Investigators are encouraged to review this information before submitting a human subjects request.
What is the IRB? What is the HSRRC?
The acronym IRB stands for Institutional Review Board. The acronym HSRRC stands for Human Subjects Research Review Committee. The IRBs at Occidental College includes the HSRRC along with the IACUC (Institutional Animal Care and Use Committee) and the Institutional Biosafety Committee (IBC). The mission of HSRRC is to ensure that all research participants are treated with the utmost respect, fairness, and safety throughout the research process as stipulated by the Belmont Report and be in compliance with Title 45 Code of Federal Regulations, Part 46 Protection of Human Subjects. The HSRRC oversees this process by reviewing research involving human participants conducted by faculty, staff, and students who have to seek such approval.
Where does the IRB/HSRRC get its authority?
Authority for the IRB/HSRRC is granted through the federal regulations that require any institution receiving federal money for research to establish internal Institutional Review Boards.
Why do I have to have approval by the HSRRC? I am only planning to interview fellow Oxy students and am not forcing anyone to do anything! Why is the college making this so hard?
The Human Subjects approval process is not something that Oxy made up. The federal government has set regulations for the protection of human subjects involved in research and the Committee is here to oversee that guidelines and ethics are followed, so as to protect research subjects, researchers and the college from harm. For more information, see our website page titled Resources.
What is the difference between (1) Exempt, (2) Expedited, and (3) Full Committee Review?
[Source: UCI: http://www.research.uci.edu/ora/hrpp/levelsofreview.htm]
- Exempt Research: Although this category is titled "exempt," this type of research does require some level of IRB review. Approval is, however, usually granted much faster than an expedited or full-committee review. To qualify, research must fall within the six (6) federally defined exempt categories offering the lowest amount of risk to potential subjects because they involve either collection of anonymous or publicly-available data, or include the least potentially harmful research experiments. The majority of research studies that qualify for exempt review involve the use of anonymous existing data or specimens. For the list of the exempt categories in 45 CFR 46.101(b), click here.
- Expedited Review: To qualify for an expedited review, the research must fall within the nine (9) federally defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous but involves no more than minimal risk. Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research.
- Full Committee Review: Proposed human subject research which does not fall within either the exempt or the expedited review categories must be reviewed by the full committee. Studies involving minor children, pregnant women, prisoners and other protected populations are examples that require full committee review.
I understand that the HSRRC committee meets monthly and they have already met for this month. Do I have to wait an entire month to have my proposal reviewed?
Not every proposal requires review by the full committee. Most proposals will qualify for what is known as an “expedited review," meaning that they will be reviewed only by the HSRRC coordinator and the committee chair. Proposals requiring full committee review are usually those that involve minors or other protected populations, such as pregnant women or prisoners. Please go ahead and submit your proposal and we will let you know if it qualifies for expedited review or must wait for a full committee review. If you are working with minors or other vulnerable populations then, yes, your proposal will have to wait for a full committee review—so be sure to plan accordingly and submit your proposal to us in time to meet one of our published deadlines. And, please keep in mind—even “expedited review" can take several weeks, depending upon the volume of proposals we have on hand at the time of your submission, and the readiness of your proposal being submitted.
I am planning to submit a proposal soon but I haven’t gotten around to it. In the meantime, can I start gathering some data?
No, you cannot begin research or data collection until your proposal has received HSRRC approval. Engaging in human subject research without first obtaining HSRRC approval raises serious ethical concerns and violates college and federal policies. Students, faculty, and staff are required to submit their proposals for HSRRC review before beginning any data collection.
What forms do I need to submit?
The required forms vary based on the nature of each project. The proposal document can be found on our website under Approval Requests. Other documents may be required such as Informed Consent or Assent forms. Please see the Consent Forms section of our website for those templates.
What is an Informed Consent Form, and why would I need to use one? When do I need to use a Letter to Parents?
There are a couple different consent forms you may need. The Informed Consent Form for Adult Subjects is used when your subjects are over the age of 18. There is also a Informed Consent Form for Minor Child, to be used when children are the subjects of your research. The consent form for minors is intended to be signed by the parent or a legal guardian, and is used in conjunction with the Letter to Parents. The templates for these forms can be found on the Consent Forms page of our website, but you will have to add your own language when describing your project. Use care to be sure that the documents are written in language that is readable by the general public. You should avoid scientific or academic jargon wherever possible on your consent forms and Letter to Parents. Guidelines for writing informed consent documents are available at http://ohsr.od.nih.gov/info/sheet6.html. HSRRC uses the checklist provided by the Office of Human Research Protections.
