Please submit an electronic copy of all your forms.

Various IRB Forms
- IRB Exemption Form
- IRB Approval Form
- Decision Tree
- Sample Consent Forms

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

1. What is the IRB?
2. Which Form do I fill out?
3. What goes in my IRB Approval Form?
4. Where do I send my form with any documentation?

1. What is the IRB?

2.Which Form do I fill out?

• Research is on educational methods or evaluation in a normal educational setting. Research involves tests, surveys, or observations of public behavior without collecting any information to identify the subjects.
• 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). Research involves public (elected or appointed) officials in their public roles.
• Research involves publicly available information or documents. Research involves the collection or study of existing data, documents, records AND the information is recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects.
• Research or demonstration projects evaluate, or otherwise examine public benefit or service programs. Research involves taste and food quality consumer acceptance studies of wholesome food.

3. What goes in my IRB Approval Form?

d. Full information. Fill out the form with full information.
e. Faculty Supervisor. You must list a faculty supervisor and send him/her a copy of your application when sending it to me/IRB.
f. List Risks and Countermeasures. You should consider all risks to your human subjects, including legal risks (count these as ‘social/environmental’) such as susceptibility to criminal prosecution or to deportation or detention. You should list ways to minimize those risks.
g. Informed Consent. The involvement of human subjects in research should always be informed and voluntary. This means that all human subjects (except those listed in the IRB exemption form), should receive, orally or in writing, an explanation of the affiliation, purpose, eventual uses, and voluntary nature of participation in the research project. How and whether that consent is documented, however, is a different question. At a minimum, they should always be asked for prior verbal consent to the research procedure/interview except in the cases listed in the IRB Exemption Form (e.g., public officials, etc.).

In some cases, announcing the purpose of the research might affect research outcomes adversely. Consider the Stanley Milgram experiments (which might not pass IRB on other grounds today), or a group research project testing whether subjects react differently to the same questions when asked by people of different races. In such cases, the purpose of the research should be framed broadly, rather than omitted or presented in a misleading manner.

ii. Verbal Consent required. Given the above, among the ways listed to reduce risks, all SIS researchers (you) should include a paragraph indicating that you will seek verbal consent from each human subject (not exempted) after fully explaining:

1. your institutional affiliation (e.g., American University);
2. 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
3. the voluntary nature of the interview and the right of subject to terminate the interview at any time

iii. Written Consent forms? You are NOT required to collect signed Consent Forms from your subjects if either of two conditions are met:

1. Your research poses no more than minimal risk to your human subjects, or
2. Collecting a written consent form would prove more dangerous than not collecting one, if the form would link the subject and the research and the principal risk would be potential harm resulting from a breach of confidentiality.

Most SIS research will meet one of these two criteria, meaning there is no requirement to use or collect written consent forms. However, if conditions permit, collecting written consent forms can both reassure the subject and provide the researcher with evidence of voluntary nature of the exercise. Ethics may induce the researcher to collect a written form (see website for examples).

h. Should I offer subjects anonymity? How can I ensure confidentiality? There are three scenarios that call for different approaches to whether you should offer anonymity or observe anonymity of subjects in your research:

(a) No potential risks/harm. Scenario here is that absolutely no potential harm is posed to the human subject (or other humans, like the subject's family or cellmates or fellow union members) by either
(i) association with the researcher or the research project (eg, villagers see you talking to the interviewee), OR
(ii) the event that the research/data provided falls into the hands of certain people (the police, the prison guards, immigration authorities, refugee camp overseers, local guerrillas).

Under this scenario (common for interviewing citizens of a consolidated democracy with an effective rule of law that upholds universal human rights, let's say), then neither anonymity nor secrecy is required, though subjects’ requests for such conditions should always be respected (unless extenuating circumstances like reports of felonious behavior or pending armed attacks – ethical dilemmas).

(b) Potential harm from content OR process of research.
Scenario here is where potential harm IS posed to the human subject (or other humans, like the subject's family or cellmates or fellow union members) by either
(a) association with the researcher or the research project (eg, villagers see you talking to the interviewee), OR
(b) the event that the research/data provided falls into the hands of certain people (the police, the prison guards, immigration authorities, refugee camp overseers, local guerrillas).

Under this circumstance, then the interviewees’ anonymity should be offered and granted if accepted. (Journalism norms don’t apply: 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). If anonymity is adopted, then no consent form should be signed, unless the researcher has interviewees sign a code number or name that is retained. NB that the retention of a “key” (i.e., a list of the actual name or other identifying info linked to the code name or number) may pose harm to the human subjects here, and should only be undertaken with care.

(c) Potential harm from content, not process of research.

Here there is absolutely no potential harm posed to the human subject (or other humans, like the subject's family or cellmates or fellow union members) byassociation with the researcher or the research project (eg, villagers see you talking to the interviewee), BUT there IS potential harm in the event that the research/data provided falls into the hands of certain people (the police, the prison guards, immigration authorities, refugee camp overseers, local guerrillas). Under this circumstance, the researcher should seek to develop a key, and store it separately from the data collected,somewhere as safe as possible from potential harm-doers. Creativity (multiple linked keys, e.g.) may be called for.

4) Where do I send my form and documentation?