EXPLORATORY-DESCRIPTIVE QUALITATIVE 4.

Were the length and depth of the researcher-

RESEARCH participant relationships in the study appropriate to
 To obtain information needed to develop a program or the study approach and study purpose?
intervention for a specific group of patients. DATA COLLECTION METHODS
 The researchers are exploring a new topic or describing Interviews
a situation.  Quantitative studies - structured interviews (to
collect participants’ responses to questionnaires or
Studies consistent with this approach are not a specific type surveys)
of research; rather, they are studies conducted for a specific  Qualitative - Semistructured interviews (fixed set
purpose that do not fit into another of the categories. of questions, no fixed responses); unstructured
interviews or open-ended interviews (open-ended
 Developed to provide information and insight into questions, with probes)
clinical or practice problems.  Probes - are queries made by the researcher to
obtain more information from the participant about
The philosophical orientation of exploratory-descriptive a particular interview question.
qualitative research may vary, depending on the purpose of
the study, but often the researcher has a pragmatic Exploratory-Descriptive Qualitative Study - the interviewer
orientation. may ask more structured questions to achieve the purpose of
the study. 
 The pragmatic researcher is in search of useful
information and practical solutions and designs Strategies
studies to understand what works.  Writing notes during the interview
 Writing detailed notes immediately after the
Intended Outcome interview
 The findings of the study are applied to the practice  Recording the interview (video or audio)
problem that instigated the inquiry.
Focus Groups
SAMPLING AND RECRUITMENT  Were designed to obtain the participants’
Selection of Participants perceptions of a specific topic in a permissive and
 Individuals in qualitative studies are referred to as nonthreatening setting.
participants because the researcher and  Group dynamics can help people express and clarify
participants carry out the study cooperatively. their views in ways that are less likely to occur in a
 Sampling is purposeful - the researcher recruits one to one interview.
participants because of their practical knowledge,  5-8 participants; members of the research team may
experience, or views related to the study. take notes of the proceedings.
 Heterogenous participants - participants have  Moderator or facilitator - may or may not be the
different characteristics researcher
 Homogenous participants - similar characteristics
Observation
Researcher-Participant Relationships  Is a fundamental method of gathering data for
 The researcher creates a respectful relationship with qualitative studies, especially ethnography studies.
the participants.  The aim is to gather first-hand information in a
 The researcher’s personality plays a key factor → naturally occurring situation. “What is going on
skills in empathy and intuition are cultivated. here?”
 The researcher must be open to the perceptions of  The observer role is on a continuum from being a
the participants, rather than to attach their own complete participant to being a complete observer.
meaning to the experience.  Field notes - notes taken during or shortly after
Key informants - persons with extensive knowledge and observations
influence in a culture.
Examination of Documents and Media
Critical Appraisal Guidelines Textual Data:
1. Did the researchers identify the specific type of  Clinical notes in electronic health records
sampling that was used?  Policy manuals
2. Were the participants’ characteristics and life  Annual reports
experiences appropriate to the qualitative approach?  Newspaper articles
3. Was the number of participants adequate to fill the
purpose of the study? Media:
 Photographs
  Recordings  “When the purposes, questions, and methods or
 Photovoice - a specific use of media in qualitative research are interconnected and iterrelated”, and
studies involves participants taking photographs reseacher describes the study as a “cohesive
related to the research topic as a source of data.  whole”, the study has methodological congruence.
 Qualitative researchers are expected to maintain an
DATA MANAGEMENT AND ANALYSIS open mind and allow the meaning to be revealed.
Transcribing Interviews  The extend to which the findings of a qualitative
 Transcripts are the most commonly used textual study are dependable, confirmable, credible, and
data in qualitative studies. transferable is the degree of rigor of the study.
 “a verbatim transcript captures participants’ own This is the most important takeaway that everyone has to
words, language, and expressions” and allows the remember.
researcher to “decode behavior, processes, and
cultural meanings attached to people’s
perspectives.”
 Prepared by typing everything in the recording
word for word of what the person said including
audible noises, such as laughing, coughing, or
hesitating.

Data Organization
 Includes multiple locations where data will be
stored (online service or electronic network).
 Computer-Assisted Qualitative Data Analysis
Software (CAQDAS) - records decisions that are
made; automatic creation of an audit trail, ease of
retrieving text with the same code, maintenance of
an organized storage file system, development and
ability to share analysis with fellow researchers.
 Audit trail - one way that a researcher can assure a
reader that the methods of the study were
implemented appropriately.

