Submission Instructions and Forms

Contents

Important note regarding fillable PDF forms:
You will likely be prompted to open the form outside of the browser using a supported program/different viewer. Doing so should allow you to fill in the fields. There are two options for completing forms: Either (1) follow the instructions to open or save in another program where you can then fill in and print or (2) print and fill out by hand. Forms can easily be filled out by hand or by Adobe, and both are acceptable for submission to the IRB.

 

Important! Training requirement for all research proposals
All faculty, staff, and students seeking approval from the LC IRB (Human Subjects Research) for research proposals must pass a basic training course on research ethics offered by the Collaborative Institutional Training Initiative (CITI).

Successful completion of this training is required to ensure that all members of the Lynchburg College community who plan to conduct research are familiar with ethical research practices given the fact that the IRB is registered and holds an assurance policy with the federal government.  See the appropriate page, below, for instructions.  Once completed, your certification will last for three years.

  

Full Board Review Submission Deadlines for 2014-2015

These deadlines apply only to proposals submitted for full board review, which are reviewed once per month when the full board convenes.

Full Board Meeting Date Deadline for Submissions
Monday, Sept. 8 5 p.m., Friday, Aug. 29
Monday, Oct. 13 5 p.m., Friday, Oct. 3
Monday, Nov. 10 5 p.m., Friday, Oct. 31
Monday, Dec. 8 5 p.m., Friday, Nov. 28
Monday, Feb. 9 5 p.m., Friday, Jan. 30
Monday, Mar. 2 5 p.m., Friday, Feb. 20
Monday, Apr. 13 5 p.m., Friday, Apr. 3
Monday, May 11 5 p.m., Friday, May 1

General Submission Information

For handwritten submissions, write only in black or blue ink. Materials submitted in pencil or in another ink color will not be reviewed. Submit all materials in polished, final format. Do not submit drafts with markups or editing notations.

All documents with signaturerequirements must be submitted in hardcopy format with original signatures (no electronic signatures, scanned signatures, jpeg signatures, or faxed signatures).

There are three ways to submit to the IRB Director – please choose one:

  • Campus mail (preferred): Dr. Sharon Foreman-Kready, IRB Director, Carnegie 112
  • Hand deliver to faculty mailbox for Dr. Sharon Foreman-Kready, first floor of Carnegie One. Walk in the Schull Porch entrance to Carnegie, and the faculty mailboxes are directly across the hall from the staircase. Deliver in an envelope and place in mailbox only. Please do not slide under office door.
  • US Mail: Dr. Sharon Foreman-Kready, IRB Director, Lynchburg College, 1501 Lakeside Drive, Lynchburg, VA 24501.

Forms, worksheets, and other proposal support documents that do not have signature requirements can be submitted to the IRB Director in hardcopy (see above for instructions) or electronic format. Do not submit in multiple formats. Electronic submissions and inquiries should be sent to the IRB Director at IRB-HS@lynchburg.edu. If the person submitting the materials is not the PI, then the PI must be carbon copied on all correspondence. It is ultimately the responsibility of the PI to ensure that materials and correspondence (including revisions, modifications, renewals, and closures) are submitted in a timely fashion and in accordance with the instructions outlined by the IRB. See the section on Withdrawal from Review for more information.

Reviewability Determinations - Assessment, evaluation, class projects, and other special activities

If you are not sure if your study qualifies as “human subjects research” using the definitions provided in our Policies web page OR if you would like a confirmation, in writing, that your activity is not considered human subjects research by the LC IRB, then an email should be sent to the IRB Director at IRB-HS@lynchburg.edu.

Individuals who are disseminating links for and/or conducting assessment or evaluation activities, conducting secondary data analysis (including chart reviews), are gathering information through service learning or practice methods training, and/or are distributing recruitment information on behalf of another individual (e.g., as professional courtesy to a doctoral student at another institution) may find it helpful to contact the IRB Director before conducting the activity. There is a difference between being involved with a research study and being engaged with a research study. One would likely require an IRB review and one might not. The IRB Director can assist you by conducting a reviewability assessment and subsequently provide you with a reviewability determination.  

