Loyola University Maryland

Office of Research and Sponsored Programs

Frequently Asked Questions

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I. Research and Human Subjects

a. How is “research” defined? 

b. What constitutes research with human subjects? 

c. What types of research need to be submitted to the Institutional Review Board (IRB)?   

II. Projects involving human subjects – what does and does not require HSRRC review?         

a. What types of projects do not require IRB review? 

b. Do surveys of Loyola students where information is shared with external organizations need to be reviewed by the IRB?
 
c. Do students need to get IRB approval for classroom projects?

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

e. Are projects involving oral histories subject to committee review?

III.  The Application Process

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

b. What types of research are considered “exempt?”

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

d. What types of research are considered “expedited?”

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

f. What is the difference between anonymity and confidentiality?

IV.  Human Subjects Education

a. Who is required to complete the National Institutes of Health's Protecting Human Research Participants online course?
 
b. Why do I have to complete human subjects education?

c. Where can I access the NIH Protecting Human Research Participants online course?

d. How much time does it take to complete the online course?

e. Do I have to pay to complete the online course?

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

g. How often do I have to retake the online course?

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

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

V.  The Consent Process

a. Do exempt applications require informed consent from participants?

b. How does a researcher request a waiver of consent?

c. 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?

VI. Issues for Special Consideration

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

b. 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?

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

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

a. Is Loyola's Institutional Review Board registered with OHRP?

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

I. Research and Human Subjects

How is “research” defined?

The federal definition of research is a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge involving human subjects.” (45 CFR 46.102)  

By definition, examples of research would include (but would not be limited to) written or online surveys, in-person or telephone interviews, observations of public behavior, program or treatment evaluations, studies involving a manipulated variable, extraction of identifiable personal information from institutional records. 

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 obtains data through intervention or interaction with the individual or identifiable private information.” (45 CFR 46.102)

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.

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II. 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 and if it is used for internal purposes only and will not be distributed externally in any way, then the project would not be subject to the review of the IRB. 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 surveys of Loyola students where information is shared with external organizations need to be reviewed by the IRB?

Surveys of Loyola students, where information is shared with external organizations or presented publicly in any manner outside of the University, need to be reviewed by the IRB.

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 on 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 these evaluations 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.

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III.  The Application ProcessWhat 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 six 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 approximetly three business days 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 two IRB committee members for review. The expedited review process will take approximately three weeks (fifteen 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.

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IV. Human Subjects Education
 

Who is required to complete the National Institutes of Health's Protecting Human Research Participants 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 NIH's free, online education course, Protecting Human Research Participants, 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.

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 NIH Protecting Human Research Participants course?

The web address for the NIH Protecting Human Research Participants online course is: http://phrp.nihtraining.com/users/login.php

A frequently asked questions section is provided on the NIH website that address specific questions regarding registration, copies of certificates and trouble-shooting.

How long does it take to complete the online course?

The Protecting Human Research Participants online course contains a total of seven modules, four of which are followed by short quizzes.  The entire course will take approximately 1-2 hours to complete and can be taken in multiple sessions.

Do I have to pay to take the online course?

No. As a public service, the NIH Office of Extramural Research offers this free tutorial that Loyola University Maryland has elected to use to fulfill the requirement for education in the protection of human subjects.

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. Further submission of a copy of the certificate will not be required unless updated information is released through the online course. A sample certificate can be viewed here.

How often do I have to retake the online course?

You will not need to retake the online course unless updated information is released through the program.

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,  the investigator must take the online course that Loyola has selected even if required to take another education course for other programs.

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V.  The Consent Process

Do exempt applications require informed consent from participants?

Exempt applications do not require informed consent from participants, however, informed consent 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. 

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VI. Issues for Special ConsiderationIf 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 IRB must review and approve all proposed data collection or recruitment of human subjects on the Loyola campus prior to a researcher initiating the data collection or subject recruitment on campus.

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VII. Registration and Assurance from the Office of Human Research Protections (OHRP)Is Loyola's Institutional Review Board registered with OHRP?

Yes, Loyola's Intitutional 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.