Submitting New Research for Approval

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In addition to IRB review, submission to other Penn entities may be required to gain full approval of your study. The IRB has developed a new tool to help researchers find out what other reviews are needed.

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What documents must be submitted to the IRB in addition to the HSERA application?

The following documents may also be required for initial submission:

  • Informed Consent/ Assent/ Parental Permission Forms when consent will be documented
  • Consent Scripts or Information Sheets if verbal consent is being obtained
  • HIPAA Authorization Form (this is part of the Biomedical Consent Form Template) or a Request for a Waiver of HIPAA Authorization Form for research that involves accessing (using), collecting, and/or disclosing (sharing) protected health information (PHI) generated under the Penn Medicine or Penn Dental covered entities
  • Stand-alone protocol for non-exempt research (NOTE: Research meeting the FDA definition of a clinical investigation requires a standalone protocol)
  • Recruitment materials (e.g., brochures, flyers, videos, scripts for radio advertisements, etc.)
  • Questionnaires, Surveys, or Interviews that are developed for the purposes of the study. Validated and published questionnaires, etc. may be described in the application or protocol and DO NOT require submission. If validated and published questionnaires are required to be submitted by the Sponsor, please combine these into one PDF binder to faciliate IRB review. 
  • Other participant facing materials not detailed above
  • Investigational Brochures, FDA approved product labelling, and/or Device brochures for studies meeting the FDA definition of a clinical investigation
  • Documentation of the IND or IDE number or exemption for studies meeting the FDA definition of a clinical investigation
  • Data and Safety Monitoring Plan for research that is greater than minimal risk and/or meets the FDA definition of a clinical investigation
  • Vulnerable populations form for the inclusion of pregnant women, children, or prisoners
  • Other supplemental IRB forms for research involving devices, community research, DOD funded research, etc. Please review the IRB forms page for all supplemental forms.
  • CITI Training Certificate (if HSERA Personnel page does not reflect up to date training)
  • Approval or authorization from external research or community sites (as applicable)

Is IRB Review Required?

The IRB must review all human subjects research conducted at the University of Pennsylvania.

Research is defined as:

  • “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" 
  • Additionally, FDA regulations define a clinical investigation to be any study that administers a drug product OR any study that is investigating a drug or device product.

Human subject is defined as:

  • “A living individual, about whom an investigator [whether professional OR student] conducting research obtains a) Data through intervention or interaction with the individual, or b) Identifiable private information.” 
  • Additionally, FDA regulations define a human subject as “an individual (healthy volunteer or patient) who is a recipient of an FDA regulated product (e.g., drug, biologic, device, dietary supplement, etc.) or a control.” 

If your project does not meet the definition of research or does not involve human subjects, you do not need to submit for IRB approval to conduct your research.

Not sure about the criteria? Please review guidance online here: https://irb.upenn.edu/mission-institutional-review-board-irb/guidance/types-research under Human Research - Is IRB Review Required?

Still not sure after reviewing the guidance? Download and fill out the Human Subjects Research Determination Form (available on the linked guidance page above, or on the IRB Forms page) and email it to any analyst. 

If your project requires IRB review and is Minimal Risk the IRB will conduct either an Exempt or Expedited review...


Exempt level of review 

"Exempt" means review by one IRB member, sometimes in consultation with others. A research activity may be declared exempt if it is considered low-risk and the only involvement of human subjects will be in the categories briefly described below:

1.Research conducted in established or commonly accepted educational settings, involving normal educational practices.

2.Research using anonymous or no-risk tests, surveys, interviews, or observations.

3.Most research involving public officials.

4.Research involving the collection or study of existing data if it is publically available or if subjects cannot be identified.

5.Research examining public benefit or service programs.

6.Taste and food quality evaluation and consumer acceptance studies.

Note: Penn researchers are not permitted to self-exempt. Exempt research requires submission to the IRB.

Although subject consent is always needed, signed consent forms are typically not recommended if they are the only identifying variable in an otherwise anonymous project. Approval for exempt projects does not expire, unless the study is modified and no longer qualifies as exempt. Most exempt level reviews are completed within two weeks after being received by the IRB from the department chair.

Expedited level of review

Projects not eligible for an exempt review may be eligible for an expedited review. "Expedited" means review by the IRB chair and one or more experienced reviewers. In general, research may qualify for expedited review if it is judged to involve only minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate informed consent procedures. For example, the collection of physical data through non-invasive procedures is eligible for an expedited review, including:

- Height and weight

- ECG, MRI, Ultrasound

- Moderate exercise

- Blood or other bodily fluids

The full list of categories of research that may be reviewed as expedited can be found on the DHHS website. Most expedited reviews are completed within approximately three weeks after being received by the IRB from the department chair.

If your project does not qualify for expedited review due to being Greater Than Minimal Risk, the IRB will schedule a Full Board review...

Research that does not qualify for expedited or exempt review and/or presents more than minimal risks to subjects will receive review by a fully convened board. The Penn IRB has 8 boards that meet once a month. Each board has various areas of expertise and is comprised of physicians and other community members.

The following are examples of research requiring full board review:

  1. Studies for which the level of risk is determined by the IRB Chair to be greater than minimal.
  2. All sponsored and non-sponsored-driven Clinical Trials (investigational drug or device) subject to FDA regulations.
  3. Studies that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants.
  4. Studies that involve sensitive or protected populations (such as children or cognitively disabled individuals).
  5. Studies that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial or legal).