This is also helpful for faculty who are not sure if their class assignments, projects, etc. should be considered “human subjects research,” and if so, if the activity would qualify (en masse) as an exempt status research activity. Again, the IRB Director can assist you by conducting a reviewability assessment and subsequently provide you with a reviewability determination.

Initial Research Study Proposals

Step One:  Determine the level of review for your study. While Investigators are not permitted to determine on their own the final review level, investigators are asked to consider the federal regulations list of six categories of exempt research (45 CFR 46.101(b)), the federal definition of ‘minimal risk’ (according to 45 CFR 46.012(i)), and the federal regulations list of nine expedited categories (and in keeping with 45 CFR 46.110) in order to make an educated assessment of the level of review. These are critical components of the assessment of the review status. Additional considerations include risk, benefits, privacy, and confidentiality. Federal regulations are viewed as a “floor,” and not a “ceiling” for the LC IRB’s assessment of and regulations on the protection of human subjects in research. The final determination of level of review is that of the LC IRB. To assist investigators with determining the level of review, a resource has been developed by the LC IRB – visit the Resources web page.

Step Two:  Complete and submit the appropriate materials required for the specified level of review.

For exempt level of review:

Exempt Status Worksheet (instructions on worksheet for additional proposal materials; can submit electronically or hardcopy; see above for submission details)

Research Team Signature Page (submit hardcopy original; see above for submission details)

For expedited and full board levels of review:

Expedited and Full Board Review Worksheet (instructions on worksheet for additional proposal materials; can submit electronically or hardcopy; see above for submission details)

Research Team Signature Page (submit hardcopy original; see above for submission details)

At least one of the following:

Informed Consent Agreement (subjects age 18 or older)

Informed Assent Agreement (subjects under the age of 18 on the date that the assent/consent is provided; parental consent also required unless a waiver is being requested)

Parental Consent Agreement (for use if any subjects will be under the age of 18 on the date that the assent/consent is provided; if investigator has any reason to believe that a parent or guardian may also be under the age of 18, then contact the IRB Director for further instructions)

Submission of Revisions

Revision requirements, clarification inquiries, and requests for additional documentation/information are common as these are often necessary to ensure that the IRB records are sufficient to assess risk and approval for a study. Often, these can be executed via email. If the person submitting the materials is not the PI, then the PI must be carbon copied on all correspondence. It is ultimately the responsibility of the PI to ensure that materials and correspondence (including revisions, modifications, renewals, and closures) are submitted in a timely fashion and in accordance with the instructions outlined by the IRB. See the section on Withdrawal from Review for more information. There is not a specific form for submitting revisions because the nature of the requests and requirements will vary. Communicate directly with the IRB Director at IRB-HS@lynchburg.edu.

Research Modifications (changes to the approved protocol)

Sometimes investigators determine that there needs to be a change to a protocol after it is approved – the addition (or removal) of a member of the research team, a change in wording on the recruitment invitation, or a change in method. Any change to an approved research project, including research plan, consent process and form, investigators, other research personnel, and/or methods of subject recruitment, requires submission of a Research Modification Form. Attach and submit any revised instruments, questionnaires, letters of cooperation, informed consent forms, etc. to the form. Modifications to research projects may not be initiated until IRB approval has been obtained. Complete this form, and read all statements and instructions carefully. Upon processing of the form, researchers will be provided with a unique modification reference number for record keeping purposes; however, the original approval number and the date of approval will remain as the approval of record. As such, renewal and closure dates are tied directly to the initial approval date – approval of a modification does not extend or otherwise change the one-year approval term.

Research Modification Form (submit hardcopy original; see above for submission details)

Request for Continuation/Renewal

All research that has been approved by the IRB must be reviewed annually (if the study has not been completed), and closed once the study has been completed. The LC IRB considers a study to be completed once the Principal Investigator (PI) determines that there will be no further contact with human subjects – for many studies, this means that the study is completed once data are collected.  

