Ethical Issues, Dilemmas, and Resolutions in Nursing/Health Research:

Philosophical Perspective and Experience in Thailand

Associate Prof. Aranya Chaowalit, APN, PhD

Faculty of Nursing, Prince of Songkla University

Introduction

The focus of nu rsing and health care is to improve the quality of care and patients

well being. In order to improve quality of care to p atients, families and communities, resear ch

in nursing/health is essential. Nurses and other h ealth care personnel have an obligation to

develop knowledge for the advancement of their professions. Recently, research studies in

nursing and health have increased dramatically and these studies are conducted with humans.

As practitioners and researchers, nurses and health personnel are not only faced with ethical

issues and dilemmas in their daily work, but also in conducting research with human

participants. Unethical research studies in nursing/health bring negative consequences to

human participants. Researchers need to p rovide special protection to patients who participate

in research studies. Ethical conduct of research ers guided by ethical principles and codes of

conduct will help resolve ethical issues/dilemmas in conducting nursing/health research and

ensure that the rights of human participants are pro tected. In addition, health care

organizations are responsible to provide mechanisms/resources to facilitate their researchers

in conducting ethical research.

Ethical Principles and Ethical Codes as Frameworks for Ethical Conduct

There are some historical events regarding unethical treatment to humans. Burns and

Grove (2011) provide examples of four experimental projects which have been highly

publicized for their misconduct, including the Nazi medical experiments, the Tuskegee

Syphilis Stud y, the Willowbrook study, and the Jewish Chronic Disease Hospital study.

Unethical treatments in these four p rojects were: (1) ex posing participants to serious physical,

mental, and social risks/harm, or death, (2) withholding information to participants, and (3)

conducting research without the participants informed consent.

In response to these unethical studies, codes and declarations were formulated which

include the Nuremberg code, the Declaration of Helsinki, and the Belmont Report. The

Nuremberg code was developed in Germany in 19 48 with three basic elements: (1) voluntary

and informed consent, (2) a risk/benefit analysis, and (3) the right to withdraw without

penalty (Burns and Grove, 2011). World Medical Association Declaration of Helsinki was

adopted in Finland in 1964. It provides basic principles for all medical research which

includes (1) protection of the life, health, privacy, and dignity of humans, (2) conformity with

scientific principles and with adequate knowledge, (3) reviews b y ethical review committee,

(4) identification of ethical consideration statement, (5) research b y scientifically qualified

persons and under supervision of competent medical person, (6) careful assessment of risks

and burdens in comparison with foreseeable benefits , (7) participants must be volunteers and

adequately informed, (8) obtaining informed consent from participants/legally authorized

representative, and (9) obligations to publish the results accurately (World Medical

Association, 2002). The Belmont Report was issued by the National Commission of the U.S.

in 1978. It provides three principles for researchers in conducting ethical research. Principle

1: respect for person incorporates two ethical convictions related to autono my: (1) individuals

are treated as autonomous agents, and (2) persons with diminished autonomy are given

protection. Principle 2: beneficence requires researchers to secure the well-being of the

research participants. Principle 3: justice indicates that the potential risks of research should

be borne equally by the members of society who are likely to benefit from it, and the research

does not select specific classes or types of individuals because of their ease of availability o r

their compromised positions (Amdur & Bankert, 2011).

The National Research Council of Thailand (1998 ) develop an ethical code of conduct

which requires that researchers:(1) must have integrity in academic and management , (2)

must maintain the commitment to the research agencies or their affiliates, (3) must be

knowledgeable in the research stud y, ( 4) must be responsible to the research participants, (5)

must respect for participants dignity and rights, (6) must have freedom of intellect and have

no prejudice in every step of the research, (7) should utilize research findings for the good of

the society, (8) should respect others opinions, an d (9) should have responsibilities to all

levels of society.

Ethical principles in bioethics are also well known in health car e professions. They

provide a guideline fo r health care professionals as practitioners and as research ers.

