Research Project Lifecycle

If you are a full-time faculty or staff member, please go directly to step two (2).

If you are a student or someone who is looking to do research on Cecil College’s campus, but you do not work for Cecil College, you need a primary PI who is an approved faculty or staff member at Cecil College.

• If you are a student, you should identify a faculty member who will serve as the PI for your project.
• If you are an outside entity and already have IRB approval from another institution, your research project does need to be documented, but does not require IRB review. Please see the Outside Approval Form.
• If you are an outside entity or a staff member, and do not have IRB approval from another institution, you must email the irb@nullcecil.edu, who will consult with administration about an appropriate PI. If you have someone you have approached to be the PI at Cecil College, please specify that person in your correspondence with the IRB. You should not move forward until a PI has been identified.

Please note that all investigators who are directly involved with human subjects and data collection/analysis must complete training. Please be mindful of who is considered a co-investigator and is directly involved with human subjects and data collection/analysis. If you have completed the appropriate training in the past five (5) years, you do not need to retake the modules, just attach the previous certificate of completion. All certificates of completion must be included in the initial application form. See Required Training for PIs for more information.

• Primary PI Human Subjects Research HSR – Basic module
• Student co-PI – Responsibility C RCR
• Outside entity HSR – Basic module if not approved by an outside IRB

Decide if the project requires exempt, expedited, or full review.

Federal guidance describes three levels of IRB review, including exempt, expedited and full. Please note that all three of these levels require approval of the IRB and simply refer to the level of review that the project will receive. Exempt research still requires submission of an application. The determination of the level of review is dependent on the purpose of research, the human subjects under review, the type of intervention to be studied, and the data to be collected and analyzed.

Individuals gathering data on human subjects at Cecil College should consult the provided tables that highlight levels of IRB review prior to completing the IRB application. Once the Primary Investigator has identified the level of IRB review required, they should submit the appropriate application to the IRB. If there are questions about level of IRB review or if a project does not need to be reviewed, the Primary Investigator should contact the IRB chair for clarification.

Exempt research projects do not put the subjects at risk and do not gather data that:

• Asks about criminal or civil liability such as illicit drug use, underage drinking or criminal behavior.
• Causes increased distress (i.e., asking questions about past sexual abuse/assault; prior traumatic experiences; history of STDs, HIV, abortions, schizophrenia, mental health disorders, child abuse or neglect, elder abuse or neglect, incest, suicidal or homicidal thoughts or behaviors, sexual experiences).
• Damages the subjects’ financial standing, employability, educational advancement, or reputation.
• Uses deception.
• Includes a behavioral intervention.
• Requires collection of data from voice, video, digital, or image recordings (this excludes recordings of public observation).
• Requires collection of data from minors or vulnerable populations.

Additionally, exempt research includes:

• Research that gathers data on customer satisfaction for a single office or event if the information gathered will not be presented externally. Information that may be presented in forums outside of the college, for example grant applications, publications, or conferences, should be approved by the IRB through the expedited submission process.
• Research that is conducted annually, and that has previously received IRB approval.

Expedited research projects do not present more than a minimal risk to human subjects and involve either of the following:

• data that is gathered with the purpose of sharing externally, or
• data that is not anonymous, where the subject can be linked back to his/her/their response through subject id number or other means.

Full research projects meet all the criteria for expedited and involve any of the following:

• conducting human subjects research on campus or with Cecil College employees or students by an outside entity;
• gathering data for grant-based research;
• exposing subjects to risks greater than those normally encountered in daily life or in routine medical, dental, or psychological examinations; and/or
• gathering data on vulnerable populations.

The following table is provided to help clarify the types of projects that will require IRB review and the appropriate application process:

Complete the appropriate application form: exempt, expedited, or full review. Once you are in the form, you can pick which form needs to be completed. Additional forms that PIs may need during the application process include conflict of interest and a sample informed consent form.

Submit the application form electronically with all supporting documents to irb@nullcecil.edu up to ten (10) business days prior to the next IRB meeting.

Special populations include groups such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Special risks might include physical harm, psychological harm, or a breach of privacy and confidentiality.

When the IRB identifies such a population or risk, the IRB chair will include a schedule for verification, which will constitute an added section to the usual Compliance Statement (below). Although the exact schedule will be tailored to each project, the PI must inform the IRB chair of the actual start of data collection, so that at a minimum a first stage of verification can occur during the first ten (10) days of data collection.

The IRB chair or his/her designee will interview the PI, focusing on the following matters:

• Joint review of actual written materials and procedures used, to be compared against the approved research design.
• PI’s oral review of objective evidence of research subjects’ experiences in the study (statistics for research subjects to that date, including how many pointed questions or expressed concerns are raised; rate of withdrawal from the study before data collection is complete; any visual evidence of anxious behavior, physical discomfort, or adverse reactions to substances administered within data collection; results of debriefing).
• PI answers any questions from IRB chair or designee and affirms verbally that no material changes have been made to the research design and materials, and that no concerns have arisen that might indicate changes to IRB approval.
• IRB chair or designee writes a report of the findings within ten (10) business days of the meeting, and both parties approve the report, which goes into the PI’s file for the research study. This document constitutes permission to continue data collection under the approved procedures until the next scheduled stage, or until data collection is complete if no further verification stage was deemed necessary.
• After final data collection, PI drafts a brief final report summarizing how the research met IRB verification requirements.

