The Research Office

Wilson Hall
371 Wilson Boulevard
Rochester, Michigan 48309-4486
(location map)
(248) 370-2762
(248) 370-4111
[email protected]

Institutional Review Board (IRB)

Oakland University (OU) is committed to the highest ethical and legal standards for the protection of human subjects who participate in research. To comply with these standards, all research conducted by OU researchers, faculty, students, or staff that involves the participation of human subjects must be submitted to the Institutional Review Board (IRB) for review and approval prior to initiation.

The IRB applies the ethical principles of respect for persons, beneficence and justice as set forth in the Belmont Report and the regulations codified by the Department of Health and Human Services (HHS) in 45 CFR 46 and the FDA as applicable in its review of research. The IRB considers additional protections when vulnerable populations are included in the research such as fetuses, pregnant women, prisoners, children, and cognitively impaired subjects.

OU commits to complying with these ethical principles and regulations through its Federal wide Assurance with Office for Human Research Protections (OHRP).

  • FWA#: FWA00003480   (FWA Expires 8/31/2028)
  • IRB Registration #: 00000087
Requirements & CITI
Who Can Apply and How to Apply

Who Can Apply:

  • All research must be conducted or sponsored by Oakland University (OU) tenure track faculty
  • Non-tenure-track OU faculty and individuals holding other titles must identify an OU faculty sponsor OR obtain special permission from the head of the research office (see below). Investigators not employed by OU must identify an OU faculty sponsor AND obtain special permission from the head of the research office. 
  • Students, graduate or undergraduate, who are principal investigators must identify an OU faculty advisor. The faculty advisor must be a tenure track faculty or have obtained a special permission from the head of the research office to serve as a faculty advisor (see below)
  • The Special Permission Form can be found in the espace IRB Forms and Templates Library, under Cayuse Forms.  The signed form and supporting documents need to be emailed to Dr. Judette Haddad, IRB Manager, at [email protected] for approval. A copy of the approved Special Permission Form must be attached with the submission in Cayuse.

How to Apply: 

Prior to submission of applications to the IRB, all researchers, including faculty, student, staff and key personnel conducting research involving human subjects need to comply with the following requirements:

  • Sign into Cayuse: This is a single server sign on so use your NetID and password.
  • To create a new Study, click on +New Study in the upper right hand corner of the Dashboard or the Studies page.
  • Enter your title and click the blue check mark to save your study.
  • Then click on New Submission in the upper right hand corner to start completing the online forms.
  • If you cannot access Cayuse, contact the research office for assistance.
  • Assistance can be found at You will have to create a separate username and password to access this site. There are overview videos as well as screen shot explanations.
  • For additional instructions, please see the Cayuse PowerPoint Instructions and Cayuse Instructions documents available in espace IRB Forms and Templates Library.
CITI Training Requirements
  • Completion of CITI training is required for anyone conducting human subjects research.
  • A CITI equivalent training may be accepted; however, this is decided on case by case basis. A detailed course completion report should be submitted.
  • CITI training is valid for 3 years. Please note that CITI training must be valid for a period of 30 days or more from the date of submission to be accepted.
  • Researchers need to complete the Faculty or Student and Faculty Advisor Course in Human Subjects Research.
  • Valid CITI training Completion Report will automatically link in your Cayuse study for all added personnel that completed CITI using their email address. Any Non – OU personnel must have CITI training Completion Report attached in the Cayuse submission.

Directions to complete CITI for first time users

  • Log onto CITI
  • If you don’t have an account, please register as a new user and affiliate yourself with Oakland University.
  • On the main page, click on View Courses.
  • Then click on Learner Tools.
  • Click on Add a Course.
  • Under Question 1- OU Human Subject Research, select one of the following: Faculty, Student and Faculty Advisor or IRB Member.
  • Under Question 2- Optional Modules, click on modules applicable to your research (see below). If none of these categories apply to your research, do not check any boxes.
  • Click No or Not at this time for the rest of the questions, unless special circumstances apply, otherwise you may be assigned courses from other university committees.
  • Click on Submit and the next screen will allow to access the Human Subject Research (Faculty, Student and Faculty Advisor or IRB Member) Basic/Refresher Course.
  • Click on the course and start completing the modules.