Beau champ and Childress (2001), Burkhardt and Nathaneil (2002), and Fry and Johnstone

(2002) propose ethical principles which include respect for autonomy, beneficence, non-

maleficence, justice, veracity, and confidentiality. These principles will be discussed along

with the discussion of ethical issues/dilemmas related to each principle.

Ethical Issues/Dilemmas in Nursing/Health Research

There are common ethical issues/dilemmas in conducting research in nursing and

health as follows:

1. Respect for autonomy

Beau champ and Childress (2001) describe respect for autonomy as

acknowledgement of persons right to hold views, to make choices, and to take actions based

on personal values and beliefs. They an alyze autonomous action in terms of normal choosers

who act (1) intentionally, (2) with understanding, and (3) without external controlling

influences. Burns and Groves (2011) assert that in conducting research with human

participants, researchers must respect prospective participants as autonomo us agents who

have the right to self-d etermination. Polit and Beck (2008) define self-determination as

prospective participants have the right to make decision whether to participate in a study

without penalty or prejudicial treatment, have the right to ask questions, to refuse to give

information, or to withdraw from the study.

Agreement of prospective participants to particip ate in a research study is called

consent. Based on the ethical principle of respect for autonomy, researchers must inform

their prospective participants before obtaining the consent from them which is called

informed consent. Beauchamp and Childress (2 001) define an informed consent as an

individuals autonomous authorization of medical intervention or of involvement in research.

In this sense, a person must authorize something through an act of informed and voluntar y

consent. In addition, Polit, Beck, and Hungler (2001) define informed consent in the research

context as research participants having adequate information regarding the research,

comprehend the information, and have the power of free choice, enablin g them to consent

voluntarily to participation or decline participation. Beauchamp and Childress (2001) classify

five elements as the components of informed consent: (1) competen ce, (2) disclosure, (3)

understanding, (4) voluntariness, and (5) consent.

In obtaining informed consent from the prospective participants, ethical researchers

must strictly follow the consent process. The first step is assessment of prospective

participants competence. Beauchamp and Childress (2001) indicate that participants are

competent to make decision if they have the capacity to understand the info rmation, to make

a judgment about the information in light of their values, to reason about the consequences of

ones actions, and to communicate freely their wishes to researchers. An issue related to

assessment of competence occurs when the p rospective participants have diminished

autonomy, eg. persons with a mental disorder that may affect their decision-making capacity.

In this case, an independent, qualified professional is required to assess the prospective

subjects capacity to consent.

The second step is full disclosure of information to prospective participants. Without

adequate information delivered to participants, they will not have an adequ ate basis for

decision making. Researchers have an obligation to disclose information related to the

research study which includes aims and methods of the research, anticipated benefits and

risks, any anticipated inconvenience or discomfort, and the participants rights to withdraw

from the research without any negative consequences ( Beauchamp & Childress, 2001). A

common ethical issue related to full disclosure of information is that some research

participants do not realize that they are involved in a research study or some participants

consent without being informed of critical information. If the p articipant is not aware of the

true nature o f the research and the participant gives consent, the consent is not informed. The

researcher has not obtained an informed consent if only partial info rmation about the research

is provided. (Wood & Ross-Kerr, 2011 ).

Although researchers realize the principle of autonomy which supports the right to

full disclosure of the prospective participants, they may face difficulty in fo llowing the

principle. Some researchers may feel that the righ t to full disclosure must be violated to yield

meaningful information to the research. Violation to full disclosure might result in invalidity

of the research findings, but full disclosure might result in biases (1) the bias resulting from

distorted information, and (2) the bias resulting from failure to recruit a r epresentative sample

(Polit & Beck, 2008; Polit, Beck, & Hungler, 2001; Polit & Hungler, 1999). Examples of

research studies that researchers may feel difficulty in full disclosure to the participants ar e: a

study exploring unethical behaviors of health care professionals when providing care to

patients in their real practice, a study on child abuse at private child care centers, and a study

on caregivers neglect of the elderly in nursing home. From these examples, if the prospective

participants are fully informed about the research purpose and the methodo logy, they may

decline to participate in the study. In these circumstances, it is the responsible of the

professional organizations or employers to delegate their personn el to conduct studies to

improve the quality of their employees perfo rmance as well as to their services for the

benefits of the society.

