Question 1: I don’t think that my activity falls under the auspices of “human subjects research” and/or my area of scholarship is not typically referred to as “scientific.” Can I ignore the IRB? In other words, What does not have to be reviewed by the IRB?”
While you may not consider yourself to be a ‘scientist’ and you may not consider your scholarship to be ‘scientific’ in nature, your work may fall under the auspices of human subjects research and be subject to review and approval by the IRB.
If you are proposing a project/activity that involves human subjects and involves the “systematic investigation… designed to develop of contribute to generalizable knowledge” (Code of Federal Regulations, CFR, §46.102; link on our “Resources” webpage), then you are conducting human subjects research and therefore your research must be submitted for review to the IRB. Approval by the IRB is required before the research may begin.
In order to further clarify the preceding statement, we are defining the key concepts in case there are questions about what qualifies (and does not qualify) as human subjects research:
- Human subjects - “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” (CFR §46.102; emphasis added).
- Research - “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 purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities” (CFR §46.102; emphasis added). The intent to publish (or not publish) has no bearing on determination of whether a research activity must be reviewed by the IRB. “Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published (University of California at Irvine IRB; retrieved from www.research.uci.edu/ora/hrpp/definition.htm).
- Systematic investigation – “A ‘systematic investigation’ is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question. Examples of systematic investigations include:
- surveys and questionnaires
- interviews and focus groups
- analyses of existing data or biological specimens
- epidemiological studies
- evaluations of social or educational programs
- cognitive and perceptual experiments
- medical chart review studies.” (material in quotations taken from: University of California at Irvine IRB; retrieved from www.research.uci.edu/ora/hrpp/definition.htm).
- Generalizable knowledge – There are two aspects of generalizability that must be taken into account when defining the concept of generalizable knowledge. These are generalizing to a population and generalizing to a theory. For example, action research (including Participatory Action Research and other community-based methodologies) might not be intended for generalization to a population but are most certainly are intended for generalizing to a theory (whether it be an informal theory, a practice theory, or any other theory). For more information on the differences between these two types of generalizability, we recommend the following site: www.iwh.on.ca/wrmb/generalizability. In light of this distinction, researchers must recognize that the motivation/intent to generalize to a population AND the motivation/intent to generalize to a theory are considered generalizable knowledge.
Below are examples of activities that are rarely generalizable and therefore very rarely require review by the IRB (this list is taken/adapted from University of California at Irvine IRB; retrieved from www.research.uci.edu/ora/hrpp/definition.htm and supported by countless federal and institutional policies, procedures, and memos; this source was selected because of):
- Oral histories that are designed solely to create a record of specific historical events
- Service or course evaluations, unless they can be generalized to other individuals
- Services, courses, or concepts where it is not the intention to share the results beyond the LC community (NOTE: The LC Student Scholar Showcase, as well as other similar campus events that showcase students’ work, is open to those from outside the campus; therefore, studies to be presented at the Student Scholar Showcase must have received approval prior to conducting the research that will be presented).
- Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices only if the findings are not to be disseminated outside of that particular classroom, only if the data are gathered from individuals who are not considered to be members of vulnerable populations, and only if the instructor deems the activity does not present risk/discomfort to human subjects. Vulnerable populations include, but are not limited to: Prisoners, pregnant women, children (individuals under the age of 18), individuals with mental illnesses and disabilities, individuals with HIV/AIDS, individuals with terminal illnesses, and individuals who are homeless and/or living in poverty. Research projects conducted for class credit typically do not fall under this because most research projects require students to collect data from individuals outside of their class and therefore are subject to review by the IRB.
- Quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the LC academic community (for more information, see our Internal Assessment and Evaluation Research Policy.)
While certainly generalizable, the analysis of publicly available data sets (i.e., United State Census data; General Social Survey) does not require review by the IRB. Content analysis of data that were not collected by the researcher and which have absolutely no identifiable information about the participants/subjects is a form of research that rarely requires review by the IRB. For more information on secondary data analysis and IRB review, see Question 14 (below).
If you are unsure about your inquiry or research activity, then contact the IRB at firstname.lastname@example.org.