The renewal review requirement at LC includes studies approved at all levels of review (exempt, expedited, and full board review status). This is the form to use for annual renewal review, and this form must be submitted to the IRB Director following the instructions provided below at least 30 days before the end date of the approval period as stated in the most recent approval letter for the study. While the LC IRB makes an effort to send reminder correspondence 60-90 days before the end of the approval period, it is ultimately the responsibility of the PI and research team, not the LC IRB, to ensure that this deadline is met. This deadline will allow adequate time for the IRB to review the form so that a decision can be made before the research proposal approval expires. Research studies approved at the exempt status level will be reviewed by the IRB Director; expedited level either by the IRB Director or members of the Board; full board level by the full Board.

Research Renewal Request Form (submit hardcopy original; see above for submission details)

Failure to complete the Renewal Form or the Closure Form in the stated time frame will result in the automatic closure of the study due to noncompliance with stated policy and the IRB will no longer accept any responsibility for the research; noncompliance with stated policy will serve as a barrier for approval of future research at LC as it is a violation of the Research Integrity & Misconduct Policy.

Closure of Study

All research that has been approved by the IRB must be reviewed annually (if the study has not been completed), and closed once the study has been completed. The LC IRB considers a study to be completed once the Principal Investigator (PI) determines that there will be no further contact with human subjects – for many studies, this means that the study is completed once data are collected; however, some investigators choose to keep the study open throughout the data analysis phase because this would allow for collection of more data and/or accrual of more subjects. Once a study is closed, it cannot be reopened; a new research study proposal must be submitted if the investigator wishes to collect data and/or accrue additional subjects for a research study that has been closed.

The study closure requirement at LC includes studies approved at all levels of review (exempt, expedited, and full board review status). This is the form to use for study closure, and this form must be submitted to the IRB Director following the instructions provided below within 30 days of the end of data collection OR at least 30 days prior to the end of the one year approval period* as stated in the most recent approval letter for the study. While the LC IRB makes an effort to send reminder correspondence 60-90 days before the end of the approval period, it is ultimately the responsibility of the PI and research team, not the LC IRB, to ensure that this deadline is met. This deadline will allow adequate time for the IRB to review and process before the initial approval expires. The closure materials will be reviewed and processed by the IRB Director; in the event that there are discrepancies or concerns, additional assistance and consultation may be sought from the members of the Board.

The Board recommends that investigators who question whether additional data will be collected and are not sure about closing the study err on the side of caution, and thus complete the Renewal Form instead of this form.

Research Study Closure Form (submit hardcopy original; see above for submission details)

*Again, some investigators wish to close their studies after the data are collected, while others choose to close their studies after the data are analyzed. These two deadlines are provided in order to accommodate these two approaches.

Failure to complete the Renewal Form or the Closure Form in the stated time frame will result in the automatic closure of the study due to noncompliance with stated policy and the IRB will no longer accept any responsibility for the research; noncompliance with stated policy will serve as a barrier for approval of future research at LC as it is a violation of the Research Integrity & Misconduct Policy.

Adverse Events and Unanticipated Problems

Per IRB policy, any adverse events and unanticipated problems must be reported to the IRB in writing immediately following any such occurrence and should not be held for notification until the renewal review or closure. There is not a form for reporting these items – contact the IRB Director, Dr. Sharon Foreman-Kready, immediately via email at IRB-HS@lynchburg.edu, and provide as much detail as possible (including the study approval number, PI name, and title of the study in addition to the details of the adverse event and/or unanticipated problem).

Withdrawal from Review

If for any reason the Principal Investigator (PI) wishes to withdraw the research study proposal from review, she/he may do so by sending an email to the IRB Director at IRB-HS@lynchburg.edu. Documentation and communication will be retained by the IRB; however, a determination will not be made upon the request for withdrawal. If a PI wishes to have the IRB reconsidered (placed under review), then a new submission must be made. In other words, once a study is withdrawn it will not be reopened and reviewed.

If a Principal Investigator (PI) does not respond to a request for clarification, revisions, or additional information within 15 business days of the date of the request, then the research study proposal will be automatically classified as “withdrawn by PI due to non-response.”  This is applicable to initial submissions (new submissions), requests for modifications, requests for determining reviewability, and renewal requests.

Questions?

Please contact the IRB Director, Dr. Sharon Foreman-Kready, at IRB-HS@lynchburg.edu.