Experimental Research

Experimental Research
In experimental research, the researcher is an active agent rather than a passive observer. To do an experimental research, the researcher has to follow these principles such as
1. Manipulation
2. Control
3. Randomization

• Manipulation

It means the researcher intervenes something in the group and analyze the outcome. In other words, the researcher varies the independent variable by administering an intervention or treatment and analyzes its effects on the dependent variable. For example, the researcher analyzes the level of knowledge (dependent variable) before and after video teaching programme (intervention).

• Using control group

Control group refers to a group of participants whose performance on dependent variable is used as a basis for evaluating the performance of the experimental group (a group which receives intervention) on the same dependent variable. The researcher keeps the control group (a group with no intervention or administers an alternative or false intervention such as placebo) parallel to experimental group. For example, to evaluate the effectiveness of nutritional supplements, the researcher divides the newborns into two groups with different mode of strategies.
Strategy I: A group of newborns receiving nutritional supplements daily (experimental group) and other group without any nutritional supplements (control group).
Strategy II: A group of newborns receiving nutritional supplements daily (experimental group) and other group with alternatives to nutritional supplements such as glucose powder called a group with placebo intervention (control group).

• Randomization

Randomization means the researcher randomly select the participants in the study without any bias. Through randomization, the every participant gets an equal chance to participate in the study. The methods of randomization may vary from flipping a coin to computerized randomization method.

Experimental designs
Basic Designs
The researcher assigns the subjects randomly into experimental and control group, intervenes the intervention in the experimental group and collects the data after intervention from experimental and control group. This is also called as after only or post test only design. In another way, the researcher collects the information from experimental and control group before and after intervention is called as before-after design or pretest-post test design.
Factorial design

Factorial Design

In factorial design, the researchers manipulate two or more variables together on the study subjects and evaluate the main effects and also interaction effects. Here, the subjects are assigned at random to a combination of treatments. The term cell represents in a schematic diagram as a box. The independent variables are referred to as factors. Each factor is exposing in different levels. For example, a study to assess the effectiveness of supplementary feeding versus normal feeding among toddlers on weight gain. Here, the researcher designs the study on 2×2 table with two factors such as type of feeding A (Supplementary feeding (A1) and normal feeding (A2) and frequency of feeding B one time/day (B1) and two times per day (B2). The researchers assign the toddlers randomly to one of the cells, which consist of combination of treatments. The results will show the best mode of feeding and also the interaction effects resulting from the combination of treatment methods.
Repeated measures design/ Cross over design
The researchers intervene two or more interventions among the same subjects called within subjects design or cross over design. It involves the exposure of the same study participants to more than one treatment. The study subjects are randomly assigned to receive different ordering of treatment. For example, to compare the effects of auditory and tactile stimulation on infants, some subjects would like to randomly assign to receive auditory stimulation first and others would receive tactile stimulation first with the subjects serving as their own control group.  It prevents participant bias by achieving possible equivalence among subjects exposed to different conditions. There is an expected disadvantage of carryover effects of first treatment among study participants. When the researcher introduces two or more treatments and intervenes the treatments in the randomized order is called as experimental repeated measures design.
Clinical trials
The researcher evaluates the effectiveness of new treatment through a randomized clinical trial. It involves the testing of a clinical treatment, random assignment of subjects to experimental and control groups and assesses the effectiveness of treatment. Clinical trials can be done using before – after or after only design.
Advantages of experiments
These are the most powerful designs for testing hypothesis of cause and effect relationships. It also meets the criteria of causality, by Lazarsfield (1955).
1. A cause must precede an effect in time. For example, to test the hypothesis- smoking causes lung cancer; subjects should not have developed cancer before exposure to smoking.
2. There must be an empirical relationship between the presumed cause and effect. For example, in case of smoking and lung cancer, the researcher should collect the evidences regarding higher incidence of lung cancer is directly related to occurrence of smoking.
3. The relationship of presumed cause and effect should not affect by a third variable. For example, a relationship between smoking and lung cancer might reflect an underlying causal relationship between prolonged dust exposure and lung cancer.
Through manipulation, presence of control groups and randomization, an alternative explanation to a causal interpretation can be ruled out.
Disadvantages of experiments
All variables can not be manipulated such as race, ethnicity and history of diseases.
There are many variables, which can not be manipulated ethically. For example, withdrawal of vaccines from control group to test the effectiveness of vaccines in experimental and control group.
Hawthorne effect- Awareness of being in a study may alter the participant’s behavior, which affects the study results.
Double hawthorne effect- Those who administer the treatment know the subjects who are in experimental and control group; alters the study results. In a double blind experiment, neither the subjects nor those administering the treatment know who is in the experimental or control group; are so powerful.