Is posting on Clinical Trials.gov required?

Research that is designed and/or written by the principal investigator, a sub-investigator, or a faculty member at Penn or another academic institution AND meets the NIH definition of a clinical trial (see below) may be required to post on clinicaltrials.gov. Please review the following flow chart to determine if you are required to post on the NIH's Clinical Trials.gov website: flow chart.

NIH Definition: “A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” NIH has published case studies to help investigators identify whether astudy would be considered by NIH to be a clinical trial. They may be reviewed here: https://grants.nih.gov/policy/clinical-trials/case-studies.htm.

If required to post, please do so at https://clinicaltrials.gov/

NOTE: 
  • “Interventions” may include, but are not limited to, a drug or device product, a treatment procedure or surgery, social-behavioral intervention, etc.
  • The regulatory sponsor/lead investigator is responsible for making the decision about: 1) whether posting is applicable and 2) posting on CT.gov. 
  • Please be aware that the International Committee of Medical Journal Editors (ICMJE) and affiliated journals may also require registration on clinicaltrials.gov as a contingency for publication.

Associated Requirements

  • Studies meeting the NIH definition require study teams to complete Good Clinical Practice training. The IRB will not monitor compliance with this requirement. Penn Medicine researchers should continue to reach out to OCR Operations regarding GCP training. Researchers from non-Penn Medicine schools are responsible for compliance with these requirements.
  • The consent form must be posted on a publicly available website approved by the U.S. Office of Human Research Protections (OHRP) for such posting. Two publicly available federal websites have been identified that will satisfy the consent form posting requirement. These include ClinicalTrials.gov OR a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). For studies that are registered on ClinicalTrials.gov, the consent form must be posted on ClinicalTrials.gov.
  • The following language must be placed into the consent form: “A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law.  This web site will not include information that can identify you.  At most, the web site will include a summary of the results.  You can search this web site at any time.” 

IRB Processes

  1. At initial review, teams will be required to provide the NCT registration number, or an explanation of why the study does not require posting, before final IRB approval will be given. Penn Medicine researchers may require consultation with OCR compliance for concurrence of studies not posted on CT.gov. 
  2. At the time of closure with the IRB, the study team will be asked to confirm that results have been posted on CT.gov. A copy of the confirmation that results were received must be submitted. Closure with the IRB will not be accepted without this confirmation. 

Questions? Please contact the following individuals for guidance: 

 

Guidance Documents for Initial Submissions

Guidance on Submitting Research Conducted at Princeton Health to the Penn IRB

The Penn IRB will serve as the IRB for Penn Medicine Princeton Health as of April 26, 2021.

New Projects

Any new projects to take place at Penn Medicine Princeton Health (PMPH) or PMPH affiliated sites, enroll PMPH patients, or utilize PMPH patient data should submit to the Penn IRB as of the above date. 

  • Within HSERA, Personnel Page: UPHS staff under Responsible Org 2100 (Health System) engaging in research at Princeton Health should change their Responsible Org on the Personnel Page in HSERA to 10755 - Princeton HealthCare Holdings Inc. This Responsible Org will auto populate for any Princeton Health researchers. 
  • These new projects will also require review by the PMPH Scientific Review Committee before participant enrollment may begin. Submission to the Penn IRB and the PMPH Scientific Review Committee should occur in tandem. Please contact Sheryl Smolensky with any questions about the PMPH Scientific Review Committee process. 
  • Princeton Health investigators do not currently have access to the Penn FIDES Financial Interest Disclosure system. Princeton Health investigators must work with Sheryl Smolensky to complete their Financial Interest Disclosure Forms. 

Existing Projects Previously Reviewed by the PH IRB

All active* research protocols that were previously reviewed by the Princeton Health IRB must be submitted to the Penn IRB no later than June 1, 2021. 

  • Active research protocols include any studies that have not been permanently closed/terminated with the Princeton Health IRB.
  • Within HSERA, Personnel Page: UPHS staff under Responsible Org 2100 (Health System) engaging in research at Princeton Health should change their Responsible Org on the Personnel Page in HSERA to 10755 - Princeton HealthCare Holdings Inc. This Responsible Org will auto populate for any Princeton Health researchers. 
  • Princeton Health investigators do not currently have access to the Penn FIDES Financial Interest Disclosure system. Princeton Health investigators must work with Sheryl Smolensky to complete their Financial Interest Disclosure Forms. 

If you require an extension of this deadline you must email Jessica Yoos with rationale for the extension request. 

Please review the attached instructions prior to submitting an existing Princeton Health study to the Penn IRB.

 

Existing Projects where Penn is the IRB of Record 

If an existing research protocol was previously submitted to both Princeton Health IRB AND the Penn IRB, a modification may be required to the Penn IRB protocol. This would be applicable only to Penn and UPHS affiliated principal investigators.

  • Please review your protocol. A modification is likely not required to the Penn IRB if the engagement of Princeton Health as a Penn site is covered within the Penn IRB protocol. If you need assistance with determining if a modification is required, please email Jessica Yoos. 
  • If you require an extension of this deadline you must email Jessica Yoos with rationale for the extension request.  

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