DATA ANALYSIS

Codes and Coding

 Coding is the process of reading the data, breaking
text down into subparts, and giving a label to that
part of the text.
 These labels provide a way for the researcher to
begin to identify patterns in the data because
sections of text that were coded in the same way
can be compared for similarities and differences.
 A code is a symbol or abbreviation used to classify
words or phrases in the data.
 Codes may result in themes, processes, or
exemplars of the phenomenon being studied.

Themes and Interpretation

Themes emerge as codes are combined into more abstract
phrases or terms.

Rigor in Qualitative Research

 Assessed in relation to the detail built into the
design of the qualitative study, carefulness of data
collection, and thoroughness of analysis.
 ETHICS IN NURSING RESEARCH the research project. The study was conducted without
informed consent and institutional review.
INTRODUCTION
 Ethical research is essential for generating credible and ETHICAL STANDARDS FOR RESEARCH
trustworthy knowledge for evidence-based practice
(EBP). INTERNATIONAL STANDARDS
 National codes and regulations were developed to  Ethical principles for research were first articulated
promote the ethical conduct of research and following the Nuremberg Tribunals of German war
dramatically reduced the number of unethical studies. crimes.
 IRBs in universities and clinical agencies have been  In 1949, the Nuremberg Code was released.
organized to examine the ethical aspects of studies  The Nuremberg Code provided the basis for the
before they are conducted. development of the Declaration of Helsinki, which
was adopted in 1964.
UNETHICAL RESEARCH  Declaration of Helsinki – a major focus was
 Nazi Medical Experiments from 1933 to 1945 – the clarifying the difference between therapeutic
3rd Reich in Europe was engaged in atrocious and research and nontherapeutic research.
unethical medical activities, including research. Medical  Therapeutic research provides patients with an
experiments were conducted on prisoners of war and opportunity to receive and experimental treatment
persons considered to be valueless, such as Jews that might have beneficial results.
confined in concentration camps.  Nontherapeutic research is conducted to generate
knowledge for science; the results may help future
 Tuskegee Syphilis Study – in 1932 the US Public patients but are not expected to benefit those acting
Health Service initiated a study of the natural history of as research participants.
syphilis in black men in the town of Tuskegee,  Researchers are responsible for protecting the health,
Alabama. Many of the subjects were not informed about privacy, and dignity of human subjects and for selecting
the purpose and procedure. By 1936, evidence was important study topics concerning the risks and burdens
clearly available that the men with syphilis had for subjects.
developed more complications than the men in the  The World Medical Association (WMA) has initiated
control group. Ten years later, the death rate among and published the most recent revision of the
those with syphilis was twice as high as it was for the Declaration.
control group.
 The subjects were examined periodically but were not THE NUREMBERG CODE: CHARACTERISTICS OF
treated for syphilis, even when penicillin was ETHICAL STUDIES
determined to be an effective treatment for the diseases
in the 1940s. Information about an effective treatment Rationale for Study
for syphilis was withheld from the subjects, and  Conducted when necessary knowledge cannot be
deliberate steps were taken to deprive them of gained any other way
treatment.  Based on the results of previous studies, including
animal experimentation and knowledge of natural
 Willowbrook Study – From the mid-1950s to the early history of disease
1970s, Dr. Sau Krugman conducted research on  Designed to yield results that are needed by society
hepatitis at Willowbrook, an institution for the mentally  Anticipated results justify conducting the study
retarded in Staten Island, New York. The subjects were
children who were deliberately infected with the Rights of Human Subjects
hepatitis virus.  Voluntary consent
 May withdraw at any time with no penalty
 Jewish Chronic Disease Hospital Study – The
purpose of this study was to determine patients’ Risk Avoidance
rejection responses to live cancer cells. A suspension
 No unnecessary physical or mental suffering and
containing live cancer cells that had been generated
injury
from human cancer tissues was injected into 22 patients.
 Study terminated if the risk of harm increases
The researchers did not inform the patients that they
were taking part in a study; and did not know that the
Resources
injections were live cancer cells.
 The physicians caring for the patients were unaware that  Adequate resources to protect subjects
the study was being conducted. The physician directing
the study was an employee of the Sloan-Kettering STANDARDS IN THE UNITED STATES
Institute for Cancer Research and there was no  The first major ethical guide was the Belmont Report
indication that this institution had conducted a review of written by the National Commission for the Protection
 of Human Subjects of Biomedical and Behavioral
Research (1979). PROTECTING HUMAN SUBJECTS
 The Belmont Report identified ethical principles to
guide selecting subjects, informing them of the risks APPLICATION OF ETHICAL PRINCIPLES
and benefits of a study and documenting their consent.  Three ethical principles guide ethical research: respect
