Protection of Human Subjects: The Internal Review Board
By Patricia Winstead-Fry PhD, RN
In practice, the protection of human rights in research is
operationalized through the informed consent
protocol. Many Offices of Research will offer a
sample consent form for a researcher's review. Rather than
focus on the formalities of informed consent, I will discuss
protection of specific human rights including
self-determination, anonymity and confidentiality, privacy,
fair treatment, and protection from discomfort and harm.
Self-determination means potential research
subjects need to know what the research is about, that they
are asked to participate in research, that they choose to
voluntarily participate or not with no penalties, and they
can withdraw from the study at any time with no penalties. Anonymity
and confidentiality protect the identity of
research participants. People have a right to share
personal information or to keep secrets. Researchers have
to protect the identity of participants. Many researchers
use code numbers for data identification, especially is data
collection is accomplished more than once in the course of a
study. Data can be stored in locked files with the consent
form separated from the data; so identity cannot be linked
with data. It is even possible not to get a signed consent
form, if that is the only link between the identity of the
participant and the data. The researcher says something to
the effect that "Consent is implied if you return these
questionnaires". This is especially helpful when the data
is collected electronically with a program such as Survey
In exempt research, identities may not be protected because
of the public nature of the participants. In expedited and
full reviews, anonymity and confidentiality issues are
Privacy needs to be assured for research
participants. This means that data cannot be recorded or
videotaped without the person's knowledge. Research
participants who are going to be recorded or video-taped
need to understand who will listen/view the materials; what
specifically the researcher's are looking for and what will
be done with the materials after the research is completed.
Researcher's need to be very clear about what their research
question is and have questions phrased in such a way that
answers are focused on the research question and don't allow
respondents to say more than the research requires.
In qualitative research where a group may be convened to
discuss their experience in research, privacy is a major
concern. A group member may let slip a participant. The
researcher needs to do everything possible to impress upon
the participants the requirement of Privacy.
Fair Treatment requires a balance between
risk and benefit, suitable subject selection, and respectful
treatment by the researcher. If a study is a nontherapeutic
one, the researcher does not have to promise a benefit if
there is none. However, if a benefit is promised, it must
Another aspect of fairness is subject selection. Patients
have to be treated fairly during the study. There should be
clear understanding about what exactly the participant's role
is, how much time it will take, and what benefits, if any, will
be forthcoming. The researcher's role should be equally defined
for the participants. No changes should be made without
consulting the participants.
Protection from discomfort and harm
requires that negative emotional, physiological, social and
economic events be controlled for as far as possible. It
also requires that if any of these negatives are part of the
research study, the patient knows about them in the informed
- The Nuremberg Code. In Metscherlich A, Mielke F.
Doctors of Infamy: the story of Nazi medical crimes.
New York: Schuman; 1947.
- World Medical Association. Declaration of
Helsinki. British Medical Journal; 1964;313(70):
- Rothman DJ. Were Tuskegee and Willowbrook studies in
nature? Hastings Center Report.
- Levine RJ. Ethics and the Regulation of Clinical
Research. Baltimore: Urban & Schwarzenberg; 1986.
- Rothman DJ. Were Tuskegee and Willowbrook studies in
nature? Hastings Center Report.
- Department of Health and Human Services. Final
Regulations amending basic HHS policy for the protection
of human research subjects. Code of Federal
Regulations, Title 45 Public Welfare, Part 46, 1981.
- American Nurses Association. Human Rights
Guidelines for Nurses in Clinical and Other Research.
(Document No. D-46 5M). Kansas City: American Nurses
- Burns N, Groves, SK. The Practice of Nursing
Research. 5 ed. Philadelphia: Saunders; 2004.
Don't Let the IRB Scare YOU
by Debra Lee James, RN, BSN
RN II, Washington County Hospital
Studying Reiki and Pain Control in Post-op Patients
So you finally decided that research is something you can
handle. You have a great idea for a research project that will
benefit your facility. However three little letters strike fear
in your heart of hearts whenever you think of moving forward:
IRB. While you may think the IRB (Institutional Review Board)
has more interrogation techniques to break people than the CIA,
this group is actually set up to make your life easier, to
protect you, to protect your research participants, and to
ensure frivolous research does NOT become the norm.