Question 2: How do I submit a proposal and what kind of training or certification do I need to complete in order to have the IRB review and approve my study proposal?
All faculty, staff, and students seeking IRB approval (regardless of the type of review) must pass a basic training course on research ethics offered by the Collaborative Institutional Training Initiative (CITI). The IRB will only review proposals (for all three levels) submitted by those who have passed the training. This meets a requirement for our federal registration and FWA. Instructions for completing the CITI training are available on the faculty/staff researcher or student researcher pages. If you have technical issues with the site, then contact the support service listed on the CITI site. If you have general questions about the CITI training requirement, then contact the IRB at email@example.com.
The required forms and instructions for submitting a research study proposal package are found on our website on the Submission Instructions and Forms page.
Question 3: My colleague or classmate did not go through the IRB for something very similar to what I’m doing or for something I know to require IRB review and approval. What should I do?
Please report this information immediately as it is potentially an issue of research misconduct. Report this directly to the Research Integrity Officer (RIO; Dr. Sally Selden, Associate Dean for Academic Affairs, at firstname.lastname@example.org). Your identity will be protected. See Research Integrity and Misconduct Policy for more details.
Question 4: Does research conducted by students have to undergo review by the IRB? What is the role of the faculty research sponsor?
Research conducted by students is subject to the IRB policies and procedures. Undergraduate students may not serve as the Principal Investigator (PI) for a research study; and while graduate students may not serve as the PI, they may serve as Co-Principal Investigator (Co-PI) with a Faculty Research Sponsor if authorized by their program, department, or advisor to do so. Any student interested in conducting research (or required to conduct research, as is the case in some courses) must have a Faculty Research Sponsor for the study.
As addressed above in Question #1: Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices only if the findings are not to be disseminated outside of that particular classroom, only if the data are gathered from individuals who are not considered to be members of vulnerable populations, and only if the instructor deems the activity does not present risk/discomfort to human subjects. Vulnerable populations include, but are not limited to: Prisoners, pregnant women, children (individuals under the age of 18), individuals with mental illnesses and disabilities, individuals with HIV/AIDS, individuals with terminal illnesses, and individuals who are homeless and/or living in poverty. Research projects conducted for class credit typically do not fall under this because most research projects require students to collect data from individuals outside of their class and therefore are subject to review by the IRB.
See the Student Research Policy for more information on student research at LC.
Faculty who wish to have their students receive group-based instruction on the IRB process are encouraged to contact the IRB Chair to schedule a class visit early in the semester (email to email@example.com). While most faculty members will have their students develop their proposals individually, it is critical that the faculty member review/edit the materials before they sign and submit.
When there are revision requests or other questions, IRB reviewers will communicate directly with the PI of the study and carbon copy the additional members of the research team. Faculty are encouraged to educate their students on the nature and purpose of the IRB, discuss the reasons why human subjects protection and ethical research are important, and stress the importance of approaching their interactions with members of the IRB in a respectful and professional manner.
Special note for faculty research sponsors whose students are conducting research requiring IRB review as a part of a class: You are permitted to combine all students’ proposals under the same review type (only for exempt and expedited statuses). Full board research proposals may not be combined. Please see our Submission Instructions and Forms page for the separate forms and instructions.
Question 5: My research activity qualifies under “exempt review.” Why do I have to submit a proposal?
The title “exempt” means that a study, once approved by the IRB, is exempt from continued oversight by the IRB. On our submission materials, we sometimes refer to this category as ‘exempt from continued oversight.’ The LC IRB does require that the study proposal be reviewed to insure that it does indeed meet the qualifications for exempt status. All human subjects research must be reviewed by the IRB regardless of researcher’s perception of review status type.
Question 6: How do I know which of the three types of review is the right one for my study?
New in 2013, the IRB has a unified submission form – this means that there is not a separate form for each type of review. The new form provides researchers with a series of questions that help them determine which type of review is appropriate.
Read more about the three types of review (PDF).
Question 7: How long does it take to have a proposal reviewed? When should I expect to receive notification of approval? What happens to my proposal once I submit it?
