IRB Frequently Asked Questions

What is the Institutional Review Board? "
Institutional Review Boards (IRBs) are committees designated by an institution to review research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of people involved in research. Learn more about Pitzer's Institutional Review Board.
What are the historical origins of IRBs?
IRBs have been implemented to prevent unethical treatment of human subjects. The history of contemporary human subjects protections began in 1947 with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis. The Code captures many of what are now taken to be the basic principles governing the ethical conduct of research involving human subjects. Similar recommendations were made by the World Medical Association in its Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects, first adopted in 1964 and subsequently revised many times. Basic regulations governing the protection of human subjects in research supported or conducted by HHS (then the Department of Health, Education and Welfare) were first published in 1974.
How is Pitzer College's IRB administered?
The college established the IRB as a standing committee with committee membership compliant with the Office for Human Research Protections (OHRP), a subsidiary of the US Department of Health and human Services. In order to be compliant with federal laws governing the protection of human research subjects, the college officially registers its IRB with the OHRP every two years. In addition, the college submits a Federal Wide Assurance (FWA) with the OHRP every second year.
Who is on the Pitzer IRB?
Pitzer’s Institutional Review Board is not part of the College’s standing committee structure. Its composition is governed by 45 CFR part 46.107.
The membership must represent diverse academic and personal backgrounds including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition, the IRB includes at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (§46.107).
The Dean of Faculty and Chair of Faculty Executive Committee (FEC) in consultation with the Associate Dean of the Faculty recommends IRB members and the FEC approves the members.
How do I submit an application to the Pitzer IRB for review?
The Pitzer IRB submission process is an on-line application found located at – http://irb.hpbvtv.com/login
When will I find out about the status of my application?
Please allow a minimum of two weeks for your application to be processed and reviewed.
Is my project research? Is it human subjects research?
- In defining human subjects research activities, two separate determinations must be made:
  The first determination is whether or not the activity can be considered research. According to 45 CFR 46.102 (a-j), research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes.”
- If the answer is “yes” to the first question, investigators must follow up with a second determination: Does the research involve human subjects?
- According to 45 CFR 46.102 (f), “Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains
  - (1) Data through intervention or interaction with the individual, or
  - (2) Identifiable private information.
- Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes 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 (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Investigators unsure of whether an activity constitutes human subjects research should contact the IRB.

If I'm conducting researching involving animals, is there a parallel approval process?
Yes. Please contact Prof. Jenna Monroy (email), Dept. of Natural Science, for more information.
What is considered minimal risk?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(i)).
Are there special provisions for "vulnerable populations"?
The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons [Federal Policy §___.111]. Federal regulations set forth specific provisions on research involving fetuses, pregnant women, and human in vitro fertilization [45 CFR 46 Subpart B]; prisoners [45 CFR 46 Subpart C]; and children [45 CFR 46 Subpart D].
Are any human research activities exempt from IRB review?
If research is done for a class project, does not include vulnerable populations, involves no more than minimal risk, and will not be presented or published (e.g., as a thesis, scholarly paper, or community forum), then this research does not require formal review. However, the IRB recommends that the investigator complete ethics training identified on the Pitzer IRB main page, when possible.
Furthermore, Institutional Research for internal use, that will not be presented or published outside of the college, does not need IRB approval.
Do students carrying out senior theses, senior projects or independent studies involving human research need to submit appllications for IRB approval?
Yes.
Does the IRB/human subject protection guidance also apply to pilot studies and questionnaire development?
Yes. The definition of research in the federal regulations includes research development, testing, and evaluation (45 CFR 46.102(d)). Some IRBs might not consider such studies research if they are not systematic but, overall, pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB. Ordinarily the data collected from subjects in a pilot or feasibility study are not used for study findings.
I'm not asking anything about the respondent. I want to know only about the place where she works. Does my survey still need to be reviewed by the IRB?
Yes. The project may not meet the definition of human subject if the questions are not about any individual (attributes, attitudes, or private knowledge). However, this determination is sometimes difficult to make and the decision rests with the IRB, not with the investigator.
I'm not asking any sensitive questions. Does my survey still need to be reviewed by the IRB?
Yes. All research must be reviewed by the IRB. If the project is minimal risk, then it may be handled in an expedited review by the IRB. The specific decision rests with the IRB, not with the investigator.
