NUR308 Nursing Research Lecture 1 PDF

NUR308 NURSING RESEARCH LECTURE 1 Dr Sara Poon 12 September 2024  COURSE INTRODUCTION Lectures and tutorial arrangement Assignment & groupings Today’s Lecture is about… Introduction to nursing research What is research? Why do research? The importance of r...

NUR308 NURSING RESEARCH LECTURE 1 Dr Sara Poon 12 September 2024  COURSE INTRODUCTION Lectures and tutorial arrangement Assignment & groupings Today’s Lecture is about… Introduction to nursing research What is research? Why do research? The importance of research in nursing An overview of quantitative (QUANT) and qualitative (QUAL) approaches Ethical issues in nursing research A brief history of unethical issues Regulatory bodies Human rights & ethical principles Informed consent Confidentiality & Anonymity Applying ethics knowledge into practice 3  PART 1 Introduction to Nursing Research  What is Research? Research is a process of discovering new knowledge Research is a systematic inquiry that uses disciplined methods to answer questions or solve problems 5  What is Research? Research can be done with human beings, animals, plants, other organisms and inorganic matter. When research is done with human beings and animals, it must follow specific rules. No matter what topic is being studied, the value of the research depends on how well it is designed and done. 6  Research is like… Does it work? Requires lots of thinking & writing Expertise Expensive Systematic & highly controlled activities Funders Hard Time work consuming 7  Why research? The ultimate goal of research is to develop and expand knowledge → Generate trustworthy evidence and share with the world 8  Why do we need to do research? Engagement Train your Collaboration Skills Originality mind 9  What is Nursing Research? A systematic inquiry designed to generate trustworthy evidence about issues of importance to the nursing profession, including nursing practice, education, administration, and informatics (Polit & Beck, 2017). 10  The History of Nursing Research It Began with… 11 Sources of Knowledge for Nursing Practice (1) Traditional knowledge & authority Books, word of mouth and observing the practice of others Intuition and experience Trial and error Borrowing knowledge from other disciplines 12  Sources of Knowledge for Nursing Practice (2) Logical reasoning Inductive and deductive reasoning Assembled information (e.g. EBP practice) Gather information from multiple sources to make clinical decisions Research Provide new insight into phenomena, or add to, confirm or reject what is already known 13  Logical Reasoning Inductive reasoning Develop generalizations from specific observations Deductive reasoning Develop specific predictions from general principles 14 The Importance of Research to Nursing Know-how Know-why 15 The Importance of Research to Nursing (1) Provide strong evidence for informing nurses’ decisions and actions Clinical appropriate Cost-effective Result in positive outcomes for clients → Evidence-based practice (EBP) 16 The Importance of Research to Nursing (2) Innovation Generate creative and innovative solutions to problems Disseminating research findings Promote evidence-based practice Strengthening interdisciplinary collaboration 17  The Role of Nurses in Research Question the knowledge and rationale on which nurses base their practice Seeking and implementing the best available evidence Identify research priorities Protect patients’ rights by ensuring that patients are fully informed of the implications of participating in research Provide training on research skills 18 A very Important Concept in Social/Nursing Research Prove The results of any social research are only the probability of something to happen. 19 P AR AD I GM S 20  Paradigms Schools of thoughts In any era, one paradigm is likely to be dominant. When a paradigm is no longer influential, it will be replaced by a new one. It is just like the music field… 21  Positivism Postpostitivism Paradigms Interpretivism Constructivism 22  Paradigms 1) Positivism Based on tested and systematized experience The scientific method used in natural science should equally be appropriate for the study of social phenomena Mathematics was thought to be potentially able to explain and predict human actions Believe in the separation of researchers and their object of enquiry Believe in the notion of cause and effect and look for explanations 23  Paradigms 2) Postpositivism Criticize the idea of ‘reality’ independent of the experience of people → there are many ways to look at a problem Researchers’ influences or biases can be avoided by devising strategies to make tools more objective Accept some social facts are not observable → self-report Acknowledge the ‘probable’ nature of predictions Cause and effect → correlations between variables The probability of