Quantitative research designs

Quantitative research designs
Research designs in quantitative approach refer to the researcher’s overall plan for answering the research questions and/or testing the research hypothesis. It guides the researcher to adopt well defined strategies based on the decisions. 

There are some areas the researcher has to look on it before reflecting research design;
-Need of implementing any interventions
-Need of compare groups
-Need of control factors extraneous to research
-Need of collecting data at different time periods
-The nature of setting, in which the study takes place.

The researcher has to select an appropriate design based on dimensions of research question.

• Dimension; Control over independent variables

Appropriate designs are;
Experimental–manipulation of independent variables, control group and randomization
Quasi experimental –manipulation of independent variables but no randomization or control group
Non experimental –no manipulation of independent variables

• Dimension –Type of group comparisons

Appropriate designs are;
Between subjects –participants in groups being compared are different people
Within subjects –participants in groups being compared are the same people

• Dimension –Number of data collection points

Appropriate designs are;
Cross sectional design- one time data collection
Longitudinal design- multiple points data collection

• Dimension –Occurrence of independent and dependent variables

Appropriate designs are;
Retrospective – a study begins with dependent variable and looks the past for a cause
Prospective –study begins with independent variables and looks forward to identify the effect

• Dimension –Setting

Appropriate designs are;
Naturalistic-data collected in real world setting
Laboratory – data collected in artificial setting

What may be the sixth sense, which can be applicable in nursing?

Dear colleagues,

I am Mrs.Ponnambily Jobin, working as Asst.Lecturer in College of Nursing. This is to bring to your kind information that I have published a conceptual model (under mid range theory) in 2015, addressing 'child sex abuse' as a problem domain. (Please see PCSA Model &List of nursing theories). Now, I am working on a grand theory focusing on 'Inter-sensory Perception in Nursing Care'. I have attempted to develop a classification of senses based on a specific criteria, which highlights sixth sense, in addition to five traditional senses such as vision, hearing, smell, touch and taste. I would like to gather suggestions from you to accept or to refute the theory. I humbly request you to have a response on 'what may be the sixth sense, which can be applicable in nursing?'. 

Disclaimer:  

• If you are interested, please forward it and discuss among your co-workers. If not, kindly ignore the post.
• This blog does not represent any institutions and any organizations that the owner may be or may not be associated professionally and personally.The aim of this blog is informational purpose only.

Nursing research and theory

Nursing research and theory
Theory
A theory is a broad and abstract characterization of phenomena. The theories are two types; classical and descriptive theories. Classical theory refers to an abstract generalization that presents a systematic explanation about how phenomena are interrelated. The theory explains about the phenomena and their interrelationship.
Descriptive theory describes a single phenomenon which means that describing a specific characteristic of individual or events by summarizing commonalities found in discrete observation.
Theories allow the researcher to order the observations together. It guides the researcher’s understanding not only of the ‘what’ of natural phenomena but also of the ‘why’ of their occurrence. Theories are abstractions that are created or invented by humans through observations and experiments. It shows the theorist’s ingenuity in pulling those facts together, drawing conclusion and making sense of them. It represents a theorist’s efforts to describe and explain phenomena. Based on level of generality, the theories are two types; grand (macro theories) and middle range theories. Grand theories are intended to explain large segments of the human experience (foe example, stress adaptation among human being). Middle range theories are purported to explain a portion of the human experience (for example; stress adaptation among post operative patients).
Conceptual model
Conceptual models are loosely structured and concepts are assembled based on their relevance to common theme. It presents an understanding of the phenomenon of interest and reflects the assumptions and philosophical views of the model’s designer. The conceptual models are two types: Statistical models and Schematic models. Statistical models are mathematic equations that express the nature and magnitude of relationships among a set of variables. A schematic model represents a phenomenon of interest and expresses the relationships in a diagram. Concepts are represented in boxes and relationship is represented by using directional and non directional arrows and/or symbols.
Conceptual Framework
A framework is the conceptual base of all the studies. If a study based on a theory, the framework is referred to as theoretical framework and a study based on a conceptual model, a framework called as conceptual framework. The conceptual framework helps the researcher to understand how concepts are defined and operationalised. 

