1. What's an IRB?
Answer: The IRB stands for Institutional Review Board for the Use of Human Subjects in Research. Any Institution that receives federal funding to conduct research with human participants, such as NPS, is required to establish an IRB to review all research that directly or indirectly involves human subjects, and to set forth institutional policy governing such research. Their major responsibility is to assess the risks and benefits of proposed research.
2. How do I know if I'm conducting Human Subjects Research?
Answer: The Federal Regulations definitions:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for this policy.
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.
In order for your project to be considered Human Subjects Research, both definitions (Research and Human Subject) must be met. If you are unsure whether your project involves research with human subjects, please contact the the Human Research Protection Program Office at 831-656-2998 or firstname.lastname@example.org.
3. How long will it take for me to obtain approval to do my study?
Answer: That depends on the nature of your study and the characteristics of the people you intend to recruit. You should allow at least 4-6 weeks for review and approval of your study.
4. When may I begin data collection for my study?
Answer: You must receive written approval from the IRB and NPS President before beginning participant recruitment, data collection, or data analysis. A memo will be sent to you via e-mail when your project has IRB approval.
5. Do projects conducted by NPS students need IRB approval?
Answer: It depends on whether the student project is intended to be an education exercise or a project that truly fits the definition of research with human subjects as described above. NPS considers thesis and dissertation work to meet the definition of “research”, requiring IRB review and approval if it involves human subjects. For further guidance in determining whether your project is research with human subjects, please contact the Human Research Protection Program Office at 831-656-2998 or email@example.com. Please note that students may not be the principal investigator (PI) on research projects submitted to the IRB.
6. I've heard that the Federal Regulations make certain categories of research exempt. If my research fits into one of these categories, does this mean that I don't have to have it reviewed by the IRB?
Answer: No. SECNAVINST 3900.39D is clear that investigators may not make the determination of a project’s exempt status. All research, if determined to meet the definition of human subjects, need IRB review. “Exempt” does not mean exempt from review, nor does it mean exempt from ethical responsibility (i.e., exempt surveys should still have informed consent).
7. Do I always have to obtain the informed consent of the research participants?
Answer: In general, yes, but there are some limited exceptions. The IRB has the authority to waive some or all of the Federal requirements for informed consent in certain extenuating circumstances. The NPS IRB is responsible for ensuring that basic ethical principles are abided by in all research. The expectation that the informed consent of research participants be obtained is based upon the Belmont Principle of respect for persons, and regarded as extremely important in conducting ethical research.
8. Do research participants always have to sign the consent document?
Answer: Not always. In certain situations (all involving no more than minimal risk) the IRB can waive the requirement that you obtain the participant's signature on the consent form.
9. What do the terms “consent” and “assent” mean? Aren't they the same thing?
Answer: Sometimes the word “consent” is used to include consent and assent. In research involving adults, “consent” is obtained from the participant to participate in the study. In research involving minors, a parent must give permission to allow the child to participate in the research, and children who are able to understand information about participation are asked to “assent” or agree to participate as well.
10. My research will be done at another location. Do I have to obtain IRB review and approval from NPS?
Answer: Yes. If you are a member of NPS and responsible for the conduct of the study (PI), you must get NPS IRB and NPS President approval to conduct your research regardless of where the research takes place. You should also be aware that your project may need IRB approvals in addition to NPS if being conducted in another location.
11. Is it true that I need IRB review even if I am not doing an “experiment”, but I am only conducting interviews or surveys, using secondary data, or simply observing people?
Answer: Yes, as long as your research involves collecting data or information from or about living individuals, you need to have it reviewed by the IRB.
12. What constitutes deception and is it allowed?
Answer: Deception involves withholding information from subjects that might affect their decision to participate in the study. The IRB regards any use of deception as a very serious issue, since withholding information violates the fundamental ethical principle of autonomy. If we have respect for subjects as autonomous individuals, we also respect their right to a make a decision about their participation based on full information. Nonetheless, there are certain types of research that would be impossible to conduct without deception (e.g., if subjects know exactly what a researcher is looking for, they might alter their behavior).
Deception is acceptable under federal regulations as long as appropriate protections are provided. Deception occurs in varying degrees of severity. In its most benign form - incomplete disclosure - subjects are told the truth but not the whole truth. The information that is typically withheld relates to ensuring an unbiased response by the participant. Progressively more severe examples include (a) deceiving subjects about the purpose of the experiment, (b) deceiving them about the status of other individuals who they believe to be subjects (confederates), and (c) deceiving them about the status of individuals supposedly outside of the experiment (e.g., persons allegedly needing help in a study of helping behavior). The most extreme form of deception occurs when participants are not even aware that they are subjects until after the experiment has concluded. Studies involving deception require an IRB approved waiver for the alteration of elements of informed consent (for further details see the informed consent waiver form).
