IRB Help | Office of Research Compliance | Kent State University

IRB Help, Processes, and Approval Timelines

The following resources contain information on KSU Policies, Common Mistakes and Questions, the IRB Process and more. We encourage you to review these resources to learn more about human subjects protections, processes, and approval timelines. If you need help don't ever hesitate to contact us at researchcompliance@kent.edu or call 330-672-2704. 

Kent State University FAQs and Policies:

Consent
  • What types of informed consent exist?
    • Investigators can seek signed informed consent, a waiver of signed consent, and waive or alter elements of informed consent.Only under certain circumstances may the IRB approve a request to waive signed consent or waive or alter the elements of informed consent. Requests must be made by the PI through the IRB application (Section 8) and supported by submitting Appendix M1 or M2.
  • Are there any additional consent requirements when working with children?
    • Yes. Generally, prior to consenting/assenting anyone under the age of 18 into a research project, investigators must seek the permission of the child’s parents/guardians through the use of a parental consent form. Assent is required of children age 12 years and younger in additional to parental permission. Assent is a child’s affirmative agreement to participate in research. Informed consent is required for children aged 13 to 18 and is required in additional to parental permissions. Please be aware that you must be in compliance with Kent State University  Policy 5-19, University Policy Regarding On-Campus Activities Involving Minors.

 

Research that Involves access to Protected Health Information (PHI)
  • What is PHI?
    • PHI is individually identifiable health information held or transmitted by a covered entity or its business associates, in any form or media, whether electronic, paper, or oral. More information can be found on the Health and Human Services website.
  • What is the Health Insurance Portability and Accountability Act (HIPAA)?
    • HIPAA has three components, all of which are enforced by the federal Office for Civil Rights:
      • HIPAA Privacy Rule: protects the privacy of individual identifiable health information.
      • HIPAA Breach Notification Rule: requires covered entities and business associates to provide notification following a breach of unsecured PHI.
      • HIPAA Security Rule: sets standards for the security of electronic PHI.
  • How do I know if I am affected by the HIPAA privacy rule?
    • The HIPAA privacy rule affects research and researchers when:
      • Research requires access to and/or use of PHI that is created or maintained by covered entities, or
      • A covered entity component of KSU performs research that creates or generates PHI.
  • What should I do if my research involves access to PHI?
Research Involving Children
  • What are the consent requirements for working with children?
    • Generally, prior to consenting/assenting anyone under the age of 18 into a research project, investigators must seek the permission of the child’s parents/guardians through the use of a parental consent form. Assent is required of children age 12 years and younger in additional to parental permission. Assent is a child’s affirmative agreement to participate in research. Informed consent is required for children aged 13 to 18 and is required in additional to parental permissions.
  • Are there any other University policies I need to be aware when working with minors?
  • What special protections for Children as Research Subjects are required?
  • What are the consent requirements for working with children?
    • Generally, prior to consenting/assenting anyone under the age of 18 into a research project, investigators must seek the permission of the child’s parents/guardians through the use of a parental consent form. Assent is required of children age 12 years and younger in additional to parental permission. Assent is a child’s affirmative agreement to participate in research. Informed consent is required for children aged 13 to 18 and is required in addition to parental consent.
  • Do I need a letter of support to recruit children from schools?
    • Yes. If you plan to recruit children form a school (inclusive of high school, middle school, elementary and pre-k schools) your submission must be accompanied by an acceptance letter from the school’s principal or superintendent. If it is not practical to obtain an acceptance letter prior to approval please notify the reviewer/Office of Research Compliance.
  • Do any of the exemption categories apply to research on children?
    • Yes. All elements of Category 1, 3, 4, and 5 apply to children. Category 2 research (educational tests, surveys, interviews, public behavior observation) applies only when procedures are limited to the observation of public behavior in which the investigators do not interact with the children. Research involving surveys or interviews with children, or observation of public behavior when investigators interact with children, does not qualify for exempt status under this category.
  • Does the Children's Online Privacy Protection Act (COPPA) apply to research? 