Researchers who feel that full disclosure is incompatible with the conduct of rigorous

research sometimes use two techniques: covert data collection or con cealment, and deception

(Burns & Grove, 2011).

Covert data collection occurs when research data are being collected without

participants knowledge and thus without their consent. This might happen if a resear cher

wanted to observe peoples behavior in the real wo rld. Full disclosure may change the

participants behaviors. Therefo re, researchers may use concealed methods such as observin g

through a one-way mirror, videotaping with hidden equipment, or observing while pretending

to be engaged in other activities. Deception is another technique used when researchers fear

that full disclosure would result in prospective participants refusal to participate. Deception

involves deliberately withholding information about the study, or providing false information

to the participants. Some people ar gu e that deception is never justified, while others believe

that deception may be justified if the study involves minimal risk to participants and if there

are anticipated ben efits to the profession and society (Polit & Beck, 2008). However, Wood

and Ross-Kerr (2011) propose that deception is considered more unethical than withholding

of information. With deception, participants were deliberately misled about the study b y f alse

information, while withholding of information, incomplete information is provided. In

studies where placebos are compared with the effect of real treatment, withholding of

information might be used. Beau champ and Childress (2001) support that withholding

truthful information from research participants sometimes is acceptable. For example,

epidemiological study using medical records could not be conducted if consent form of

participants were always required. Thus, using those records without consent is often

ethically justified.

In some studies such as a study comparing eff ectiveness of general massage and Thai

traditional massage to Thai elders, participants might not be told whether they are receiving

what type of massage. Knowing the type o f massage may influence the participants response

which will result in invalidity of the study. According to Burns and Grove (2011), when

research participants are not completely info rmed about the study because that knowledge

would alter their actions, consent to incomplete disclosure is needed. With consent to

incomplete disclosure, prospective participants must be told that certain information will be

withheld deliberately.

Another issue relating full disclosure of information is using of appropriate language

to the prospective participants during the consent process. The researchers must be careful in

communicating consent information. Understandable language in the consent form for certain

group of participants is crucial in providing information. Wood and Ross-Kerr (2011)

suggest that prospective participants must be informed in their own language, at their own

level of understanding, and in their common vocabulary. Researchers must avoid research

and medical jargon. Language that is in favor of consenting to participate in the study should

be avoided because biased langu age does not prov ide full comprehension of the persons

decision to participate.

The third step of informed consent is understanding in which researchers evaluate

whether prospective participants understand the in formation provided. Participants who are

calm, attentive, and eager for dialogue can understand information provided to them, while

some who are n ervous or distracted hav e difficulty in understanding information. Many

conditions, such as illness, irrationality, and immaturity limit their understanding

(Beauchamp & Childress, 2001). Because informed consent is based on the prospective

participants evaluation of potential risks and benefits, the researcher is required not only to

communicate critical information to them but also evaluation of participants understanding

of the information provided (Polit & Beck, 2005).

The fourth step of info rmed consent is voluntarin ess. A person acts voluntarily

when the actions are performed without being und er the control of another s influence. There

are three categories of influence: co ercion, persuasion, and manipulation. (Beauchamp &

Childress, 2001). Coercion occurs when a researcher intentionally presents overt threat of

harm or an excessive reward to the prospective participants to obtain compliance. Some

persons are forced to participate in research because they fear harm or discomfort if they

refuse to participate (Burns & Grove, 2011).

In persuasion, a p erson must believe in something through reasons another person

advances- it is the influence by reason. Manipulation, another form of influence, is neither

persuasive nor coercive. Manipulators use informational manipulation, a deliberate act of

managing info rmation to alter a persons understanding of a situation and motivate him/her to

comply (Beauchamp & Childress, 2001). Based on the principle of respect for autonomy, it is

required that a researcher cannot control prospective participants by any means to participate

in the study.

