This page contains guidance on recruiting subjects and guidelines for consent.
Guidance on Remote Consent Procedures- Updated 6/2022
In the event of a health pandemic (e.g., COVID-19 declared on March 11, 2020), documenting consent from subjects utilizing methods other than pen and paper will be permitted and recommended. Guidance on Remote Consent Procedures during the COVID-19 pandemic contains information on documentation and consent discussions. Please follow the guidance for your school.
Penn Medicine and Penn Dental: Please review the attached guidance document for more information (Updated 6/2022). The IRB has collaborated with the PSOM Office of Clinical Research to develop this guidance.
Penn Medicine Guidance on the Use of Electronic Signatures in Research and 21 CFR Part 11 Compliance: Please review the attached guidance document for more information. (New 1/2022).
All other schools: Remote Consent Guidance for non-Penn Medicine and non-Penn Dental Schools (Updated 6/2022)
Subject Recruitment Plans and Recruitment Materials - Updated 5/2022
Recruitment of Human Subjects
The Institutional Review Board is responsible for reviewing study recruitment plan procedures and materials to ensure protection of the rights and welfare of human subjects and equitable subject selection into research [21 CFR 56.107(a), 56.111(a)(3)]. Any method of advertisement must be approved by the IRB before it is implemented. All advertisements must comply with informed consent and subject selection regulations pursuant to 21 CFR 50.20, 50.25, and 56.11(a)(3)as well as the institutional policy described in the document provided below.
Direct Recruitment of Penn Medicine Patients
Contacting patients for recruitment purposes is permissible under the federal HIPAA regulations and is described in the Notice of Privacy Practices (NPP) that Penn Medicine patients acknowledge before clinical care is delivered.It is standard practice for clinical and research teams within Penn Medicine to communicate with patients in various ways. Regarding contact for research recruitment, IRBs are required to review and approve the appropriateness of the recruitment methods proposed in a research study. The IRB provides detailed guidance for investigators contacting patients for participation in research.
For additional assistance with developing recruitment materials, please contact: https://irb.upenn.edu/directory.
The Electronic Medical Record (EMR) and Release of Study Related Information under the 21st Century Cures Act
The biomedical informed consent form template includes template language to inform subjects about the potential for research information to appear in their electronic medical record maintained by Penn Medicine. This language is required for research being conducted within Penn Medicine when research information and results may be placed into the electronic medical record, or are otherwise built in the EMR. Studies must be built into the EMR/ PennChart if the study will be utilizing PennChart EMR ordering, billing or recruitment capabilities.
21st Century Cures Act and Electronic Medical Records Access
As a result of the 21st Century Cures Act, Penn Medicine is required to allow patients increased access to their electronic medical record. With the Cures Act, by default, research-related information* that is placed in the participant’s EMR will now be available within 10 days via MyPennMedicine (MPM), Penn Medicine’s patient portal. This went into effect on April 2, 2021.
Research-related information refers to research data or information that may be contained in research notes, clinical progress notes, physician orders, test results, etc.
The law allows for suppressing research-related information within the medical record. The law also allows for delayed release of research-related information within the medical record. Please review the IRB Guidance on the impact of 21st Century Cures Act on research protocols here.
If you have more general questions about the Cures Act, please review OCR's FAQ: https://www.med.upenn.edu/ocr/cures-act-research-faq.html
Certificates of Confidentiality (COC) and the EMR
If you have obtained a COC from the NIH and need more information about entering information protected by a COC in a subject's medical record, please see https://irb.upenn.edu/mission-institutional-review-board-irb/guidance/other-elements-research under Certificates of Confidentiality (CoC).
Frequently Asked Questions about the Electronic Medical Record (EMR) and Release of Study Related Information
1. What do you mean when you say Electronic Medical Record?
The electronic medical record (“EMR”) refers to all potential sources of electronic information in which an individual’s record of care may be captured. This includes but is not limited to EPIC, Medview, eWebHealth, Sunrise, Cerner, GECentricity and other diagnostic testing systems.
2. My study does not use Penn Medicine or UPHS clinical services. Why do I have to include this language in my consent form?
Even if your study uses an external service (e.g. a commercial lab) there is a potential that results from these tests may feed back into the EMR for an individual. This could occur because of links established for billing purposes or may occur simply because an individual scans the record and inputs it into the system. Since there can be no guarantee that research results will not be included in a subject’s EMR, this language is required to inform subjects of this potential.
