����������Ƶ

��’m a student conducting research for the first time. What do I need to know?

First, welcome to the St. ����ɲ�����’s University research community! We want you to know that the process of ethics review is an important part of human subjects research in academia, government, and private sectors. In the United States and many other countries, human subjects investigators must obtain approval from an ethics board before they carry out a scientific study. This process is fundamental to a researcher's work, and, as such, it is expected that a human subjects researcher will interact with ethics review boards continually throughout their career. 

As a student researcher, you have the benefit of familiarizing yourself with this important process with the support of a faculty advisor. The mission of the Institutional Review Board (IRB) is to protect the dignity, the well-being, and the safety of all human participants. Keep these principles in mind while designing your study, and remember that your St. ����ɲ�����’s University research community is here to help you.

Is my project Human Subjects Research?

If your project meets both the definition of research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Please see the definition of generalizability in the section labeled Definitions, below, for more on this term.

and includes

human subjects: living individuals about whom an investigator conducting research obtains data through A. intervention or interaction with the individual or B. identifiable private information. 

If your project meets both of these definitions, then it is considered to be human subjects research and therefore requires review by the IRB. This can be a helpful tool to decide if your project is human subjects research. 

You can review the Step by Step Guide For Researchers for the criteria for the classifications of review, and you're also encouraged to email the IRB office with questions that come up.

Where do I start?

You can start by checking the to see if your research is Exempt, Expedited, or Full Board Review. Then, use the Step-By-Step Guide For Researchers which will guide you through creating a proposal and the required supporting materials. The  provides a tool to check for completeness of your proposal before submitting.

Who can I ask for help?

It's a good idea to reach out when you have questions! Here are three individuals who can help you:

1.  Your faculty advisor.
2.  The IRB Administrator at IRB@stedwards.edu
3.  The IRB Chair, Dr. Lisa Holleran, lhollera@stedwards.edu

How do I submit my proposal?

For an Exemption request, fill out the online . For an Expedited or Full Board Review proposal, fill out the . Please see the or the Step-By-Step Guide For Researchers for more information about each of these processes.

What is CITI certification?

CITI stands for Collaborative Institutional Training Initiative. It is a required online course at on ethics in research.

All SEU researchers conducting human subjects research must complete this course and submit their certificate to the IRB during the application process. The IRB will not review any proposals without accompanying CITI certificates. See below for more information on CITI.

Who must submit a CITI certificate?

All principal investigators, co-investigators, and faculty advisors on a research project, as applicable. Student researchers will submit the "Student Social Research" CITI, and faculty advisors will submit the "Faculty Social Research" CITI.

How do I sign up for a CITI course?

Please refer to on how to get CITI certified. After creating or logging in to your CITI account at , click View Courses. On the course page, go to the very bottom of the page where you will see a section labeled Learner Tools. The first option under Learner Tools is Add a course. When you select that option, you will see questions that walk you through the steps to choose a course. In the first question, Human Subjects Research, you will see these options:

• Faculty Biomedical Research
• Faculty Social Research
• Student Biomedical Research
• Student Social Research
• IRB Members
• Community-Engaged Research (CEnR)

Students will select Student Social Research and Faculty will select Faculty Social Research. After saving your selection, the coursework will populate in your Courses menu.

Note: CITI coursework can take several hours to complete.

How long does my CITI certification last?

CITI certification is valid for 3 years. 

What do I need to submit with my proposal?

• CITI certificates from all investigators, including your faculty advisor(s) if applicable
• a Consent Form
• all recruitment materials (text of any emails that would be sent out, announcement scripts, fliers, social media posts, etc.)
• copies of all data collection instruments (surveys, interview questions, etc.)
• working links to data collection instruments, if online
• any authorization letters from other universities, if you will be recruiting outside of SEU
• a debrief, if deception is part of the research protocols, or if mental health resources need to be provided again post-measures.

Please refer to this  to check your materials for completeness. 

Which proposals qualify for an Exempt review?

A proposal is classified as Exempt if it is an activity that qualifies as human subjects research but does not pose greater than minimal risk to participants. There are categories in section of DHSS , and you can use these to review the criteria. Remember that Exempt does not mean that your proposal will not be reviewed, but rather it will receive limited oversight. You'll still need to submit a CITI certificate, and any supporting materials to include Consent Form, survey or interview questions. 