The last step of informed consent is consent. R esearch ers obtain voluntar y consent

after the p rospective participant receives the essential information about the study and has

demonstrated comprehension of this information. Informed consent typically involves

disclosure of essential information which covers researcher credentials, research title,

purposes of the study, study procedures, benefits to the participants or others, anticipated

risks or harm and how the researcher will prevent risks/harm, maintaining of participants

anonymity and confidentiality, participants right to refuse participation, to fair selection and

treatment, as well as contact information (Burns & Grove, 2005; Haber, 1998; Nieswiadomy,

1998; Polit & Beck, 2008)). All of these elements of informed consent need to be

documented in a consent form. The documentation of informed consent depends on the level

of risk involved in the study. Most studies require a written consent form. However, in some

studies, the requirement for written informed consent is waived (Burns & Grove, 2011).

Autonomous persons, who are capable of understanding the benefits and risks of the study

are competent to give consent. The resear chers cannot collect data on participants before

obtaining informed consent. In Thailand, the National Health Act (Office of the Council of

State of Thailand, 2007) Article 9 states that health care professionals who plan to include

their patients as research participants must inform them and obtain written consent prior to

conduction of the research and participants can withdraw from p articipation any time.

There is an ethical issue related to the inability of certain individuals, i.e. v ulnerable

participants or persons with diminished autonomy, to make well-informed choices about risks

and benefits associated with participation, and therefore th ey are incap able of giving fully

informed consent (Burns & Grove, 2011). In research, vulnerable is defined as a person who

is likely to have compromised autonomy related to decisions about research participation

(Amdur & Banket, 2011). Vulnerable groups of individuals within a research contex t include

pregnant women, human fetuses, neonates, children, aged people, persons with learning

disabilities, poor , prisoners, mentally incompetent persons, confinement to an institution,

sedated or unconscious, and terminal illness (Burns & Grove, 2011; Fauka & Mantzorou,

2011; Polit, Beck, & Hungler, 2001; USDHHS, 2005 as cited in Burns & Grove, 2011).

Persons should not be coerced to p articipate in any research study even though their

autonomy is diminished. (Burns & Grove, 2011; Polit, Beck, & Hungler, 20 01). When a

research study is conducted by nurses or physicians and when prospective participants are

patients in the unit, the patients fear that their medical and nursing care will be negatively

affected if they do not participate in the study, make them vulnerable. This phenomenon is

common in the Thai cultural contex t because Thai patients pay respect to physicians/nurses

and perceive that physicians/nurses have high er power than them. In addition, relationship

between patients and physicians/nurses is based on trust. They believe that physicians and

nurses are ethical persons who will never harm them and the research studies will be for the

benefit of the society. Therefore, the patients usually agree to participate in research studies

conducted by physicians or nurses. Furthermore, the culture of humblen ess in the Thai

context influences patients not to refuse any requests from physicians o r nurses in order to

maintain a good relationship. In Thai language, it is called "Kren g Jai, which means do not

want to bother or trouble others.

Since patients in health care settings are involved in many research studies conducted

by nurse researchers or other health care professionals, their rights must be protected. The

American Hospital Association presents

A Patien ts Bill of Rights

, and health care

professions in Thailand present

Thailands Declaration of Patients Rights

which require

health care professionals to perform effective and respectful care to their patients.

A

statement proposed in

A Patients Bill of Rights

regarding patients rights as a research

participant is The patient has the right to consent to or decline to participate in proposed

research studies or human experimentation affecting care and treatment or requiring direct

patient involvement, and to have those studies fully explained prior to consent. A patient who

declines to participate in research or experimentation is entitled to the most effective care that

the hospital can otherwise provide (Burkhardt & Nathaniel, 2002). Similarly, a statement

presents by

Thailands Declaration of Patients Rights

is The patient has the right to receive

adequate information for making decision whether to participate or withdraw from being a

research participation in experimentation conducted by health care professionals

(Boonchalermwipas & Yomjinda, 2003).

