General Questions regarding conducting research involving human subjects and the Human Subjects IRB.
1. Where can a faculty member learn more about seeking IRB approval for a class research or demonstration project?
2. I am applying for a Faculty Study and Research (FS&R) grant for a project that involves human participants. When do I need to submit a protocol application for IRB review?
Submit it as early as possible. No funds will be disbursed until the secretary of the FS&R Committee has received notice of IRB approval.
3. Do students' academic research projects require IRB approval?
If human subjects are involved, yes. Student research that involves human subjects requires approval or granting of exemption by the IRB prior to initiation. PLEASE NOTE: Student researchers, including those doing independent research, are required to have their protocol reviewed and approved by a faculty sponsor before submitting their protocol to the IRB.
4. I am the recipient of an internally-funded student research grant award (i.e., Dean Rusk, Abernethy, Bank of America, etc.) and my research project involves human subject research. When should I submit a protocol application for IRB review?
Submit it as soon as you receive notification of your award; it is NOT necessary for you to submit an IRB protocol prior to your grant application. Once you have received notification of your award, funds will be disbursed to you after you provide the office distributing the grant monies notice that you have submitted a protocol to the IRB and that it has been approved.
NOTE: All student researchers, including those doing independent research, are required to have their protocol reviewed and approved by a faculty sponsor before submitting their protocol to the IRB.
5. I am a student planning to do independent research over the summer. Since this research is not associated with any class that I am taking, do I have to have a faculty sponsor?
Yes. The college requires ALL student researchers to have a faculty sponsor who is willing to review and advise them on their research project.
6. What is a Faculty Sponsor Assurance Form, and why is it necessary?
The Davidson College IRB requires that all student research projects have a faculty sponsor. The purpose of this requirement is to ensure that all projects reviewed by the committee have been carefully vetted by a person with professional expertise in the student's area of research. Because individual members of the IRB may not have expertise in a given research area, we rely on the professional guidance of our faculty to affirm that a student's research project is feasible, appropriate, and sound.
The student's faculty sponsor must complete and submit (from their Davidson e-mail account) the Faculty Sponsor Assurance form to the IRB indicating their support of the proposed project.
7. I have been asked to collaborate with a colleague at another institution who has already received IRB approval for this project from their institution. Do I have to submit this same protocol application to Davidson College's IRB?
If the other institution is willing to allow Davidson College to rely on their federal-wide assurance (FWA) for the research project, it is not necessary for you to submit the protocol application to the Davidson IRB.
However, you must inform Davidson's IRB of your intent to collaborate with someone at another institution. Davidson's IRB will then contact the IRB of the collaborating institution, and execute an IRB Authorization Agreement for Collaborating Institutions and add the collaborating institution's IRB to Davidson's federal-wide assurance (FWA).
8. What are the most common reasons a protocol must be revised?
Missing or incomplete information is the most common reason, so please make certain that you have answered every required question thoroughly and have provided enough information about your project so that your protocol will make sense to someone who is reading about your project for the first time. Pay special attention to the submission checklist on the last page of the protocol application.
Another common problem is that the consent form does not clearly describe the research project, the risks to the participants, or the rights of the participants to refuse to participate or withdraw from the study.
Similarly, the consent form may have errors in syntax and style, may be written in unclear language, may use an inconsistent point-of-view, or may be written at a level that is not appropriate for the age and educational level of the participants. Consulting the consent and assent form templates will help you avoid these problems.
9. Is training required for conducting a project involving human subjects?
Yes. Effective August 1, 2015, all investigators (faculty, students, staff – anyone named as personnel on a new or existing non-exempt research project), and faculty serving as faculty sponsors for student research projects, to complete human subjects training using the National Institutes of Health (NIH) tutorial on Protecting Human Subjects Participants. Please see Human Subjects Research Training for additional information.
10. What should I do if I encounter an adverse event or an unanticipated problem as part of my research with human subjects?
Contact the IRB immediately (firstname.lastname@example.org) and your faculty sponsor if you are a student. Complete the Report of an Adverse Event or Unanticipated Problem form and submit it to the IRB (email@example.com) from your Davidson College email account.
1. Does my project need to be reviewed?
The Human Subjects IRB is charged with reviewing research that involves humans as research participants. You project needs to be reviewed if it meets the following criteria:
(a) The project is a systematic investigation designed to discover or contribute to a body of generalizable knowledge ("research"), regardless of whether or not the results will be publicly disseminated.
