The How-to of Dealing with Human Subjects
Narrative by Frieda Glantz, June 2002.
All the information provided is based on my experiences with the University
of California, Santa Barbara Human Subject policy. I imagine the policies and
guidelines are quite universal among the academic community.
One of the essential aspects of conducting an oral history project entails
interviewing persons involved in the research program: students, experts, other
historians, bystanders, etc. To the bureaucratic, academic community, such interviewees
are referred to as "human subjects," as these individuals are human beings and
subjects within oneís respective research project. Because the University system
must permit and okay all research conducted on its premise, you will be required
to fill out numerous protocols, explanation forms, and draft permission slips.
But never fear, as this "How to of Dealing with Human Subjects" will provide
you with the following:
(1) definitions of frequently used terminology;
(2) the simple steps for getting started with Human Subjects Research;
(3) the necessary information you must provide;
(4) understanding and completing the protocol; and
(5) links to and examples of the University of California, Santa Barbaraís Human
Subjects Research web page.
The purpose of the "Definitions" section is to provide you with a sample of
the typical Human Subjects Committee (HSC) jargon you are likely to encounter
and provide you with the opportunity to familiarize yourself with such languageĖ
before you delve into all the notorious paperwork.
- "Human Subject" means a living individual about whom an investigator (whether
professions or student) conducting research obtains data through intervention
or interaction with the individual, or identifiable private information.
- "Intervention" includes both physical procedures by which data are gathered
and manipulations of the subjects environment that are performed for research
- "Interaction" includes communication or interpersonal contact between investigator
- "Private information" included information about behavior that occurs in
a context in which an individual can reasonably expect that no observation
or recording is taking place, and information which has been provided for
specific purposes by an individual and which the individual can reasonably
expect will not be made public.
- "Minimal risk" means that the risks of harm anticipated in the proposed
research are not greater than those ordinarily encountered in daily life r
during participation in routine tests or examinations.
- "IRB" means Institutional Review Board
- "CFR" means the Code of Federal Regulations
- "Children" are persons under 18 years of ageĖthose who cannot legally consent
to treatments or procedures involved in research.
- "Assent" means a childís affirmative agreement to participate in research
- "Permission" means the agreement of parents or guardians to the participation
of their child or ward in research.
II. Simple Steps for getting started with Human Subjects Research
The following is a simple approach to dealing with the HSC:
- Go to your respective universityís search engine and type in "Human Subjects
Committee" and then press "Search." Another key word to search under, if "Human
Subjects Committee" is too specific or goes under a different term, is "Research."
For an example, go to www.research.ucsb.edu to view the UCSBís HSC web page.
- When this page appears on your computer screen, go to "Connections" (for
the UCSB web page) and scroll down until you see "Human Subjects Committee."
Click on it.
- This page will provide a list of all the required information you as a researcher
are expected to complete: a protocol, exemption sheets, consent forms, and
an interviewer quiz. This page should also display a HSC contact. Locate that
person and his contact information and call right away. You should have prepared:
your name and position in relation to the research project, the nature of
your research project, the projectís tentative time duration, and who your
presumed "human subjects" are.
- Find out when the HSC will be reviewing applications and the exact deadlines
you must meet. Mark them on your calender.
- Schedule a time to meet with the HSC representative or coordinator.
- Refer back to your HSC web page and print out the protocol, exemption sheet,
and list of basic information to be included in your consent forms.
- Meet with HSC representative before filling out the protocol and exemption
sheet. You may find that much of your research and human subjects will be
exempt based on the type of research you are conducting. Ask the HSC representative
to review the forms and explain any questionable or ambiguous sections to
- Draft a consent form. In dealing with minors, the consent form should be
addressed to the child human subjectís parent or guardian. There is either
a long form or a short form. Draft a long form, as much of the information
included in the long term is required in the protocol. Thus, the information
will be accessible and complete. The long consent form should include the
Fill out the "Application for Human Subjects" protocol. See web page www.research.ucsb.edu/compliance
for an example protocol template.