Researchers must provide justification to include participants with diminished

autonomy or in vulnerable groups (Burns & Grove, 2011). In addition, researchers must pay

special attention to the ethical dimensions of a study when participants are in vulnerable

groups (Polit, Beck, & Hungler, 2 001). Those wh o are not competent to sign the consent

form because of diminished autonomy, p ermission and sign ature of their legal guardian or

representative are required (Haber, 1998). If prospective participants are ch ildren, the

researcher must explain the study usin g simple language at the appropriate level that the child

can understand, and obtain the consent from the child as well. If the prospective participants

cannot understand either the spoken or the written words, then only p ermission of the

guardian are required (Wood & Ross-Kerr, 2011). In addition, researchers should provide

adequate time for prospective research participants/guardians to review the document and

decide whether to participate in the study.

Another ethical issue related to the principle of r espect proposed b y Polit and Beck

(2008) is when data are collected from people over the internet. The issue is whether

messages posted to chat rooms or listservers can be used without the author s permission and

their informed consent. Some researchers believe that anythin g posted electrically in the

public domain can be used without consent, while the others feel that same ethical standard

must be applied to all groups of prospective participants. In order to conduct ethical research,

researchers should follow guidelines for conducting research on the intern et.

2. Beneficen ce/non-maleficence

The ethical principle of beneficence requires th e researchers to prevent and remove

harm as well as to do or promote good, while the ethical principle of non -maleficence fo cuses

on the obligation not to inflict harm or do no h arm (Beauch amp & Childress, 2001). In

research, it is known as risk-benefit ratio (Matthews & Venables, 1998). A risk-benefit ratio

is a comparison between levels of risk present for participants and the lev el of benefit

(Macnee & McCabe, 2008). Resear ch in humans should be intended to produce ben efits for

participants themselves or for other individuals or society as a whole. Researchers have an

obligation to not induce unnecessary harm or discomfort to participants. Harm and

discomfort in participation in research can be physical, emotional, social, or financial. Ethical

researchers must use strategies to minimize all types of harms and discomfort (Polit & Beck,

2008).

Skilled researchers is required to prevent harm and discomfort of participants.

Researchers must have skills in their research p ro cess. Harm and discomfort caused by

inexperienced researchers can be found during the development of items in a questionnaire,

especially sensitive items. When answering questions of such items, participants might recall

their past traumatic experiences. In some intervention studies, resear chers must have

adequate kno wledge and skills to carry out the proposed interventions. In qualitative studies,

harm and discomfort are also common when researchers lack experience in asking sensitive

questions during the interviews.

Five categories of studies based on levels of h arm and discomfort are as follows:

(Reynold, 1972 as cited in Burns & Grove, 2011)

No anticipated effects:

In this type of study, the researcher does not interact directly

with the participants, for example reviews of patients records, student files, pathology

reports, or other documents that have no anticipated eff ects on the research participants.

Temporary discomfort:

This type of study is a minimal-risk study in which the

discomfort is similar to discomfort in their daily lives such as physical discomfort (fatigue,

headache, or muscle tension from being interviewed or answering questionnaire), emotional

and social risks (anxiety or embarrassment when answering certain questio ns), and economic

risks (time, travel costs). The discomfort will cease when the study is terminated.

Unusual levels of temporary discomfort:

In this type of study, participants frequently

have discomfort both during the study and after th ey have completed it, such as prolonged

muscle weakness, joint pain, and dizziness, experience failure, extreme fear, or threats to

participants identity. Matthews and Venables (1998) provide an example of psychological

harm in qualitative studies which seek to explore and describe participants feelin gs or

experiences of illness or bereavement b y probing questions which force them to confronts

areas o f person al trauma. In qu antitative research, Parahoo (2006) asserts that survey items

can bring back traumatic memories.

Risk of permanent damage:

This type of study is more common in biomedical

research than in nursing resear ch such as studies on new drugs and surgical procedures.

Studies on sensitive issues such as sexual behavior, child abuse, HIV/AIDS status, or drug

use have the potential to cause permanent damage to a participants personality or reputation.

Decrease in job performance or loss of employment are examples of potential economic risks.