Optional Modules (must be completed if applicable)

If the research involves any of the following (Question #2 on the CITI training site):

  • Avoiding Group Harms – US Perspectives
  • FERPA for Researchers
  • International Research
  • Research with Children
  • Research Involving Prisoners
  • Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates
  • Research and HIPAA Privacy Protections

Additional Course (must be completed if applicable)

  • If the researcher has a conflict of interest (Question # 6 on the CITI training site) complete the Conflicts of Interest course

Directions to complete CITI for returning users who have expired CITI

  • Log onto CITI
  • On the main page, click on View Courses.
  • Scroll down to the section "Completed Courses"
  • To re-take an expired course, click on Review Course. The required and optional modules will be listed.
  • Select Review or Start to reload the module. This will allow you to review the module and take the quiz.
Tips Before You Submit For IRB Review
  • Oakland University uses an online IRB submission system called Cayuse. Researchers will access this site using their NetID and password. You must have internet access to complete your submission.
  • Benefit from the training site You will have to create a separate username and password to access this site. There are overview videos as well as screen shot explanations on how to submit your online application.
  • Ensure that all of your key personnel are registered users in Cayuse.
  • Download the recent versions of any necessary forms (consent, information sheet, assent etc.) from espace, OU IRB Forms and Templates Library.
  • Use the “suggested language” on the consent form template.
  • Include other items given to subjects such as recruitment materials and data collection tools.
  • For Student Principal Investigators: Upon completion of your Cayuse submission, the study will automatically be routed to your faculty sponsor for approval. Follow up with your faculty sponsor.
  • All projects will be automatically sent to your department chairperson or your school dean. If the department chair or school dean is also a researcher, he/she needs to change his/her role in Cayuse from Researcher to Org Approver by clicking on the Role box on the top right of the screen. The IRB will not review a project until it has obtained these electronic certifications. 
  • Allow ample time for the review process to take place.
After Submission and Review Timeline

After Project is submitted:

  • Pre-review by IRB staff for completeness
  • Check for other regulatory compliance i.e. Biosafety, Radiation Safety
  • If not exempt, the project is assigned to IRB member(s)
  • During the submission process, the IRB staff may send communication to the PI in the form letters notifying the principal investigator (PI) of status changes, approvals, and needed information. Letters are sent via email and are available to download directly from Submission Details in Cayuse IRB.
  • The submission may be returned to the PI to make required changes before approval is issued.

Review Timeline:

  • Exempt determination 1 day to 3 weeks
  • Expedited Review:
    • IRB member is given 10 business days to complete a review.
    • May be approved within 2 to 4 weeks.
  • Full Board Review
    • The primary reviewer is given 10 business days for a preliminary review.
    • You may be asked to attend the meeting if needed.
    • IRB meets monthly on the last Thursday of the month.
    • May be approved within 1-2 months, this depends on the complexity of the project.

NOTE: Timely approval depends on the complexity of the project and on the collaborative efforts between the PI and IRB

Approved Research and Additional Reviews

After IRB approval, investigators must comply with the following requirements:

  • Conduct the research as described in the approved or exempted application. 
  • Obtain approval prior to implementation of any changes in approved research by submitting a Modifications (Amendment) to the IRB.  No proposed changes may be implemented prior to IRB approval.
  • Obtain continuing review approval if required by submitting a Renewal (Continuing Review) Application prior to the expiration date of the study.
  • If the research is completed or not continuing, submit a Study Closure Form prior to the expiration date of the study.
  • Report any unanticipated problems and noncompliance to the IRB within 5 working days of becoming aware of the problem by submitting an Incident Report (Event Reporting)
  • For instructions in submitting subsequent submissions to an approved initial project, please see Cayuse PowerPoint Instructions and Cayuse Instructions document available in espace, OU IRB Forms and Templates Library and visit Cayuse Help Center.
  • Research projects may be subject to intramural or external inspection or audit.
Do I Need to Apply?

Researchers who need help in determining if their proposed activities constitute "human subject research" that require a review by the IRB should check the Not Human Subject Research Determination Guidance document available in the IRB Forms and Templates Library in the Oakland University espace at

Researchers not conducting "human subjects" research are encouraged to complete the Not Human Subjects Research application in the online system to get a determination letter from the IRB. The letter may be needed for publication purposes.