something to happen 24  Paradigms 3) Interpretivism Reject the positivism principles, Believe human behaviour can only be understood when the context in which it takes place and the thinking process that give rise to it are studied Focus on subjective experience, perception and language in order to understand intention and motivation which can explain behaviour Researcher cannot be a detached observer → get insight into how and why people behave through interactions 25  Paradigms 4) Constructivism Reality is not a fixed entity There are multiple interpretations of the reality Knowledge is constructed/co-constructed through interaction with others and with the environment → putting ideas and structures together in new ways The voice of participants is crucial to understanding a phenomenon 26  Methodological Approaches Quantitative research Qualitative research Mixed methods research 27 Quantitative? Qualitative? 28  Topic / Research idea Evaluation Literature review Interpretation Research Process Study design Data analysis Measurement Data collection 29  Should I Do Quantitative or Qualitative Research? What kind of focus on my topic do I want to achieve? Do I want Will I learn more about a What exactly am I trying to to study a phenomenon or topic using quantitative or find out? Different situation in detail? Or am I qualitative methods? What questions require different mainly interested in making will be the knowledge methods to answer them standardized and systematic payoff of each method? comparisons and in accounting for the variance? 30  Common Types of Quantitative Research If little knowledge is available, Descriptive descriptive studies are often Correlational conducted. As knowledge level increases, correlational, quasi- Quasi-experimental experimental, and experimental Experimental (RCT) studies are conducted The type of quantitative research conducted is influenced by the current knowledge of a research problem 31  Introduction to Quantitative Research Quantitative research is a formal, objective, systematic process for generating numerical information about the world Quantitative research is conducted to… Test theory Describe variables Examine relationships (correlations) Determine cause-and-effect interactions, such as the effectiveness of interventions 32 33  Introduction to Qualitative Research Qualitative Inquiry Qualitative research is a systematic, subjective approach to understanding social or human problems in their natural setting Qualitative research is conducted to… Describe and explore the experiences of people in their daily lives Develop theories More effective than quantitative research in investigating emotional responses 34  Common Types of Qualitative Research Approaches Exploratory-descriptive qualitative research* Phenomenological research* Grounded theory research* Ethnographic research* Case study Action research 35 36  Introduction to Mixed Methods Research Research in which the investigator collects and analyses data, integrates the findings, and draws inferences using both quantitative and qualitative approaches or methods in a single study 37  What Research Problems Fit Mixed Methods Research? A need exists because one data source may be insufficient A need exists to explain the initial results A need exists to generalize exploratory findings A need exists to enhance a study with a second method 38  Challenges in Using Mixed Methods The question of skills The question of time and resources The question of convincing others 39 Mixed-methods research is not recommended to use at undergraduate level 40  PART 2 ETHICAL ISSUES IN NURSING RESEARCH 41 Introduction – Ethics & Research Not to Research? Research? 42 Definition of Ethics in Research A system of moral values that is concerned with the degree to which research procedures adhere to professional, legal and social obligations to the study participants 43  Ethics & Research Debate on the ethical conduct of research continues because of complex human rights issues 44  Ethics & Research Ethics is concerned with the rules and principles of human behaviors. Researchers who study human beings or animals must deal with ethical issues. Ethical demands can be challenging because ethical requirements sometimes conflict with the desire to produce rigorous evidence. 