Certainty of permanent damage:

Conducting research that has a certainty of

permanent damage to participants is highly questionable, regardless of the benefits that will

be gained.

Researchers may face ethical issues/dilemmas related to the principle of beneficence.

Wood and Ross-Kerr (2011) describe an ethical issue related to withholding ben efits from the

control group of participants. As patients, they all have rights to access to effective care and

treatment. However, they are deprived of the ben efits when they are in the control group.

This issue can be solved by providing ben efits for the control patients after the data have been

collected. Parahoo (2006) notes that in health and nursing studies, researchers ar e often h ealth

professionals which leads to dual roles as a health care provider and as a researcher. They

should ensure that the need to obtain data does not take preceden ce over patients needs,

wishes, rights, well-being, and safety.

3. Justice

Justice is the ethical principle that relates to fair, equitable, and appropriate

treatment in light of what is due and owed to persons (Burkh ardt & Nathaniel, 2002). In

research ethics, the principle of justice refers to en suring that the benefits and burdens of

participation are equally distributed across the sample group. It also requires some indication

of fairness in the selection of participants. Some groups of participants are vulnerable with

respect to the principle of justice or fair treatment within research studies (Matthews &

Venables, 1998). Some researchers select participants because they like them and want them

to receive sp ecific benefits of the study, while some researchers treat participants in

vulnerable groups carelessly and have little regard for the harm and discomfort. Therefore,

research report is required to indicate how the researchers ensure fair and equal treatment of

participants during data collection (Burns & Grove, 2011). The process of randomization is

perceived as the best way to ensure fair selection o f participants (Matthews & Venables,

1998).

4. Anonymity and confidentiality

Based on the right to privacy, the participant has the right to anonymity and the

right to assume that the data collected with be kept confidential (Burns & Grove, 2011).

Anonymity means that names, address, or personal characteristics of participants are not

known by the public. Research findings must be published or reported in such a way that the

participants remain anonymous (Wood & Ross-Kerr, 2011). C onfidentiality is the ethical

principle that requires nondisclosure of private or secret information (Burkhardt & Nathaniel,

2002). It is the researchers management of private information shared b y a participant

(Burns & Grove, 2011). Furthermo re, confidentiality implies that all participants records will

be kept closed and those records can be accessed only by persons involved in the research.

(Wood & Ross-Kerr, 2011). In conducting ethical research, the researcher has an obligation

not to share private info rmation of the participant to the others without the participants

permission (Burns & Grove, 2011).

Anonymity and confidentiality of participants can be breached when an un authorized

person gains access to raw data, or when participants identity is accidentally revealed in

reporting or publishing a study (Ramos, 1989 as cited in Burns & Grove, 2011). A breach of

confidentiality can cause harm to persons such as embarrassment, ridicule, discrimination,

deprivation of rights, physical or emotional harm, and loss of roles or relationships

(Burkhardt & Nathaniel, 2002). In studies of groups of people, it is frequently impossible to

maintain anonymity of the group when publishing the results. It may be the only group of its

kind, so that it is possible to identify the members. This group of participants must be

informed of the intention of researcher to publish the results befo re they sign the consent.

Another issue related to maintaining of participants anonymity occurs during data analysis.

Some data shown in published reports will make it easy to identif y participants (Wood &

Ross-Kerr, 2011). Parahoo (2006) asserts that in qualitative studies, the opportunities for

sharing confidences are greater than in quantitative research because of probing technique

which can reveal intimate and personal details. In addition, the small sample size in

qualitative studies, and the use of quotes can also lead to identification of participant in

published reports. Therefore, researchers must r ealize these issues and provide special

protection to ensure anonymity and confidentially throughout the research process.