Complete the "Exemption" form. See web page at www.research.ucsb.edu for an example "Exemption" form template.
Schedule a follow up meeting with the HSC representative to review your
drafted consent form, protocol, and exemption sheet. Make the appropriate
Get your department chair and faculty advisor to sign the protocol and exemption
Turn in the necessary final drafts to the HSC for review.
All research project investigators are required to go through the HSC training
module, which basically familiarizes the investigator with human subjectís
rights and actions that would register as misconduct. Login as a "Guest" user.
How did you do? If it took you more than one try to get the correct answer,
donít worry. HSC makes it impossible for you to fail. When it comes time to
login for the real test, get your research projectís HSC number and login
under that number. All research project investigators will use the same HSC
number but will provide their own personal information.
After approval, contact the authority at your respective interviewing location
and obtain consent (i.e. from the principle of a high school). Once obtained,
give a copy to the HSC.
Distribute consent forms to appropriate recipients.
Collect signed, consent forms.
Congratulations! You successfully made it through the Human Subjectís Committee
without a problem!
- a statement that the study involves research and an explanation of purpose
- the expected time duration of the subjectís participation
- a description of the procedures to be followed (what the subjectís participation
- a list of any foreseeable risks or discomforts to the subject
- a list of any foreseeable benefits to the subject
- alternative procedures for subject participation
- a statement describing the lengths taken to ensure confidentiality of
records and identification
- For research involving more than minimal risk, an explanation as to whether
any compensation and whether any medical treatments are available if injury
- whom to contact for information about the research
- whom to contact for information about the subjectís rights
- whom to contact in the event of a research injury
- a statement that participation is voluntary and there is no penalty or
loss of benefits for not participating in research
- List the options to be checked off:
I agree Ö
III. Come prepared to HSC with ...
- An explanation of purpose and the nature of your research project
- Potential human subject sample
- "Application for Human Subject Use" protocol
- "Exemption Form"
- Long consent form (example)
IV. Understanding the protocol
When completing the protocol, pay special attention to the following elements
that are asked of you.
Part I: The subject. Define the:
- age range of your subjects
- how the subject will be obtained or selected
- characteristics of the subject population
- the dominant language used for the project and the dominant language of
Part II: Procedures
Explain the purpose and design of project. Where will the project be conducted?
What equipment will be used? How will date be recorded?
Part III: Risks
This is one of the most important sections. HSC pays extended attention
to this section, the most attention, so be careful how you phrase your information.
It is safest to be as ambiguous and general as possible. Although it may appear
to be more efficient and thorough, the less detail you outline, the less restrictions
you set upon yourself. Most of the risks will not apply to you if you are not
interviewing prisoners, pregnant women, or disabled individuals.
Things to address:
- Psychological damage
- Invasion of privacy
- Loss of job
- Incomplete consent
- Physical injury
- Assess likelihood of risk!!!
Part IV: Safeguards
This is also one of the most important sections. Make sure that the
safeguards are greater and more detailed than the risk section. The benefits/
safeguards must out weigh the risks if you want your research project to pass
with no problems.
Things to address:
- How invasion of privacy will be minimized
- Procedures of destroying data upon subjectís request
- Where the data will be stored
- Assess likelihood of effective safeguards
Part V: Consent
Include your long form consent form and base responses to on your draft of
the consent form. Be sure to write that consent for will be distributed, sign,
and archived before any research commences.
Part VI: Benefits
Similar to the "Safeguard" section, the subjectís participation should have
more listed benefits than risks.
Part VII: Risk/ Benefit Ratio
This is basically a restatement of the "Benefits" section. State your reasons
for believing that the benefits of your proposed activity outweigh the possible
UCSB Oral History Project Homepage > Oral History Resources Homepage > Dealing with Human Subjects
Last Updated January 1, 2003/some links updated 4/14/08
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