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.

Introduction

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 one’s 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 Barbara’s Human Subjects Research web page.

I. Definitions

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 language– 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 purposes.
• "Interaction" includes communication or interpersonal contact between investigator and subject.
• "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 age–those who cannot legally consent to treatments or procedures involved in research.
• "Assent" means a child’s 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

1. Go to your respective university’s 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 UCSB’s HSC web page.
2. 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.
3. 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 project’s tentative time duration, and who your presumed "human subjects" are.
4. Find out when the HSC will be reviewing applications and the exact deadlines you must meet. Mark them on your calender.
5. Schedule a time to meet with the HSC representative or coordinator.
6. 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.
7. 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 you.
8. Draft a consent form. In dealing with minors, the consent form should be addressed to the child human subject’s 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 following information:
• a statement that the study involves research and an explanation of purpose
• the expected time duration of the subject’s participation
• a description of the procedures to be followed (what the subject’s participation entails)
• 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 occurs.
• whom to contact for information about the research
• whom to contact for information about the subject’s 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 …
9. Fill out the "Application for Human Subjects" protocol. See web page www.research.ucsb.edu/compliance for an example protocol template.
10. Complete the "Exemption" form. See web page at www.research.ucsb.edu for an example "Exemption" form template.
11. Schedule a follow up meeting with the HSC representative to review your drafted consent form, protocol, and exemption sheet. Make the appropriate modifications.
12. Get your department chair and faculty advisor to sign the protocol and exemption forms.
13. Turn in the necessary final drafts to the HSC for review.
14. All research project investigators are required to go through the HSC training module, which basically familiarizes the investigator with human subject’s 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, don’t worry. HSC makes it impossible for you to fail. When it comes time to login for the real test, get your research project’s HSC number and login under that number. All research project investigators will use the same HSC number but will provide their own personal information.
15. 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.
16. Distribute consent forms to appropriate recipients.
17. Collect signed, consent forms.
18. Begin interviewing.
19. Congratulations! You successfully made it through the Human Subject’s Committee without a problem!

III. Come prepared to HSC with ...

1. An explanation of purpose and the nature of your research project
2. Potential human subject sample
3. "Application for Human Subject Use" protocol
4. "Exemption Form"
5. 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 the subjects

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 subject’s 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 subject’s 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 risks.

V. Links

• www.research.ucsb.edu see: compliance