45  Ethics & Research An ethical research study must have: Scientific integrity Social value Contribution to knowledge Without these elements, human research participants are subjected to research risks without potential benefit to them 46  Ethics & Research Ethical aspects of a proposed study take precedence over other areas of the study The rights of the participants must be protected in all research studies 47  Ethical Problems in Research Two main areas: Unethical study & Research misconduct 48 History of Unethical Treatment of Human Subjects & The development of Ethical Codes and Regulations 49  History of Unethical Treatments of Human Subjects 1) Nazi Medical Experiments, Europe (1933-1945) Subjects: Prisoners and people considered to be racially valueless who were confined in concentration camps Experiments: exposed subjects to freezing temperatures, infectious diseases, poisons, untested drugs and perform surgical procedures with anesthesia, …. Studies were poorly conceived and conducted → unethical and generate little if any useful scientific knowledge → Nuremberg Code (1947) 50 In recognition that human rights violations have occurred in the name of science, various codes of ethics have been developed 51 Nuremberg Code (Grove, Gray & Burn, 2015) 52  Declaration of Helsinki (1964) Differentiation of therapeutic research from nontherapeutic research It includes the following ethical principles: The investigator should protect the life, health, privacy and dignity of human subjects The investigator should exercise greater care to protect subjects from harm in nontherapeutic research The investigator should conduct research only when the importance of the objective outweighs the inherent risks and burdens to the subjects Researchers must use extreme caution in studies in which participants receive a placebo treatment 53  History of Unethical Treatments of Human Subjects 1) Tuskegee Syphilis Study, USA (1932-1972) Purpose: to determine the natural course of untreated syphilis in African American men By 1936, men with syphilis had developed more complications than the men in the control group By 1942, the death of those with syphilis was twice as high as it was for the control group Subjects were examined periodically, but no treatment was offered even penicillin was determined to be effective in the 1940s’ No effort was made to stop the study until 1972 54  History of Unethical Treatments of Human Subjects 2) Willowbrook Study, USA (1950s’ to 1970s’) A research on hepatitis was conducted in an institution for the mentally retarded Subjects: children who were deliberately infected with hepatitis virus Parents had to give permission for their child to be in the study in order to gain the child’s admission to the institution 55  History of Unethical Treatments of Human Subjects 3) Jewish Chronic Disease Hospital Study, USA (1960s’) Purpose: to determine patients’ rejection responses to live cancer cells Experiment: a suspension containing live cancer cells were injected into 22 patients Subjects were not informed they were taking part in a study or that the injections they received were live cancer cells Institutional review was not performed Physicians caring for the patients were unware that the study was being conducted 56  The Belmont Report (1979) Ethical principles for the conduct of research involving human subjects 3 ethical principles: The principle of respect for persons The principle of beneficence The principle of justice 57  Institutional Review Board (IRB) An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities Responsible for reviewing, prior to its initiation, all research (whether funded or not) involving human participants IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by institutional policy 58  Institutional Review Board (IRB) Other names: Human Research Committee Human Subjects Committee Committee for the protection of human subjects Research Ethics Committee Examples: Institutional Review Board of the University of Hong Kong/Hospital Authority West Cluster (HKU/HA HKW IRB) The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical REC 59  Institutional Ethics Committees Saint Francis University Research Ethics Committee Saint Francis University School of Health Sciences Student Ethics Workgroup **Research policies and procedures vary from institutions → check specific requirements 60  Research Guidelines for Nurses American Nurse Association Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research (Silva, 1995) Canadian Nurse Association Ethical Research Guidelines for Registered Nurse (2002) Royal College of Nursing Research Ethics: RCN Guidance for Nurses (2004) 61  Research Guidelines for Nurses Subjects must be protected from harm, their privacy should be ensured, and their dignity preserved Nurses who are asked to participate in the research must be fully informed about the research and be included on the IRB that reviewed the proposals Emphasis on research integrity; careful reporting of suspected, alleged, or unknown incidents of scientific misconduct in research 62  How About Hong Kong? Code of Ethics and Professional Conduct for Nurses in Hong Kong Research ethics committees in different universities/institutions (IRBs) Research ethics committees in private hospitals and HA clusters Guidelines Hospital Authority Head Office Steering Committee on Research Ethics Clinical Research Management and Compliance in Study Sites: A Practical Handbook for Investigators, Clinical Research Personnel and Administrators of the Hospital Authority of Hong Kong (2015) 63 Ethical Dilemmas in Conducting Research Participants’ right Vs. Study demand? 