We will answer the last question first because it will help you understand the timeline. The IRB does not consider a proposal to be “under review” until all materials are submitted and until proposal submission package is complete. Once received, the IRB Chair looks at the basic components of the proposal materials to make sure that the proposal submission package is complete. While the reviewer may determine that more materials are needed (i.e., letter of support from community organization where data are to be collected; invitation to participate script for questionnaire), the IRB Chair is looking for four basic things:
- Does the proposal have real signature(s) in the appropriate place(s)? (scanned signature with the understanding that the original is on file with the researcher in the event that it is needed in an audit.)
- Was the data collection instrument (i.e., questionnaire, observation log, interview schedule) submitted?
- Is the Principal Investigator (PI) a faculty member or a staff member at LC (or one of the Co-PIs, in the case of graduate student research)?
- Have all Lynchburg College affiliated the members of the research team completed the required CITI training? All faculty, staff, and students seeking IRB approval for research proposals requiring full or expedited review must pass a basic training course on research ethics offered by the Collaborative Institutional Training Initiative (CITI). The IRB will only review proposals submitted by those who have passed the training. Instructions for completing the CITI training are available on the faculty/staff researcher or student researcher pages.
Once all of these have been confirmed, the proposal submission package is considered to be “under review” and the review process will begin.
Exempt and Expedited Review: The Chair assigns exempt status proposals and expedited status proposals to a reviewer and that reviewer’s assigned reader. Both are members of the LC IRB and are trained in the review of proposals for human subject research. The reviewer will consult with the reader if she/he feels that it is necessary to do so. Reviewers are not assigned reviews based on their own disciplines or professional backgrounds. Again, all members are trained and qualified to review all proposals for human subject research. The reviewer may; however, reach out to others on the IRB for discipline/profession-specific questions. The reviewer might also reach out to the PI if there is a need to ask clarifying questions about the study proposal.
Frequently, there is a request for revisions. The reviewer will convey this request directly with the PI via email (and carbon copy the additional research team members if their email addresses are available). If these revisions are resubmitted without being completed or without satisfying the reviewer’s request, then an additional request for revisions will be sent until all revisions are satisfied. Once the revisions are received and satisfied, the reviewer will certify to the Chair that the study has been reviewed and is in compliance with the regulations for human subjects research. At that point in time, the Chair will issue, via email, notification to the PI (and carbon copy the additional research team members if their email addresses are available) to confirm that the study has been approved.
The average exempt status review proposal takes 1-2 weeks for the review and approval process, depending on the revisions requested and the resubmission/review of revisions. The average expedited review proposal takes 2-4 weeks for the review and approval process, depending on the revisions requested and the resubmission/review of revisions.
Full Board Review: For full board review, the deadline for submission of materials is recommended before the stated deadline (sent via email to all faculty and staff at the start of the semester) since the submission package must be complete on or before the deadline. The members of the IRB will review the proposal submission package(s) prior to the full board meeting. A majority of the members of the IRB must be present at the full board meeting in order for a decision to be made about the approval of the proposal. Consistent with the OHRP requirements, a member of the IRB who joins the meeting via telephone or video conference does count as being present at the meeting.
Frequently, there is a request for revisions. The Chair or Vice-Chair will convey this request directly with the PI via email (and carbon copy the additional research team members if their email addresses are available). If these revisions are resubmitted without being completed or without satisfying the request, then an additional request for revisions will be sent until all revisions are satisfied. Once the revisions are received and satisfied, the Chair will issue notification to the PI (via email, and carbon copy the additional research team members if their email addresses are available) to confirm that the study has been approved.
Full board review proposal review process varies depending on when the proposal is submitted, revisions requested, and resubmission/review of revisions. Researchers are encouraged to carefully and comprehensively address all revisions requested by the IRB reviewer in order to minimize the amount of time that the proposal is under review. If a researcher has a question about a revision request, then the researcher should address the inquiry directly with the IRB reviewer.
Question 8: My study does not qualify for exempt or expedited review. What is full board review?
If you do not qualify for exempt status or expedited status, then your study proposal must be considered under full board review. The full board meets at least once per month for the months of September, October, November, December, February, March, April, and May. The schedule for meetings and the deadline for submitting proposals for each meeting will be sent out at the beginning of each semester. At this time, the IRB is composed of 9-month employees and as such the full board does not meet during official breaks (Winter Break, Spring Break, and the summer sessions). Inquiries about the 9-month structure of the IRB can be directed to Dr. Sally Selden, Associate Dean for Academic Affairs, at firstname.lastname@example.org.