If deception is sanctioned by the IRB, the participants must receive a thorough debriefing at the conclusion of the experiment. This includes a disclosure of the deception and an explanation of why it was necessary. To restore subjects' autonomy and control (that is, to restore the right to decide on participation based on full information), experimenters typically, at the conclusion of the debriefing, offers subjects the opportunity to withhold the use of their data if they are unhappy with the deception.
13. Do I need IRB approval if my research isn't externally funded?
Answer: Yes, all research involving human subjects conducted at NPS must be approved by the IRB and NPS President regardless of funding source.
14. If I have approval to conduct research involving human subjects from another IRB, do I still need to get approval from NPS?
Answer: Yes. All research involving human subjects conducted at NPS must have NPS IRB and NPS President approval.
15. After I download the IRB form from the internet and complete it, can I send it back to you by e-mail?
Answer: Yes. Electronic copies of documents may be emailed to the IRB Administrator in the Human Research Protection Program Office at firstname.lastname@example.org.
16. What is the difference between the terms “confidentiality” and “anonymity?”
Answer: Something that is truly anonymous has no known name or identity or known source. For research to be considered anonymous, no identifiers of any kind (e.g. name, code number, etc.) are used that can link the data or information to the individual who provided it. In contrast, research data that contains identifiers that link individual participants with their information, need to have appropriate provisions that protect confidentiality. The researcher has been entrusted with private information and is responsible for addressing how sensitive information will be protected.
17. Can the IRB approve a project “retro-actively”?
Answer: No. There is no provision in the Federal Regulations that allow for IRB approval of research that has already been done. If data was collected for purposes that the IRB determines to be non-research (e.g. classroom projects) IRB approval can be sought for the data analysis going forward.
18. Do I have to promise confidentiality? What if my participants want to be identified?
Answer: The research should be designed in such a way that you protect the information that needs to be protected. The issue needing to be addressed is not one of requiring confidentiality or anonymity on participants in research where none is needed, but rather making sure that participants are fully informed. Some consent procedures allow for a participant the option of having their identity disclosed.
19. When do I need to complete the Human Research Protections training course?
Answer: The DON-HRPP uses the Collaborative Institutional Training Initiative (CITI) for its web-based training. All personnel who conduct, review, approve, support, manage, or oversee research are required to complete initial and continuing training. A completed training certificate from the PI should accompany your IRB Application. For more information about the CITI program, follow this link: http://navymedicine.med.navy.mil/humanresearch/index.cfm?docid=18687 To register and complete the CITI training, go to the following web page: http://www.citiprogram.org/
20. I don’t know where to start to write a protocol. What needs to be included?
Answer: Information about putting together a complete IRB Application can be found at the following NPS web page: http://www.nps.edu/Research/IRB_Applications.htm
21. Is there a deadline for submission to the IRB?
Answer: For protocols that do not require review of the full board (i.e., exempt and expedited protocols), there is no specific deadline for submission. These protocols are reviewed as they are received. If all documentation is provided, then the review usually takes no more than a couple of weeks. If you believe your project will need to be reviewed by the full board, (i.e., more than minimal risk or using special populations) please submit your application at least 4-6 weeks in advance.
22. What if I need to change my protocol after it’s been approved?
Answer: Any changes to the protocol, including consent forms, questionnaires, research personnel, number of participants recruited, additional research sites, must be submitted to the IRB for review and approval before implementation. An amendment form is found on NPS IRB application page http://www.nps.edu/Research/IRB_Applications.htm
23. Which changes to the consent form need to be submitted to the IRB?
Answer: The IRB needs to have the most recent versions of consent forms on files, so all changes to consent documents must be submitted to the IRB for review.
24. Does the IRB provide any training for investigators?
Answer: Yes. The IRB strives to provide information and assistance to investigators and research staff in several ways.
1. NPS IRB for the Human Research Protection Program Office web site: http://www.nps.edu/Research/IRB.htm
2. DON-HRPP web-based training: http://www.citiprogram.org/
3. Arrangements can be made to have an IRB Representative provide a brief (send an email to: email@example.com to set-up this up).
4. Questions can be sent to the IRB chair at
firstname.lastname@example.org, or the IRB Administrator at email@example.com.