5. Veracity or truth telling

The principle of veracity is defined as the obligation to tell the truth and not to lie

or deceive others. In many cultures, truthfulness has long been regarded as fundamental to the

existence of trust in the relationships (Fry & Johnstone, 2002). In Buddhist teaching, one of

the five

Precepts

states that Buddhists must refrain from telling a lie to others because telling

a lie is sin (Buddhadasa, 1992). Truth telling is a process of responsible, caring, and hon est

communication (Livingston & Williamson, 1992). If there is no confidence in the truthfulness

to others, there is no way to assess their fairness, their intentions to help, or to harm (Bok,

1978 as cited in Williamson & Livingston, 1992). Truth telling is based on the belief that the

receiver has the right to self-determinationthe right to be autonomous (Williamson &

Livingston, 1992).

In the research contex t, telling the truth is an integral part of full disclosure of

information in the consent process as previously mentioned.

Institutional Review Board (IRB) as a Mechanism to Protect Humans Rights

An institutional review board (IRB) is a committee that reviews research to ensure

that the research er is conducting the research ethically. Each IRB has at least five members of

varyin g b ackgrounds, such as cultural, economic, educational, gender, racial), to promote fair

and most effective review of research. The IRB in hospitals often are composed of

physicians, nurses, lawyers, scientists, clergy, and community lay persons (Burns & Grove,

2011).

IRB review is classified into three categories: exempt from IRB review, expedited,

and full committee (Amdur & Banket, 2011)

1. Exempt from IRB Review

Research projects usually are ex empt from review if they cause no risk for the

participants (Burns &Grove, 2011). An exempted research study does not require initial or

continuing review by the IR B committee (Amdur & B ankert, 2011). Examples of research

studies under the exempt from IRB review are: (1 ) research conducted in established or

commonly accepted educational settings, involving normal educational p ractices, (2) research

involving the use of educational tests, survey procedures, interview procedures, or

observation of public behavior that cannot form a link to the participants or cause harm, (3)

research involving the collection or study of existing data, documents, reco rds, pathological

specimens, or diagnostic specimen if are publicly available or if information is kept

confidential, and (4 ) research and demonstration projects conducted by or subject to the

approval of department or agency heads, and which are designed to examine public benefit or

service program (U.S. DHHD, 2005 as cited in Burns & Grove, 2011).

2. Expedited Review

A study that causes some risks or minimal risks are qualified for an expedited

review. Minimal risk means that the probability of and magnitude of harm or discomfort

anticipated in the research are not greater in and of themselves than those ordinarily

encountered in daily life or during the performance of routine ph ysical o r p sychological

examinations or tests. Research studies und er an expedited review are: (1) collection of blood

samples by finger stick, heel stick, ear stick, or venipuncture in small amount from health y,

nonpregnant adults or healthy children and adults, (2) collection of biological specimens b y

noninvasive means such as hair and n ail clippings, excreta and external secretions, (3)

research involving materials such as data, documents, records, and specimens collected for

nonresearch purposes and is not exempted, (4) collection data from voice, video, digital, or

image recordings made for research purposes, and (5) research on individual or group

characteristics or b ehavior (U.S. DHHD, 2005 as cited in Burns & Grove, 2011). Expedited

review can be carried out by IRB chairperson or by one or more experienced reviewers

(Amdur & Bankert, 2011).

3. Full committee or Complete Review

A study that causes greater than minimal risks must be reviewed through the full

committee (Burns & Grove, 2011). The IRB review requir es a majority vo te by the full IR B

committee with continuing review at least annually (Amdur & Bankert, 2011). To obtain IR B

approval, researchers must ensure that (1) risks ar e minimal, (2) risks are reasonable in

relation to anticipated benefits, (3) selection of participants are equitable, (4) informed

consent will be sought, (5) informed consent will be appropriately documented, (6) the

research plan makes provision of participants saf ety, and (7 ) adequate provisions are made to

protect privacy and confidentiality (U.S. DHHD, 2005 as cited in Burns & Grove, 2011).

Conclusion

Ethical issues/dilemmas in conducting research in nursing and health ar e increasing as

the number of research studies increases. Ethical codes of conduct and ethical principles in

bioethics can be effective guidelines to researchers who are practitioners and researchers at

the same time. Institutional review board is also an effective mechanism in health care

organization and educational institutes in promoting researchers to conduct ethical research

for the benefit of mankind and the society as a whole.

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