Frequently Asked Questions
- What is the IRB?
An Institutional Review Board (IRB) works to ensure ethical treatment of human participants in research. It serves to educate the community about the commonly accepted standards for ethical treatment of volunteer research participants. It reviews ongoing research to ensure it complies with those standards. In so doing, it IRB committee has the authority to approve, disapprove or require changes in research that involves human subjects (i.e., people).
- What criteria does the IRB use to evaluate proposals?
The IRB follows the regulations set by the Office of Human Research Protections, a government agency that is part of the Department of Health and Human Services (HHS). You can read this code at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. The process involves a weighing of the costs or risks (to participants) and the benefits (to society).
- How do I know if my project needs to be reviewed by the IRB?
The IRB only needs to review research that includes people as participants. Your project needs to be submitted before IRB for review if it meets BOTH the following criteria:
- It has the goal of generating generalizable knowledge.
- It involves human participants.
- I’m doing a class project. Do I have to submit it for IRB review?
Many class projects do not need to be reviewed by IRB. It is expected, however, that they will uphold the same standards for ethical treatment of research participants as other research projects. We recommend you consult with your instructor, who may require you to take part in online ethics training at http://phrp.nihtraining.com/index.php and/or obtain/document informed consent.
In some cases, however, it IS necessary for students to submit their projects for IRB review). You must submit your project for IRB review IF it meets any of these criteria:
- You wish to include individuals in your study who are under 18 and do not have permission from parents to consent to research studies (on file with the Provost’s Office).
- You are including vulnerable populations in your study (e.g., minors, those with a history of alcohol or drug abuse or other mental illness, victims/survivors of abuse and trauma, the homeless, those who are suicidal, undocumented immigrants, refugees, prisoners, and ex-convicts). For more examples of vulnerable populations, click here.
- Your research concerns sensitive topics (e.g., information related to sexual preferences or practices, information related to illegal behaviors, information that if released could be damaging to the individual). For more examples of sensitive topics, click here.
- You intend to publish or present the results outside of Goucher.
- You are directly identifying the individuals taking part in your study by name.
- Your goal is the generation of generalizable knowledge.
- Does my senior thesis or independent study project have to be reviewed?
- I am doing a research project involving minors. Are there any additional requirements to which I must adhere?
For research involving minors, the consent form must be signed by the parent or guardian of the minor, and the minor should (when possible or appropriate) sign a separate assent form. The assent form does not have to include all of the elements of an informed consent document, but it must give the participant enough information about the project that he or she can make an informed choice about whether to participate. The assent form should also be written in a way appropriate to the age of the participant.
- Can I include Goucher students who are under the age of 18?
Yes, if they have their parent or legal guardian complete the "Parental Consent Form for Research Participation for Goucher Students Who Are Under 18 Years of Age," which is available here. Students under age 18 must show you the completed form prior to participating in your study.
- What must I include in my application?
- The appropriate form (expedited, exempt, full…).
- Your certificate of completion of the human participants training at phrp.nihtraining.com (for tips on saving a web-page as a pdf, see http://howto.cnet.com/8301-11310_39-20111396-285/five-ways-to-save-a-web-page).
- Your proposal.
- Your consent form.
- Your interview/survey/focus group questions or any other instruments of data collection.
- Your recruitment materials, if any.
- Your debriefing form, if any.
- Supplemental forms as appropriate (ex: minors form)
- What is meant by exempt review? If research is exempt, why does it need to be reviewed?
Goucher is governed by federal regulation 45 CFR 46, which stipulates that some categories of research are exempt from regulation 45.10b. When research is “exempt”, the IRB can use less stringent application of review requirements than it must apply to federally regulated research. In this instance two board members review the project to ensure that it complies with the regulations and that human subjects are duly protected.
- Whom to I talk to if I’m not sure if my project needs to be reviewed?
If you are a student working on a class project, the first person to speak with is the instructor in the course. However, if your questions are still not fully addressed at that point, please contact the IRB at firstname.lastname@example.org.
- Where can I get training in the ethical treatment of human research participants?
Click on http://phrp.nihtraining.com/index.php.
- I’m a faculty member conducting research, and Goucher students assist me in my research. Do they need to be listed as researchers on my IRB Proposals? What if a student stops working on my project or starts working on my project, once it has been approved?
Yes, student researchers need to be listed on your IRB Proposals. They also need to provide evidence to the IRB that they have completed the NIH Human Participants training (as do you). If student researchers start or stop work on your project after your project is approved, please send the IRB an updated list of researchers along with certificates of completion of the Human Participants training for any added researchers.
- You asked me to submit my modifications in both “tracked changes” and “changes accepted” formats. What does this mean?
You can find information on using “tracked changes” at http://office.microsoft.com/en-us/word-help/track-changes-while-you-edit-HA001218690.aspx or you can email the helpdesk if you have trouble (email@example.com). We like for you to track your changes so we can go through point by point and see what has been modified since the prior review. However, sometimes this approach yields messy documents, so we also ask that you send us a version with the changes accepted.
- I need to encrypt my recordings. How do I do this?
Nicolas Sheon, PhD, at the UCSF Center for AIDS Prevention Studies, has developed a very helpful document to guide you through encryption using TrueCrypt (which is free). You can access his tips at http://www.palmpal.org/truecrypt.pdf.