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Institutional Review Board | SIS

The IRB Journey for SIS Research – Four Simple Stages / Questions

What is the IRB?

Which form do I fill out?

What goes on the IRB Research Proposal Review Form?

Where do I send my form and documentation?

1. What is the IRB?

"IRB" stands for the Institutional Review Board for the Protection of Human Subjects. It consists of faculty and staff from across the University, plus a community member, who review proposals involving human subjects research. Each teaching unit has its own designated representative. For SIS, the IRB Rep is Professor Linda Lucia Lubrano.

Our main objective is to protect the people you may be interviewing, or otherwise working with, as subjects of your research. We also wish to protect you and the University.

Federal law requires the University to follow an approval process for research involving humans, animals, and radioactive materials.

If you are using people (or animals or radioactive materials) as subjects in a research project, you will either have to fill out a form stating why your research is exempt from the IRB review process, or fill out a form describing risks and the measures taken to minimize them in order to protect your subjects.

2. Which form do I fill out?

Claim Form for IRB Exemption

IF the subjects of your research are NOT in a wartime or postwar society, AND

IF your research does NOT involve vulnerable populations (such as children, victims of violence, people in politically repressive regimes, etc.), AND

ALL of your research falls within the following exempt criteria:

a. Research is on educational methods or evaluation in a normal educational setting

b. Research involves tests, surveys, or observations of public behavior without collecting any information to identify the subjects.

c. Research involves no sensitive information (i.e., no physical, psychological, or social harm would come to the subject if he or she were identified with the information collected).

d. Research involves public (elected or appointed) officials in their public roles. (This does not include NGO officials or academic experts.)

e. Research involves publicly available information or documents AND you are not conducting any interviews.

f. Research involves the collection or study of existing data, documents, or records AND the information is recorded by the investigator in such a manner that the subjects cannot be identified, either directly or through identifiers linked to the subjects, AND you are not collecting any new data nor conducting any interviews.

g. Research or demonstration projects that evaluate, or otherwise examine, public benefit or service programs.

h. Research involves taste and food quality for consumer acceptance studies of wholesome food.

THEN fill out the Claim of IRB Exemption Form. After you have completed the Claim of IRB Exemption Form, then proceed to Question #4 (Where do I send my forms?).

IRB Research Proposal Review Form

If ANY part of your research does NOT satisfy the above criteria, then you MUST fill out the IRB Research Proposal Review Form. See Question #3 and obtain the Research Proposal Review Form. After you have completed the IRB Research Proposal Review Form, then proceed to Question #4 (Where do I send my forms?).

3. What goes on the IRB Research Proposal Review Form?

  1. Full information. Fill out the form with full information.
  2. Faculty supervisor. You should discuss the methodology and research ethics of your project with your faculty supervisor. Ask for permission to include the name of your faculty supervisor on the form, and send her/him a copy.
  3. Provide a clear description of your project. This should be sufficiently complete for someone to understand exactly what you propose to do.
  4. Indicate how human subjects are involved. Describe how human subjects are part of your proposed research. Include a description of your sample population, your techniques of data collection, and what you propose to do with the results.
  5. List risks to the subjects of your research. You should consider ALL actual and potential risks to your human subjects, including possibilities of physical harm or psychological trauma resulting from your research. Also include any legal risks such as susceptibility to criminal prosecution, deportation, or detention (considered as 'social / environmental' risks on the form).
  6. Plans to minimize risks. You should list the steps you will take to minimize the above risks, and how you will follow through to be sure they are effective.
  7. Informed consent. The involvement of human subjects in research should always be informed and voluntary. This means that all human subjects should receive, orally or in writing, an explanation of your affiliation, research purpose, eventual use of the data, and the voluntary nature of their participation in the research project. They should also be asked for prior verbal consent to the research procedure (e.g., note taking, interview conditions, observers, etc.). In some cases, announcing the details of hypotheses and the research methodology might adversely affect the research outcome. In such situations, the purpose of the research should be framed broadly and honestly, rather than omitted or presented in a misleading manner. See the book by Oliver for guidelines.
  • Verbal consent. Include a statement indicating that you will seek verbal consent from each human subject (not exempted) after fully explaining: a. your institutional affiliation (e.g., American University); b. the purpose of the research and how that research will be circulated (e.g., MA thesis; policy recommendations for the U.S. government or another government; published article; research paper; etc.); AND c. the voluntary nature of the interview and the right of subject to terminate the interview at any time.
  • Written consent forms. You are not required to collect signed consent forms from your subjects IF either of two conditions are met: a. your research poses no more than minimal risk to your human subjects, OR b. collecting a written consent form would prove more dangerous than not collecting one, i.e., there is potential harm to your human subjects if the form were to link the subject to the research through a breach of confidentiality (e.g., if your notes were confiscated).