Developing and testing of theory
Research plays a vital role in theory developing and testing.  Theory guides the research and researcher to assess the theory, thus, it provides a foundation for new ones.
Developing theory using qualitative research
Through qualitative research, researcher identifies patterns, communalities and its relationship among events. During the data analysis, the researcher moves from specific pieces of data to abstractions that synthesize and give structure to the observed phenomena. The main purpose is to derive a data which is grounded in reality, to provide explanation of events as they occur in reality and it should not be conceptualized in preexisting theories. 

Testing theory using quantitative research
The researchers deduce concepts in the form of hypothesis and do test through quantitative research. Then, hypotheses are predictions about how the variables would be related, if theories were correct. The researchers cannot test the theory directly, as it’s a combination of testable and non testable concepts into the form of hypothesis and test it through quantitative research. The comparison between the observed outcomes of research and the relationship predicted by the hypothesis are the major focus of the testing process. 

Review of literature

Review of literature
A research literature review is a written summary of the state of existing knowledge on a research problem. It helps the researches to seek knowledge on a topic of interest and synthesize evidence based information to gain knowledge and improve nursing practice. 

The purposes of review of literature among researchers are:
It helps to;
-assemble knowledge on a topic
-identification of relevant research problem
-refine research questions
-gain insight to what is known and not known about an area of inquiry
-determine gaps in a body of research
-determine he need of replication of many nursing studies
- identify the suitable methodology to carry out a study
-interpret study findings and in developing implications and recommendations
The research reviews also included in research proposals, documents that describe what a researcher is planning to study, how the study will be conducted and how much will cost to complete the study. 

The purposes of review of literature among non researchers
The nurses involved in policy making organizations are depended on review of literature to review and synthesize evidence based information.
It helps to;
-gain knowledge on a topic
-gather evidence to critique of existing nursing practice or recommend or implement the new nursing interventions
-develop proposals
-develop a theory or conceptual framework
-revise curriculum of nursing
-develop policy statements and practice guidelines

Sources of literature reviews 

• Electronic literature reviews

Most of the universities offer electronic data base with bibliographic files that can be accessed either through an online research. Nurses can access the data through online search, CD-ROM (Compact disks that store the bibliographic information) or commercial vendors (Ovid, Silver platter and so on). These services provide trial run for a few months for testing accessibility before subscribing. For example, CINAHL (Cumulative index to nursing and allied health literature), MEDLINE (Medical literature online), AIDSLINE (AIDS information online), CANCERLIT (Cancer literature) and CHID (Combined health information data base). In the electronic research data base, the studies can be searched by the key words, variables and researcher’s name.

• Print resources

These sources are overshadowed by electronic resources. The main disadvantages are time consuming due to manual search and unable to access to all researchers widely. The main advantage is one can access to reports before 1982, as it is not published in electronic sources.
Print indexes are books used to locate research reports in journals and published periodically with an annual cumulative index. For example, International nursing index, Index Medicus and so on. When using a print index, you need to first identify the appropriate subject heading. It can be located in Index’s thesaurus, which lists commonly used terms or key words. Abstract journals are useful for researchers, as they provide a summary if a study rather than lengthy report.

Writing a literature review
Researcher can collect reviews from two sources such as primary and secondary sources. The primary sources are written by the researchers who conducted them. The secondary sources are description of research articles prepared by some one. The review articles help the researcher to gin insight on what is known and what is unknown or related topic. 

The steps of preparing a written research review are:
Step 1: Identify the key words/concepts to be searched
Step 2: Identify the potential references through electronic/manual search
Step 3: Retrieve promising references
Step 4: Screen references for relevance and appropriateness
Step 5: Read relevant articles and concise the reports
Step 6: Organize the reports based on subject/year/nature of the results
Step 7: Write a review

Types of literature references
There are varieties of literature such as empirical literature, conceptual literature and others include opinion articles, anecdotes, incident reports or clinical impressions.
Empirical literature is objective and addresses the research questions with evidence based information. It increases the strength of the study.
Conceptual literature is based on a theory or conceptual model. In the conceptual literature, a primary source is a description of theory, written by the developer of the theory and a secondary source is a discussion or critique of the theory. Opinion article, anecdotes, incident reports and clinical impressions are mostly subjective; an expression of point of view by the researcher and it does not address any research questions. However, it plays an important role in formulating research ideas. 