3. Can certain research-related information remain outside of the EMR?
Although there are mechanisms in place to restrict the information that may be included in the EMR, these mechanisms cannot be guaranteed as research-related information can be placed in the EMR by a simple action such as a fax between investigators for consultation on a test result. For this reason, subjects must be informed of the potential that research-related information may be included in the EMR. Furthermore, once placed in the record, clinicians may subsequently incorporate that information into future clinical decision making.
4. What if a subject asks not to have research-related information included in their EMR?
The study team should inform the subject that unfortunately, this cannot be guaranteed and agreeing to participate in this study means that the subject is willing to participate knowing that this may occur.
For additional assistance, please contact the Office of Clinical Research.
Required Elements of Consent (Revised 1.21.19 for New Common Rule)
Please click here to download our guidance document which outlines the required elements of consent according to the Common Rule regulations.
To assist researchers at Penn and other institutions which rely on Penn IRB review, the Penn IRB routinely provides templates for developing appropriate consent forms for both Biomedical and Social/Behavioral research. Please visit the forms and templates page of this website to download the most recent versions of these templates. The forms and templates page also includes templates to assist with:
- Developing a Concise Summary of research for prospective subjects- The template for concise summary is built into the Biomedical ICF template and the Social Behavioral ICF template.Click Here to download additional guidance for developing a concise summary using our template.
- Adding appropriate HIPAA language to your consent form
- Adding conflict of interest disclosure language
- Adding Risks of Social Media
- Adding Genetic Information Non-Discrimination Act (GINA) language
- Developing appropriate assent forms for children/minors
- Obtaining Short Form consent - please note that short form consent templates are available on the forms page in select languages. If you need a short form in a language that is not available please utilize the English short form to obtain a translation.
Incidental Inclusion of Subjects not Fluent in the English Language & IRB Consent Short Form Translations
Guidance for Incidental Inclusion of Subjects not Fluent in the English Language
Non-English speaking subjects should not be systematically excluded from research without a sound scientific or ethical rationale to ensure equitable subject selection. Investigators (particularly those conducting greater than minimal risk and clinical research) must prospectively review protocol requirements to ensure applicable provisions are in place to support the safety of a non-English speaker to participate in the research.
Federal regulations at 45 CFR 46.116(a)(3) and 21 CFR 50.20 require that informed consent be obtained in language that is understandable to the subject (or the subject’s legally authorized representative). In accordance with these regulations, informed consent discussions must include a reliable interpreter when the prospective subject does not understand the language of the person who is obtaining consent. Likewise, the written informed consent document should embody, in a language understandable to the participant, all the elements necessary for legally effective informed consent.
When non-English speaking participants (or LARs) are incidentally encountered, a short form process is appropriate.
What is the Process?
If investigators use a “short form” to document informed consent, they must also provide subjects (or LAR) with
- A written summary of the information that is presented orally. The written summary must contain the basic and additional elements of consent; in most cases this will be the full-length informed consent document in English;
- An interpreter who speaks English and the subject’s (or LAR’s) language, who can take part in the oral informed consent discussion (in-person or remotely) to provide the oral summary and to ensure subject’s understanding through facilitating exchange of information related to questions and/or concerns. For FDA-regulated research, the interpreter must be through a qualified translation service vendor. For additional details please review IRB SOPs;
AND the investigator must also confirm there is
- A witness to the oral presentation. The witness must be a legal adult and fluent in both English and the language spoken by the research subject. It is preferred that the witness be impartial to both the study team and subject. However, if an impartial witness is not otherwise available, the witness may then be an adult family member/friend of the subject, or an adult staff member not otherwise involved with the study. The investigator obtaining consent may NOT be the witness to the consent process. For additional details on the role and requirements of the witness, review IRB SOPs.
- The “short form” consent document written in the subject’s (or LAR’s) language must be signed by the subject (or LAR) and the witness to the oral presentation.
- The written summary of the information that is presented orally (i.e., the full-length English consent document) must be signed by the person obtaining consent and the witness to the oral presentation.
It is recommended that the interpreter also sign both documents, when possible.