 

Recruitment
  • What must be included in research advertisements?
    • The IRB must approval all recruitment plans and advertisements prior to use. Please see our forms page for additional guidance and templates. In general, research advertisements must include,
      • Name of PI and contact information and institution
      • Title and purpose of the project and disclosure that project is for research
      • Inclusion/exclusion criteria in summary form
      • Brief listing or summary of procedures,
      • Time commitment
      • Potential compensation
      • Additional information – should not emphasize compensation or use catchy or enticing language or graphics.
  • May I use social media to recruit?
    • Yes. Many researchers use social media as part of their recruitment strategy. If your research recruitment plans include using social media (Facebook, Twitter, blogs, Instagram, etc.) you must submit a description of your plans (i.e., platforms, frequency of posting, and process of corresponding), copies of the exact text (including pictures) proposed for use during recruitment. Recruitment strategies using social media platforms should, whenever possible, use the basic standards used for any other form of research recruitment. To help ensure privacy and ensure that potential participants are fully informed about the study, the IRB typically requires that initial posts on social media be more general in nature and allow users to link to a site that contains more detailed information about the study (consent form, eligibility requirements, etc).
    • The IRB does not recommend posting directly/publicly to any individual or organization’s social media account without prior authorization- such plans will be reviewed in context of the entire project.
    • To further help protect the privacy of participants, the IRB does not typically endorse the use of social media as a form of two way communication or the use of private accounts.
    • Additional Guidance  https://www.hhs.gov/ohrp/sites/default/files/ohrp/sachrp/mtgings/2013%20March%2  0Mtg/internet_research.pdf
  • Are recruitment templates available?
    • Yes, visit the templates section of our forms page
Other
  • What is FERPA and does it apply to research?
  • Should I submit an amendment or a new application?
    • The general rule of thumb is that if you change any two of the three Ps (purpose, population, procedure) with one amendment request you need to submit a new application. If you change any two of the three over multiple amendment requests or if you are unsure if you need to submit a new application or an amendment, please contact the Office of Research Compliance.
  • What requires IRB approval?
    • Any systematic investigation that is designed to develop or contribute to generalizable knowledge via interaction (or obtaining identifiable data about) with living individuals.
    • Determinations can be obtained by completing online determination form that is available on our forms page or by contacting our office.  
    •  See OHRP decision charts here 
    • Does Title IX apply to research?
      • Yes. All KSU employees and students are Title IX reporters and must follow KSU Policy 
    • Who do I contact with questions? 
      • The Office of Research Compliance is here to help and we can be contacted at researchcompliance@kent.edu. You can also contact any IRB member.
    • Is my study regulated by the FDA and does it invoke 21CFR 50?
      • The FDA defines a human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
      • A test article is defined as any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354- 360F of the Public Health Services Act.
      •  To know more about 21CFR50   
      • A comparison of the HHS and FDA regulations is available here  
    • Practicum and Internship Guidance 

      Practicums and internships are required by many academic programs and offer students an excellent opportunity to gain firsthand experience in their field of study.

      The majority of practicums and internships do not involve human subjects research. However, practicums and internships that include systematic investigations that are designed to develop or contribute to generalizable knowledge may require IRB review.

      Common internship and practicum activities and scenarios are listed below along with guidelines for IRB review. In all circumstances, students are to adhere to the principles of the Belmont report and abide by relevant professional ethics.

      The faculty person overseeing the practicum or internship is responsible for obtaining an IRB determination/review from the host site or KSU as necessary.

      If a student is to obtain or access medical or educational records for projects that are not under the oversight of the KSU IRB, the faculty person overseeing the project is responsible for ensuring the proper approvals are in place

       

      Activity

      KSU Review

      An experience that falls within the business activities of the hosting agency and data is collected, but research (as defined in the federal regulations) is not the intent.