Question 9: What I am doing is journalism, but sometimes the term “research” is used in my field to describe the methods we use to interview informants and report our stories. Do journalism activities fall under the auspices of the IRB?
Once you have reviewed the information provided in our materials in which human subjects research is defined (see above), determined that your activity is not research and instead falls under journalism then you do not have to provide the IRB with a proposal outlining your activity. The IRB would deem your activity to be journalism, and not research. Journalism enjoys constitutional protection from censorship and restraint under the First Amendment. One does not need to be from the journalism program/department at LC as a qualification for conducting a journalism activity.
Question 10: Someone in my department/school served on the IRB a few years ago. Should I just consult with that person and/or have that person come and speak to my class about the IRB?
We do not recommend that you do so because we cannot guarantee that requirements, regulations, and/or policies have not changed since that person was on the committee. Contact email@example.com to request a consultation or class visit. Furthermore, do not use old forms. We will not review proposals submitted using outdated forms/templates.
Question 11: What is the IRB? Who else is involved with human subjects research oversight at LC?
The Institutional Review Board, or “IRB” for short, is the committee designated to ensure that research at LC is conducted ethically. A list of current members of the IRB is found on the right hand side of this page. Members of the IRB undergo training when they join the IRB and participate in additional training as needed. The IRB is an appointed faculty committee – faculty who are interested in serving on the IRB are encouraged to indicate this by updating their preferences using the link in the myLC portal (contact Faculty Steering with questions).
The IRB leadership structure involves a Chair and a Vice-Chair. Once nominations are made, the chair and co-chair are elected by the IRB committee. Members of the IRB are also referred to as “reviewers” as this is the primary responsibility of members of this committee.
The structure of the LC IRB is outlined in the Faculty Handbook as follows (with the annotation added to this website for clarification purposes):
18.104.22.168 Membership and Tenure of Institutional Review Board (Faculty Handbook 2013-2014)
- No fewer than twelve faculty members, serving three-year staggered terms.
- One committee member shall serve as chair and one committee member shall serve as vice-chair.
- Federal regulation of committee membership requires the following:
- Membership must include both genders [sic].
- At least one member’s primary concerns must be in scientific* areas.
- At least one member’s primary concerns must be in nonscientific* areas.
- At least one community member who is not affiliated with nor part of the immediate family of a person who is affiliated with Lynchburg College.
*As per the OHRP documentation regarding the scientific versus nonscientific membership requirement:
“Scientist/Nonscientist - Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist.”
The chief academic officer at LC, the Vice President and Dean for Academic Affairs, has the ultimate responsibility for research integrity and human subjects research compliance at LC. In this capacity, Dr. Julius Sigler has appointed himself and the Associate Dean for Academic Affairs, Dr. Sally Selden, as the institution’s Research Integrity Officers (RIOs). RIOs are responsible for investigations of and determinations related to accusations of research misconduct. Associate Dean Selden is the Senior Officer of record with the OHRP. Financial support for LC’s subscription to the CITI training program is provided by the office of the Associate Dean for Academic Affairs.
Question 12: I do not agree with the revision(s) requested and/or the decision(s) provided to me by the IRB reviewer. What do I do?
It is critical that researchers understand that, by joining the IRB committee, IRB members are responsible for insuring that all research proposals are consistent with LC policies and federal regulations and recommendations for the ethical conduct of human subjects research – the process is in place to protect the researcher, the human subjects, and the institution. In order to work effectively and efficiently and to benefit all involved, the review process must be a collaborative and collegial one, and not an adversarial process. IRB reviewers have received training and are qualified to review all proposals for human subjects research.