Which proposals qualify for an Expedited review?

A project qualifies for Expedited review if the project poses minimal-to-greater risk to participants. Expedited review does not require the convening of the IRB and can often, but not always, take less time than a Full Board Review.

Which proposals will require a Full Board Review?

When a project has a greater-than-minimal risk to participants, the IRB must discuss the proposal in detail during its monthly meeting attended by a quorum of voting members. Examples of projects that require Full Board Review:

• includes vulnerable populations (minors, pregnant women, incarcerated persons, or persons with diminished decision-making capacity)
• includes sensitive subject matter that leads to greater participant risk (disclosing private or illegal behavior, etc.)
• includes measures that might cause a high level of discomfort or distress (recollections of trauma or abuse, mental health challenges, etc.)

Do I need IRB review if ��’m conducting an oral history or marketing study?

No, these are types of projects usually do NOT meet the definition of human subjects research. We recommend that you review the definitions of human subjects and research carefully, and also contact the IRB office to discuss your project if you are unsure, IRB@stedwards.edu.

How long do I need to keep records from my study?

All records must be retained by the principal investigator for three years after completion of the research. Records include documents such as research proposals, informed consent documents, progress reports, reports of injuries to subjects, and all correspondence concerning the use of human subjects. Unless otherwise stipulated by the IRB, these records may be destroyed at the end of three years after the completion of the research project.

Does the IRB review proposals during the summer?

The IRB usually reviews only Exempt and Expedited proposals during June and sometimes July, depending on faculty/staff availability. Typically there is no IRB service at all in August.

The IRB Full Board does not convene May-August. 

How do I know if I qualify for an Exempt review?

You can review the  (.pdf) and these  (2-10) to check the criteria. If you qualify, an online  should be submitted along with the appropriate documentation listed in the file upload section of the form.

How long will it take for my Exempt Application to be reviewed?

Exemption reviews usually take between 7-10 days. 

Where can I submit my IRB proposal materials?

For the Exempt proposals, fill out the .

For all other proposals, fill out the .

How long will it take to hear back from the IRB about my project?

Typically an initial review will be conducted by the IRB Chair and the IRB Administrator within 7-10 days of the submission date. You should receive initial feedback within that time. The entire approval process usually takes between 14-21 days for Expedited proposals, but could take longer depending on the number of revisions required. A project designated Full Board Review can take several weeks to be approved.

In general, researchers should plan for up to six weeks, considering the length of time between their initial application submission and final IRB approval.

After receiving initial feedback from the IRB, the researcher might need to make adjustments to their proposal and submit corrected materials. When studies involve higher risk to participants or when the materials lack sufficient details, this back-and-forth process could happen multiple times. For this reason, a well-prepared first submission can save you time.

What happens after I submit?

After you submit, there is a waiting period while your proposal is reviewed. If your project is classified as Exempt, it will be processed at the administrative level, which takes about 10 days. If your project is classified as Expedited, it will be reviewed by two IRB members and review will take roughly 14 days for the first round of review notes. A proposal reviewed by the Full Board will likely take more than 21 days. View the dates for the IRB monthly meetings. Proposals that are likely to require a Full Board Review should be submitted at least 14 days before a monthly meeting.

How do I know if my project will need a Full Board Review?

This  can give you a good idea of how your proposal will be designated. There are several automatic triggers for Full Board Review and some that are harder to identify without a closer look. If you are working with pregnant women and fetuses, minors, prisoners, or persons with diminished decision-making capacity, your project will require Full Board Review.

If you are unsure, please contact IRB@stedwards.edu and explain your research protocol. The IRB Chair will ultimately determine whether or not you will need Full Board Review.

Since the levels of review have different timelines, you may wish to examine the potential of review needed by your project. For instance, if you submit a proposal that is determined to be in need of Full Board Review, then you may have 4-6 weeks before you are able to start data collection because you missed that month's Full Board deadline (at least 14 days ahead of our meeting, see meeting dates here.) In this case, you would need to wait until the next month to receive a review. To avoid delays, contact IRB@stedwards.edu if you are unsure whether you need Full Board Review. Keep in mind also that these review take longer than other reviews, sometimes up to 6-8 weeks in the case revisions are required. 

How do I respond to a Revisions Request Letter from the IRB?