      No

      Student conducts a unique project that involves data collection in order to inform business processes, measures quality initiatives, or similar and the results will not develop or contribute to generalizable knowledge.  

      No

      An experience where no data of any kind is collected.

      No

      Serving as an engaged* investigator on a KSU IRB approved project.

      Yes – appendix A must be filed.

      Serving as a research associate on a human subjects research project approved by a non-KSU IRB.

      An IRB reliance agreement if required by the external institute.

      No- if not required by the external institute.**

      Independent research project that meets the federal definition of human subjects research regardless of performance site.

      Yes – if reviewed by a non-KSU IRB please contact the Office of Research Compliance.

      *engaged means interacting with human subjects and/or obtaining or viewing identifiable data

      **a written determination from the external PI/IRB should be maintained in the faculty files

    • Retroactive IRB approval
      There are no provisions in the federal regulations that allow the IRB to approve research that has already been conducted.
    • Does the IRB have a stance on scholarly and journalistic activities?
      Generally, scholarly and journalistic activities do not fall within the scope of the IRB.
      For more details on guidance from OHRP 

     

     

    Research Personnel
    • Who is considered an investigator?
      • The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. Some research studies are conducted by more than one investigator, and usually one investigator is designated the “principal investigator” with overall responsibilities for the study. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects.
      • For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects research studies. Such involvement would include:
        • obtaining information about living individuals by intervening or interacting with them for research purposes
        • obtaining identifiable private information about living individuals for research purposes;
        • obtaining the voluntary informed consent of individuals to be subjects in research; and
        • studying, interpreting, or analyzing identifiable private information or data for research purposes
    • What is required of the principal investigator?
      • The requirements are detailed in the application’s Assurance Page, but in general the principal investigator has overall responsibility for the study and the ongoing conduct of the approved research. This includes completing an IRB application and obtaining IRB review/approval, including continuing review and amendments if necessary, and ensuring the research is conducted as described in the protocol. Finally, the principal investigator must ensure all personnel working on the project are adequately and knowledgeable about research procedures and the ethical conduct of research.
    • Minors: Are there any special requirements for minors working in my lab?
      • Please review the KSU University Policy 5-19 Regarding Minors (http://www.kent.edu/policyreg/university-policy-regarding-campus-activities-  involving-minors) and complete any action that may be required of that policy. The minor must complete applicable training programs including CITI, lab specific training, and applicable training offered through Compliance and Risk Management. Additionally, the minor’s parent/guardian must complete a waiver that is available through Compliance and Risk Management.
    • Volunteers: Are there any special requirement for volunteers working in my lab?
      • Please review the KSU Administrative Policy 6-04.4 Regarding Volunteers (http://www.kent.edu/policyreg/administrative-policy-regarding-volunteers), complete appendix B and indicate they are volunteers (this will add the personnel to the project  or change the status of the personnel), and complete the Volunteer Agreement form. The Volunteer Agreement form must be signed by your Chair or Dean and maintained in the investigator/department file for at least two years beyond the completion of the volunteer’s duties. The minor must complete applicable training programs including  CITI, lab specific training, and applicable training offered through Compliance and Risk Management.
    • I am new faculty at KSU or I am new to human subjects research, what are tips on getting started?
      • We recommend starting by reviewing our IRB Help page (including the video overview) and completing CITI training. In most cases, if you completed CITI at another institute we will accept your certificate through its expiration date. You must change your affiliation to Kent State no later than your next required refresher.
    • I have an open project at my former institute. What do I need to do?
      • In most cases you will need to seek approval of a new application or inter institutional authorization agreement from the KSU IRB if you want your former institute to remain as the IRB of record. Additionally, you should contact your former institute for guidance on their policies.
    • I have data that needs to be transferred from my former institute. What do I do? 
      • Please reach out to the Office of Research Compliance for guidance. In general, you will need to seek IRB approval and data should be managed as described in the in the protocol for which the data was collected under. Also, you should contact your former institute’s IRB (and funder if applicable) to ensure you are compliant with their rules.
    • Leaving Kent State University?
      • If your study is funded, contact Sponsored Programs. 
      • PI leaving KSU: if an open project is to continue and the PI is leaving there are one of two things typically happen. First, if KSU will continue to be the main contributor (including primary recipient of funds) a change in PI must be submitted. The person leaving KSU will need to be added as external personnel (using appendix B) and if they continue to be engaged in the research, an IAA must be completed. Second, if KSU will cease being the main contributor, the study must be closed and the PI needs to consult their new institute’s IRB. 
      • Co-Investigators leaving: if a Co-I continues to be engaged they will need to obtain their own  IRB approval or seek an IAA (IAA’s are mandatory for federally funded projects). Co-Is can be removed via the annual review form. If your study is not subject to annual review you do not need to notify the IRB. If they are no longer engaged, access should be revoked as described in the IRB application. If only using de-identified data, complete a de-identified data use agreement.
      • If a student is to leave the institute and continue to be engaged in the research they will need to be added as external personnel (using appendix B). If they are unaffiliated after leaving KSU, they may be considered volunteers.
      • Questions regarding data ownership, management, and use must be directed to your Department Chair or College Dean.
    • Do transcriptionists and translators need to be added to my protocol?
      • Typically not. Transcriptionists and translators are not considered engaged so long as all of the following apply: their services do not merit professional recognition or publication rights, their services are typical of those performed for non-research purposes, and they are not administering a study intervention or being evaluated under a protocol.