Organizing the review
After collecting the relevant articles, the researcher should read carefully till she understands the research. The researcher prepares a summary of article by highlighting the main points such as author, year of the study, place of the study, type of approach and design, sample, data collection, data analysis, results, interpretation, implications, inconsistencies in the results, faults in the research and weakness of the research.

Types of literature reviews
There are several types of review that can be used to support evidence based practice such as:
1. Traditional narrative reviews
This type of review synthesizes and summarizes, in narrative terms, a body of research literature. These reviews are frequently published in nursing journals. It provides the state of the art research based information and foundation for the development of innovations for clinical practice.
2. Meta analysis
It is a method of integrating quantitative research findings statistically. Here, the writer will consider the individual studies are the unit of analysis in a meta-analysis. The writer will review the findings from multiple studies on the same topic are then combined to create a data set that can be analyzed. While reading meta-analysis, the reader gets an idea of strength and weakness of association of dependent and independent variable on related topic. 

3.Qualitative meta-synthesis
It is an integration of narrative information and summary of qualitative findings. It has been defined as the ‘theories, grand narratives, generalizations or interpretive translations produced from integration or comparison of findings from qualitative studies. 

To conclude, the nurses have to read literature reviews to gain insight on the various problem statements and its findings that is existed in the society, which helps to equip them to explore from known to unknown world.

Research Problem

Research Problem
A research problem is a state or source of troubling and perplexing situation or condition. The purpose of the disciplined research is to solve the problem in the reality by exploring and identifying the contributing factors. A problem statement reveals the nature of the problem. A research question is the statement about what the researchers want to answer. Hypothesis is the statement, in which the researcher predicts the answer before data collection and is tested empirically. A statement of purpose is summary of specific objectives and the researcher hopes to achieve by conducting the study. 

An example of the research problem is ‘level of stress among adolescent girls’.
An example of the problem statement is ‘a quantitative study to assess the level of stress among adolescent girls in urban area, India’.
An example of the research question is ‘what is the level of stress among adolescent girls?’
An example of the hypothesis is ‘there is an association between the level of stress and socio demographic variables’.
An example of the statement of purpose is ‘the purpose of the study is to assess the level of stress among adolescent girls and test association between level of stress and socio demographic variables’.
Examples of the objectives are ‘to assess the demographic variables of adolescent girls, to assess the level of stress among adolescent girls and to associate the level of stress and socio demographic variables of adolescent girls’.

The developments of an interesting and innovative research process, researchers begin with a topic of interest, explore its relevance in the current scenario, having discussion with experts and then develop the topic into a more specific problem.

Sources of research problem
The researchers can identify and develop research problem from own clinical experience, thorough review of literature, current political and societal issues, testing and validating theory and emerges ideals from external sources such as conference, interviews, brain storming session with other faculties and so on. The researcher can select an appropriate approach such as qualitative and quantitative, based on the nature of the problem to be explored in detail. For example; (1)if the researcher wants to assess the level of stress among adolescent girls, he/she has to select quantitative approach, which gives the results in numeric terms, in which, the researcher can assess the level of stress in terms of low, moderate and high level of stress. (2) If the researcher wants to explore the stress and its contributing factors among adolescent girls, he/she has to proceed with qualitative approach, which gives the narrative details of information regarding stress and its contributing factors. Thus, the researcher can develop a theory or conceptual model from related qualitative study.

Problem statement
A problem statement is an expression of troubling situation that needs investigation. It identifies the nature of the problem being studied, the population, setting, its content and its significance. In general, in qualitative study, problem statement shows the nature of the problem in terms of concepts, population being studied and setting being carried out in the study, for example; a study to assess the knowledge on child abuse among the mothers of under five children in rural area in India.
In qualitative study, the problem statement expresses the phenomena to be explored, population being studied and setting being carried out in the study. For example; a qualitative study to explore social burden among wives of alcoholics in tribal area, India.

