Submitting New Research for Approval
All initial submissions require submission using the Human Subjects Research Electronic Application (HSERA) system.
- Download and review this walkthrough which includes step by step guidance, tips & screenshots about submitting an HSERA application.
- Log in to HSERA
Note: All initial submissions undergoing convened board review (including response to initial review) should always provide a cover letter that includes a complete list of all documents being submitted for approval (Document name, version, date).
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.
- For common HSERA questions- see HSERA guidance page
- For technical issues related to using HSERA : Contact the HSERA Help Desk
- For assistance with completing the initial application: PROVOST-IRB@pobox.upenn.edu
- For help with Quality Improvement projects (QI/QA): Please review our separate QI Guidance
What documents must be submitted to the IRB in addition to the HSERA application?
The following documents may also be required for initial submission review:
- 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.
- DHHS regulations define a human subject as: “a living individual, about whom an investigator [whether professional OR student] conducting research
a) obtains information or biospecimens through intervention or interaction with the individual AND uses, studies, or analyzes the information or biospecimens;
b) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
NOTE: Information and specimens collected during the course of clinical care from Penn Medicine or Penn Dental patients are considered to be private.
NOTE: Identifiable private information and biospecimens from Penn Medicine or Penn Dental patients are protected by HIPAA for 50 years after death, and the use of such is considered to meet the definition of human subjects' research.
- 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 / Limited Review
"Exempt" means review by one IRB member, sometimes in consultation with others. "Limited Review" refers to exempt research under the Revised Common Rule that requires ongoing modification submissions to the IRB.
NOTE: Penn researchers are not permitted to self-exempt. Exempt research requires submission to the IRB.
A research activity may be deemed exempt from ongoing review or undergo limited review if it is considered low-risk and the only involvement of human subjects will be in the categories briefly described below:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices.
- Research using anonymous or minimal risk tests, surveys, interviews or observations of public behavior. NOTE: surveys and interviews with children are excluded from exempt review, unless the study qualifies under Category 1 above. Audio-visual recording is permissable. LIMITED REVIEW applies in some scenarios.
- Research involving benign behavioral interventions* with adult participants, if the subject prospectively consents. Audio-visual recording is permissable. *NOTE: Benign behavior interventions are brief in duration, harmless, painless, not physically invasive; not likely to have a significant adverse lasting impact on the subjects; not offensive or embarrassing. This category excludes medical interventions. LIMITED REVIEW applies in some scenarios.
- Secondary research uses of identifiable private information or biospecimens. One of the following must apply: i) the information or biospecimens are publicly available; OR ii) the information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; OR iii) The research involves identifiable health information when that use is regulated under HIPAA. NOTE: Secondary research uses of identifiable biospecimens that are not publicly available must be reviewed under Limited Review Category 8 OR Expedited Category 5.
- Research examining public benefit or service programs.
- Taste and food quality evaluation and consumer acceptance studies. Products must be established food products or additives.
- LIMITED REVIEW: Storage of identifiable private information or biospecimens for secondary research use. NOTE: Does NOT allow for collection.
- LIMITED REVIEW: Secondary research for which broad consent is required, involving identifiable private information or biospecimens, IF the investigator does not include returning individual research results to subjects as part of the study plan AND the research to be conducted is within the scope of the broad consent obtained. NOTE: When broad consent was not obtained, expedited category 5 applies.
Expedited level of review
Projects not eligible for an exempt or limited 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 minimal risk, does not employ sensitive populations or topics, and includes appropriate informed consent procedures. Research categories eligible for an expedited review include:
- Clinical studies of drugs and medical devices, WHEN: the study is fully exempt from IND and IDE regulations AND the risks of the products administered are minimal. Device research qualifying under this category generally will involved in vitro diagnostics, assays, etc.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture. In a non-healthy or pediatric population, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period AND collection may not occur more frequently than 2 times per week. For more information, please review guidance online HERE. Note that arterial blood collection does not qualify under expedited category 2.
- Prospective collection of biological specimens for research purposes by noninvasive means (e.g., hair, nail, teeth at time of extraction, sweat, saliva, skin /buccal swabs, sputum collected after saline mist nebulization, etc.)
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice. Medical devices must be cleared / approved for marketing. (E.g., ECG, ultrasound, blood pressure measurements, MRI without contrast, collection height, weight, mild to moderate excercise in a healthy population, etc. NOTE: Excludes the administration of contrast in any form as well as procedures involving x-rays or microwaves.
- Research involving materials (i.e. data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis) that does not qualify for exempt review under category 4.
- Collection of data from voice, video, digital, or image recordings made for research purposes that does not qualify for exempt or limited review
- Research on individual or group characteristics/behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies that does not qualify for exempt review under categories 2 and 3.
If your project does not qualify for expedited review due to being Greater Than Minimal Risk, the IRB will schedule a Full Board review...
Some reasearch requires convened board review. 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 that generally do require full board review:
- The study involves procedures that do not qualify for review under the designated exempt, limited review, and expedited categories outlined above.
- Studies which involve procedures where the level of risk is unclear or clearly greater than minimal.
- Studies involving the administration of drugs and devices that do not qualify for exemption from IND and IDE regulations
The following are examples of research that may require full board review:
- Studies that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants.
- Studies that involve sensitive or protected populations (such as children or cognitively disabled individuals).
- Studies that collect sensitive information where identification of the subjects and / or their responses would reasonably place them at risk of criminal or civil liability, or be damaging to the subjects' financial standing, employability, reputation, or be stigmatizing.
- 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/.
- “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.
- 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.”
- 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.
- 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
- IRB & Penn Medicine Requirements regarding PHI Security and Storage - Updated 3/2021
- Penn Medicine Guidance on Sharing Data and Biological Samples with Third Parties - NEW 11/2021
- Is IRB Review Required?
- Minimal Risk Research FAQ document
- IRB Approval Criteria Guidance for Initial Submissions
- Initial Submission Completeness Guidance
- Greater than minimal risk research where pregnancy is exclusionary
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.
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.
- Financial Interest Reviews: Princeton Health investigators do not currently have access to the Penn FIDES Financial Interest Disclosure system. Princeton Health investigators must complete a paper version of the Financial Interest Disclosure Forms until the new e-COI system goes live. This form can be found online here: https://irb.upenn.edu/forms. Questions should be directed to Kim Craig at firstname.lastname@example.org. Please ensure all forms are completed and signed. To facilitate review, please combine all the forms into 1 PDF binder or portfolio, and upload the document into HSERA. Upload the forms on the Confirmation Page in HSERA under Additional Documents.
Please review the attached instructions prior to submitting an existing Princeton Health study to the Penn IRB.