Free Use of Qualtrics for Internet Research

The use of Qualtrics for internet research is strongly recommended as the University Technology Services (UTS) currently maintains an agreement with Qualtrics. This survey service is free for Oakland University (OU) researchers.

To use Qualtrics at OU, researchers need to do the following: 

1) Log into:

2) Login using your existing OU NETID and password

3) Create surveys!

Qualtrics provides the following protections:

  • All Qualtrics accounts are password protected.
  • Data collected in the United States are stored in the United States.
  • Data backups are performed nightly.
  • Data are owned and controlled by the researcher.
Permission to Conduct Research

Research on Oakland University Campus

Oakland University (OU) researchers need to obtain permission letters if they are conducting human subject research that involves recruitment of participants or data collection with participants in the following locations:

  • Research in any OU building or classroom to which the researcher(s) does not ordinarily have access, or
  • Research in OU common areas (e.g., Oakland Center, Library, Student Housing)

The permission letter should be obtained from appropriate administrative personnel (e.g., Director of Oakland Center, Library Administrator, Director of Student Housing) before the research can be initiated.  Researchers are reminded to keep copies of the all permission letters for their records. The IRB does not collect these letters.

Research Credentials Badge

OU student researchers should check with the administrators at the OU research site to determine if a Research Credentials Badge is needed.  If needed, the Research Credentials Badge can be obtained from the IRB Office when a permission letter from the research site is provided.  The Research Credentials Badge should be worn at all times when recruiting or collecting data in Oakland University buildings.  Upon research completion, the badges should be returned to the IRB Office.

Non-Oakland University Researchers Using Oakland University as a Research Site

Non-Oakland University researchers who wish to use Oakland University as a research site or enroll Oakland University students, faculty or staff in their research must do the following:

  • Obtain IRB approval from their institution
  • Email copies of the IRB approval or exemption letter and IRB approved documents (e.g., research proposal, consent form, recruitment materials, and data collection tools, HIPAA waiver/authorization, etc.) to the Oakland University IRB Manager, Dr. Judette Haddad, at [email protected]
  • Upon administrative review, permission to conduct IRB approved research at Oakland University will be emailed to the researchers.
Online System
(Cayuse IRB)

The IRB online system, Cayuse:

  • All projects must be submitted in Cayuse You must use your OU Net ID to login.
  • If you attempt to login and get an error message, it may be because your name is not in Cayuse. Please contact the IRB Staff (see below) to add your name to Cayuse.
  • IRBNet is closed. IRBNet active projects are available in Cayuse under the subheading “Submission Type” as “Legacy.” These projects retain their IRBNet numbers and titles. If you are not able to find your “Legacy” project, contact the IRB Staff.
  • For training in using Cayuse, please benefit from the following:
Definitions and Determinations

Research must meet the Department of Health and Human Services (HHS) definition of both “research” and “human subject” or the Federal and Drug Administration (FDA) definition of “clinical investigation” to come under the purview of the IRB.

  • Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. 
  • Human Subject means a living individual about whom an investigator conducting research:
    • obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
    • obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens. 
  • Private Information:
    • Information about behavior that occurs in a setting in which an individual can reasonably expect that no observation or recording is taking place
    • Information that has been provided for specific purposes, other than research, where the individual can reasonably expect that it will not be made public (e.g., medical records, student records)
  • Clinical Investigation means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA...or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. 

All research studies meeting the definition of human subjects research MUST be submitted to and approved by the IRB BEFORE the research is initiated.

Human Subject Research Requiring OU IRB Review

  • The research is sponsored by Oakland University (OU) regardless of the location of the project
  • The research is conducted by, or under the direction of, any faculty, student, or other agent of OU
  • OU is “engaged” in the research (collaborative human subject research project)
  • The research involves the use of OU’s non-public information to contact human research subjects or prospective subjects
  • OU is the main recipient of a federal grant that involves human subject research

An IRB Regulations and Procedures Presentation in PowerPoint is available in the IRB Forms and Templates Library in the Oakland University espace at

Not Research and Not Human Subjects Research Determinations

Not all research conducted at OU must be reviewed by the IRB. Researchers are highly encouraged to consult with IRB staff regarding "Not Research" or "Not Human Subjects Research" determinations. Researchers seeking an IRB determination letter must submit a "Not Human Subjects Research Determination" application as an "Initial" application in the online system, Cayuse IRB.