The report also detailed difference between therapeutic for persons, beneficence, and justice.
and nontherapeutic research and the application of  The principle of respect for persons indicates that
research findings in the practice of medicine. people should be treated as autonomous agents, with the
 President Obama issued and executive order creating right to choose whether or not to participate in research
the Presidential Commission for the Study of and to withdraw from a study.
Bioethical Issues (active from 2009 to 2017), a diverse  Diminished autonomy: children, people who are
group of national leaders to advise government leaders terminally or mentally ill, and prisoners (entitled to
on emerging ethical and social issues as a result of additional protection).
scientific advances.  The principle of beneficence encourages the researcher
to do good and “above all, do no harm.” This principle
FEDERAL REGULATIONS FOR THE is the foundation for analyzing the benefits and risks of
PROTECTION OF HUMAN SUBJECTS a specific study. Researchers guided by this principle
seek to reduce the risks and ensure that the subjects
 Code of Federal Regulations (CFR) – each US receive the benefits.
Department involved in human research has a chapter in
the CFR that guides research funded by the department.
The CFR is called the Common Rule.  Beneficence also involves maintaining the integrity of
 The Common Rule includes requirements related to the the study and disseminating the findings so that
content of an informed consent document, processes for maximum scientific benefit can be gained from the
obtaining informed consent, maintaining an IRB, and study.
implementing special precautions for studies with  The principle of justice states that human subjects have
vulnerable populations. a right to fair treatment, which includes access to the
 Vulnerable populations are defined as persons who are potential benefits of a study and not overexposure to its
susceptible to undue influence or coercion: children, risks. Maintaining justice in research means that
prisoners and persons who are economically or inclusion and exclusion criteria for subjects must have
educationally disadvantaged. Persons who have scientific and/or logical explanations.
impaired decision making were also identified as being  Consistent with the ethical principles, nurses who
vulnerable (those with Alzheimer’s diseases, traumatic critically appraise published studies, review research for
brain injury, and those born with intellectual conduct in their agencies, or assist with data collection
limitations). for a study, have an obligation to determine whether the
 The US Food and Drug Administration (US FDA) – rights of the research participants have been protected.
responsible for managing the elements of the Common  The human rights that require protection in research are
Rule that involve testing drugs, medical devices, the rights to the following: 1) self-determination; 2)
biological products, dietary supplements, and electronic privacy; 3) anonymity and confidentiality; 4)
products for human use. protection from discomfort and harm; and 5) fair
 Health Insurance Portability and Accountability Act selection and treatment.
(HIPAA) (Privacy Rule) – protected health  The American Nurses Association (ANA) Code of
information; privacy protections for most individually Ethics for Nurses (2015) reiterates these rights and
identifiable protected health information by establishing provides nurses with guidelines for ethical conduct in
conditions for its use and disclosure by certain nursing practice and research. This code focuses on
healthcare providers, health plans, and healthcare protecting the rights of patients and research
clearinghouses. participants.
 The Privacy Rule defined protected health
information (PHI) as data generated and collected for RIGHT TO SELF-DETERMINATION
research that can be linked to an individual person.  Based on the ethical principle of respect for persons,
 US Department of Health and Human Services and it indicates that humans are capable of
(DHHS) Protection of Human Subjects Regulations controlling their own destiny.
(Common Rule) – human subjects research; protect the  People should be given autonomy, which means
rights and welfare of human subjects involved in having the freedom to conduct their lives as they
research conducted by the DHHS. choose, without external controls.
 The Common Rule provide guidelines for federally  Researchers protect the autonomy of subjects when
and privately funded research to protect subjects, ensure they are provided information about a study and
their privacy, and maintain the confidentiality of the allowed to choose whether or not to participate.
information obtained through research.
 Withdrawal from the study is allowed even if  The HIPAA Privacy Rule expanded the protection of
consent was previously given. a person’s privacy specifically, his/her protected,
 A subject’s right to self-determination can be individually identifiable health information.
violated through the use of coercion, covert data
collection, and deception.
 According to the Common Rule, identifiable private
 Coercion occurs when one person intentionally presents information (IPI) is “private information for
an overt threat of harm or an excessive reward to which the identity of the subject is or may be
another to obtain compliance. readily ascertained by the investigator or
 Covert data collection – subjects are unaware that associated with the information.”
