Research Protocols
Human Subjects
Human Subjects Review Process
Introduction
The purpose of this document is to assist researchers planning to conduct projects
involving human subjects. Please read all of the information carefully.
Policy Statement
The United States Department of Health and Human Services (DHHS) and Ouachita Baptist
University have established standards and guidelines to protect individuals who may
be at risk as a consequence of participation in a research activity. Standards for
the committee’s reviews are based on the Code of Federal Regulations, 45 CFR 46, and
researchers will want to refer to this code in planning their research. All applications
must reference specific sections of the Code that apply to the project.
To What Does This Policy Apply?
All projects undertaken by faculty, staff, or students in the School of Natural Sciences
at Ouachita Baptist University involving human participants in any way, regardless
of the source of funds, must be reviewed and approved by the School of Natural Sciences
Research Committee. This includes activities in which a faculty member is supervising
student research activities. All ongoing research projects must be reviewed annually.
How Is A Project Submitted For Review?
Projects are submitted by completing the form “Application for Approval of Investigations
Involving the Use of Human Subjects.” Other information is requested on the application,
including the survey or questionnaire (if appropriate), and the consent form. Applications
are available in the School of Natural Sciences Office.
The Research Committee meets at least once each month during the academic year, if
there are projects in progress. Applications must be received in the School of Natural
Sciences Office at least one week prior to an upcoming Research Committee meeting
in order to be presented at the next meeting.
What Kinds Of Projects Must Be Reviewed By The Research Committee?
A project meeting any of the specific guidelines spelled out in the Code of Federal
Regulations, 45 CFR 46.
Some examples are that the research
1. Places subjects at more than minimal risk (physical, emotional, psychological,
or social risk). Minimal risk is defined as those risks experienced in everyday life.
2. Involves minors or other vulnerable populations (pregnant women and fetuses, mentally
disabled individuals and other special populations).
3. Investigates behaviors and/or experiences related to sensitive topics.
4. Involves the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of public behavior that identifies
human subjects’ and/or their responses.
What Action Does The Research Committee Take?
The Research Committee will take one of the following actions in regard to applications
reviewed:
1. Approve: The Research Committee will approve the project as submitted.
2. Approve with minor revision: If only minor modification is needed the Research
Committee will approve the application with the stipulation that described changes
are made before the project begins. Additional review is not required.
3. Defer for revisions: The Research Committee will defer a project contingent upon
modification. The project may not proceed until final approval from the Research Committee
is received.
4. Disapprove: When the Research Committee disapproves a project, considerable revision
is needed. The investigator may revise and resubmit the proposal. The project may
not proceed until final approval from the Research Committee is received.
Instructions for the Application for Approval of Investigations Involving Human Subjects
The application and cover sheet are to be accompanied by a description of the project
and associated materials as described below. The main headings and relevant subheadings
will form the organization of the application. Typically proposals should require
no more than two pages plus copies of consent forms, questionnaires, or other instruments
which would facilitate review. Unnecessarily voluminous proposals will be returned
without review.
1. Human participants protection cover sheet.
2. Very brief statement of project goals.
3. Protocol
- Procedures
- Name and description of data-gathering tool
- Number of participants
- From where will participants be obtained?
- How long will the procedure take?
- If data collection is done in class, explain what students who do not participate will be doing.
- Attach letter or form of approval from any other agencies or organizations that will be involved with data collection.
4. Benefits - Describe the benefits to the individual, university and/or mankind.
5. Risks and Analysis of Risk:Benefit Ratio When Relevant
- Describe the risks to the participant. This includes physical, psychological, and/or sociological risks.
- Compare benefits to possible risks
6. Procedures for Minimizing Risk
- Describe precautions that will be taken to minimize the risks described above.
- How will confidentiality of data be maintained?
- Final disposition of data (what will be done with questionnaires, inventories, videotapes, and/or audiotapes?)
7. Procedures for obtaining informed consent.
Informed Consent
Informed consent should include all of the following that apply:
1. Explanation of research purpose and procedures.
2. Description of any procedures which are experimental.
3. Benefits to the participant, university and/or society.
4. Risks; even minor risks that would be significant to only a few.
5. Participation is voluntary and the participant can withdraw at any time without penalty or loss of benefits.
6. Alternate procedures/treatments available for a condition.
7. Who to contact with pertinent questions.
8. The amount of time required of the participants.
9. Confidentiality of data and final disposition of data.
10. If the research involves more than minimal risk, a description of compensation and treatment that is available for injury and who to contact in the event of a research related injury.