The official Revisions Request Letter that you receive from the IRB will contain specific instructions about what should be changed or added to your proposal.

You will revise the original IRB Application or other supporting documents as needed. The IRB requires that you highlight in yellow all changes within each document. Then, save the revised documents with the word REVISED in the file names. Resubmit the necessary documents as email attachments to IRB@stedwards.edu. Include the IRB Protocol ID in the subject line.

How do I make changes to my previously-approved project?

If your project was approved by the IRB, but you need to alter or revise it, you can submit your request via the  online form and attach your supporting materials. It is also available in the Forms and Templates section. 

How can I use deception ethically in my project?

The American Psychological Association (APA) has developed guidelines for research that includes deception. The guidelines are as follows: 

1. Don't use deception unless you have determined that the use of a deceptive technique is justified by the study's significant prospective scientific educational or applied value and that equally effective non-deceptive alternative procedures are not feasible. 
2. Do not deceive participants about significant aspects that would affect their willingness to participate, such as risks, discomfort or unpleasant emotional experiences
3. Any deception that is an integral feature of the design or conduct of the experiment must be explained as early as possible in the process. Ideally, this would happen at the conclusion of their participation but no later than the conclusion of the study. 
4. Keep in mind that deceptive procedures make it impossible to obtain full informed consent. A debrief is always required if deception is present in the protocol.

What if ��’m using data that is publicly available and has been stripped of identifying information?

This type of research likely qualifies as Exempt under use of secondary-data. Good practice would be to submit the for review.

How do I find appropriate resources to provide to subjects in case of distress? 

The IRB requires that research which might result in any type of emotional or psychological distress include mental health resources in the Consent Form and sometimes on a debrief.

The  is a useful document for this purpose. Or, consult this list of

What if I work with another institution for recruitment? 

If you are recruiting participants from a non-SEU agency or institution, ��dz�’l�� need to request an official permissions letter or email from an appropriate person of authority (such as the external IRB or an institutional director) and have it available to upload along with your proposal.

Every institution has different rules for the recruitment of their faculty, staff or students for research. It is your obligation as the researcher to find out what those requirements are and meet them.

Anonymity

Anonymity occurs when no personally-identifiable data is collected and all participants are unknown, even to the researcher. For example, an online consent form and survey with IP addresses hidden and that asks for no identifiable information (such as names, emails, etc.) is considered anonymous research. Conversely, if any personally-identifiable information is present in the protocols, the data is not anonymous.

Confidentiality

Confidentiality refers to how personally-identifiable data will be protected in order to guarantee that access to such data will be restricted to the research team only. This guarantee should be explained in detail in the Informed Consent document.

Debrief

A debrief is a supporting document provided to participants after the conclusion of their participation. This document is necessary if deception was part of the research protocol, as it should explain to participants how and why the deception was necessary. A debrief could also provide additional mental health resources if any measures might be particularly distressing to subjects.

Deception

Deception in research is the intentional misleading of subjects or the withholding of full information about the nature of the project. Deception is sometimes necessary in a protocol, but it must be fully justified and explained in the proposal's application and it must include a debrief. If deception is present, subjects are not able to provide full, informed consent. Therefore, research that includes deception is automatically Full Board Review.

De-Identified Data

De-identified data is data in which personal identifiers have been removed or replaced with pseudonyms or alpha-numeric coding so that the identify of the subject can not be readily determined.

Generalizable Knowledge

Generalizability refers to how reliably the results can be generalized to a setting outside of the controlled laboratory. Generalizability is one of the conditions that must be met for something to be considered human subjects research.

An example of a study that is not generalizable would be if an investigator conducts interviews for historical purposes. This study is not generalizable because the interviewees would be expressing opinions that could not be generalized outside of that setting. This study would not require IRB review.

However, if the researcher were conducting a formal assessment of how the phrasing of a question might influence a person's answer, then a systematic investigation of these results may lead to generalizable knowledge, and would require review by the IRB.

Human Subjects Research

The Department of Health and Human Services (DHHS) defines research as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" .

Research is considered to involve human subjects when an investigator conducting research obtains (1) data through intervention or interaction with a living individual, or (2) identifiable private information about a living individual. In both cases, the generalizability of the study design will determine whether the activity qualifies as human subjects research ().

The definition of a human subject, as it pertains to research involving human subjects in the HHS regulations defined in , Subpart A, is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, (2) personally identifiable information, or (3) private information.

