Nurses often conduct studies with hospitalized or institutionalized people (e.g., prisoners) who might feel that their care would be jeopardized by failure to cooperate. Researchers studying institutionalized groups need to emphasize the voluntary nature of participation. Pregnant women. The U.S. government has issued additional requirements governing research with pregnant women and fetuses. These requirements reflect a desire to safeguard both the pregnant woman, who may be at heightened physical or psychological risk, and the fetus, who cannot give informed consent. Example of research with a vulnerable group Knutsson and Bergbom (2016) studied 28 children’s thoughts and feelings related to visiting critically ill relatives in an adult ICU. The custodians of the children signed an informed consent form. In addition, prior to the start of the interviews with the children, the researcher asked the children if they wanted to participate. f. Institutional Reviews, Boards and External Reviews Researchers may not be objective in developing procedures to protect participants’ rights. Biases may arise from their commitment to an area of knowledge and their desire to conduct a rigorous study. Because of the risk of a biased evaluation, the ethical dimensions of a study are usually subjected to external review. Most hospitals, universities, and other institutions where research is conducted have established formal committees for reviewing research plans. These committees are sometimes called human subjects committees or (in Canada) Research Ethics Boards. In the United States, the committee is often called an Institutional Review Board (IRB). Before undertaking a study, researchers must submit research plans to the IRB and must also undergo formal IRB training. An IRB can approve the proposed plans, require modifications, or disapprove them. Example of IRB approval Fishering and colleagues (2016) studied the experience of neonatal intensive care (NICU) nurses who themselves became NICU mothers. The procedures and protocols for the study were approved by the Washington University Medical School’s IRB. Republic Act 10532 - “Philippine National Health Research System Act of 2013" Anchored on the principles of the Essential National Health Research (ENHR) on inclusiveness, participation, quality, equity, and effectiveness, the Philippine National Health Research System (PNHRS) is an integrated national framework for health research in the country. It is a convergence strategy that aims to promote cooperation and integration of all health research efforts and stakeholders in the country to ensure that research contributes to evidence-informed health policies and actions. Objectives The PNHRS aims to improve the health status, productivity and the quality of life of Filipinos by: Ensuring that health research is linked to the health system needs; Ensuring that investments in health research yield the most benefit; Promoting good governance among health research organization through efficient, effective, transparent and ethical health research management system; Engaging in national and international partnerships and networks for health research development; and Ensuring sustainability of resources for health research (Sec. 5, RA 10532). The Department of Science and Technology (DOST) and Department of Health (DOH) initiated the creation of a coordinated system for health research to contribute to the goals of an improved the quality of life of Filipinos. This coordinated system of convergence strategy is the Philippine National Health Research System (PNHRS). Formally began upon signing of Memorandum of Understanding (MOU) between DOST Secretary Estrella F. Alabastro and DOH Secretary Manuel M. Dayrit on 17 March 2003. In 2007, the Commission on Higher Education (CHED) and University of the Philippines Manila (UPM) joined as core agencies of PNHRS by virtue of a MOU signed by DOST Secretary Alabastro, CHED Chair Carlito Puno, UPM Chancellor Ramon Arcadio and DOH Secretary Francisco Duque III. On 7 May 2013, President Benigno Simeon Aquino III signed the Republic Act 10532, also known as “Philippine National Health Research System Act of 2013," which provides the institutionalization of the PNHRS. The Law was published on 16 May 2013 in the Manila Bulletin and became effective on 1 June 2013. Pursuant to Section 15 of RA 10532, the Implementing Rules and Regulations (IRR) were then crafted through a series of consultations with the stakeholders and key persons from the implementing agencies to prescribe the procedures and guidelines for the implementation of the PNHRS Act. On 30 July 2013, the IRR was signed by DOST Secretary Mario G. Montejo, DOH Secretary Enrique T. Ona, CHED Chairperson Patricia B. Licuanan, and UP Manila Chancellor Manuel B. Agulto. The IRR was published on 31 October 2013, making it effective on 15 November 2013. The PNHRS organogram composed of the Governing Council (GC), the Steering Committee, the Technical Working Committees (TWC), the Secretariat and the whole research community. Today, the DOST through Philippine Council of Health Research and Development (DOST-PCHRD), the DOH through Health Policy Development and Planning Bureau (DOH-HPDPB), the CHED and University of the Philippines Manila-National Institutes of Health (UPM-NIH) form the PNHRS implementing agencies, with PCHRD as the lead Secretariat. The Philippine Health Research Ethics Board (PHREB) is an integral part of the Philippine National Health Research System (PNHRS). Established through Republic Act 10532 (Philippine National Health Research System Act of 2013), the PNHRS provides a national framework for health research that aligns research efforts with the country’s health needs and priorities. PHREB serves as the ethical backbone of the PNHRS, ensuring that health research in the Philippines is conducted with integrity and respect for participants, while aligning research activities with national health objectives. PHREB’s Role within PNHRS 1.Ethics Oversight: PHREB is responsible for ensuring that all health research under the PNHRS adheres to ethical principles. It provides guidance, ethical standards, and oversight to safeguard the rights and welfare of research participants. 2.Accreditation of RECs: Within the PNHRS framework, PHREB accredits Research Ethics Committees (RECs) in institutions involved in health research. This ensures that all RECs conducting reviews are properly trained and equipped to uphold ethical standards. 3.Policy Development and Compliance: PHREB helps create ethical policies and guidelines within the PNHRS, guiding institutions and researchers in ethical conduct and compliance with Philippine laws and international standards. 4.Collaboration with Government Agencies: As part of the PNHRS, PHREB works closely with other key agencies, including the Department of Health (DOH), the Department of Science and Technology (DOST), the Commission on Higher Education (CHED), and the University of the Philippines Manila. This collaboration supports an ethical, coordinated, and responsive approach to health research in the country. GENERAL GUIDELINES IN WRITING A QUANTITATIVE RESEARCH PROPOSAL 1. Title Page 13. CHAPTER III METHODOLOGY (M) 2. Table of Contents 14. Research Design 3. CHAPTER I INTRODUCTION (I) 15. Research Locale (if applicable) 4. Background of the Study 16. Research Participants (Population 5. Statement of the Problem (General and Sample; Yamane’s Formula) and Specific) 17. Research Instrument 6. Hypotheses (QUESTIONNAIRE) 7. Significance of the Study (Nursing 18. Data Collection Procedure Education, Nursing Practice, and 19. Data Analysis (for proposal, include Nursing Research) in METHODOLOGY; for final, RESULTS) 8. CHAPTER II REVIEW OF LITERATURE 20. Ethical Considerations 9. Related Literature and Studies 21. Scope and Limitation (for proposal, 10. Theoretical Framework (One Nursing include in METHODOLOGY; for final, and One Nursing-related) RESULTS) 11. Conceptual Framework 22. REFERENCES (at least 25; 5 years most recent publication) 12. Definition of Terms 23. GANTT CHART For regular Faculty: A maximum of 4 advisees Additional 1 advisee will be allowed by the dean if necessary For part-time faculty: 2 advisees Fees for the Thesis Advisory Committee (TAC) Breakdown of P2000: Adviser – P1000 Chairman of the Panel – P400 Panel1 – P300 Panel2 – P300 Other Fees: English critic - P300 Statistician – P500 Submission of thesis: 1 hardbound and 1 soft copy in USB – Adviser 1 hardbound and 1 soft copy in USB – Dean 1 soft copy in CD – University Learning Information Resource Center 1soft copy in CD – Research Unit