The Research Office

Wilson Hall
371 Wilson Boulevard
Rochester, Michigan 48309-4486
(location map)
(248) 370-2762
(248) 370-4111
research@oakland.edu

Woman at laptop

IRB

Institutional Review Board (IRB)
Commitment to the Highest Ethical Standards in Human Subjects Research

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
  • IRB Registration #: 00000087
Regulations
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 projects 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

Not Research and Not Human Subjects Research Determinations

Not all research conducted at OU must be reviewed by the IRB. Not research or not human subjects research determinations are done by IRB staff. Researchers seeking IRB determination letter need to submit a completed Not Human Subjects Research Determination Form in IRBNet as a new project for IRB staff to review. The form is available in the Forms and Templates library in IRBNet. The form details the activities that are not under the purview of the IRB.


IRB Review Types

Based on the type of research activities and the level of risk to participants, projects 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

  • Projects 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 Exempt 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

  • Projects 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

  • Projects 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, forms and templates are located in the Forms and Templates library in the online system, IRBNet.  IRB reviews and determinations are communicated to researchers through IRBNet.

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 the IRBNet Forms and Templates library. Researchers are highly encouraged to use the template to facilitate the review process. Most current version should be downloaded from IRBNet. 

Researchers must note the following:

  • The IRB approved date-stamped consent documents MUST be used in consenting participants. They are published as Board Documents under Reviews in IRBNet.  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. If a waiver is requested, Appendix D- Waiver or Alteration of Consent and/or Appendix E- Waiver of Documentation of Consent must be completed and submitted along with other documents in the IRBNet submission package.

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.

New Forms labeled Final Rule MUST be downloaded from the Forms and Templates library in the online application submission system, IRBNet.org.

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.
  • New Exempt and new Expedited/Full Board projects must be submitted using the Final Rule version applications available in the Forms and Template library of IRBNet.  
  • To facilitate IRB review, researchers may use the Template Consent Documents and Research Recruitment/Advertisement available in IRBNet Forms and Template library.

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.

Click here for a Detailed Summary of 2018 Requirements – Final Rule Key Changes

Click Here for Detailed Final Rule Exempt Research Changes and Limited IRB Review

Submission
Requirements
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 Forms and Templates library in IRBNet.  The
    signed form and supporting documents need to be emailed to Dr. Judette Haddad, IRB Manager, at haddad@oakland.edu for approval. A copy of the approved Special Permission Form must be
    included with the project submission in IRBNet.

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:

  • Register as a user in IRBNet.org to submit to the IRB.
  • All IRB documents i.e., applications, forms, appendices and templates are located in the Forms and Templates library of IRBNet. Relevant applications, forms and templates must be downloaded, completed and submitted through IRBNet.
  • The most current version of IRB documents must be used by downloading them from IRBNet and all sections must be completed.
  • Click on “Create a New Project” in IRBNet in order to submit your documents for IRB review.
  • For additional help, see the IRBNet Training Videos and Presentations that are available by using the following login information:
    • Username: Oakland     
    • Password:  training

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 must be included in the submission in IRBNet for all researchers listed on the project including the faculty advisors/sponsors. 

Directions to complete CITI:                                                                            

  • Log onto CITI
  • If you don’t have an account, please register as a new user and affiliate yourself with Oakland University
  • In the main page, click on Learner Tools
  • Click on Add a Course
  • Under Question 1- Learner Group, click on 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)
  • 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
  • Internet Based Research
  • Research with Children
  • Research with 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

TIPS Before You Submit For IRB Review
  • Register as a user in IRBNet.org
  • Benefit from the training site:
  • Download the recent versions of the forms from IRBNet.org in the Forms and Templates library and save onto your computer.
  • Complete the forms and use spellcheck in all the major sections of the application (Abstract, Procedures, etc.).
  • Use the “suggested language” on the consent form template.
  • Include other items given to subjects such as recruitment materials and data collection tools.
  • Provide any appendices referenced in the application.
  • Include CITI training certifications for all personnel.
  • If a conflict of interest exists, include Conflict of Interest Form.
  • Share the submission in IRBNet with the research team.
  • Students must obtain their faculty sponsors approval before submission
  • Ensure all required signatures are in place on applications and in IRBNet submission package.
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)
  • Request for modifications, conditional approval, or approval letters are published as Board Documents under Reviews in IRBNet.
  • IRBNet submission package may be unlocked for the principal investigator (PI) to make required changes before approval is issued. 

NOTE: Subsequent submissions (Amendment, Event Report, Continuing Review, and Closure) are submitted in “New Packages” in the same IRBNet project. Do NOT “CREATE A NEW PROJECT”.

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 an Amendment Form to the IRB.  No proposed changes may be implemented prior to IRB approval.
  • Obtain continuing review approval if required by submitting a Continuing Review Application prior to the expiration date of the study.
  • If the research is completed or not continuing, submit a Study Completion/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 Event Reporting Form

All applications, forms and templates are available in the Forms and Templates library of the online system, IRBNet. Make sure to DOWNLOAD THE CURRENT VERSION.

