The Common Rule was updated in 2017 for the first time since it was issued in 1991. The revisions were set to take effect in 2018, but were amended twice to delay the date that regulated entities must comply with the revised version of the rule. These revisions are commonly referred to as the "revised Common Rule," the "Final Rule," or the "2018 Common Rule." Some Final Rule changes were made in an effort to clarify how the pre-2018 Common Rule is applied. The most significant revisions are intended to “modernize, strengthen, and make more effective” the current system of oversight. The revisions propose to:

Better protect human subjects
Expedite research
Increase trust in the research enterprise
Reduce regulatory burden

The Common Rule revisions aim to better manage the many types of research (specifically including behavioral and social science research) that are being conducted today, as opposed to the research conducted in 1991. One of the Final Rule’s main purposes is to facilitate the conduct of minimal risk research. It also recognizes the evolving technologies used today which have changed the scale and nature of information collected in modern research activities. Large databases, bio-specimen repositories, electronic health records, and clinical research networks have shifted research priorities. Please go to Common Rule Revisions for a detailed explanation of the changes and how they impact human subjects research at Loyola.

II. Research and Human Subjects

How is “research” defined?

The federal definition of research is a “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.[1]

Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities” (46.102 (1)).

For purposes of this part, the following activities are deemed NOT to be research:

Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.[2]
Public health surveillance activities, including the collection and testing of information or bio specimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
Collection and analysis of information, bio specimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes
Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

What constitutes research with human subjects?

Research with human subjects involves research on living individuals “about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

What types of research need to be submitted to the IRB?

Generally, research that involves contact with human subjects or obtaining data about living human beings requires review when that data will be used to generalize findings or draw conclusions. For more information on whether or not your project requires IRB approval, please review this guidance on when IRB review is needed. You can also take the online survey, “Do You Need to Submit Your Project for IRB Approval?”, that will ask you a series of questions and let you know whether or not IRB review is required for your project.

III. Projects Involving Human Subjects – What Does and Does Not Require IRB Review?

What types of projects do not require IRB review?

If a survey is being conducted by a Loyola office or department for the purpose of gathering institutional information only to be used for internal, self-improvement purposes, and will not be distributed externally, the project would not be subject to IRB review. However, these surveys should be conducted in accordance with the principles embodied in the University's “Policies and Procedures for Research Involving Human Participants.”

Do students need to get IRB approval for classroom projects?

In some cases, faculty members may assign projects that are for educational purposes only and that involve human participants. These projects may not require review by the IRB.

Classroom projects involving human participants are not subject to review, if and only if:

1. The research does not include topics of a sensitive or personal nature;
2. The participants in the study will be limited to other Loyola students who volunteer to participate;
3. No minors (individuals under 18 years of age) or other vulnerable populations are involved in the research; and
4. The project will not involve dissemination of any kind (such as public presentation, publication, posting of findings on a webpage, etc.).

When review is not required, faculty members also may choose to have students submit Applications for Approval of Investigation Involving Human Participants in order to educate students about the process of completing and submitting an application to the IRB.

For further information please review the human subjects review process for classroom projects.

Do student course evaluations of faculty need to be reviewed by the IRB?

Student course evaluations of faculty do not need to be reviewed by the IRB, unless the evaluation results will be used for research purposes or will be published or disseminated.

Are projects involving oral histories subject to committee review?

Oral history interviews are not considered research if their main intention is to document the experiences of individuals or historical events without intending to generalize findings or draw conclusions. If the oral history interviews do intend to generalize findings or draw conclusions, then these interviews would be considered research and would be subject to IRB review.

IV. The Application Process

What are some of the things I should look for to make sure that my human subjects application is complete?

In order to ensure that your application is complete and provides all necessary information, please check the following before submitting it:

Ensure the application is complete, that the information provided in the application is consistent, and that all necessary supplementary documents (e.g., survey instruments, consent documents) have been included with the application.
Ensure that age range and number of participants have been included (please note that if the study involves participants who are under 18, then the application must be sent out for expedited or full review).
Participant responses should be noted as anonymous or confidential.
Ensure that your consent document(s) include(s): a) a description of the research project; b) contact information for the investigator should the participant(s) have any questions; c) a statement that the survey is anonymous or confidential; d) if applicable, contact information for your faculty sponsor and/or contact information for Loyola's Counseling Center and e) a statement that participation is voluntary and that participants may withdraw without penalty at any time.

What types of research are considered “exempt?”

"Exempt" means that ongoing review of a project by the IRB is not necessary unless the research is changed in such a way that it no longer meets the criteria for exemption. If the research falls within one of the eight categories defined by federal regulations, the project may be determined to be exempt. Exempt review will not be given for projects involving minors. Please review further information on these categories.