For additional information, a Not Human Subject Research Determination Guidance document and a Defining Human Subjects Research Powerpoint presentation are available in the IRB Forms and Templates Library in the Oakland University espace at

IRB Review Types

Based on the type of research activities and the level of risk to participants, studies may be reviewed by the IRB under the following categories:

  • Exempt
  • Expedited (Minimal Risk)
  • Full board Review (More than minimal risk)

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Exempt Review

  • Studies that present no more than minimal risk to the participants and do not compromise the privacy of the participants or confidentiality of the data
  • Fits certain regulatory exemption categories (listed in the Application)
  • Reviewed by IRB Staff and/or IRB members
  • Common in research that involves the use of surveys, interviews, focus groups, educational tests, observations of public behavior, etc.
  • Oakland University requires providing research participants with an Information Sheet.

Expedited Review

  • Studies that present no more than minimal risk to the participants, and for minor changes in approved research
  • Has to fit 1 of 7 categories
  • Reviewed and approved by 1 or 2 IRB members
  • Common in research that involves the collection and analysis of audio/visual/digital data, and/or research with children including behavioral research, surveys, interviews, focus groups, etc.

Full Board Review

  • Studies that present more than minimal risk to participants or do not fit under any of the Expedited categories
  • Reviewed by the full board at a convened meeting scheduled for the last Thursday of each month
  • Applications are first reviewed by primary and secondary reviewers
  • Researcher may be invited to present the research
  • At the meeting, recommendations are made and vote is taken

All applications are completed through Cayuse. IRB reviews and determinations are communicated to researchers through Cayuse.

Informed Consent Process

Informed consent is a process and not just a form. It includes:

  • Recruitment materials
  • Verbal instructions (in person or via video, DVD)
  • Written materials
  • Q & A session(s)
  • Documentation of consent by signature

The informed consent document must be:

  • Informative: participants must understand the nature of the research, purpose, procedures, risks and benefits to make an informed decision
  • Emphasize voluntary participation: free of coercion, undue influence, or exculpatory language
  • Comprehensive: well organized, written in lay language appropriate for subject
  • Inclusive of all the applicable required regulatory basic elements and additional elements

IRB Consent Document Templates (i.e., Adult Informed Consent, Child Assent, Parental Permission, and Information Sheet) are available in our espace, OU IRB Forms and Templates Library. Researchers are highly encouraged to use these templates to facilitate the review process. Most current version should be downloaded from espace

Researchers must note the following:

  • The IRB approved date-stamped consent documents MUST be used in consenting participants. 
  • Researchers need to download and save it for their records. 
  • Researchers must allow participants ample time for consideration and opportunities for questions
  • Signed consent documents must be kept with the research records for three years after the completion of the study. An additional copy of the consent form should be given to participants.
  • For exempt research, OU IRB requires providing participants with an Information Sheet.  Information Sheets are not collected by researchers.
  • A waiver or alteration of consent and/or a waiver of documentation of consent can be granted by the IRB for no more than minimal risk projects if the research meets certain regulatory criteria.
Revised Regulations: 2018 Requirements - Final Rule

Federal regulations related to human subject research changed on January 21, 2019.
The revised regulations, also referred to as the “2018 Requirements – Final Rule” strengthen protections of research participants and reduces administrative burdens for researchers, IRB members and administrators.

Please note the following:

  • Projects approved prior to 1/21/2019 remain under the “Pre-2018 Requirements - Old Rule”.
  • On-going Expedited/Full Board projects will be evaluated for transition to the revised regulations on a project by project basis at the time of continuing review.