Statement of purpose
It is vital to articulate the researcher’s goals as a broad statement of purpose in declarative form. In a quantitative study, a well worded statement or purpose identifies the key study variables and their possible interrelationship as well as the nature of the population of interest. For example; the purpose of the study was to assess the knowledge on child abuse among the mother’s of under-five children. The statement identifies the population of interest (mothers of under-five children), independent variables (socio demographic variables) and dependent variables (knowledge on child abuse).
In qualitative study, the statement of purpose indicates the nature of the inquiry (exploration), the phenomenon under investigation (social burden), the group (wives of alcoholics) and the setting (tribal area) under study. For example; the purpose of the study was to explore the social burden among wives of alcoholics in tribal area. In quantitative study, the researcher uses verbs of ‘assess, test or compare’ to show the degree of purpose of research. In qualitative research, they use ‘explore, describe, understand and develop’ verbs to show the nature of the purpose of the study. 

Research questions
Research questions are rewording of statement of purpose which phrased interrogatively. This questions help to focus on the data needed to give the answer. In qualitative study, research questions identify key variables (most often dependent and independent variables), the relationships among them and the population under study.
Is there any relationship between knowledge (dependent variable) and education level of participants (independent variable)?
In qualitative study, the researcher starts the study and evolves questions during the study period. 

Research hypothesis
A hypothesis is a statement of prediction about the relationship between two or more variables.

• Hypothesis and qualitative research

In a qualitative study, the researchers don’t begin with hypothesis because the study is guided by the participant’s view points rather than researcher’s view points. Some qualitative studies may lead to the formulation of hypothesis.

• Hypothesis and quantitative research

In quantitative research, a hypothesis is the translation of research question into a prediction of possibilities of outcomes.
Research question: Is there any relationship between weight bearing exercises and loss of weight among women?
Hypothesis: There is a relationship between weight bearing exercises and loss of weight among women.

The theory is too abstract and not able to be tested. However, predictions based on the theory can be tested. For example, theory of reinforcement tells that behavior is positively reinforced (rewarded) tends to be learned. The researcher can develop hypothesis based on the reinforcement theory to test the validity of the predictions such as nursing students who are praised by nursing authority are more hardworking than who are not praised. This proposition can be tested in the real world. The theory gains support if the hypothesis is confirmed.

Testable research hypothesis states the expected relationship between the independent variable (presumed cause) and the dependent variable (the presumed effect with in a population). It is otherwise called as simple hypothesis. A complex hypothesis is the prediction of relationship between two or more independent variables or two or more dependent variables. A directional hypothesis is one that specifies the expected direction of the relationship between the variables. For example, lower level of exercise in post partum is associated with greater weight retention. A non directional hypothesis does not stipulate the direction of relationship, for example, there is a relationship between post partum exercise and weight retention. Research hypotheses are statements of expected relationship between variables. For example, there is a relationship between antenatal exercises and stress reduction among women.

Null hypothesis states that there is no relationship between the independent and dependent variable. For example, there is no relationship between antenatal exercises and stress reduction among women. 

To conclude, hypotheses are never proved through hypothesis testing rather they are accepted or supported. The study results are always vary if the same findings are replicated in many study projects, greater confidence can be placed in the conclusions. The strength of the supported hypothesis depends on the replication of the same results in numerous researches.

Nursing Research Ethics

Nursing Research Ethics 

Most of the professions have established their own code of ethics. The American Nurses Association has formulated ‘human rights guidelines for nurses in clinical and other research’.
In the United States, the National Commission for the Protection of Human Subjects of Bio medical and Behavioral Research issued a report, referred it as Belmont report and served as a model for many of the guidelines adopted by discipline. The Belmont report tells about three primary ethical principles on which standards of ethical conduct in research are based.