Informed Consent

In informed consent, investigators fully disclose the following information to participants:

1. The purpose of the research, its expected duration and specific procedures.
2. The subjects' right to decline to participate and to withdraw from the research without penalty at any time.
3. The foreseeable consequences of declining or withdrawing.
4. Reasonably foreseeable factors that might influence subjects' willingness to participate, such as potential risks, discomfort, or adverse effects.
5. Any prospective research benefits.
6. Guarantees of anonymity or confidentiality, and any limits thereof.
7. Incentives for participation.
8. Contact information for questions about the research or the participants' rights.

Informed consent also provides the opportunity for the subjects to ask questions and receive answers. This definition is found in the .

Institutional Review Board (IRB)

The IRB is an ethics committee that is required by federal law for all institutions that receive federal funding for research. Without exception, the IRB must review all research involving human subjects at its host institution. The IRB upholds the ethical principles of beneficence, respect for human dignity, and justice, defined in , Subpart A of 45 CFR part 46.

Minimal Risk

The research is considered minimal risk if the probability and magnitude of harm or discomfort anticipated are to be no greater than the discomfort encountered in everyday life, or encountered during the performance of routine physical activities, or during routine physical/psychological examinations.

Personally-Identifiable Information

Personally-identifiable information includes any of the following data about participants: first or last name, date of birth, address, IP addresses/GPS coordinates, phone number, email, social security number, taxpayer or other unique ID number, photographs or video recordings, handwriting, fingerprints, DNA, etc.

Privacy

Privacy refers to the right of research participants to control or limit access to their personal information. Autonomy over personal information must be guaranteed when human subjects volunteer to participate in research.

Private Information

Private Information includes behavior that occurs in which an individual can reasonably expect that no observation or recording is taking place. Also, this includes information that an individual has provided for specific purposes but is expected will not be made public (for example, a medical record) or their identity revealed.

Sensitive Information

Sensitive information is information that, if known by others, could potentially harm the reputation, occupation, or freedom of a participant. Examples include but are not limited to, information about substance use, sexual behavior (excluding sexual orientation and/or gender identity), illegal activity, or experiences under an employer.

What are the kinds of risk research subjects might face?

The following are descriptions of the potential risks associated with research. (Adapted from University of Portland IRB)

• Psychological Risk - Includes psychological impact that may occur during the research and/or later as a result of participating. Includes anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, and altered behavior.
• Social/Economic Risk - Includes alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject's opportunities and powers in relation to others. Economic risks include actual costs to the subjects for procedures, loss of wages or income, and damage to employability.
• Legal Risk - Includes risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally or civilly liable.
• Loss of Confidentiality - Confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Loss of confidentiality can lead to any of the other risks described above. 
• Physical Risk - Includes discomfort, pain, injury, illness, or disease brought about by the methods and procedures of the research.

What groups are considered vulnerable populations?

Federal guidelines identify vulnerable populations as pregnant women and neonates, minors, prisoners, and persons with diminished decision-making capacity.

The St. ����ɲ�����’s IRB also seeks to protect all subjects with vulnerability in any of the following areas: cognitive or communicative, institutional, medical, deferential, economic, social, or legal.

How do I mitigate the risks in my research to get IRB approval?

Make sure your Consent Form includes all of the required information and assurances so participants know what to expect and their rights. The IRB recommends using one of the Consent Form templates found on the Forms & Templates web page. On the consent, you must also provide at least one appropriate to your study group.

If you are collecting personally-identifiable information, make sure to explain how this data will be kept confidential and securely stored.

If remuneration is part of the protocol, make sure the distribution method does not compromise confidentiality and that opportunities to receive are fair and equal.

I want to conduct a minimal-risk, anonymous, online survey. What does the IRB require?

Consult this on how to set up an anonymous survey in Qualtrics. The IRB requires the following specifics:

• The St. ����ɲ�����’s logo is visible on the top of every screen. (This is a default setting when using Qualtrics through your St. ����ɲ�����’s MyHilltop login.)
• No personally-identifiable information is requested in the survey.
• Digital consent is assessed by YES and NO buttons, or equivalent.
• Location data and IP addresses are anonymized within the Qualtrics settings.
• A working link to the fully functional consent & survey is included in the IRB proposal submission. (The IRB will check all aspects of the consent and survey flow.)