The best way I have found to prepare for IRB approval is to
actually speak with someone on the board. There should be a
point of contact for anyone wanting to conduct research. This
person will provide you with general guidelines, information on
when the IRB meets and submission deadlines, as well as
information on mandatory training for researchers working with
human subjects, research archiving requirements, and specific
requirements for research conducted in your facility.
Each IRB is unique to the institution over which it governs.
Just because you've been through the IRB review process in one
facility, don't presume the same will hold true for another.
There are even different requirements regarding archiving of
research materials, updates to be provided to the IRB (monthly,
quarterly, semi-annually, etc.) and length of time allowed to
complete a research project.
So here are a few practical tips:
- Be prepared to answer just about any question you can
think of regarding your project.
- Ask yourself the obvious questions: does anyone even
care about this? Will there be any benefit to this
facility's patient population? Has anyone else done this
research and what were there results compared to what I
- It's ok to perform research that's been conducted
elsewhere because your research will show how your
facility can benefit in similar ways.
- After you've asked the obvious questions, then ask
the off-the-wall questions. Trust me, there is a good
chance someone will think one of the off-the-wall
questions is not too far out there (been there, done
- Make sure you have the resources lined up to perform
- If you have grant opportunities, it's always nice to
have that at least in the pipeline if not already lined
up before you present to the IRB.
- If you don't have grant money, be prepared to have
answers on how to fund your project, or have answers on
why your project is so cost effective that the
institution will be willing to put up the money. Don't
forget the other researchers involved - will there be
over-time charges to consider? Are people willing to
"donate" their time/salaries to work this project? Do
you have a paid statistician on hand or will this be
- Be honest about why you want to conduct the research and
be passionate. If the IRB doesn't feel you're willing to
fight for this research, they will be less likely to approve
it. Don't pick a project because it's convenient, but
choose something in which you have a true interest.
That true interest goes a long, long way in helping you
prepare and follow-through.
Happy trails and happy research!
Research Profile: Colleen Delaney PhD, RN,
Delaney is an Associate Professor in the School of
Nursing at the University of Connecticut. Her health
outcomes research program is focused on examining questions
related to the efficacy of holistic nursing interventions
aimed at improving health related outcomes in
community-dwelling elders with cardiovascular disease.
"When the student is ready, the teacher appears" is a
well-known saying that best describes the start of my
holistic journey. For the first 15 years of my nursing
practice, I devoted my career as a home care nurse to
helping individuals and their families maximize their
understanding and self-management skills during chronic
illness. After many years of working with individuals, their
families, and the staff who cared for them, I decided to
pursue a MS and doctorate in nursing. I wanted to create
knowledge to enhance the lives of individuals and their
families who were experiencing physical and mental health
transitions due to chronic illness and aimed to redirect my
focus from having an impact on small numbers of patients to
larger numbers of people through advanced education and
research. In my first graduate course, my instructor was a
holistic nurse and by the end of the semester so was I, this
course launched my holistic journey and provided the
foundation for my program of research. I have been a
dedicated member of the American Holistic Nurses Association
since 1998 and am certified in advanced holistic nursing.
My research program and professional passion is rooted in
community/ public health nursing and particularly in the
area of improving health-related outcomes for
community-dwelling elders with chronic disease. I have 3
focus areas: spirituality, home care patients with
cardiovascular disease, and dementia patients and their
family caregivers. The common thread among the studies in my
research program is a philosophy grounded in holistic
nursing that aims to address the whole older adult with
chronic illness, in body, mind, and spirit in community
AHNA Grant Reviewers Needed
We need you if you have a doctoral degree
and are willing to volunteer to be a
research grant reviewer--please contact Kim
as soon as possible. To facilitate making
the best reviewer-application matches, she
will e-mail you a brief questionnaire to
identify your preferred research methods and
holistic nursing areas of expertise. In
early February, Kim will send you 2-3
blinded study proposals with review forms
for you to complete and return via e-mail
within 3-4 weeks. Many reviewers make the
job quick and easy, and are essential to
helping us pick high-quality grant
recipients, so please volunteer!