Summary of Most Relevant Key Changes:

  • Exempt research is expanded to allow for a) collection of identifiable, possibly sensitive information or biospecimens, b) limited benign behavioral intervention using adults, and c) secondary research using both existing and prospective information, records, or biospecimens. New exempt criteria may require limited IRB review to ensure adequate provisions to protect the privacy of participants and the confidentiality of data.
  • Expedited review is simplified to eliminate continuing review.
  • Informed Consent is changed to include a required summary of key information at the beginning and a statement regarding possible future use of research data. Also, additional requirements are added regarding clinical and/or biospecimens research when applicable.
  • Screening, recruiting, or determining eligibility of prospective participants can be done, under IRB review, without informed consent if it meets certain conditions.
  • For waiving, altering or documenting consent, additional conditions are added.
  • For federally funded clinical trials, a requirement for posting of an IRB-approved consent form used in the study is added.
  • IRB grant review requirement is eliminated.

Detailed documents regarding the Final Rule changes are available in the IRB Forms and Templates Library in the Oakland University espace at


For Oakland University IRB guidance on important topics related to human subjects research, visit the Guidance section in the IRB Forms and Templates Library in espace at

HIPAA and the Use of Protected Health Information (PHI) in Research

Researchers using or collecting PHI from medical records or databases in their research must comply with the additional regulations in Standards for Privacy of Individually Identifiable Health Information. The Health Information Portability and Accountability Act (HIPAA) includes additional provisions for protecting the privacy and security for storage and transmission of PHI.  PHI includes 18 patient identifiers that are considered individually identifiable. 

In accordance with 45 CFR 160.103, individually identifiable health information is information that is a subset of health information, including demographic information collected from an individual, and:

(1) Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and

(2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and

(i) That identifies the individual; or

(ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual.

Covered entities are health plans, healthcare clearinghouses, and health care providers that transmit health information in electronic form related to billing any payment for services or insurance coverage for treatment, payment and healthcare operations.

Researchers may use and/or disclose PHI from a covered entity as part of a research study provided one of the following conditions is met:

  • The researcher obtains an individual’s written permission or authorization to use and/or disclose the individual’s PHI for research purposes.
  • Individual research authorization is not required because one of the following conditions applies:
    • De-identified PHI - The health information has been de-identified. De-identified health information, as described in the HIPAA Privacy Rule, is not PHI, and thus is not protected by the Privacy Rule. Health Information is considered de-identified if the set of 18 specific direct and indirect identifiers defined under the Privacy Rule have been removed. Note that data may be de-identified under the HIPAA Privacy Rule, but may still fall under the human subjects research regulations at 45 CFR 46.
    • Research on Decedents’ Information – A decedent’s PHI may be used for research if the covered entity providing the PHI obtains the following from the researcher: (1) oral or written representations that the use and disclosure is sought solely for research on the PHI of decedents; (2) oral or written representations that the PHI for which use or disclosure is sought is necessary for the research purposes; and (3) documentation, if the covered entity requires it of the death of the individuals whose PHI is sought by the researchers.
    • Reviews Preparatory to Research – Covered entities may use or disclose PHI to a researcher for activities involved in preparing for research, such as identifying prospective research participants for purposes of seeking their authorization to use or disclose PHI for a research study. The covered entity must obtain the following representations from the researcher: (1) the use or disclosure is requested solely to review PHI as necessary to prepare a research protocol or for similar purposes preparatory to research; (2) the PHI will not be removed from the covered entity in the course of review; and (3) the PHI for which use or access is requested is necessary for the research. 
    • Limited Data Set and Data Use Agreement - A limited data set may be used or disclosed for research if the researcher enters into a data use agreement with the covered entity. A limited data set refers to PHI that excludes the 16 identifiers that directly identify an individual, but may include the indirect identifiers of city, state, zip code, any elements of dates such as birth date, dates of service, dates of discharge, etc., and other numbers or codes not listed as direct identifiers. 
    • Waiver or Alteration of Authorization - The researcher has obtained a waiver or alteration of authorization from an IRB or Privacy Board to use and/or disclose an individual’s PHI. An alteration of an authorization may include removing required elements or statements from the authorization.  A waiver of authorization permits use and disclosure of PHI without an individual’s authorization.  In order to grant a waiver or alteration of authorization, an IRB or Privacy Board must determine the following criteria are satisfied:

1) The use or disclosure of the PHI involves no more than minimal risk to the privacy of individuals based on at least the presence of the following elements:

  1. a) an adequate plan to protect health information identifiers from improper use and disclosure;
  2. b) an adequate plan to destroy identifiers at the earliest opportunity consistent with the conduct of the research (absent a health or research justification for returning them or a legal requirement to do so);
  3. c) adequate written assurances that the PHI will not be reused or disclosed to (shared with) any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of the PHI would be permitted under the Privacy Rule;

2) the research could not practicably be conducted without the waiver or alteration; and

3) the research could not practicably be conducted without access to and use of the PHI.