How can I disable collection of location data and IP addresses in Qualtrics?

1.  In the left menu of your Qualtrics survey, select Security. On the right side, scroll all the way to the bottom.
2.  Check the box for Anonymize Responses.
3.  Click Save at the bottom of the screen.
4.  Distribute the survey via the “anonymous link” option. 

What is a faculty advisor’s role in student research projects? 

All student-led proposals must be sponsored by a faculty advisor. Student Principal Investigators are expected to carry out the majority of the work for the IRB submission, as it is a low-risk opportunity to become acquainted with the ethics review process, but faculty advisors should be involved in a supervisory role.

Students will likely need assistance understanding the level of research detail required in the IRB Application, plus the level of risk associated with their project. They might also need proofreading of revised or resubmitted IRB materials.

Do I need to check and approve my student’s proposal materials?

Yes, the IRB now requires that faculty advisors review and approve their student's proposal before IRB reviewers can be assigned. This process is outlined below:

1. When a student researcher submits the online IRB application, their faculty advisor receives an automated email from Smartsheet that includes the student's application and supporting materials.
2. The faculty advisor should read/check all the documents for errors, clarity, and thoroughness.
3. Download and use the  to track what is missing or needs extra work in the proposal.
4. The faculty advisor can then determine whether to "Approve" or "Decline" the proposal and leave comments for the IRB team.
5. Once the IRB receives the faculty advisor's response, the proposal will progress to the next step in the IRB process.
6. If the proposal is "Declined", the IRB Administrator notifies the student and coordinates corrections before assigning faculty reviewers.

Please note if there is not enough project detail provided within the submitted materials, IRB approval could be delayed. Students may use the  to prepare.

Do faculty advisors need CITI certification?

Yes, faculty advisors will need to provide a copy of their up-to-date CITI certificate (“Faculty Social Research”) to their students for each research proposal. Students are required to submit it during the application process.

Can I approve the student projects that will be conducted under my supervision? ��’m concerned it will take too long for the IRB to review them.  

No, all proposals must be reviewed by the IRB. We urge you to support your students in creating a strong protocol and application so that the IRB can efficiently process their applications with minimal revisions. The IRB’s purpose is the protection of human subjects in research, and therefore it must review for inexperienced researchers conducting studies involving human subjects. 

��’m a faculty member who will have student projects that involve research in the classroom. Do I need IRB approval?

Yes, please submit an . The IRB Chair will determine if your classroom project qualifies for exemption.

Can I offer extra credit to my students who participate in my research study? 

Extra credit is allowed and is considered as remuneration. The IRB will require that you offer other opportunities that are equally accessible for students to earn extra credit in the event they choose not to participate. 

If you invite students to participate during a class period, you can often avoid the need for the extra credit. You can step out of the room and have a colleague or teaching assistant administer the protocol to avoid coercion and also potentially maintain confidentiality. 

Can someone from the IRB come talk to my class?

Yes, the IRB Chair can be available for a presentation or Zoom session. To schedule, contact IRB@stedwards.edu. We also recommend that you review the information within this Frequently Asked Questions section, the , and the Step-by-Step Guide For Researchers. 

��’m a St. ����ɲ�����’s faculty researcher. How do I collaborate with an investigator from another university?

The answer to this depends on what you would like to do, where you are in the research process, and which institution would be the IRB of record. Please contact IRB@stedwards.edu to discuss your situation.

How early should I/my student submit an application prior to data collection?

Review by the IRB on average takes 14-21 days, however, a full board review may take longer. In general, we recommend that researchers plan for up to (6) weeks when considering the length of time between their initial application and final IRB approval. After receiving feedback from the IRB, the researcher may need to make adjustments to their proposal and re-submit the updated application and documents. When studies involve higher risk to participants, this back-and-forth process may happen more than once. 

For this reason, a well-prepared first submission can save you time. If you would like to receive preliminary feedback on your proposal, please contact the IRB office by email at IRB@stedwards.edu

I am engaged in Scholarship of Teaching and Learning (SoTL). What do I need to know?

The IRB frequently recommends that SoTL investigators arrange for another person (a non-co-investigator) to distribute and collect all measurement tools while the instructor steps out of the classroom. This policy is intended to help the university avoid the potentially coercive situation of an instructor directly asking students to participate in their study. With the teacher outside of the classroom, this gives students more freedom to freely give their consent to participate in a SoTL study.