A Brief Overview of Qualitative and
Quantitative Paradigms of Research
Click here to read an article and guide sent to us by
Susanne Tracy RN, PhD from the University of
New Hampshire. It is a guide she created for qualitative and
quantitative paradigms in research. While we acknowledge other
approaches as well and welcome articles from you about other
approaches, this is a useful reference paper. She has included a
grid of qualitative and quantitative designs that are adapted
from a book by Polit and Beck (2004).
Research Committee News
The data from the collection of healing stories
at the '09 conference are being analyzed. A meeting is planned
of the investigators at conference 2010 to create a meta story
of holistic nursing. Marlaine Smith,
Diane Wardell, Joan Engebretson,
Rorry Zahourek, Mary Hines,
Carla Mariano, and Jeanne Crawford
are the investigators.
The study looking at the development of a mentorship program has
been given IRB approval and the data from the recipients of this
year's conference being analyzed. Focus group methodology will
be used at conference 2010 to explore the process and need for
mentorship in holistic nursing research. Ruth McCaffery,
Sue Robertson and Evelyn Clingerman
are the investigators.
A new study is in the early planning stages called the "Legacy
Project". This project plans to interview some of our most
senior and sage leaders and to capture how they became holistic
nurses. They are a valuable resource for our profession to honor
and to learn from. A publication of their histories is planned.
Investigators include: Bernadette Lange,
Carla Mariano, and Rorry Zahourek.
The researchers have been aware of their process as they have
planned this project. They will present this process (Birthing a
research project) in an expanded and extended consultation
format at conference 2010 in Colorado Springs.
We need help:
- Want to help edit and write for research eNews
- Want to help compile materials for our web site?
Contact Rorry or Amber.
- How about reviewing grants when they begin to come in
in February. Contact Kim Stiles (email@example.com)
if you can review.
- Ideas for fund raising. Do you know a
person or a company that might want to sponsor a grant for a
research purpose? Or do you have other ideas for
fundraising? Contact Rorry (firstname.lastname@example.org)
or Amber (email@example.com).
Generating Research Ideas from General Press Reports
reports in the general press can highlight areas that
might be good for Holistic Nurses to consider
researching. The following article, "Face
masks something to smile about
," from the San
Francisco Chronicle is one that poses holistic nursing
questions such as: what populations might find this
especially helpful? Is there a difference in children's
anxiety level when the nurse wears a plastic mask while
caring for them in an ICU? Does reduced anxiety improve
Jeanne Hahne's was a nurse was working with patients in
a burn ward. She was dressed in head-to-toe protective
gear - including a mask that covered most of her
face."These people were in crisis and they were scared,
and you'd see them every day and they wouldn't even
recognize you," Hahne said. She had an idea: face masks
made of clear plastic, so patients could see her smile
and facial expressions. She explained, "There are a lot
of studies about what this portion of the face conveys.
A lot is said in facial expressions. We like to see the
smile and reassurance. Anxiety is decreased when you can
feel connected to somebody."
Hahne and California Pacific Medical Center will conduct
studies to prove that her masks are as hygienic as
current masks. Doctors, nurses and patients seem
receptive to the new masks. They seem especially useful
for young patients.
Hahne said her idea originally was geared toward easing
patient anxiety, but now that doctors and nurses have
actually tested the masks, she said one surprising
aspect is how the masks help improve communication
between health care workers.
Click here to read the entire article
A pain research study that recently captured the
attention of the popular media was "Swearing
as a Response to Pain
." Participants were able to
keep their hand in ice water longer when swearing than
when repeating a neutral word such as table.
Click here to read more
Think for a minute about the further research questions
that this article generates. Some that come to mind are
why does this occur? What are the implications for
clinical care? Should we ask patients to swear during
painful procedures? How could we further research this?
Remember to keep your eyes and mind open for research
We Need You!
For the next issue of Connections we are
asking for information about assessment and evaluation tools
and instruments. Please share your experience of
that with us. Have you developed a tool? Found a tool?