Exempt projects must be conducted in accordance with the general principles of human subjects protection.

How long does it take for the IRB to review exempt applications?

Exempt research must be reviewed by the ORSP to confirm that it meets the criteria for exempt status. Once a complete application is received by the ORSP, it will take approximately one week to review. The ORSP may send applications submitted as exempt to additional IRB committee members for further review; this review process will take approximately three weeks.

What types of research are considered “expedited?”

Research that (1) presents no more than minimal risk to human subjects, and (2) involves procedures identified in Title 45 CFR Part 46 qualify for expedited review. Of particular note is research outlined by the federal guidelines that does not meet the requirement for exempt review and involves the following: "research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies." A human subjects application that does not qualify for exempt or expedited review is required to go through the full committee review process.

For further information on expedited research visit the webpage.

How long does it take for the IRB to review expedited applications?

After a complete application is received by the ORSP, it is sent to IRB committee member(s) for review. Exempt applications must be reviewed by the committee to confirm that they meet the criteria for exempt status. The exempt review process takes approximately 5-10 business days. The expedited review process will take approximately three weeks (15 business days). Annual review is required for expedited projects lasting longer than one year.

What is the difference between anonymity and confidentiality?

Anonymity indicates that participants in a research study cannot be identified by the researcher in any way because their identities are not known, while confidentiality indicates that the identities of participants in a research study are known but will not be disclosed. Therefore, information in a research study cannot be both anonymous and confidential.

Examples of anonymous studies:

a)  A researcher approaches subjects at a shopping mall and asks them to complete a survey that does not provide any identifying information and is returned to the researcher in a sealed, unmarked envelope.

b)  A researcher is doing statistical analysis of patient data from a hospital. The data, which is archival, was stripped of all identifiers before it was delivered to the researcher.

Examples of confidential studies:

a)  A researcher is conducting interviews with residents in a community. He/she learns the names of the participants in the process of interviewing them and agrees to keep the identities of the participants confidential.

b)  A researcher is administering surveys that ask for student ID numbers to students in a class. The individual informs participants that he/she will keep surveys secure in a locked cabinet and that their identities and responses will be kept confidential and only reported as a group.

When do I use a request for amendment form?

When a researcher wishes to make changes to a research protocol that has already been reviewed and approved by the IRB, a request for amendment must be submitted to the IRB for review and approval before the proposed changes are implemented. The amendment request must include a detailed description of the proposed changes and all revised documents reflecting the proposed changes.

When do I use a request for renewal form?

All IRB approvals for expedited and full-review applications are valid for one year. If the research activity extends beyond one year, the researcher is required to submit a request for renewal (hyperlink) no less than three weeks prior to the expiration of the approved period. If the approval expires before a renewal request is approved, all research must cease, including any manipulation of collected data.

V. Human Subjects Education

Who is required to complete the CITI Training Human Subjects Research course?

Any faculty member or other Loyola employee conducting independent research or overseeing student-conducted research and any student working on independent research, a dissertation or thesis that involves research with human subjects is required to complete the CITI's, online education course, Human Subjects Research (HSR), prior to the review of his or her Application for Approval of Investigation Involving Human Participants. This requirement pertains to all investigators, as listed above, including those in academic departments that do not typically conduct research involving human subjects. Investigators must take the Social Behavioral and Educational Researchers training.

Why do I have to complete human subjects education?

Loyola University Maryland, its Institutional Review Board, and investigators have a shared responsibility to protect the rights and welfare of individuals who participate in research involving human subjects. Completing the required training course will help to ensure the fulfillment of that obligation.

Where can I access the CITI Human Subjects Research course?

Go to CITIprogram.org to set up or log in to an account.

Additional information on how to set up an account can be found under Institutional Review Board, Human Subjects Education.

How long does it take to complete the online course?

The Human Subjects Research online course contains a total of seventeen modules, followed by short quizzes. Each module takes approximately 10-15 minutes to complete and can be taken in multiple sessions.

Do I have to pay to take the online course?

No. As part of Loyola's subscription to CITI, faculty, administrators, and students can take this course free of charge.

How often do I have to submit a copy of my certificate of completion?

A copy of the certificate of successful completion of the online course must be submitted directly to the ORSP or submitted with the next Institutional Review Board application. At that point, ORSP will maintain a database indicating investigators who have received certificates. Certification must be renewed every three years.

How often do I have to retake the online course?

You will need to take the online refresher course every three years or when new regulations are released.

I'm a faculty member and my application is for a classroom project. Do I have to complete the online course?