64  Ethical Dilemmas in Conducting Research Example(1): A study investigates the coping mechanism of parents whose children are terminally ill. Dilemma: To collect data, the researcher may need to probe into the psychological state of the parents at a vulnerable time. This could be painful or even traumatic to the parents. Yet knowledge of the parents’ coping mechanisms might help to design effective ways of dealing with parents’ grief. 65  Ethical Dilemmas in Conducting Research Example(2): A research investigates whether a new medication prolong life in patients with cancer Dilemma: The best way to test the effectiveness of a drug is to administer to some participants but withhold it from others to see if there are any differences. However, if the new drug is untested, the group receiving the intervention may be exposed to potential hazardous side effects. In contrast, the group not receiving the new drug may be denied a beneficial treatment 66 Protecting Human Rights – Ethical Principles Respect for Beneficence Human Justice dignity 67  1. Beneficence Actions that intend to benefit or promote the good of other people (Do good) Do no harm (nonmaleficence) Physical, psychological, social, and economic harm (or any combination of them) Free from unfair treats Reaching a balance between risks and benefits 68  Beneficence *The right to freedom from harm and discomfort Research should only be performed by qualified people, especially those require the use of equipment or specialized procedures A study must terminate if injury, death, or undue distress to participants are suspected Animals or tissue cultures is often advised to carry out before testing a new medical procedure or drug on human Be sensitive to subtle psychological consequences of a study 69  Beneficence Levels of discomfort and harm No anticipated effects No expected +ve/-ve effects Temporary discomfort Similar to what the subject would encounter in daily life Unusual levels of temporary discomfort E.g. description of traumatic experience → anger, fear, sadness → need to refer participants to appropriate professional intervention Risk of permanent damage Physical, emotional, social, economical Certainty of permanent damage 70 2. Respect for Human Dignity The right to self-determination The right to full disclosure 71  Respect for Human Dignity 1) The right to self-determination Voluntary participation, no risk of penalty Right to withdraw at any time, no pentalty Right to ask questions/ clarification Right to refuse to give any information How about people with diminished autonomy? 72  People with Diminished Autonomy - Vulnerable Subjects Unable to understand the information of a study Incapable of giving informed consent or at high risk of unintended side effects because of their circumstances E.g. Pregnancy, cognitively impaired Studies involving vulnerable subjects should only be undertaken when a study is therapeutic, the researcher has determined that the risk/benefit ratio is low or when there is no alternative 73  Who is Vulnerable ? Children Mentally or cognitively impaired (seek approval from the subject and/or legally authorized representative) Severely ill or physically disabled Terminally ill Institutionalized Pregnant/breastfeeding women Prisoners 74  Respect for Human Dignity 2) The right to full disclosure Researcher needs to provide a full description of the study to the participants Right to know every detail of the study Any problem Right to know the risks and benefits would possibly be created from Right to know the researchers’ responsibilities this? Right to refuse to participate 75  3. Justice The right to fair selection and treatment The right to privacy The right to confidentiality and anonymity 76  Justice 1) The right to fair selection and treatment Fair selection of participants and allocation of treatments Selection is based on research requirements, but not because of the availability of participants or agreements between researchers and participants Fair treatment to people who decline to participate or those who withdraw from a study Researchers have to provide thoughtful and sensible treatments to participants before, during and after a study Conflict of interest? Dual relationship? 