Discovered a method that might be uniquely applicable to
AHNA Researchers in Action
We are adding an article,
Metaphors: A Way of Being for Holistic Nurses
EdD, RN, NPP, AHN-BC to our
online article library. She has done research on the use of
metaphor in holistic nursing and has two recent publications
on this topic. Her publications on metaphor include:
Sharoff, L. (2007).
Metaphors: A Creative Expression of Holistic Nursing
Spirituality and Health International
, 8, 9-19.
Sharoff, L. (2008).
Exploring Nurses' Perceived Benefits of Utilizing Holistic
Modalities for Self and Clients
. Holistic Nursing
, 22(1), 15-24.
Sharoff, L. (2009).
The Power of Metaphors: Images of Holistic Nurses
Holistic Nursing Practice
, 23(5), 267-275.
Sharoff, L. (2009).
Expressiveness and Creativeness: Metaphorical Images of
, Nursing Science Quarterly
PhD, RN, AHN-BC and
PhD, RN, AHN-BC
recently published an article called Staff
Nurses Perceptions of a Healing Environment
Holistic Nursing Practice
. This study investigated
staff nurses perceptions of the characteristics of the
healing environment that supported their practice of
holistic nursing. Candid discussions resulted from their
multiple method qualitative interview process. The themes
identified as the essence of healing environments included
context, connections and calling. Additional characteristics
were identified within each category.
Rozzano Locsin, Ruth McCaffrey ND,
ARNP, & Marguerite Purnell RN, PhD,
AHN-BC published Nurses' experiences of being cared for
in a hospital healing arts space in The UPNAAI
AHN-BC recently had a book published, Intentionality:
the Matrix of Healing
, by VDM Verelag Dr. Muller
Aktiengesellschaft & Co. Germany. Available on
. This book describes the development of a
theory of intention and intentionality in healing using
the grounded theory qualitative research method.
Research and literature is reviewed and the implications
of the theory discussed related to other theories as
well as to practice, education and future research.
Models for understanding the theory and for devision
implications are presented.
Rozzano C. Locsin and Marguerite J. Purnell
RN, PhD, AHN-BC have a new book, A Contemporary
Nursing Process: The (Un)Bearable Weight of Knowing in
from Springer Publishing Co. AHNA member
contributors to the book include : Richard
, Marlaine Smith
and Christopher Johns
The book is available from
Barnes and Noble
. At the heart of a thoughtful
practice process of nursing is coming to know persons.
This book embraces the diverse philosophical and
theoretical viewpoints of nurse scholars whose
appreciation of persons as unitary human beings grounds
their understanding of professional nursing practice.
Opportunities are provided in each chapter for the
practicing nurse to understand knowing the person
through a lens that is responsive to what matters and
is grounded in what matters. The realization that
nursing cannot truly take place without the intentional
and knowing engagement of the nurse is emphasized.
We would love to hear about your research. Send your
"Researcher in Action" to
Research in the News
Extra Exercise Trims LDL Cholesterol Levels in Women
Click on the title to read
One extra hour of moderate physical activity per
week can reduce levels of LDL or bad cholesterol in
middle-aged women, a nine-year study found. The
benefits were greater for postmenopausal women. (New
York Times, 8/09) Click on the title
to read article.
AHNA Discussion Forum
There are some requests for help on the AHNA Research Discussion
Forums. Please read the following posts and reply if you are
able to help.
I am very interested in developing a research project around
the effects of various enery modalities. In my search for
instruments, I have been unable to locate
any "energy" assessment/evaluation tools with
documented reliability and validity. Are there any out there?
Have collected forms filled out by HCP to measure types
of Complementary (Adjuncti ve) therapies they have
experienced, their personal success with each type they have
tried and the end result of if they have ever recommended
actively to a patient... will be happy to discuss sharing
the information to achieve an outcome study.
To reply just click on the links above, you will be asked to
login to the web site before being taken to the Discussion
Forum. Then click the Reply button near the bottom of the
screen. Write your comments into the editor and click
Submit. You will be given a chance to review your comments
before they are published to the web site.
You must have activated your AHNA online
account to visit the Member's Only section. If you have not
activated your online account, please