Instructions to Researchers:

  • Complete the additional CITI training module- Research and HIPAA Privacy Protection
  • Submit the completed application in Cayuse 
  • NOTE: No PHI can be brought to OU campus or stored on OU computers
FERPA and the Use of Educational Records in Research

For research involving the use of student educational records, the Family Educational Rights and Privacy Act of 1974 (FERPA) provides additional protections that must be followed. 

Consent Requirements for Using Education Records in Research

The Family Educational Rights and Privacy Act (“FERPA”), and Oakland University’s FERPA policy, generally prohibit the disclosure of personally identifiable information from a student’s education records without the student’s prior written consent. 

  • Education Records: “Education records” include all records directly related to a student that are maintained by the University or someone acting for the University. Examples include, without limitation, grades, course projects and assignments, journals, quizzes, exams, papers, enrollment information, e-mails or other correspondence to, from or about students, disciplinary records, advising notes and files and electronic information recorded or maintained in any form, format (e.g., Banner, Empower, Oasis, Moodle or any other electronic information system) or location (e.g., on-campus, off campus or in the “cloud”).
  • Student Consent: Researchers must obtain a student’s consent before requesting, accessing or using personally identifiable information from the student’s education record for research purposes. Consent is required even if the researcher might have access to the same information in another capacity. For example, a faculty member who has access to the grades, course assignments, journals, exams and projects for students in his or her course cannot use that information or those records for research purposes without student consent.
  • Consent Forms: Researchers should use the Informed Consent form provided by the IRB, and follow the FERPA instructions in the form for all research involving personally identifiable information from education records. Alternatively, a University FERPA consent form is available on the Office of the Dean of Students
  • Consent Not Possible: If it is not possible to obtain a student’s prior written consent, the IRB may be able to help researchers obtain de-identified information from student records that can be used for their research. Researchers will not be permitted to personally de-identify information from education records that they will be using for their own research.
  • Relevant exceptions to the general rule:
    • Legitimate education interests – disclosure to school officials, including professors, if they have a legitimate education interest. This exception does not include research.
    • Directory information – disclosure to researchers in response to a request for directory information, unless the student has selected not to allow disclosure of directory information. Need to check with the Office of the Registrar.

Other Educational Institutions: Researchers seeking to use personally identifiable information from the education records of students at other educational institutions must comply with the FERPA policies of those institutions. 

Instructions to Researchers

Researchers intending on using educational records in their research must do the following:

  • Obtain consent whenever practicable.

NOTE: If you anticipate the use of educational records in future research and you do not have current IRB approval, you can obtain student consent by using the FERPA Form available on the Office of the Dean of Students webpage.

  • If consent is not practicable, de-identify the records. The records must be de-identified by a neutral third party who has access to the information as part of their legitimate job responsibilities.
    • Submit the completed De-identification of Student Education Records for Research by a Neutral Third Party in section 13.5 of Cayuse. This form is located in espace, OU IRB Forms and Templates Library.
  • Complete the additional CITI Training module- FERPA for Researchers
Additional Information:  Questions regarding the University’s FERPA policy, which can be found at, should be directed to the Office of the Dean of Students at (248) 370-3352.
European Countries and General Data Protection Regulation (GDPR)

Researchers who will be collecting data from individuals who reside or are present in European countries at the time of research, need to contact IRB Staff to ensure compliance with consent under General Data Protection Regulation (GDPR).