A  may be required for students to understand what is expected and to ensure they agree to participate or decline without penalty.

In most cases, SoTL research will not exceed "minimal risk" to student participants. For these cases, the investigator will simply complete an  and upload all relevant documents through the online form.

If you are unsure if your research qualifies as Exempt, consult the for more information, or contact the IRB Administrator at IRB@stedwards.edu.

Here's , from Vanderbilt University.

I am interested in serving on the IRB. What are the requirements?

Contact the IRB Chair first, or IRB@stedwards.edu, to express your interest. You might also need to check with your Dean.

For IRB members, the IRB requires two (2) CITI certificates: "IRB Members" and "HIPS" certification.

Members are assigned to a (2)-person faculty team to review Expedited proposals via Smartsheet. Members also meet once a month on the last Fridays during the school year to discuss official business, approve new policies or procedures, and review Full Board proposals.

Further information can be provided by reaching out to IRB@stedwards.edu.

��’m a researcher from another institution and wish to recruit research participants at St. ����ɲ�����’s. How can I do this? 

If you have IRB approval from another institution and you would like to request recruitment of participants at St. Edward's, please complete the form below and attach supporting materials.

•  (online form).
• Letter of IRB approval from the Investigator’s academic institution (i.e., the IRB of Record).
• Copies of recruitment materials (flyers, emails, etc).
• Copies of informed consent and debriefing forms.
• Copies of all measures that will be administered.
• Certificate of Research Ethics Training () for all individuals who will carry out the research and any faculty advisor CITIs.

What if I have research approval from another institution? Can I conduct the same study at St. ����ɲ�����’s?

If you are not affiliated with St. ����ɲ�����’s, you must have a research partner who is St. ����ɲ�����’s-affiliated. The St. ����ɲ�����’s co-investigator should submit the following online form and attach supporting materials. The original proposal should be designated Exempt or Expedited; reciprocity approval for a Full Board study is unlikely.

•  (online)
• Letter of IRB approval from the Investigator’s academic institution (i.e., the IRB of Record).
• Copies of recruitment materials (flyers, emails, etc).
• Copies of informed consent and debriefing forms.
• Copies of all measures that will be administered.
• Certificate of Research Ethics Training () for all individuals who will carry out the research, and, if students, the faculty advisor CITIs.

��’m a researcher from another institution, but I do not already have approval from an IRB. How can I work with the St. ����ɲ�����’s IRB? 

You will need to identify a research partner at St. Edward's University before requesting the St. ����ɲ�����’s IRB to act as the IRB of Record for your project. The St. ����ɲ�����’s partner may be a faculty or staff member who elects to participate as a co-investigator or simply as a local sponsor to the research. The St. St. ����ɲ�����’s University partner will submit the request to the IRB on your behalf using the St. ����ɲ�����’s IRB submission portal. 

What if I need permission from St. ����ɲ�����’s first before getting approval from another institution's IRB?

The St. ����ɲ�����’s IRB can issue a "Conditional Approval Letter" under certain circumstances. Please email IRB@stedwards.edu to discuss your specific situation.

What will happen if I conduct my research without prior approval from IRB?

If you conduct human subject research without approval from the IRB, you will be in violation of university policy. There are many other potential implications, including loss of funding, loss of ability to publish, and for students, credit may be withheld. 

What if I encounter a problem during my study that puts my participants at additional risk?

If a safety issue, data breach, or other major problem occurs during your study, then you are required to alert the IRB immediately through the. The researcher is required to submit this form within 5 business days of the unanticipated event.

Do research protocols need to be changed because of COVID-19? 

When the COVID-19 pandemic began, investigators conducting human subjects research were notified that all face-to-face human subjects research must be halted to ensure the safety of study participants and researchers.

At this time, COVID-19 risks have been mitigated to a minimal level due to widely available and frequently updated vaccinations, allowing researchers to resume in-person protocols. Zoom conferencing and online survey software (i.e Qualtrics) are still useful alternatives to in-person measures.

All pandemic and public health emergency guidances are highly dependent on ongoing updates to federal, state, local, and institutional policies. Guidance for minimizing the risk of exposure to COVID-19 in human subjects research can be found at , , and .