What is a Site Approval Form, and when would I need one?
A Site Approval Form is required whenever you plan to collect data in an institution or an establishment other than the Oxy campus. These forms can be found on the Consent Forms page of our website. Let’s say you are collecting data at an elementary school—in that case, you would take the Site Approval form to the school principal, along with copies of any documents that you planned to give out to the participating families. Check the boxes on the Site Approval Form to show what documents you shared with the principal and ask him or her to sign the form to show that the school has granted you permission to conduct your research there. Site approval forms are not generally required if you are conducting your research in a public place such as a public park, but please check with the HSRRC coordinator if you are uncertain about this requirement.
I plan to conduct my interviews/survey in a language other than English. Can I translate them myself? If I cannot speak the language I need, who will pay to have my forms translated?
Yes, if you are fluent in the language you intend to use you are allowed to translate the documents yourself. However, we require that a professional-level person (e.g., faculty member, administrator, other professional - including family members) fluent in both languages confirm that your translations are accurate. If you do not speak the language you want to use, or if there is no appropriate person you know of who speaks that particular language, you will need the assistance of a professional translation service. The one we use most often is Inline Translation Services. Please see their website at http://www.inlinela.com for information about obtaining a quote for their services. You may want to wait for the HSRRC to approve your English-language documents before you seek translation, just to avoid having to make multiple or repeat translations of the same document(s). If you cannot do the translations yourself and are seeking grant funding, remember to build in the cost of translations into your project proposal. Under most circumstances the college is not prepared to pay for your translations—the cost will be your own responsibility.
If I am conducting interviews in a language other than English, what forms do I need to translate?
All forms that will be seen by the participants must be presented to them in a language they understand. The Federal Regulations require that "The information that is given to the subject or the representative shall be in language understandable to the subject or the representative." Thus, you should have a version of your informed consent document prepared in the language of your intended participants, whether that is English, Spanish, Chinese, etc., also (if applicable) your Letter to Parents, Assent Form, etc. Probably the only document that will not need to be translated is the Approval Request itself because that is only read by the HSRRC committee. Also, use care to be sure that the documents are in language that is readable by the general public. You should avoid scientific or academic jargon wherever possible. Please keep in mind that you must submit copies of all applicable documents to the committee in both English and the secondary language. However, the PI should first submit the document(s) in English for HSRRC review and approval. Once approved, the PI will be asked to submit the document to the HSRRC-IRB in the appropriate language, and have someone fluent in both languages verify for the HSRRCthat the two documents are equivalent. Refer to further information under the Consent Forms page.
What other information do I need to submit?
It is important that investigators undertake training in ethical considerations for the conduct of human subject research to acquaint themselves with the expectations surrounding such research. Occidental College has arranged to offer training to members of the campus community through a program called the Collaborative Institutional Training Initiative (CITI) Program. This is a respeced training program used by numerous colleges and universities. CITI training in human subject research is required as part of the HSRRC-IRB review process, and before approval of a research project. Refer to the Required Training page regarding details about CITI training requirements.
I do not intend to interview people in person, I want to use an online survey instrument such as “Qualtrics or Survey Monkey." Can I do that? Do I still need HSRRC approval?
Conducting interviews online is fine, but yes, you will still need HSRRC approval for your project and you must include an informed consent section in your online survey. That means you will have to do a little extra work and cannot just rely on our templates, but you are welcome to lift the language from our templates to create your online informed consent.
I’m confused about the “submission date." Should I use the date I submitted the proposal to my advisor? Or the date I submitted my proposal to the HSRRC?
We would like for you to use the date upon which you electronically submitted your proposal to email@example.com for review. We recognize that you might obtain your advisor’s signature on a different date, and turn in your printed copy to us on yet another date, so by using the original electronic submission date your records will match ours. Even if you have multiple revisions please continue to use that original submission date on each proposal draft. There is a section on the form to add a “revision date," if applicable, and that date should change with every subsequent revision you submit.
In Section 10 you state that all research involves risk. I do not think my research involves any risk since I am just asking questions! Why do I have to answer this question?