     

             

    Interinstitutional Authorization Agreements (IAA)
    • How should data collected under the approval of the KSU IRB be stored?
    • How can I expedite the review of an IAA? 
      • As early as possible let all institutes involved in the IAA know of your plans to request single IRB review.
    • What is an interinstitutional authorization agreement?
      • An IAA is a formal written agreement between two or more institutions that have IRBs, which permits IRB review to be limited to one institute – the reviewing institution is referred to as the IRB of record. In general Kent State University does not enter into IAAs for exempt/level I projects. If your project is exempt, please contact the Office of Research Compliance for guidance.
    • How do I know which institute should be the IRB of record?
      • External Review:
        • Kent State faculty/staff will be performing the majority of the study procedures at an external institution/site and the institution/site holds a current FWA and IRB registration.
        • The involvement of the KSU investigator(s) is limited. (For example, data analysis of information collected at another institution.)
        • Another institution’s reviewing IRB is more properly constituted to review a certain scope of work, or may have knowledge of the local research context. (For example, an international research project where the interaction with subjects is performed at an external site and the site has a FWA.)
        • This is a multi-site study with multiple IRB reviews/approvals.
        • This is a multi-site study and all sites are deferring to only one approving IRB.
      • KSU Review:
        • The majority of the study procedures will be performed at Kent State, or by Kent State faculty/staff.
        • This is a multi-site study and all sites are deferring to one approving IRB.
        • This is a multi-site study with multiple IRB reviews/approvals.
    • How long do IAAs last?
      • IAAs last for the life of the project unless there is a change to the agreement (including an institute ceasing engagement in research).
    • I have an IAA, what do I need to do now?
      • External Review: you correspond with the other institution in accordance with their procedures. You must contact the KSU Office of Research Compliance and IRB if there is a change in study risk level, if a subject complaint or unanticipated problem occurs, the project is suspended or terminated by the IRB of record, change in funding, change in KSU role, or the study is closed. You should also file copies of approved amendments and continuing reviews with the Office of Research Compliance.
      • KSU Review: you should correspond with the Office of Research Compliance and the IRB as you normally would, such as submitting renewals, amendments, closures and etc…
    • Does KSU have any standing agreements?
      • We have standing agreements with Akron Children’s Hospital, Akron General Hospital, Summa Health System, Ursuline College (only KSU to be IRB of record), and Cleveland Clinic (only Cleveland Clinic to be IRB or record).
    NIH FAQs and Kent State IRB Policies