    However, if conditions permit, collecting written consent forms can both reassure the subject and provide the researcher with evidence of the voluntary nature of the interview / observation.

  • Should I offer subjects anonymity? How do I maintain confidentiality? Anonymity refers to the identification of your sources; whereas confidentiality refers to the privacy of information (see Oliver chapter 5). Here are three scenarios that call for different approaches regarding anonymity and confidentiality:
  • a. No potential risks/harm. Scenario (a) is that there is absolutely NO potential harm to human subjects (including the interview subject's family, friends, fellow employees, or ethnic group members, etc.) by association either with you (the researcher) or with the research project. This also means that there is absolutely NO potential harm to human subjects in the event that the research/data provided falls into the hands of other people (e.g., the police, prison guards, immigration authorities, refugee camp overseers, security intelligence officers, the news media, OR local guerrillas, rival camps, political opponents, criminal gangs, etc.).

    In this scenario, neither anonymity nor secrecy is required, unless your subjects specifically request it. You should always respect your subject’s request for anonymity or confidentiality, except in extenuating circumstances of illegal or unethical practices (see Oliver book), which would most likely not come under this scenario.

  • b. Potential risks/harm from the research process. Scenario (b) is that there IS potential harm to human subjects (including the interview subject's family, friends, fellow employees, or ethnic group members, etc.) by association either with you (the researcher) or with the research project (e.g., people see you talking to the interviewee). This also means that there is potential harm to human subjects in the event that the research data provided falls into the hands of other people (e.g., the police, prison guards, immigration authorities, refugee camp overseers, security intelligence officers, the news media, OR local guerrillas, rival camps, political opponents, criminal gangs, etc.).

    In this scenario, the circumstances of the interview should be discreet AND the interviewee’s anonymity should be offered and respected. (If the researcher believes that the interviewee may not be fully cognizant of the dangers posed, then the researcher should maintain anonymity even if it was refused by the subject.) In the interests of anonymity, then, no consent form should be signed, unless the researcher asks the interviewee to sign a code number or code name that is memorized or retained separately.

    You should NOT keep a written list of the actual names or other identifying information in your notes or on your computer, because that would betray anonymity and expose your subjects to risk in the event that your notes or computer were lost or confiscated. You should also be cautious about the way you record confidential information.

  • c. Potential risks/harm from the research results. Scenario (c) is that there is NO potential harm to human subjects (including the interview subject's family, friends, fellow employees, or ethnic group members, etc.) by association either with you or with your project during the research process (i.e., there would be absolutely no potential harm if other people knew that you spoke to the interviewee, nor would there be any potential harm to human subjects if you had the names of your interviewees in your notes or computer). BUT there IS potential harm to human subjects in the event that confidential information is revealed, or in the event that substantive data gathered during the research process is subsequently made available in ways potentially damaging to the individuals or groups under study.
  • This could occur, for example, if confidential information is linked to specific individuals by name, either in your notes or in your written results. In this scenario you must maintain the anonymity and protection of your sources by NOT linking individuals to specific information either in the note taking process of research or in the publication of research results.

4. Where do I send my form and documentation?

Ask yourself the following questions:

  • Is the research externally funded in any way by non-AU sources?
  • Are participants / interviewees / human subjects of research paid?
  • Does the research involve surveys of the AU community or discuss community sensitive issues?

If you answered YES to ANY of these three questions, then send your form and documentation directly to the University IRB at one of the following addresses:

Faculty research projects go to:

AU IRB Review Board

Liz Kirby, Office of Sponsored Programs

Sports Center Annex Room 121

Campus Mailbox 8066

Tel: 202-885-3457

Fax: 202-885-3453

Email: ckirby@american.edu

Student research projects go to:

AU IRB Review Board

Matt Zembrzuski, Office of Sponsored Programs

Sports Center Annex Room 121

Campus Mailbox 8066

Tel: 202-885-3447

Fax: 202-885-3453

Email: zembrzus@american.edu

IF you answered NO to ALL of these three questions, then send your form and documentation to the SIS IRB Representative. Keep in mind that some of these cases may still have to go to the University IRB after review by the SIS IRB Representative (especially if your research involves vulnerable populations):

SIS IRB Representative

Professor Susan Shepler

School of International Service

Campus Mailbox 8071

Tel: 202-885-2454

Email: shepler@american.edu


Please submit an electronic copy of your form AND supporting documents if necessary (e.g., research proposal with methodology / project design / survey instrument) as described in step 4.