If the application is for a classroom project, the faculty member who assigned the project is responsible for both completing the online program and acquainting the students with human subjects education information. The faculty member is also responsible for ensuring that classroom-based projects are conducting in accordance with the Policies and Procedures for Research Involving Human Participants.

What if I've already taken another human subjects education course?

In order to ensure that all investigators are learning a consistent human subjects education curriculum, Loyola will accept CITI training on Human Subjects Research.

VI. The Consent Process

Do exempt applications require informed consent from participants?

Exempt applications do not require informed consent from participants, however, informed consent or a research cover letter is strongly recommended. The process of consent ensures that participants have adequate understanding of information about the study, confidentiality or anonymity of participants in the study, contact information for the principal investigator, potential risks and benefits, and that their participation in the study is completely voluntary.

How does a researcher request a waiver of consent?

In the case of an expedited application, a waiver of informed consent must be approved by the two IRB committee members who are reviewing the application. The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all of the subjects if it finds either: a) that the only record linking the participant and the research would be the consent document and the main risk would be potential harm resulting from a breach of confidentiality; or b) that the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

If an investigator requests a waiver of parental consent for a project involving minors, the application must be reviewed and approved by a minimum of three members of the IRB.

If a survey is being administered to Loyola students, some of whom may be just under 18, and the survey procedures present no to minimal risk to subjects, is parental consent required?

In the case of an application that meets the federal definition of exempt review but involves Loyola students who are under 18 years of age, it is possible that parental consent may not be required. If there is no more than minimal risk to the subjects, the researcher would need to go through the appropriate procedures to request a waiver of parental consent.

VII. Record-keeping

Once my research has ended, do I have to keep any paperwork?

Researchers are required to retain copies of documents related to the use of human participants in their research project including but not limited to all signed consent and assent documents and complete records of any adverse incidents that occurred during the research as well as any follow-up correspondence or actions taken in response to the adverse incident. Researchers are responsible for maintenance and retention of these documents for a minimum of three years after the completion of the research.

What if I graduate or leave Loyola before the three-year period is over?

If you leave Loyola University Maryland within this period, all records must be provided to your department so that they can be retained for the required three-year period.

VIII. Issues for Special Consideration

If a PI is planning to conduct web-based research, what issues do they need to consider?

Researchers must obtain participant consent in the process of doing web-based research. It is recommended that the principal investigator send a preliminary e-mail or letter to request participation. This statement will guarantee the participant's e-mail address or other identifying information is not included when the survey is submitted. It is recommended that researchers provide the subjects with the link to the consent form, and not the survey itself. The consent form should include the following information: a) a description of the research project; b) contact information for the investigator should the participant(s) have any questions; c) a statement that the survey is anonymous; and d) a statement that participation is voluntary.

It is also important for principal investigators to provide information on how the data is secured in the process of transmission to ensure that the identity of the participant is protected.

In the email sent to participants, there should be a line that states, "I certify that I am at least 18 years of age" and "By clicking on the following link I consent to participating in this study." If the subjects consent, they will then click on the link to the survey ordinarily located at the bottom of the consent form.

If a PI is working with data obtained by another institution, does he/she need to obtain IRB approval to use it for his/her research, even if approval was obtained to gather the data by the other university?

If a Loyola faculty member, student, or other member of the Loyola community is planning to analyze data involving human subjects obtained from another institution, he/she must obtain approval from Loyola's IRB before beginning the data analysis. This approval must be obtained even if another institution has given IRB approval for the study.

If a researcher from another college, university, or organization wants to collect data or recruit subjects on campus, does he/she need IRB approval?

Yes, the researcher will need to obtain IRB review and approval from their host institution. The department granting access to this researcher must obtain a copy of that approval before allowing the research to take place.

IX. Registration and Assurance from the Office of Human Research Protections (OHRP)

Is Loyola's Institutional Review Board registered with OHRP?

Yes, Loyola's Institutional Review Board registration number is IRB00006503.

Does Loyola's Institutional Review Board have Federalwide Assurance (FWA) from OHRP?

Yes, Loyola's FWA number is FWA00013527.

Announcements

Meet the New ORSP Director

Loyola School of Education receives grant for school-based mental health services

Dr. Maren Blohm receives grant from Maryland Native Plant Society

Loyola faculty receives grant to increase the number of STEM educators working in high needs schools

Loyola faculty associates receive grant to fund training supporting people with disabilities

Loyola faculty member, Qi Shi, receives grant to support STEM education research

Loyola faculty receive grant to help develop courses for special education leaders

Loyola receives grant to enhance vocational discernment in Messina

Research Expense Funds

Limited funds are available for tenured or tenure-track faculty members to cover expenses for research or scholarship. Preference given to activity that supports grant-seeking. See Research/Scholarship Expense Funds for more information.