Federal guidelines require an assessment of whether the risks to subjects posed by participation in a research project are beyond a level that is considered minimal. You may not think that your project poses any risk, but we ask the question because we want you to consider it from all sides. If you feel there is no risk involved, then an appropriate response here would be “No risks beyond those ordinarily encountered in daily life levels will be involved."
What would be considered “minimal" risk?
The code of federal regulations 45 CFR 46.102 definition of “minimal" risk is as follows: “Minimum 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."
What is the difference between privacy, confidentiality, and anonymity?
- “Privacy" refers to a research subject’s interest in or desire to control the access of others to their person or to information about their person. Privacy allows an individual to protect information that is inherently sensitive. Researchers need to take adequate steps to ensure that a subject’s privacy is protected. This may mean, for example, that subjects are made aware that they can opt out of particularly sensitive questions or voluntarily end participation in an interview or survey at any time (e.g., during sensitive questions in a study on adult recollection of physical abuse); in other cases, this may mean holding interviews away from a stigmatizing location (e.g., an HIV-clinic or pregnancy-counseling center).
- “Confidentiality" refers to the agreement between the researcher and subject regarding how collected data will be managed and used. An agreement of "confidentiality" means that the researcher will be able to connect data about the subject to his or her identity (e.g., through the assignment of identifiers), but that the data will not be released to anyone else not authorized to have access (e.g., departmental colleagues, students in undergraduate courses).
- "Anonymity" means that no one, not even the researcher, will be able to connect the subject's responses to his or her identity. This may require that researchers not collect any data that will identify subjects (e.g., names, gender, etc.), or adopting a protocol that precludes the possibility that researchers can link any data to particular research subjects.
Where should I mention my intentions regarding anonymity and confidentiality on my proposal?
When writing your proposal, you should mention your plans for anonymity/confidentiality in section 5A (summary of proposal); section 15 (wherein you must describe your plans for securing and storing data); section 17 (regrading how you will protect the confidentialtiy and privacy interests of participants. You should also include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained in the Informed Consent Form, as your subjects do not have access to your approval request form.
When can I expect a decision from the HSRRC?
It’s hard to say. It’s conceivable that a very well-written proposal that is turned in with all related forms and necessary signatures and involving little risk to participants could be approved in as little as a few days. As a rule, however, even a proposal qualifying for “expedited review" takes several weeks. For proposals requiring full committee review, there is a required submission date of at least two weeks prior to a scheduled meeting (to allow the Committee time to review all proposals). Because proposals are seldom approved without revisions, you should allow as much time as possible for review. It’s in your best interest to submit your proposal as soon as it is ready—do not wait until the deadline because that is when the committee is at our busiest and will have the slowest response time. As a rule of thumb, you will need to allow one to four weeks for approval. If your project is time-sensitive in nature and/or there are extenuating circumstances, please let the HSRRC coordinator know and we will try to work with you to expedite your review.
How will I be notified of the HSRRC’s decision?
You will receive an email from a member of the HSRRC committee (usually the chair) advising you when your proposal has been approved. Approvals are generally valid for one year.
I received a “Conditional Approval." What does that mean?
A “conditional approval" means your project is on track to be approved but certain changes are necessary, and/or certain required documents are pending before final approval can be issued. Please read the conditional approval form to learn what you are being asked to fulfill. You cannot begin work on your project until you have full approval, so it is in your best interest to act timely and address all requirements presented in the conditional approval form.
I cannot receive funding from the URC, Anderson Grant, Richter Fund, etc. until my project is approved. How do I make certain they are advised once my project has received approval?
We try to be aware of this and copy the funding department/source when we send out your approval. That is why we ask you to identify your funding source in section 6 (A) of the proposal. But … sometimes we may forget to notify the appropriate department and it is in your best interest to check the email addresses to be sure that we remembered to take this extra step. It is perfectly appropriate for you to forward our email on to the necessary department or to remind us that we need to notify them on your behalf.
I cannot receive course credit (or final enrollment) from the Registrar until my project is approved. How do I make certain the Registrar is advised once my project has received approval?
We try to be aware of this and copy the Registrar when we send out your approval. That is why we ask you to identify on your proposal in section 6(B) if you are receiving course credit. But … sometimes we forget to notify the Registrar, and it is in your best interest to check the email addresses to be sure that we remembered to take this extra step. It is perfectly appropriate for you to forward our email on to the Registrar’s Office or to remind us that we need to notify them on your behalf.
For additional information, refer to http://www.hhs.gov/ohrp/policy/faq/ and http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html.