research data are being collected.  According to the HIPAA Privacy Rule, identifiable
information is protected if related to a person’s past or
current health condition, the care received by
healthcare providers, and payment for health care
 Use of deception – the actual misinforming of subjects received.
for research purposes. Based on the revision of the  The revised Common Rule created a new type of
Common Rule, deception may only be used ethically in consent called broad consent, through which a
a study when the researcher informs potential subjects potential subject gives researchers permission to
that they will be unaware of or deliberately misguided store, maintain, and use IPI for other studies.  
about the true purpose of the study, and they agree to  Broad consent does not require that researchers
participate despite this condition. protect confidentiality of the identity of the subjects;
and applied to identifiable biospecimens collected for
PERSONS WITH DIMINISHED AUTHORITY other studies or clinical care.
 Persons have diminished autonomy when they have
impaired decision making due to medications, COMPONENTS OF BROAD CONSENT
mental illness, or mental capacity. May be  Description – researcher may store, maintain, and use
temporary or permanent. for future studies identifiable private information and
 They require additional protection of their right to identifiable biospecimens.
self-determination because of their decreased ability  General Requirements – similar to informed consent;
to give informed consent. broad consent will include
 They are vulnerable to coercion and deception. 1. Potential risks and benefits
 Researchers not only obtain parental consent 2. Confidentiality related to subject’s identity
(“parental permission”), they also must solicit 3. Voluntary participation
assent to participate in research from the child. 4. Right to withdraw at any time
5. Use of biospecimens for commercial profit
 Assent, “pediatric assent”, means that the child has 6. If profits occur, subjects will receive a share
agreed to participate in the study. 7. Whether analysis of the specimen will include
 When the decision is affirmative, the process will whole genome sequencing
culminate in a combination of assent, consent, or 8. Types of research for which data may be used
parental permission documents. 9. Sufficient information for a reasonable person to
 With the exception of infants and toddlers, children make a decision about participation
can and should be involved in the process of giving 10. Length of time data will be kept, which be
assent or consent. indefinite
11. Statement subjects not to be informed about specific
RIGHT TO PRIVACY studies being conducted
 Privacy is the freedom people have to determine the 12. Results not to be shared with subjects unless
time, extent, and general circumstances under which clinically relevant
their private information will be shared with or 13. Contact information to use in getting answers to
withheld from others. questions
 Private information includes a person’s attitudes,
beliefs, behaviors, opinions, and record. RIGHT TO ANONYMITY & CONFIDENTIALITY
 The research subject’s privacy is protected if the  The subject has the right t anonymity and the right to
subject is informed, consents to participate in a study, assume that the data collected will be kept
and voluntarily shares private information with a confidential.
researcher.  Complete anonymity exists when the researcher
 An invasion of privacy occurs when private cannot link a subject’s identity with his/her individual
information is shared without a person’s knowledge responses.
or against his or her will.
  Confidentiality is the researcher’s safe  Most clinical nursing studies examining the effect of a
management of information or data shared by a treatment involve minimal risk.
subject to ensure that the data are kept private  In unusual levels of temporary discomfort, the
from others. subjects may experience discomfort during and after
 The researcher agrees not to share the subjects’ the study.
information without their authorization.  Unusual levels of discomfort or harm may occur
Confidentiality is grounded in two premises: when subjects experience failure, extreme fear, or
1) Subjects may share personal information to the threats to their identity as part of a study. Qualitative
extent that they wish and with whom they researchers may ask questions that cause participants
wish. to relive a life crisis, such as being diagnosed with
2) Accepting personal information comes with an colon cancer or losing a spouse.
obligation to maintain confidentiality, an  In studies with unusual levels of discomfort or harm,
obligation that is even greater for researchers the researcher will describe the exclusion criteria for
and nurses. the sample in the IRB protocol. The exclusion criteria
 A breach of confidentiality can occur when the are developed to prevent recruitment of subjects who
researcher, by accident or direct action, allows an are at higher risk for long-term discomfort or harm.
unauthorized person to gain access to the raw data  In studies which there is the risk of permanent
of a study. damage will undergo additional scrutiny by the IRB.
 Confidentiality also can be breached in reporting or The rationale for doing the study must establish
publishing a study is a participant’s identity is reasons why the knowledge from the study cannot be
accidentally revealed, violating his/her right to gained in another way and what will be done to
anonymity. prevent or minimize damage.