Do I need IRB approval to put a survey online? (e.g., Survey Monkey)
: Yes. Computer- and internet-based research protocols must address fundamentally the same risks (e.g., violation of privacy, legal risks, psychosocial stress) and provide the same level of protection as any other types of research involving human subjects. All studies, including those using computer and internet technologies, must

ensure that the procedures fulfill the principles of voluntary participation and informed consent,
maintain the confidentiality of information obtained from or about human subjects, and
adequately address possible risks to subjects including psychosocial stress.

If I'm doing research involving human subjects and I wish to recruit students, faculty, or staff at the other Claremont Colleges either in person or electronically (via email or web), will the Pitzer IRB approval be sufficient?
IRB review/approval originates at the researcher’s home campus and is sufficient to conduct participant recruitment across The Claremont Colleges. Access to resources, e.g. student listserve or posting of flyers, would be controlled by the individual campuses and students/faculty wishing such access would be informed that they must approach the individual Dean of Student Offices for access to such resources. With the exception of Pomona College, students/faculty seeking access to resources would provide the letter of IRB approval from the home campus but generally not the IRB application. In the case of access to resources at Pomona College, all requests will go through the IRB contact and the IRB application from the home campus should be provided along with the approval letter.
• Students undertaking a research project on another campus (as part of an independent study or senior thesis) would submit their IRB application through their home campus.
How do I contact the IRBs at the other Claremont Colleges?
Scripps College; Pomona College; Claremont McKenna College; Claremont Graduate University; Harvey Mudd College; (please note; HMC uses the CGU IRB).
If I want to do a survey of high school students or children, do I need parental consent? What is assent?
Yes, you need parental consent. Because children have not yet attained legal age (18 years), the parent or legal guardian is asked to give permission for participation whenever a child is asked to take part in research (45 CFR 46.408(b)). Federal regulations require, however, that children be asked to provide assent, or agreement to participate in the research, whenever they are capable of doing so. Age, maturity and psychological state need to be taken into account when determining whether to ask for assent (45 CFR 46.408(a)). Out of respect for developing persons, it is important to involve children in the decision-making process whenever possible. Though they may not be able to give legal consent, they have the ability to assent or to dissent. It is important to keep in mind that a child’s failure to object to participation should not automatically be construed as assent. Assent implies the affirmative, explicit agreement of the child. Usually children who are age seven and older are asked to provide verbal assent or, in some cases, sign an assent form, which is stated or written in language appropriate to the ages and conditions of study subjects. The assent should include a description of the study and describe any inconveniences and discomforts subjects may experience.
What is the difference between 'anonymous' and 'confidential'? How can confidentiality be maintained?
The term “anonymous” means that the identities of the participants cannot be determined from materials gathered as part of the research. No one, including the investigator, can link an individual person to the responses of that person. For this reason, face-to-face interviews are never anonymous. If phone numbers are not stored, then random digit dialing (RDD) telephone interviews could be considered anonymous. Mailback questionnaires are considered anonymous only if no tracking codes are utilized.
The term “confidential” means that the investigator can (or could) identify individuals who participated in a study, perhaps through a code, but the identities of participants will not be revealed to third parties.
Although the identities of participants may be recorded, data can be kept confidential if they are carefully coded, if face sheets and consent documents are separated from survey instruments, if computer sheets and other papers are properly disposed, if access to identifiable data is limited, if research staff are educated about the importance of protecting confidentiality, and if records are stored in secured locations. More elaborate procedures may be appropriate for research involving sensitive data that may involve a greater risk should confidentiality be breached, and investigators may want to seek Certificates of Confidentiality to protect such data from subpoena. However, unless federal statutes mandate this confidentiality (e.g., statutes surrounding the decennial census), confidential surveys that are not anonymous are not eligible for exemption using these criteria. Confidential surveys may, however, still be eligible for exempt status if any disclosure of the human subjects’ responses outside the research could not possibly place them at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation.
Is it OK to pay respondents for their participation?
The regulations do not directly address payment of subjects. Whether or not individuals are paid for participating in research can depend on a number of factors, including availability of funds and the extent of effort on the part of study subjects. When subjects are reimbursed for direct expenses incurred due to research participation (e.g., parking and transportation), there is no ethical debate. However, the IRB will pay particular attention to inducement payments (e.g., payments for participation) to determine the effect that undue inducement could have on a prospective subject’s ability to make an informed, voluntary choice about taking part in research. This is especially important when participation may include more than minimal risk. If compensation or the use of incentives is to be part of your study, it is important to include specific information in the IRB application and to provide detailed information about payment (including terms) in the informed consent information.