(b) The research involves human participants ("living individuals"). Human participants include those who are actively involved in the research process (i.e., being interviewed, filling out surveys, etc.). They could also include those who may not be in the presence of the researcher but whose data will be used in the research. The IRB reviews research that involves living individuals (1) about whom "an investigator conducting research obtains data through intervention or interaction with the individual" or (2) which obtains "identifiable private information" (Title 45 CFR, Part 46.102(f)
). Secondary data analysis of existing datasets where participants are individually identifiable should be reviewed by the IRB.
2. Is the terminology "human research participants" the same as "human subjects"?
The phrases "human subjects" and "human research participants" can be used interchangeably.
3. Who do I talk to if I am not sure whether or not my project needs to be reviewed?
Please contact the IRB Chair or Vice Chair (IRB Membership List) or send an email to (firstname.lastname@example.org
4. Why do I need to submit a protocol for a project that in my own judgment meets the exemption criteria?
Investigators may not self-determine that their own research qualifies for exemption from IRB review. Sometimes a project may appear at first glance to meet all exemption criteria when in fact a closer reading by experienced and uninvolved outsiders reveals that it does not. Investigators who believe their human subjects research should be “exempted” must submit an IRB Application for Exempt Research (DOC).
5. What are the types of IRB review?
There are three types of IRB review: Exempt, Expedited and Full Board. The level of review depends on the risk to the human participants. The IRB makes the determination of the level of review. More details on IRB Review
(a) Exempt - Studies that meet explicit criteria set forth in the 45 CFR 46. Examples of studies in this category are anonymous questionnaires or surveys that do not involve sensitive topics, research being conducted in educational settings involving normal curricula, and research on archival data.
(b) Expedited - Studies that involve minimal risk and meet explicit criteria set forth in the 45 CFR 46. Examples include studies using questionnaires, surveys and interviews that are not anonymous and that involve only minimal risk to the participant.
(c) Full Board Review - Studies that do not meet the criteria for Exempt or Expedited Review and are usually greater than minimal risk are reviewed by the Full Board. Examples are studies that could potentially put a person at risk of physical, legal, or social harm, even if the probability of that risk is small.
6. How do I know whether my project would be considered exempt from further review or non-exempt?
7. How do I know which application form to use?
8. My research project spans more than one year. Do I have to submit a protocol each year?
Federal regulations require that IRB approved protocols be reviewed and approved no less than once every twelve months. A continuous review (renewal) application (DOC) must be submitted and approved by the IRB before the end of the one-year approval period. If your protocol was initially approved as exempt and has not been modified, then it is exempt from continuing/annual review.
9. How do I submit my protocol application?
10. Where do I send my completed protocol application?
All protocol application documentation (including consent form, questionnaires, surveys, etc.) must be sent as attachments to the IRB via e-mail at email@example.com
11. What if I need to include materials not in electronic format, such as a previously published questionnaire that I plan to use?
Materials not in electronic form should be scanned as a PDF file and submitted along with the protocol application as a separate attachment.
12. Does a hardcopy with signatures of the researcher(s) and faculty sponsor also have to be submitted?
No. As of January, 2010, a hardcopy is no longer required IF the researcher types their name and date on the signature line of the protocol application form and sends it to the IRB at firstname.lastname@example.org
from their Davidson College e-mail address. In the instance of a student researcher, their faculty sponsor should complete a Faculty Sponsor Assurance form (DOC)
after they have reviewed the student protocol, by typing their name and date on the signature line, and sending it the IRB
from their College faculty e-mail address.
13. The application form asks about how research records will be secured/stored. What do you recommend?
You should always be careful to store data so that others cannot accidentally see what participants said or did, especially if the data could reveal their identities. Locked desk drawers or locked rooms (if you live alone) would be appropriate choices. If you have a list that connects code numbers on data sheets to actual names of participants, it should be stored separately from the data sheets.
All electronic data should be secured at all times on a password-protected computer. Don't forget that some forms of data might be identifiable even if participants' names are not on them. For example, the combination of several demographic variables in a questionnaire (age, sex, eating house or fraternity, ethnicity, religion, athletic team, etc.) could easily identify an individual at Davidson College. You need not destroy your data after your project is completed, but if you plan to do so, please specify how it will be done.
If your research will be published, you might wish to store your original data securely for some time after publication. Consent forms must be kept for a minimum of 3 years in a secure location. They may be destroyed after that time, although they can be kept longer. We usually recommend that students ask their faculty mentor to store the forms and destroy them when appropriate.