Under GDPR,

  • Personal Data”’ means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person. 
  • Sensitive Data” are personal data that includes information about the following:
  • Racial or Ethnic Origin
  • Political opinions
  • Religious or philosophical beliefs
  • Trade union membership
  • Genetic/genomic data
  • Biometric data for the purpose of unique identification
  • Health data
  • Sexual beliefs, orientation
  • Processing personal data requires a freely given affirmative consent that describe all of the following:
  • Who is collecting the data?
  • What data is being collected?
  • Especially list if any of the “Sensitive Data” listed above is being collected.
  • Will the data be shared with any third parties?
  • How will the information be used?
  • How long will the data be stored for? (Researchers need to ensure that no member state has enacted additional protections or disclosures that must be made.)
  • What rights does the data subject have? (The subject’s rights to access, rectify, and erase personal data as well as the subject’s rights to restrict or object to processing personal data must be included.)
  • How can the data subject raise a complaint?
  • Request for consent must be presented clearly and in plain language.
  • Maintain a record regarding how and when consent was given.
  • If research is subject to another country or state’s privacy regulations, ensure that those are appropriately followed in the IRB protocol and conveyed in the consent form to subjects

In the design of the research project, researcher needs to consider the following regarding confidentiality of the personal data:

  • Consider lifetime of data processing
  • Retain data for shortest time period required
  • Limit processing of data to what is necessary
  • Limit accessibility of data to those requiring access
  • Pseudonymize (code) data whenever possible
  • Encrypt data where processing allows
  • When possible, de-identify data set so that it is no longer considered “personal data”

Considering the seriousness of penalty for noncompliance with this law (fine up to 4% of annual revenue or €20 Million for insufficient consent to process data), the consent form may need to be reviewed by OU Office of Legal Affairs to ensure compliance with GDPR. 

For additional information, contact Dr. Judette Haddad, IRB Manager, at (248) 370-4898 or [email protected]

Collaborative and International Research
Collaborative Research and IRB Reliance Agreements

Collaborative research occurs when two or more institutions are working together on a research project. The IRB review process can be streamlined by having one institution conduct the initial IRB review and the other institution(s) rely on the first institution for IRB oversight.

Institutions participating in collaborative human subject research may do the following:

  • Have independent review of the project if the research activities conducted at each institution are different
  • Enter into an IRB Reliance/Authorization Agreement to declare one of the institutional IRBs as the IRB of Record, or
  • Make similar arrangements for avoiding duplication of effort. 

When a collaborative research has been approved by another IRB, Oakland University researchers need to do the following:

  • If the research was determined to be exempt or approved under an expedited or full board review, researchers should create a New Study in the IRB online system, Cayuse. (See How to Apply, under Submission Requirements)
  • In the Initial Submission, researchers will have the choice to select the application based on the review type by the other IRB and complete the submission via Cayuse.
  • Copies of the IRB of Record exempt or approved application, decision letter (exempt or approval letter), consent form(s), HIPAA waiver/authorization, and other approved documents must also be submitted in Cayuse.

Please note that an OU IRB Authorization Agreement needs to be approved by the Office of Legal Affairs before the agreement is fully executed.

For additional information, contact Dr. Judette Haddad, IRB Manager, at (248) 370-4898 or [email protected]

International Research

Researchers conducting international research need to be able to describe to the IRB his/her qualifications for conducting research at the host country and how he/she will address any cultural, political, religious, or other local influences that may affect the conduct of the research. It is the responsibility of the researcher to follow all applicable policies of any outside institution.

Permission to conduct international research must be obtained from all research locations before the project is initiated. Researchers should keep copies of all permission letters for their files. The IRB does not collect permission letters. 

Consent for International Research

  • For non-English speaking participants, the IRB will approve the English version of the consent document(s) prior to translation. Then, the principal investigator will obtain translation(s) of the approved document(s). The IRB must receive translated versions of all consent documents (i.e., adult consent, child assent, parental permission, information sheet) as well as documentation of the translator’s qualifications (i.e., expertise in the foreign language, such as certified translator, native speaker or other evidence of fluency). If needed, the IRB may require a back translation or a certified translation of the consent form.
  • If personal data will be collected from European country citizens or residents who reside in a European country at the time of the research, the research may be subject to the General Data Protection Regulation (GDPR). Please see European Countries and General Data Protection Regulation (GDPR) under Additional Regulations and contact IRB staff for help.

Instructions to Researchers:

Researchers intending on conducting international research must do the following:

  • Complete the additional CITI Training module- International Research
  • Find out if local IRB, ethics committee or an equivalent board need to review the protocol and consent procedures.
  • Be familiar with the culture and traditions of the specific country

For guidance about conducting international research and additional information about what to include in the IRB application, please see the Guidance for International Research available in the IRB Forms and Templates Library under IRB Guidance in the Oakland University espace at

For a list of regulations, laws, and guidelines pertaining to international human subjects research for selected countries, see:  “International Compilation of Human Research Standards” (Office for Human Research Protections).

and FAQs

Frequently Asked Questions
Please review the frequently asked questions for additional information regarding human subject research.