11. A statement of acknowledgement of having read and understood the consent document,
having the opportunity to have questions answered by the Principal Investigator and
giving consent to participate in the study followed by the signature of the participant.
Animal Subjects
Animal Care
Animal care and use protocols must address the following:
- Justification for the use of the species
- Training in care, handling, and use of the species
- Standards for humane care and use of the species
The IACUC or research committee should seek to avoid reviewing projects for scientific
merit and should instead focus on the welfare of laboratory animals and their caretakers.
In an effort to aid the committee in this respect, the principal investigator should
provide the information needed for the committee to make basic judgments about the
rationale for the use of animals (including species and numbers), the training and
experience of investigators and research personnel, and the ability for the researchers
to provide adequate animal care in existing facilities with minimal or reasonable
modifications to those facilities.
Justification for the Use of the Species
Alternatives
The US Government Principles for the Utilization and Care of Vertebrate Animals Used
in Testing, Research, and Training states that “the animals selected for a procedure
should be of an appropriate species and quality and the minimum number required to
obtain valid results. Methods such as mathematical models, computer simulations and
in vitro biological systems should be considered.”
The National Research Council uses the term “alternative” to refer to research, testing,
or training methods that result in the reduction of number of animals required, that
incorporate refinements of procedures which result in the lessening of pain or distress,
or that provide for replacement of animals with non-whole animal systems, or the replacement
of one animal species with another, particularly if the substitute species in non-mammalian
or invertebrate.
It is important that the researcher provide evidence that he or she has considered
whether alternatives are available, and if so, why these alternatives will not be
utilized. The Animal Welfare Act requires that investigators provide an indication
of the methods and sources utilized to make this determination, whether it is a bibliography,
a relevant database, the investigator’s documented experience in the field, documented
consultation with an expert in the field, publications, etc. Although the Animal Welfare
Act only applies to warm-blooded animals (excluding mice, rats, and birds bred for
research), following this guideline will provide the committee with a reasonable assurance
that the investigator is using the appropriate animal(s) and provide documentation
of the determination should such justification be required in the future.
Replacements—approaches that might be utilized for replacements in research or teaching
- In vitro methods, including cell or tissue culture
- Mathematical models or computer simulations
- Audiovisual technologies
- Replacements of the animal species with “lower” species, particularly non-mammalian or invertebrate species
Reduction—approaches that might aid in utilizing the minimum number of animals necessary
- Increase the ability to determine the effect of interest by increasing the size of the effect, decreasing extraneous variability, optimizing sensitivity of the detection methods, changing the scale of the outcome variable
- Minimize the number of treatment groups
- Wise use of controls
- Repeated measures, replicative sample designs
- Tissue sharing with other investigators
Refinement—approaches that might aid in reducing pain or distress of the animals
- Administration of anesthetics or analgesics where pain or distress is unavoidable.
- Selection of less stressful endpoints
- Careful monitoring to detect pain/stress as early as possible
- Careful attention to housing and access to food and water in animals that are impairedHumane methods of euthanasia
Duplication of Research
The Animal Welfare Act requires that the committee determine that “The principal investigator
has provided written assurance that the activities do not unnecessarily duplicate
previous experiments.” The key word is “unnecessarily.” The investigator should provide
an explanation of how the project differs from previous work, or if it duplicates
previous work, provide justification of why this is necessary. Examples of necessary
duplication might include demonstration experiments in a course or repeating experiments
as learning tools in student research.
Training in Care, Handling, and Use of the Species
The investigator should provide an adequate description of the steps that will be
taken to adequately train students and other research personnel in the appropriate
care, handling, and use of the species. Training programs must include familiarization
with committee guidelines with a focus on the standards for humane care and use. Training
should also include necessary information about diseases that may be passed to personnel
by the animals or from personnel to the animals, identification and treatment of those
diseases, and general first aid procedures that are commonly required as a result
of injuries sustained while caring for the animals. Evidence of training of students
and personnel authorized to handle a given species should be listed in the laboratory
records along with the appropriate protocol, and each person on the list should be
notified of changes in the care, handling, or use protocol for that species.
Standards for Humane Care and Use of the Species
Good animal care is essential to good science. Animals that are sick, stressed, or
housed without appropriate attention to the maintenance of a standard, stable environment
cannot be expected to provide accurate reproducible data. Prevention of disease is
the primary objective of an animal health maintenance program. Limited space for animal
housing poses special challenges when two or more species are located in the facility,
and many of the standards for care are aimed at preventing unintended consequences
(disease, death, interference with experiments) of these interactions.
