The PPHS Introduces a Short Form Consent Process

The Program for the Protection of Human Subjects (PPHS) recently announced the Short Form Consent process and policy to the research community during the monthly Research Forum (first Wednesday of the month, from 12 noon- 1 pm). The Short Form Consent process is intended to facilitate the enrollment of non-English speaking subjects under certain circumstances where a fully translated consent form has not been approved by the IRB. The PPHS will review a request to use the Short Form Consent process on a case-by-case basis for use with incidental, unanticipated non-English speaking potential subjects. A Short Form Consent process is approved for a one time use for a specific potential subject, for a specific research study only.

Limitations and Considerations:
This process cannot be used when enrollment of non-English speaking subjects of a particular language group are anticipated, when such a group is targeted for enrollment, or if a significant number of potential subjects come from a specific language group. The Short Form Consent process cannot be used for Spanish speaking subjects. Ad hoc translation of the English consent form is not allowed.

If you plan on requesting to use a Short Form Consent process, the first step is to review the resources available to pay for interpreter services to make sure that the costs associated with services needed to enroll the non-English speaker can be covered by the study budget. Keep in mind that all future communication with the subject will also need to occur in the subject’s preferred language.

If you are planning on enrolling a non-English speaking subject, you need to plan for all research related communication with subjects during all study visits, any phone calls you may receive from the subject, and how you will handle any research emergencies. In addition, if any study materials need to be provided to, or completed by, subjects, those materials will need to be translated into the language understood by the subject.

To Request to Use the Short Form Consent process:
Email Liz Carroll in the PPHS office with the following information: Study ID#, PI, language requested, and basic non-identifiable information about the potential subject/situation. If the Short Form consent is not immediately available from the library in the target language, arrangements for the translation of the Short Form consent will need to be made. The PPHS library currently includes over 20 languages.

Contact Adriana Cifuentes, the Language Assistance Program Coordinator in the Patient Service Center to obtain a dedicated access code. This dedicated access code will allow patient services to invoice you directly for services rendered for research purposes. You should add these fees to the study budget so the sponsor of the research will cover the cost of the interpreter service.

If the use of the Short Form Consent Process is not specifically described in the Consent Process section of your protocol template (#12 under “Non-English Speaking Subjects”), you must submit a modification to add it to your study. Review your protocol template section on the Consent Process to see if you included a section on Non-English Speaking Subjects. Be sure that you indicated that if you have a potential subject who does not speak English or Spanish, you will follow the Short Form Consent Process and comply with the policy. If this section indicates that all consent documents will be translated and approved by the IRB prior to use, submit a modification to the IRB to allow for the Short Form Consent Process. This modification should be submitted to the IRB as soon as possible. A requested Short Form will be released independently of the modification review process.

Please contact Liz Carroll, Assistant Director of Regulatory Affairs for the Program for the Protection of Human Subjects with any questions related to this policy or the procedures to be followed.

Human Subjects Radiation Safety – Reengineered

In the past, all human subjects research protocols involving ionizing radiation required review by Mount Sinai Medical Center’s Radiation Safety Committee (RSC) before submission to the Institutional Review Board (IRB). This included a submission to the RSC for all protocols even if ionizing radiation was “medically indicated” for diagnosis or clinical management of the patient. This process also resulted in lengthy consent form documents that discussed exposure levels for procedures that were considered part of their standard of care for an existing condition, disease progression, or suspected medical condition.

Effective June 2014, PPHS implemented the following procedures identified on Form HRP 211 Appendix D. This form includes a table that clearly guides researchers to the requirements for their particular protocol. Depending on the nature of the use of radiation outside of standard of care, this matrix advises investigators about whether they need to fill out other forms, indicate an authorized user and credentialed reader, obtain RSC Subcommittee Review, and/or complete the Dosimetry Wizard.

A novel interactive dosimetry table is now available to calculate the total effective dose of research related radiation and provide standardized radiation exposure consent form language. The language produced for the risk section of the consent form incorporates only radiation dispensed for research.

The review and management of human subject research protocols are now stratified based upon the highest level of anticipated research specific radiationin milliSieverts (mSv) by subject participation-year.

Visit for links to the new Dosimetry Wizard, instructional videos, and related forms.

Related article:

Welcoming Diane Winiarski, Research Safety Analyst for Radiation Safety

Tips from the PPHS

To ensure a submission can be accepted by the PPHS office, the following must be true:

  1. The personnel listed on HRP-211 are the same as the persons listed under the IF# in Sinai Central.
  2. The current versions of all forms and templates are used.
  3. All personnel have completed all education requirements (N.B., the Investigator/research staff course expires after 3 years, and the Refresher course must be completed).
  4. An InfoEd submission has been started.