When conducting data collection through email or web surveys, what unique features of internet communication and data storage must be addressed?
Electronic recruiting and data collection pose some additional challenges to human protections primarily in the area of confidentiality. The key challenges can be broken down into 4 areas:
- RECRUITMENT: Computer- and internet-based procedures for advertising and recruiting potential study subjects (e.g., internet advertising, e-mail solicitation, banner ads) should follow the IRB guidelines for recruitment that apply to any traditional media, such as letters, telephone scripts, newspapers and bulletin boards. Authentication – that is, proper qualification and/or identification of respondents – is a major challenge in computer- and internet-based research and one that threatens the integrity of research samples and the validity of research results. Researchers should take steps to authenticate respondents. For example, investigators can provide each study subject (in person or by letter) with a Personal Identification Number (PIN) to be used for authentication in subsequent computer- and internet- based data collection.
- DATA COLLECTION: It is often recommended that any data collected from human subjects over computer networks be transmitted in encrypted format. This helps insure that any data intercepted during transmission cannot be decoded and that individual responses cannot be traced back to an individual respondent. In addition, if the content of the responses would pose risk to the respondents if the information were shared, it is recommended that the highest level of data encryption be used, within the limits of availability and feasibility. This may require that the study subjects be encouraged or required to use a specific type or version of browser software. It should also be noted that encryption standards vary from country to country and that there are legal restrictions regarding the export of certain encryption software outside the US.
- SERVER ADMINISTRATION: It is recommended that for online data collection a professionally administered survey server be used or that a) The server is administered by a professionally trained person with expertise in computer and internet security, b) Access to the server is limited to key project personnel and is configured with firewalls to minimize the possibility of external access to the server data, c) There are frequent, regularly scheduled security audits of the server, and d) The server is subject to the periodic security scans.
- DATA STORAGE/DISPOSAL: If a server is used for data storage, personal identifying information and IP addresses should be kept separate from the data, and data should be stored in encrypted format. Data backups should be stored in a safe location, such as a secure data room that is environmentally controlled and has limited access. Competent data destruction services should be used to ensure that no data can be recovered from obsolete or discarded electronic media. For projects that are minimal risk, if these data security safeguards cannot be put in place, then language in the consent information should be added indicating that complete confidentiality cannot be guaranteed and/or that encryption of responses is not provided.
Do I have to submit Oral History projects to the IRB for approval?
he following on Oral History is used by permission from American University’s IRB website
Oral history is defined by the Oral History Association (OHA) as “a method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life.” Many oral history projects do not need to be submitted for IRB review, because they do not seek to contribute to generalizable knowledge and therefore are not “research” per the federal regulations governing the IRB process. Instead, such projects aim to provide a deep understanding of specific historical events and actions.
On the other hand, some oral history projects do seek to contribute to generalizable knowledge and therefore would be considered research and should be submitted to the IRB. Columbia University’s policy statement on oral history and IRB gives this example: a study of the long term social impact of the Vietnam War on American culture that includes oral history interviews with veterans (not generalizable knowledge) vs. research using oral histories to gain an understanding of the impact of PTSD on Vietnam veterans as part of a project to allow the researcher to predict what kinds of exposure in war situations lead to the development of PTSD (generalizable knowledge).
Also, IRB review is required for any oral history studies, whether or not they seek to develop generalizable knowledge, when they may pose greater than minimal risk to participants. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. If the research is more than minimal risk, it should be submitted to the IRB no matter what. Finally, researchers conducting oral history projects for which IRB review is not required may, at their discretion, voluntarily request IRB review if required by granting agencies or for any other reason.
In summary, please submit your oral history project for IRB review if it:
- Seeks to contribute to generalizable knowledge; OR
- Poses more than minimal risk to participants; OR
- Is one that you wish to have reviewed by IRB for grant review or other purposes.
- Otherwise, if none of the above conditions holds, then do not submit Oral History projects for IRB review.
Can I give drugs, vitamins, or other substances to my subjects as part of my project?
Because the effects of ingested substances are so variable between individuals and hard to predict, IRB does not typically approve projects that involve subjects being asked to ingest substances (including caffeine and vitamins).