RIGHT TO PROTECTION FROM DISCOMFORT RIGHT TO FAIR SELECTION AND TREATMENT

AND HARM  Based on the ethical principle of justice where people
 Based on the ethical principle of beneficence which must be treated fairly and receive what they are owed
states that one should do good and, above all, do no or treated in a way that is equitable to the treatment of
harm. other persons in the same situation.
 In research, discomfort and harm can be physical,  Each study must include a consent form describing
emotional, social, or economic or any combination the researcher’s role and subject’s participation in the
of these four types. study.
 Studies range from no anticipated discomfort and  A consent form is actually an agreement between
harm to a high risk of discomfort and harm. the subject and researcher about what each will
 Research designs that involve a review of medical do during the study.
records, student files, or secondary analysis of de-  The research report needs to indicate that the selection
identified data collected for another study have no and treatment of the subjects were fair. Inclusion
anticipated discomfort and harm. When there is no or criteria should reflect the research problem and study
minimal interaction between the researcher and purpose.
subject, the study will usually be considered exempt
when reviewed by an IRB.
 Studies that cause temporary discomfort are described
as minimal risk studies, in which the discomfort is UNDERSTANDING INFORMED CONSENT
similar to what the subject would encounter in his/her  Informed consent is providing information to a
daily life and is temporary, ending when the study is potential subject and the opportunity to participate in
complete. the study.
 Subjects in a minimal risk study may complete  The researcher describes the study and what subjects
questionnaires or participate in interviews. will be asked to do.
 A potential subject’s decision about whether to
participate is the consenting part of the process.
 Physical discomfort in minimal risk studies may Subjects provide ongoing consent by continuing to
include fatigue, headache, or even muscle tension. participate in the study, with the assurance that they can
Anxiety or embarrassment might result from withdraw at any time.
answering questions on sensitive topics. Four elements:
 The only economic harm may be the costs of travel to 1) the researcher must disclose essential information about
the study site. To avoid economic harm, the the study to potential subjects in a way that can be
researcher may reimburse the subject for the cost of understood;
the additional testing supplies. 2) the extent to which the potential subject comprehends the
information;
 3) the competence of the potential subject and the person’s a reading of the study summary. A witness observes
voluntary agreement to take part in the study. the consent process and ensures that the presentation
includes the required content of the study summary
 Disclosure – documentation of the information that was approved by the IRB.
shared with the subject’s signature denoting agreement  In some minimal risk studies, the requirement for
to participate. written consent is waived.
 A consent form is a written document that includes the  Studies in which the researcher or data collector
elements of informed consent required by the Common interacts with the subjects require obtaining informed
Rule. consent.
 Comprehension – the researcher must take the time to  The consent process is usually presented in the
teach the subjects about the study; risks and benefits methods sections under a discussion of study
included. The amount of information to be taught procedures or data collection process.
depends on the subject’s knowledge of research and the
specific research topic.
 Competence – autonomous persons who are capable of
understanding the benefits and risks of a proposed study
are competent to give consent. Persons with diminished
autonomy because of legal or mental incompetence or
confinement to an institution are not legally competent
to consent to participate in research.
 Voluntary agreement – the prospective subject has
decided to take part in a study of his/her own volition,
without coercion or any undue influence.
 
COMPONENTS OF INFORMED CONSENT
1) Description
2) General Requirements:
a) Comprehendible – circumstances provide opportunity
to discuss and make a deliberate decision without
pressure; language that is understandable; presented
not as unrelated facts, but in a way that is meaningful
b) Cautious – subjects does not waive any legal rights or
release researcher or funder from negligence
c) Complete but concise – sufficient information that a
reasonable person would want to make a decision
d) Comprehensive – purpose and procedures of the
research study; length of subject’s involvement;
benefits and risks or discomforts; compensation for
research-related injury (if any); disclosure of
alternative treatments if available; confidentiality of
records; contact persons; right to refuse or withdraw
without loss of benefits

DOCUMENTATION OF INFORMED CONSENT

 The documentation of informed consent depends on
the study’s level of risk and the requirements of the
IRB that approves the study.
 Most studies require a written consent form that the
subject signs; the subject also receives a copy of the
consent form.
 Studies that involve subjects with diminished
autonomy will require a written signed consent form:
potential subject and his/her authorized representative
(indicates relationship with the subject under the
signature).
 For studies in which potential subjects may not be
able to read and comprehend the consent form, the
IRB may approve an oral presentation of the study or