77  Justice 2) The right to privacy Private information including participants’ attitudes, beliefs, behaviours, opinions, and records → cannot be shared against participants’ will Participants are free to determine how their information will be shared and stored Data use agreement How will data be used? (Study report? Where will it be published? Submit to journals/conferences?) How will data be protected? (How long will the data be kept? How would it be kept?) 78  Justice 3) The right to confidentiality and anonymity Confidentiality → researcher’s safe management of information or data shared by a subject to ensure that the data are kept private from others (e.g. encrypted, password-protected files / store documents in a locked cabinet /who can access the data?) Anonymity(Protect participants’ identity) → the participants’ identity cannot be linked, even by the researcher, with his or her individual responses No one can identify any participants in a study (think about whether it is necessary to collect any identifiable information from participants) Create an identification code for participants Store the hard copy of the consent form and questionnaire separately 79 (Waterworth et al., 2018) 80  How to achieve confidentiality? Obtain identifiable information from participants only when essential Assign an identification code to each participant / use a pseudonym Restrict access (Who?) All digital files/documents have to be encrypted How about audio/video recordings? Destroy identifying information after the study ends (usually within 3 - 6 years) Store all research documents in a locked cabinet General description of sample and sites 81 Other Procedures for Protecting Study Participants 1. Risk/benefit assessment 2. Informed consent 82  1. Risk/Benefit Assessment Assessing the type, degree and number of risks and benefits All research involves some risks Sometimes, the risks are just minimal → the risks are not greater than those ordinarily encountered in daily life or during routine procedures When risks are not minimal Take steps to minimize risks and maximize benefits If potential risks outweigh benefits → re-design your study 83 (Grove, Gray & Burn, 2015) 84  2. Informed Consent Inform Researchers Participants Consent 85  4 Elements of Informed Consent Disclosure of essential study information to the study participants Comprehension of this information by the participant Competence of the participant to give consent Voluntary consent of the participant to take part in the study 86  Before collecting data.... Information sheet / Briefing Researchers Participants Consent form 87  How Should Researchers Deliver Study Information to Participants? -If possible, face-to-face explanation of study details, including study title, study purposes, study process, risks and benefits, participants’ rights, data use, and researchers’ contact information. -All participants should be given an information sheet, which lists all the above information -Make sure participants are given opportunities to ask questions, and provided with enough time to consider their participation 88  Essential Information before Obtaining Consent – Information sheet (1) 1) Researchers’ identification and credentials, funding body, if any 2) Introduction of research activities (What, When, Where) 3) Statement of the research purpose I am a nursing student at 4) Explanation of the procedure SFU and am conducting 5) Description of risks & benefits a research study as part of the requirements for 6) Disclosure of alternatives, if any the final year honors project… 89  Essential Information before Obtaining Consent – Information sheet (2) 7) Assurance of confidentiality and All these information are needed to include in anonymity the study information 8) Offering to answer questions sheet 9) Voluntary participation 10) Right to refuse and withdraw at any time 11) Compensation, if any 90  Comprehension of Consent Information Make sure participants understand the information provided in the consent form Write in participants’ preferred language Suitable for participants’ reading ability Clear explanation Nurses as patients’ advocates and assess participants’ understanding of research purpose, potential risks and benefits 91  Competence to Give Consent Who are competent to give consent? Autonomous persons who are able to understand the risks and benefits of the study Consent from people with diminished autonomy is illegal How about children and teenagers? 