Contact Information

IRB Staff

For further inquiries, please contact (email preferred):

Judette Haddad, Ph.D., C.I.P.
Regulatory Compliance Officer/IRB Manager
[email protected]
(248) 370-4898

Tara Baird, M.S.
Regulatory Compliance Specialist
(248) 370-4306

Complaints and Appeals

For reporting a complaint about a research project or a suspected case of noncompliance to the IRB staff, please follow the instructions in the Reporting Research Complaint or Suspected Noncompliance Form available under the IRB General Information and Forms section in the IRB Forms and Templates Library in espace at

For appealing an IRB decision, please follow the instructions in the Appeal IRB Decision Form available under the IRB General Information and Forms section in the IRB Forms and Templates Library in espace at

IRB Members

IRB Regular Members
Victoria Lucia, Ph.D., Chair.
Kanako Taku, Ph.D., Vice Chair
Maria Beam, Ph.D.
Elise Brown, Ph.D.
John Karazim, M.D.
Zorica Kauric-Klein, Ph.D. R.N.
Julie Kruse, Ph.D. R.N.
Ji-Eun Lee, Ph.D.
Mary Lewis Ph.D.
Amanda Lynch, Ph.D., R.D.
Tracy Macpherson M.L.I.S.
Charles Marks, Ph.D.
Jean Szura, Ph.D.

IRB Alternate Members
Laurence Allen
Doreen E. Olko, M.L.A.
Michele Parkhill Purdie, Ph.D.

Expedited Reviewer
Judette Haddad, Ph.D., C.I.P.

and Meetings

IRB Training

The following PowerPoint training presentations are available under IRB General Information and Forms section in the IRB Forms and Templates Library in the Oakland University espace at

  • Instructions in Using Cayuse (Step-by-step instructions for IRB submissions in Cayuse)
  • IRB Regulations and Procedures (Human subjects research determination and review types)

If you wish to schedule a training for your class/department/school, please contact Judette Haddad, IRB Manager, at [email protected] 

For a list of monthly training sessions and sign up form, click on the following link:

IRB Training Sessions

Required CITI Training in Human Subject Research

To view information about required CITI Training, click on the tab "Submission Requirements" and then open the "CITI Training Requirements" section 

Optional Human Research Protection Training

This does not replace the required CITI training. If you wish to learn more about human research protections, the Office for Human Research Protections (OHRP) has launched the Human Research Protection Training to provide the broad research community including IRBs, researchers, and research participants with foundational knowledge on protecting human subjects. The OHRP training is free can be found at

IRB Full Board Meeting Schedule

January 25
February 22
March 28
April 25
May 23
June 20
July 25
August 29
September 26
October 24
November 21
December 12


Resuming In-Person Human Subjects Research Procedures

Updated September 13, 2022

All in-person interactions with research participants must follow the Oakland University (OU) current COVID-19 requirements and, where applicable, follow any research site requirements including facility (e.g., school, hospital, clinic, etc.) and city, county, state, or country requirements.

  • The Principal Investigator (PI) remains responsible for implementing and monitoring changes to COVID-19 control strategies to avoid increased risk to participants and assuring that the research team has appropriate staffing, resources, and training to support in-person interactions with research participants.
  • When possible, researchers should consider use of remote technology instead of in-person interactions, especially in areas of high COVID-19 transmission.
  • If the in-person interactions cannot be done remotely, researchers should consider whether it may be appropriate to delay or pause in person interactions with human participants, especially in areas of high COVID-19 transmission and where there is no direct benefit to the participants.
  • When in-person human research is conducted outside of OU, a permission letter from the research site where the in-person interaction will occur is required before IRB approval is issued.
  • International research must follow the COVID-19 requirements at the international site.
  • Visit the COVID-19 Campus Information website for current OU COVID-19 requirements.

For questions regarding the resumption of in-person research, please contact Dr. Judette Haddad, IRB Manager, at [email protected]