For studies requiring GCP compliance, the participant’s record should also include a note that documents the following:
- the elements of consent were presented orally, including study procedures, risks and benefits, time was given for questions and (if applicable) questions were answered,
- identify the interpreter, witness, and investigator obtaining consent,
- that the signed short form and summary (if not the IRB approved English consent form) was provided to the subject
The subject / LAR should be given copies of both the “short form” consent document and the written summary of the information that is presented orally.
Research Requiring HIPAA Authorization
For research requiring HIPAA authorization, when using a short form consent document to complete the primary consent process for a non-English speaking subject, a fully translated standalone HIPAA authorization is also required.
Requirements for Prospective IRB Approval to Use a Short Form
Prospective IRB approval to enroll a Non-English speaking subject with a short form is NOT required when all of the following conditions are met:
1. The approved, English version of the informed consent document is used as the written summary. Signature lines may be adapted to permit applicable signatures without additional prospective IRB review/approval. No additional changes may be made without prospective IRB review;
2. One of the generic “short form” consent documents available from the Penn or CHOP IRBs is utilized,
3. A qualified interpreter service will be utilized throughout the course of the subject’s consent process and participation.
In this case, the IRB will NOT stamp the short form consent document.
An exception request (prospective deviation) is required if ANY of the following conditions are met:
- The written summary is not the approved, stamped English version of the informed consent;
- A short form consent document translated into a language unavailable from the Penn or CHOP IRB is utilized. The IRB may accept short form translations from other AAHRPP accredited IRBs. The study team should consult with the IRB prior to utilization;
- An individual other than a qualified interpreter will be used for interpretation (e.g., a member of the study, another Penn employee, etc.)
When formal exception requests are submitted, the IRB will stamp the short form consent document.
Translated Short Informed Consent and HIPAA Forms
Currently the IRB provides translated Short forms in the following languages:
- Bassa (Nigerian Dialect) - Short IC template only
- Chinese (Traditional)
- Farsi (new as of 10/2021) - Short IC template only
- French (new as of 3/2021)
- Haitian Creole
- Portuguese (Brazil)
- Spanish (US)
NOTE: The Penn IRB will also allow use of non-Penn short forms from CHOP and the University of Utah, when translations are not available for certain languages. English short forms from these institutions have been reviewed to confirm they align with Penn's template.
Versions with CT.gov in the file name contain clinicaltrials.gov language for studies that are required to register on CT.gov.
These versions comply with the 2018 Common Rule criteria for consent. They are based on the Penn IRB provided English Short Form template and were translated by Language Line Solutions. The translation certificate is also available in the Penn Box folder linked above.
Subject Compensation & Recruitment Finders Fees / Bonuses
The Penn IRB is responsible for reviewing the rates, forms and schedules of remunerations to subjects participating in research at the university. It is the IRB’s charge to ensure that the amount of remuneration and the proposed method and timing of disbursement do not present undue influence to subjects.
Payment for Recruitment of Subjects (Finders Fees / Bonuses)
The University of Pennsylvania IRB believes that finder’s fees and bonus payments to investigators and study staff create a potential conflict of interest. The Institutional Review Boards do not approve of finder’s fees being paid to University of Pennsylvania or UPHS investigators, physicians, nurses, and others who have a treating and/or counseling relationship to a subject being referred for enrollment in a clinical trial. The Institutional Review Boards do not approve of finder’s fees or bonus payments being paid to any, house staff or University of Pennsylvania Health System (UPHS), or University of Pennsylvania employee for referring or recruiting prospective subjects. The IRB may review and approve small, nominal value gifts to staff organizations as long as such gifts are not based on any indicator of trial enrollment.
For additional assistance with developing recruitment materials, please contact: https://irb.upenn.edu/directory.
Health Literacy Guidance for Drafting Consent Forms
About 30 million Americans have below-basic literacy, which can hamper the understanding of research. Please download the attached guidance to review best practices for drafting consent forms that facilitate participant comprehension.
Please note that the IRB may stipulate that this guidance be applied to new or updated consent forms submitted for review.
Reportable Diseases: Requirements for Reporting & Informing Subjects
The purpose of this guidance is to inform researchers about the requirements related to reportable diseases and to provide template language for inclusion in the consent form to inform subjects of these reporting requirements.
Community Research Partners