- The PI should contact the reviewer to inquire about the concern(s). Most often, the reviewer will choose to remain anonymous, so the research will send her/his questions through the Chair and Vice-Chair by sending directly to IRB-HS@lynchburg.edu. As noted elsewhere in the IRB informational materials, each reviewer is assigned a reader (who is another member of the IRB Committee), and this person will discuss the PI concern(s) with the reviewer, and in many cases this conversation may have taken place prior to the issue of a revision request. The PI is the primary member of the research team with whom the IRB is authorized to communicate regarding the proposed study, and it is important that undergraduate student researchers work with their Faculty Research Sponsors to insure that inquiries are made appropriately. It is important to recognize that, upon the PI providing more information on the proposed study, the reviewer may no longer request the revision(s) in question because ample clarification is provided and documented. Alternatively, the reviewer might be able to provide additional information on why the revision is necessary in such a way that satisfies the PI’s concern(s). In most cases, this is sufficient to resolve the concern(s) and further action is not necessary.
- If the PI does not agree with the revision(s) requested, then the PI will send an email to the reviewer and carbon copy the IRB Chair (firstname.lastname@example.org). In this email, the PI will state the following within the email, “The attached proposal documents represent the final draft for review to the IRB. This draft does not include the following revisions requested by the reviewer: [enumerate revisions that were not made here]. I am appealing to the Chair and Vice-Chair of the IRB for this proposal to be reviewed and approved without the above-listed revisions that were requested by the reviewer.” The Chair and Vice-Chair will review within the next five business days (not including holidays, campus breaks, or official campus closings). The Chair will then communicate the approval decision via email, copying the initial reviewer, reader, and PI. There are three approval decision options for the Chair and Vice-Chair to make: Approval as is or revise and resubmit to the Chair and Vice-Chair for final review (which will be included in the email).
- If the PI does not agree with the approval decision of revise and resubmit, then the final phase of appeal is with the chief academic officer of the institution. The PI will send an email to Dean Julius Sigler, Vice President of the College and Dean for Academic Affairs. In this email, the PI will state the following, “The attached proposal documents represent the final draft for review to the IRB. I appealed the revision requests of the IRB reviewer and her/his reader to the Chair and Vice-Chair of the IRB. Their decision was revise and resubmit, which I am appealing. This draft does not include the following revisions requested by the Chair and Vice-Chair of the IRB: [enumerate revisions that were not made here]. I am appealing to you as the chief academic officer of the College for this proposal to be reviewed and approved without the above-listed revisions that were requested by the reviewer.” Dean Sigler will make the final determination.
Question 13: I am conducting research at or in affiliation with another institution. Do I need IRB approval from both institution’s IRBs?
It depends. Was the study previously approved at another institution before you came to LC? Will you be collecting data here at LC? The LC IRB does not accept another institution’s/organization’s IRB approval as a way to release researchers from the requirement for the LC IRB submission and approval process; however, another institution/organization might allow a researcher to use the LC IRB approval in lieu of their own procedures. With that said, it is our policy to review these inquiries individually so that all of the details can be discussed. Email the IRB Chair at email@example.com to inquire about your situation.
Question 14: I am conducting research with a community-based group/organization and they want me to design and/or provide them with a questionnaire/interview questions and analyze the results. They have agreed to administer the actual data collection. Technically, I’m conducting secondary data analysis. Do I have to go through IRB for approval?
Yes, you do. This is not traditional secondary data analysis. If the community-based group/organization agrees to administer the questionnaire/interviews, obtain consent and/or assent, and de-identify the data so subjects cannot be identified, then we need for you to have documentation of that. Complete the required proposal materials, and include a letter from the head officer (principal, executive director, superintendent, etc.) stating that: The research team members will not be administering the data collection process, will not be present for the data collection, and will not interact directly with the human subjects; and that the group/organization accepts full responsibility for obtaining consent and/or assent, de-identifying the data prior to distribution to the research team, and the administration of the data collection procedures as outlined in the proposal materials. It is advisable to utilize this procedure only if it fits with the philosophical and/or methodological underpinnings of the study; researchers are urged not to utilize these procedures solely for the reason(s) of it seeming more convenience, the perception that it lends to a faster review by the IRB, and/or its appearance as a way to release researchers from interacting with participants outside of academic settings. For more information on community-based research best practices, view the Center for Community Development and Social Justice webpage and/or contact the Chair of the IRB at firstname.lastname@example.org.