Quarantine
Newly acquired animals can introduce disease into established colonies. The first
step in the process of disease prevention is therefore procurement of healthy animals.
All incoming animals should be inspected on arrival and housed in quarantine separately
from acclimated animals until their health status has been established. Newly arrived
animals should be permitted a stabilization period to allow them to physiologically
and behaviorally adapt to their new environment before any experimental use is initiated.
Separation of Species
Some species of animals carry latent or subclinical infections that can cause serious
disease if transmitted to other species. Because of this consideration, physical separation
of species is recommended to reduce the possibility of disease transmission, and intraspecies
separation is advisable if the animals are obtained from different vendors, or if
the differ in microbiological status.
Surveillance, Diagnosis, Treatment and Control of Disease
All laboratory animals must be inspected regularly by a trained individual to recognize
signs of illness or injury. Sick or injured animals must receive immediate attention.
Methods of diagnosis, therapy, and disease control should follow appropriate standards
for the species. If a contagious disease is suspected, appropriate measures must be
taken to prevent the spread of the infection to healthy animals. Animals that die
unexpectedly should be examined to determine the cause of death.
Appropriate use of Anesthetics, Analgesics, and Tranquilizers
Animals that are in pain or are severely distressed cannot be expected to demonstrate
“normal” physiologic responses. The appropriate use of anesthetics, analgesics, and
tranquilizers provides humane care and assists in collection of valid research data.
Attention should be given to the selection of agents that are appropriate to the species
and for effective dosage regimens. If a painful procedure must be conducted without
the use of analgesics, the procedure must be carried out under the direct supervision
of the responsible investigator until the students or personnel are adequately trained
to recognize and minimize the pain without jeopardizing either the research or the
care of the animal.
Surgery and Post-Surgical Care
Individuals performing survival surgical procedures must provide evidence that the
procedures will be conducted with appropriate aseptic techniques, with well-maintained
equipment, and with appropriate surgical and post-surgical care strategies outlined
in protocol form.
Field Studies
The investigator has limited control of an animal’s environment in field study situations.
When laboratory animals are to be utilized in field experiments, the investigator
should provide evidence that the animals will not be subject to undue stress or harm.
Many professional societies provide guidelines for use of different groups of organisms
(i.e. fish, amphibians, etc.) in field studies. The committee will accept these guidelines
(where available) as an attachment to the protocol request in lieu of the standards
for humane care and use portion of the application.
Euthanasia
The following guidelines are based on the 1993 report of the AVMA Panel on Euthanasia.
Students or personnel with job responsibilities requiring animal euthanasia should
be well-instructed about theory and technique of the methods used. Consideration should
be given not only to the use of humane methods, but also to the use of methods which
produce minimal emotional distress to the personnel carrying out the procedure. Investigators
may request to use a procedure that varies from these guidelines through providing
written justification for review and approval by the committee.
Acceptable Methods
- Anesthetic overdose—barbituates or nonflammable gaseous anesthetics
- Carbon dioxide
- Commercial euthanasia agents (FP3, T61, etc. administered IV)
- Cervical dislocation—poultry, mice, rats, and fish less than 200gm
Acceptable Methods under Anesthesia
- Exsanguination
- Decapitation preceded by loss of consciousness or immediate freezing of head in liquid nitrogen
- Air embolism
- Potassium chloride
Methods Requiring Specific Justification—cost or convenience are not acceptable justifications.
- Rapid freezing in liquid nitrogen—restricted to animals less than 40 g
- Stunning immediately by an irreversibly fatal procedure such as decapitation, bilateral pneumothorax, or exsanguinations
- Decapitation without prior loss of consciousness
- Captive bolt pistol—penetrating type
- Electrocution
- Microwave irradiation
Standards of Animal Husbandry
Laboratory animal husbandry covers (1) facilities and operating procedures in facilities
including temperature and humidity, lighting, cage construction and maintenance, cage
size, and waste disposal and (2) animal health and husbandry including feeding, water,
sanitation, staffing, classification and separation, and veterinary care.
Housing
Animal housing systems should facilitate animal well-being, meet research requirements
and minimize experimental variables. Minimal space requirements are mandated in the
Animal Welfare Act and recommended by various funding agencies. Housing systems should
provide sufficient space to allow freedom of movement and normal postural adjustments,
contain a resting area appropriate to the species, confine the animal safely, provide
easy access to food and water, be well-ventilated, and meet the biological needs of
the species. All housing should be kept in good repair and allow cage occupants to
be inspected with minimal disturbance.