I. Beneficence
II. Respect for human dignity
III. Justice

 
I. Principle of Beneficence

 
The principle of beneficence aims at ‘do not harm’. It includes freedom from harm, freedom from exploitation and risk/benefit ratio.
1. Freedom from harm
It is not permitted to harm the study participants during the research. Before proceeds with humans, a new medical procedure or drug is being tested with animals or tissue culture. The psychological harm of the study participants during the study requires close attention and sensitivity, for example, interviewing a rape victim. The psychological harm can be minimized by carefully phrasing questions, obtain informed consent, assure of confidentiality and anonymity, significance of conducting research on the related topic, provide privacy, gain mutual trust, frequent counseling sessions and so on.
2. Freedom from exploitation
The researcher should not place participants at a disadvantage or expose them to situations for which they have not been explicitly prepared. The researcher maintains a relationship and it is crucial that this relationship not to be exploited, for example, sexual exploitation. It is not advisable to utilize the study participants under poor economic circumstances, for example, conducting experimental studies in developing countries by offering free treatment. In qualitative research, the risk of exploitation may be less because that gap between the investigator and participants decrease as the study progresses.
3. Risk/Benefit ratio
The researcher should weigh the potential risks to participants to benefit to society and nursing profession. The degree of risk to be taken by those participating in the research should never exceed the potential humanitarian benefits of the knowledge to be gained. Major potential benefits are accessibility of the treatment when they are in need monetary gains through incentives and so on. The potential risks are physical harm, loss of time, fatigue, boredom, loss of privacy and fear of disclosure. 

II. Principle of respect for human dignity
This principle includes right of self determination, right of full disclosure and informed consent.
4. Right to self determination
The researcher has to respect the study participants for their self determination. The participants have the right to decide voluntarily whether to participate in a study without the risk of increasing any penalty or prejudicial treatment. The participants have the right to ask questions, clarify the doubts, if they do not want to proceed, can terminate their participation. The researcher should be very carful to not to be coercive in the study. Coercion involves implying threats of penalty for failing to participate in a study or excessive rewards from agreeing to participate, for example; rewarding excess internal marks to students, who agreed to participate.
5. Right to full disclosure
The researcher has to describe the study participants regarding the nature of the study, the participant’s right to refuse participation, the researcher’s responsibilities and the potential risks and benefits that would be incurred.
6. Right to obtain informed consent
Informed consent means that the researcher provides adequate information regarding the research to the participants includes study purposes, time period, voluntary nature of the participants, potential risks and benefits and so on. The researcher asks the study participants to sign a consent form prior to the study. In qualitative research, the researcher asks the study participants to sign a process consent, which means consent is viewed as ongoing and transactional process and the researcher continuously negotiates the consent, allowing participants to play a collaborative role in the decision making process regarding their ongoing participation.
Problems related to the principle of respect
There are two biases can be expected in relation to full disclosure to the study participants during the research such as the bias resulting from distorted information and the bias resulting from failure to recruit a good sample. Sometimes, the principle of respect will be questioned while the researcher use two methods in data collection approach such as covert data collection (concealment) and deception technique. If the researcher wanted to observe people’s behavior in real world setting and the informed consent would result in changes in the behavior of interest. Deception is a technique in which, the researcher deliberately withholding information about the study or providing participants with false information. For example, the researcher conduct a study on adolescent drug abuse, might describe the research as a study of student’s health practices. Deception and concealment are problematic from an ethical stand point, if there are anticipated benefits to the society and minimal risk to the participants may be justified to enhance the validity of the findings. 

III. Principle of justice
The principle of justice includes the participant’s right to fair treatment, right to privacy and right to protect vulnerable groups.
7. Right to fair treatment
Participants have the right to fair and equitable treatment before, during and after their participation in the study.
It includes;
-selection of participants non discriminatory
-clarify the doubts of participants
-provide assistance to participants for accessing treatment
-respect their beliefs, habits and life styles
-courteous and tactful treatment at all time
8.  Right to privacy
The researcher should maintain anonymity and confidentiality through out the study. Anonymity occurs when ever the researcher can not link a participant with his or her data. Confidentiality occurs when the researcher promises the participant that any information will not be publicly reported or made accessible to other parties not involved in the research. In qualitative study, the researcher has to take extra precaution to safe guard participant’s identity as the number of participants is small by withholding information about the characteristics of the informant such as age and occupation.
9. Right to protect vulnerable groups
Vulnerable groups such as children, mentally disabled people, physically disabled, institutionalized people, pregnant women, old age groups and patients in unconscious stage are at high risk of unintended side effects because of their circumstances. The researcher should pay extra attention to the ethical dimensions of the study when vulnerable people are involved.

 It includes;
-obtain informed consent from the study participant or guardian of study participant
-explain the procedure to the study participants including benefits and risks
-allow withholding from the study when they wanted
-protect their privacy
-respect their beliefs and practices
Obtain approval of permission from the Institution Review Board or Human Subjects Committee to carry out the study among the vulnerable groups.