Research projects may be subject to intramural or external inspection or audit.


Rapid Review of Exempt Applications

Exempt application submissions are eligible for an in-office Rapid Review by the IRB staff.  The purpose of the Rapid Review is to make an Exempt Determination while meeting in with a member of the IRB staff. 

  • All the requirements that apply for a regular exempt submission also apply for the Rapid Review process.
  • Researchers must follow the instructions on the application cover page and throughout the application.
  • The Rapid Review is not possible if the application is incomplete or missing required documentation.
  • An exempt determination is not guaranteed and approval is not possible if the project is not exempt under the regulations.

Directions:

  • Submit the completed Exempt Application and all required documents in IRBNet
  • Submit the completed Rapid Review- Researcher Checklist for Exempt (NOTE: The project will not be eligible for an in-office Rapid Review if the checklist is missing from the submission.)
  • Indicate "Rapid Review" in the "Comment" Box in the submission package in IRBNet.
  • Documents must be submitted in IRBNet at least 2 business days in advance of the in-office appointment.
  • IRB staff will prioritize the submission and contact the researcher via e-mail to schedule the in-office appointment, if necessary. Well written applications may be exempted without a meeting.
  • If a meeting is needed, the Principal Investigator must attend all appointments. Faculty advisors, if applicable, may also attend the meeting.
  • It is highly recommended that researchers bring a laptop with internet access to their in-office appointment, as well as electronic copies of all draft documents requiring review.

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: oakland.qualtrics.com

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 institutions
  • 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 haddad@oakland.edu
  • Upon administrative review, a permission to conduct IRB approved research at Oakland University will be emailed to the researchers.

 

Additional
Regulations
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 Protections
  • Submit the completed Appendix K- HIPAA Summary/Waiver of Authorization along with other documents in IRBNet. 
  • 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 at https://www.oakland.edu/Assets/upload/docs/Dean-of-Students/consent.pdf

  • 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 Appendix M- De-identification of Student Records along with the other required documents in IRBNet submission package
  • Complete the additional CITI Training module- FERPA for Researchers
Additional Information:  Questions regarding the University’s FERPA policy, which can be found at www.oakland.edu/policies/generalgovernance/470/, 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 haddad@oakland.edu

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 the 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, researchers need to do the following:

  • If the research was determined to be exempt, the Report of Exempt Determination – Collaborative Research form is available in Forms and Templates library in IRBNet. This needs to be submitted in IRBNet as a new project.
  • If the research was approved under an expedited or full board review, the IRB Reliance Agreement Form – Collaborative Research is available in the Forms and Templates library in IRBNet. This needs to be submitted in IRBNet as a new project.
  • Copies of the IRB of Record exempt or approved application, decision letter (exempt or approval letter), consent form, HIPAA waiver/authorization, and other approved documents must also be submitted in IRBNet.

Please note that OU IRB Authorization Agreement need 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 haddad@oakland.edu


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) 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
  • Submit the completed Appendix B- International Research along with other documents in the IRBNet submission package.
  • 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 a list of regulations, laws, and guidelines pertaining to international human subjects research for selected countries, see:  “2017 International Compilation of Human Research Standards” (Office for Human Research Protections).


 

Contact and FAQs

FAQ

Please review the frequently asked questions document for additional information regarding human subject research.

IRB TRAINING SESSIONS

For a list of monthly training sessions for Fall 2019 Semester and sign up form, click on the following link: https://forms.gle/d2AeptoviegwBsDq9

CONTACT INFORMATION

For further inquiries, please contact IRB staff (email preferred)

Judette Haddad, Ph.D., C.I.P.
Regulatory Compliance Officer/IRB Manager

haddad@oakland.edu
(248) 370-4898

Kate Wydeven, M.S.
Regulatory Compliance Specialist

kwydeven@oakland.edu
(248) 370-4306

IRB Members

IRB Regular Members

IRB Alternate Members

Victoria Lucia, Ph.D., Chair.

Stephanie Crockett, Ph.D., Vice Chair

Maria Beam, M.S.W.
Elise Brown, Ph.D.
Tomas Giberson, Ph.D.
John Karazim, M.D.
Zorica Kauric-Klein, Ph.D. R.N.
Julie Kruse, Ph.D. R.N.
Ji-Eun Lee, Ph.D.
Amanda Lynch, Ph.D., R.D.
Tracy Macpherson M.L.I.S.
Jean Szura, Ph.D.
Kanako Taku, Ph.D.

Elizabeth (Betsy) Allan, Ph.D.
Laurence Allen
Mary Lewis, Ph.D.
Doreen E. Olko, M.L.A.
Allen Silbergleit, M.D., Ph.D

Expedited Reviewer:

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

IRB FULL BOARD MEETING SCHEDULE

2019:

  • September 26
  • October 31
  • November 21
  • December 12

 

2020:

  • January 30
  • February 20
  • March 26
  • April 30
  • May 21
  • June 25
  • July 30
  • August 27
  • September 24
  • October 29
  • November 19
  • December 10