An adverse event is an event that occurs during the course of the research that either causes physical or psychological harm, or increases the risk of such harm, or results in a loss of privacy or confidentiality to a research participant or to others. With the help of the PI, the IRB must determine if such events are anticipated or unanticipated, and also if they are serious and related to the research.

Principal investigators and research staff should be monitoring any potential adverse events that occur as a result of their research. If an adverse event occurs, an Adverse Event Form must be submitted to the IRB within twenty-four (24) hours of awareness of the event.

Adverse events are organized into two categories:

• Category A: Serious Adverse Event
  • A serious adverse event occurs within forty-eight (48) hours of participation in research, and
  • incorporates a serious adverse event (death, a life-threatening experience, hospitalization, or extended hospitalization, persistent or significant disability or capacity, congenital anomaly or birth defect).
• Category B: All three (3) of the following statements are true:
  • The event has caused harm to the subject, has impacted the subject detrimentally, has negatively impacted the subject’s ability to participate, or has resulted in increased risk to the subjects or others (even if the risk has not resulted in harm). Examples: Misplacing a subject’s record, mild distress after completing the research, etc.
  • The event or outcomes were not described or disclosed as a risk for participation in the research, or they have occurred with increased frequency after completing the research.
  • The event or outcomes were possibly, probably or definitely linked to the research.

Following receipt of the Adverse Event Form the IRB chair or designee will contact the PI and arrange an interview within ten (10) business days. In the interim, data collection is temporarily discontinued. The interview will focus on the following matters:

1. A joint review comparing the actual written procedures to the approved research design and Adverse Event Form will be conducted.
2. Joint assessment of the context and possible causes of the expressed concern, reassessment of the study’s potential risks, and either (a) a plan to eliminate or further minimize such concerns in the future, or (b) an explanation of how the adverse event does not, in fact, go beyond the level of minimal risk and, therefore, has been addressed.
3. As soon as possible following this interview, the IRB chair or designee will report to the full IRB. The Academic Programs Vice-President will also be informed. Procedures and their attendant risks will be reassessed to determine whether more than minimal risks are present.

If no unacceptable risks are found, the PI will be notified via electronic correspondence that data collection may continue under the previously agreed-upon research design. If unacceptable risks are found, the PI will be required to submit Change Forms to the IRB addressing the risks and making adaptations to the research project to be reviewed at the next IRB meeting. In either case, the IRB chair or designee will draft a report for the PI’s IRB file for that research study summarizing the results of verification and action taken.

When the IRB chair or his / her designee is notified that a research subject has expressed concern about risks or experimental procedures, he/she/they will contact the PI and arrange an interview within ten (10) business days. In the interim, data collection is temporarily discontinued.

The interview will focus on the following matters:

1. The concerns of the research subject as relayed by the IRB chair or designee.
2. Joint review of actual written materials and procedures used, to be compared to the approved research design.
3. Joint assessment of the context and possible causes of the expressed concern, reassessment of the study’s potential risks, and either (a) a plan to eliminate or further minimize such concerns in the future, or (b) an explanation of how the subject’s concerns do not, in fact, go beyond the level of minimal risk and, therefore, have been addressed.

As soon as possible following this interview, the IRB chair or designee will report to the full IRB. The Academic Programs Vice-President will also be informed. Procedures and their attendant risks will be reassessed to determine whether more than minimal risks are present.

If no unacceptable risks are found, the research subject who expressed concerns to the IRB will be contacted within five (5) business days and thanked for his/her/their intervention. He/ she/they should receive an oral report of the findings (at the time of contact), along with reassurance that even though no evidence for changing the research design was found, important issues were raised that are of prime importance to the PI and the IRB, that the research subject’s concerns remain personally valid, and that it remains the subject’s prerogative to have his/her/their data included in the study or eliminated from consideration if he/she/they are not anonymous, and, therefore, can be identified. After this communication, within two (2) business days, the PI will be notified of the conversation and informed that data collection may continue under the previously agreed-upon research design.

If unacceptable risks are found, the research subject who expressed concerns to the IRB will be contacted within five (5) business days and thanked for his/her/their intervention. He/she/they should receive an oral report of the findings (at the time of contact), including reassurance that important issues were raised that are of prime importance to the PI and the IRB, and be informed that the research study’s temporary hold on data collection will be continued so that the PI may reapply for IRB approval. After this communication, within two (2) business days, the PI will be notified of the conversation and informed that data collection may not continue until the project is resubmitted to the IRB and approved.

In either case, the IRB chair or designee drafts a report for the PI’s IRB file for that research study summarizing the results of verification and action taken.