This page contains guidance on recruiting subjects and guidelines for consent.
Guidance on Remote Consent Procedures- Updated 3/2021
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 3/2021). The IRB has collaborated with the PSOM Office of Clinical Research to develop this guidance.
All other schools: Remote Consent Guidance for non-Penn Medicine and non-Penn Dental Schools
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.
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 goes 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
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: Any Senior Analyst or Director listed on the directory
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
The Common Rule requires that the written informed consent document should embody, in language understandable to the participant, all the elements necessary for legally effective informed consent.
A “short form” may be used to document informed consent when an investigator unexpectedly encounters a subject or legally authorized representative (LAR) who does not speak English but is otherwise eligible for study participation. A short form is a written consent document, translated into the subject's native language, stating that the elements of informed consent as required have been presented orally to the subject or the subject's legally authorized representative.
Short form use is not acceptable on research studies where a significant proportion of the participants are expected to be non-English speaking. In this case, full translation of the consent form is expected.
The IRB will approve the translated short form, the process for interpretation, and plans for ongoing communication with the subject prior to use via a prospective exception request: https://irb.upenn.edu/Exception.
What is the process?
Oral presentation of informed consent information must be provided by an interpreter who speaks the subject’s or LAR’s language and may effectively convey the information in the study consent form. The oral presentation should be in a language understandable to the subject/LAR. This is to ensure that legally effective informed consent has been obtained.
The subject (or LAR) must be provided with both documents:
- A short form written informed consent document stating that the elements of consent have been presented orally to the subject or the subject’s legally authorized representative (LAR); and
- A written summary of the information that is presented orally containing the basic and additional elements of consent. The IRB-approved English language informed consent document may serve as the summary.
Requirement for a Witness
When this method is used, a witness is required to observe the oral presentation. The witness must be a legal adult and fluent in the language spoken by the research subject. The IRB recommends that the witness be an individual who is fluent in both the language understandable to the subject and English. The interpreter may serve as the witness, if permitted by their company contract or policy. The investigator obtaining consent may not be the witness to the consent.
The short informed consent and HIPAA forms must be signed and dated by:
- The subject (or their representative),
- The witness to the consent process, and
- The interpreter (if not the same person as the witness)
The IRB approved English version of the consent form must be signed and dated by:
- The investigator obtaining consent,
- The witness to the consent process, and
- The interpreter (if not the same person as the witness)
A copy of the signed summary (or stamped informed consent form) shall be given to the subject or the LAR in addition to a copy of the signed short form.
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
Translated Short Forms
Currently the IRB provides translated Short forms in the following languages:
- Chinese (Traditional)
- French (new as of 3/15/21)
- Haitian Creole
- Portuguese (Brazil)
- Spanish (US)
These are available to Penn personnel via Penn Box- CLICK HERE.
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.
Pennsylvania Law: Surrogate Consent and Mandatory Reporting Requirements
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.
Subject Recruitment Materials, Subject Compensation, Recruitment Finders Fees / Bonuses
Regarding 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.
Regarding Recruitment Materials:
The Institutional Review Board is responsible for reviewing study recruitment 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.
For additional assistance with developing recruitment materials, please contact: https://irb.upenn.edu/directory
Regarding Subject Compensation
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.
Regarding 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.
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