92  Assent An affirmative agreement to participate in a study Children ≥ 7 and < 18 year-old Able to think in terms of concrete operations → able to provide meaningful assent Still, permission has to be given by the parent(s) or legal guardian 93  Documentation of Informed Consent Depends on… The risk level of a study The decision of the researcher and the requirement of the IRB In some situations, written signed consent is wavied Questionnaires that collect relatively harmless data “Your completion of this questionnaire indicates your consent to participate in this study” → implied-consent Otherwise, a written consent document is required 94  Designing Information Sheets and Consent Forms They must contain detailed, accurate information to identify the research project: The study title, the principal investigator and the research team, and the institution to which the project is attached. The study purpose, the study process, the form of participation, the benefits, the risks, the right to refuse to participate, and the right to withdraw at any time from part or all of the study without giving a reason and with no consequences. The use of security measures in data protection and the right to ask questions 95  Designing Information Sheets and Consent Forms (cont.) They must be written in clear language that can be understood by a layperson. The information sheet has to be written in the second person, e.g. “You have been invited to participate…”. In contrast, the consent form has to be written in the first person, e.g. “I understand my participation is voluntary…”, “I have been informed of the study purpose”. Two copies of the consent form should be made: one to be kept by the participant and one to be kept by the research team. 96  Please follow the template 97 98  If there is no direct benefit, state the indirect benefits that the study could bring. Paragraph/point form are both okay. Must be in complete sentences 99  Please follow the template 100  Building Ethics into the Design of the Study Researchers need to give thought to ethical requirements while planning a study and ask themselves whether intended safeguards for protecting humans are sufficient. 101 Building Ethics into the Design of the Study General considerations: Are the participants able to give consent? Are the participants vulnerable? Does the study involve any sensitive issue? Risk and benefit Will the study involve the collection of personal identifiers, photos, audio/video-recording of participants? Conflict of interest? Dual relationship between investigator(s) and Participants? Will incentives be offered? 102 Building Ethics into the Design of the Study Research questions Ensure the research question(s) is/are clinically significant Research Design Will participants get allocated fairly to different treatment groups Will steps to reduce bias or enhance integrity add to the risk of participants? Will the setting for the study protect against participant discomfort? 103 Building Ethics into the Design of the Study Intervention Is the intervention designed to maximize good and minimize harm? Under what conditions might a treatment be withdrawn or altered? Sample Will important segments of people be unintentionally and unnecessarily excluded? Will potential participants be recruited into the study equitably? 104 Building Ethics into the Design of the Study Data collection Will data be collected in such a way as to minimize respondent burden? Will procedures for ensuring the confidentiality of data be adequate? Will data collection staff be appropriately trained to be sensitive, respectful and considerate? Reporting Will participants’ identities be adequately protected? 105 Application for Human Ethics Approval for Student Project 106 References: Blakey, E. P., & Aveyard, H. (2017). Student nurses’ competence in sexual health care: a literature review. Journal of Clinical Nursing , 26(23-24), 3906-3916. Canadian Nurses' Association. (2002). Ethical research guidelines for registered nurses. Canadian Nurses Association. Creswell, J. W., & Clark, V. L. P. (2011). Designing and Conducting Mixed Methods Research (2 nd ed.). London: Sage Publications Inc. Grove, S.K., Gray, J.R., & Burns, N. (2015). Understanding nursing research: building an evidence -based practice (6 th ed.). St. Louis, Missouri: Elsevier. Hospital Authority (2015). Clinical research management and compliance in study sites: A Practical handbook for investigators, clinical research personnel and administrators of the hospital authority of Hong Kong (2 nd ed.). Hong Kong: Hospital Authority. Northwood, M., Ploeg, J., Markle‐reid, M., & Sherifali, D. (2017). Integrative review of the social determinants of health in older adults with multimorbidity. Journal of Advanced Nursing. 74(1), 45-60. Polit, D.F., & Beck, C.T. (2017). Nursing research: generating and assessing evidence for nursing practice (10 th ed.). J.B. Lippincott Company: Wolters Kluwer. Royal College of Nursing (2004). Research ethics: RCN guidance for nurses. U.K.: Royal College of Nursing. Silva, M.C. (1995). Ethical guidelines in the conduct, dissemination and implementation of nursing research. Washington, DC: American Nurse Association. Silverman, D. (2013). Doing Qualitative Research: A Practical Handbook (4 th ed.). London: Sage Publications Inc. Waterworth, S., Raphael, D., Parsons, J., Arroll, B., & Gott, M. (2018). Older people's experiences of nurse–patient telephone communication in the primary healthcare setting. Journal of Advanced Nursing , 74(2), 373-382. 107