Environment
Animals should be maintained in an environment appropriate to the species. Care should
be taken to minimize fluctuations in environmental conditions and to ensure that the
environment within the containers is measured and not the macroenvironment of the
holding facility. When the environmental conditions for a given species are critical,
conditions should be monitored and recorded at regular intervals, and the records
should be available in the facility at all times.
Room Light in Animal Enclosures
Room light should be uniformly diffused and should provide sufficient illumination
to allow regular observation and care of the animals and safe working conditions for
personnel. Lighting should meet the biological needs of the animals in terms of intensity
and periodicity. If normal lighting in the facility does not meet the needs of all
the species housed there, arrangements must be made to provide appropriate lighting
to each species as necessary. The appropriate light cycle should be noted on the protocol
label displayed in the facility.
Food
Food must be fresh, palatable, uncontaminated with biological or chemical agents,
and nutritionally adequate for the intended species. Feeders must allow easy access
to food while minimizing contamination by feces and urine. Animals should be given
enough food to permit normal growth, maintenance of age-appropriate body weight, reproduction,
and (where appropriate) lactation. Food should be stored in designated restricted
areas that are cool, clean, dry, and free of vermin. Food containers must not be stored
or prepared in rooms with chemicals or biological agents. An appropriate feeding schedule
should be displayed alongside the protocol label for each species, and feeding records
should be maintained in the facility as necessary.
Water
Clean, fresh water must be available at all times as appropriate for the species.
Empty containers should be replaced, not refilled, to prevent disease.
Sanitation
Good sanitation is essential to maintaining healthy animal populations. Cages and
tanks must be washed and sanitized before animals are placed in them. Bedding or water
must be replaced and the containers cleaned as often as necessary to keep the animals
clean and in an optimal environment. Cleaning schedules should be posted alongside
the protocol label for each species, and cleaning records should be maintained in
the facility as necessary.
Animal facilities and other areas in contact with laboratory animals must be cleaned
and disinfected often to keep them free of dirt, debris, and biological or chemical
contaminants. Cleaning utensils must not be used for multiple species, and they must
not be moved from room to room. Deodorizers should not be used to mask animal odors.
No chemical cleaning agent or pesticide is to be used in the animal facility under
any circumstances unless its use has first been approved in writing by all investigators
housing animals in the facility. Failure to follow this guideline may harm the health
of the animals or interfere with experiments underway or scheduled in the near future.
Noise
Unnecessary noise can be stressful to animals and should be minimized. Whenever possible,
noisy activities should be restricted to non-housing areas.
Animal Identification
Animal identification is important to good animal care and data collection. Permanent
individual identification of animals using tattoos, ear notches, fin clipping, or
other methods should be supplemented by identification cards that include stock or
strain, vendor, responsible investigator, and protocol number. Additional information
should be included on the protocol labels as needed.
Care Outside of Normal Working Hours
Emergency, holiday, and weekend care must be available as dictated by the species
and care schedule. Emergency contact and normal care contact information should be
posted alongside the protocol care label, in prominent locations in and outside the
animal facility, and in the care records.
Animal Care Records
For each protocol approved by the committee, the investigator must maintain a record
of animals received/born, diseases/deaths, care schedules, and any other pertinent
information as described above or as necessitated by the species or protocol. These
records must be available for inspection in the animal facility at all times.
Radiation
Radiation Control
Ouachita Baptist University (OBU) complies with the Arkansas Department of Health
– Division of Radiation Control & Emergency Management rules and regulation guidelines for the purchase, use, storage and disposal of radioactive materials. Any individual
or researcher wishing to perform radioactive research at OBU must first contact the
campus Radiation Control Officer (Glenn Good) to obtain a copy of the OBU site license. The site license specifics which radioactive
materials may legally be stored and used on the OBU campus. Any other question’s should
be directed at the local Radiation Control Officer.
Chemical Hygiene
Biohazards
Ouachita Baptist University is committed to complying with the biosafety guidelines set forth by the U.S. Department of Health and Human Services Centers for Disease Control and Prevention and the National Institutes of Health. These guidelines are outlined in the 4th Edition of the Biosafety in Microbiological and Biomedical Laboratories (http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm). This publication describes the combinations of standard and special microbiological practices, safety equipment, and facilities constituting Biosafety Levels 1-4, which are recommended for work with a variety of infectious agents in various laboratory settings.
The National Institutes of Health has a tutorial for researchers who plan to use human
subjects and need to know what to do for an IRB approval. http://cme.cancer.gov/c01/