14. Is an English consent document acceptable when enrolling non-English-speaking subjects?
Regulations require that the consent document must be in language understandable to the participant. When the participant is non-English-speaking, the PI should submit a translated consent form for IRB review along with a certification from the translator that the English and non-English versions are the same. While a translator may be used to facilitate conversation with the participant, routine ad hoc translation of the consent document may not be substituted for a written translation. Study participants must be given a copy of the consent to be used as a reference document and to reinforce their understanding of the study.
15. How do you obtain consent from someone who speaks and understands English but cannot read?
Illiterate persons may have the consent form read to them and "make their mark." In this instance, regulations additionally require a signature of a witness to the consent process and signature of the person conducting the consent interview. Investigators should not enroll participants who may not truly understand what they have agreed to do.
1. What is the Human Subjects Institutional Review Board (IRB)?
The IRB is a diverse group of scientific and non-scientific individuals who conduct the initial and ongoing review of research studies in order to ensure the protection of the rights, safety and well-being of human subjects participating in those studies. The membership of the IRB at Davidson College changes from year to year, but most years, the committee is composed of ten members: four or five faculty, two staff, two or more students and one member of the community who is not affiliated with the college. All members are administrative appointments. The Federal Code of Regulations (Title 45 Part 46: Protection of Human Subjects
) governs the composition and conduct of the IRB.
2. How often does the IRB conduct committee meetings?
The IRB meets monthly during the academic year (September through May) and as needed during the summer months of June, July and August. Other meetings may be called at the discretion of the chair.
3. Who reviews my application after it is submitted to the IRB?
It depends on the type of review you are requesting. If you are requesting exemption from further IRB review, in most (but not necessarily all) cases only the chair or vice chair will review your application and protocol. For most other applications, however, the chair and two other selected members of the committee will carry out the review. In the case of an application requiring full board review, the entire committee reviews the protocol application and makes a decision at its monthly meeting.
4. What if the chair or vice chair of the IRB is also my faculty sponsor? Would this person also review and approve my application?
No. In such a case the vice chair (in the instance of the chair being the sponsor) or the chair (in the instance of the vice chair being the sponsor) of the IRB would oversee the review process.
5. What if there is a disagreement among the three individuals who have reviewed a non-exempt protocol?
In most cases any such disagreements are quickly and informally resolved by discussion. The chair may contact the investigator (as well as the faculty sponsor, in the case of a student protocol) to resolve any questions and ambiguities. On rare occasions, however, agreement may not be reached, and in such a case the chair will place the protocol on the agenda of the next scheduled IRB meeting for discussion and decision by the Full Board.
6. What is the average turn-around time for a protocol to be reviewed?
The review of a protocol application typically takes five to ten business days. If revisions are required, the process may require more time. On rare occasions, the entire membership of the IRB may need to discuss a protocol at its monthly meeting before making a final decision. This may cause the review period to be longer.
7. What are the most common reasons a protocol must be revised?
Missing or incomplete information is the most common reason, so please make certain that you have answered every required question thoroughly and have provided enough information about your project so that your protocol will make sense to someone else who is reading about your project for the first time. Pay special attention to the submission checklist on the last page of the protocol application.
Another common problem is that the consent form does not clearly describe the research project, the risks to the participants, or the rights of the participants to refuse to participate or withdraw from the study. Similarly, the consent form may have errors in syntax and style, may be written in unclear language, may use an inconsistent point-of-view, or may be written at a level that is not appropriate for the age and educational level of the participants. Consulting the consent and assent form templates will help you avoid these problems.
8. If I make any changes in my protocol does the IRB have to review and approve it again?
It depends. See Request for Modification to determine whether or not you need to submit a modification form. Please contact the IRB Chair or Vice Chair (IRB Membership List) with questions.
9. Do I need IRB approval if my work will be conducted outside of Davidson's campus?
Yes. To ensure that researchers comply with federal and College regulations it is important that the College, through the IRB, approve of all research conducted by any investigator working as an agent of the College (even if it is in a foreign country).
10. Can I begin my research before I receive IRB approval?
No. The IRB cannot approve a protocol submitted after the research is initiated, nor can the IRB sanction any human subjects data collected prior to approval.
11. What happens if I conduct human subject research without IRB approval?
You will be out of compliance with federal requirements for human subject research. This can result in federal or College actions that will prevent you from conducting human subject research and may jeopardize Davidson College’s access to federal research funding. Further, you will not be able to use the data collected for any reports, presentations or publications.