J-1s in the Research Scholar, Professor, or Short-Term Scholar categories cannot participate in any clinical activities. Clinical activities has a broad meaning in the world of immigration. This document provides guidance and clarity to hiring units regarding clinical activities.

• The U.S. Department of State (DOS) does not differentiate between clinical research, clinical care, or other types clinical activities. We understand in the medical world, these terms mean different things; however, these terms are broadly grouped together by DOS for immigration purposes and are deemed clinical work.

• According to the National Institutes of Health (NIH) (www.nih.gov/health-information/nih-clinical-research-trials-you/glossary-common-terms), "clinical research is medical research that involves people to test new treatments and therapies." Therefore, clinical research is not allowed for J-1 Research Scholars, Professors or Short Term Scholars.

• DOS does not differentiate between contact with volunteer research subjects (i.e. someone who signed up to be a sleep study subject) or true patients (i.e. people seeking medical care) for a human research study. Both of these are considered patients.

• Humans and animals are both considered patients by DOS. Veterinary care and veterinary clinical research for animals are considered clinical activities and are therefore not allowed on the J-1 program.

◦ Note: not all animals are automatically considered patients.

• An animal with an owner who would be saddened by its loss would be considered a patient. A J-1 could not do any activity involving this animal's well-being.
• Lab animals or animal models, whose sole purpose for existence is for research, are not considered patients by DOS. Therefore, any work with lab animals/animal models is allowed on the J-1 program. Please reach out to ISSS if you have questions about the animals.

• DOS uses direct 'patient care' and 'patient contact' interchangeably. Therefore, anything involving patient contact and/or patient care is considered clinical and is forbidden under the J-1 program. Remember, the person does not need to be a traditional patient for this to be considered clinical.

• 'Patient contact' is any physical or psychological interaction with a person that could affect their health and/or overall well-being. The person does not need to be a patient in the traditional sense. A few examples of patient contact that are considered clinical are: attaching EEGs to someone, drawing blood, performing an X-ray on a living being, dentistry, psychological interviews for study or diagnosis, and so forth. This is not an exhaustive list. Please contact ISSS if there are any questions, concerns, or doubts if an activity involves clinical work.

• Pure observation is not considered a clinical activity and would be allowed in J-1 status. However, the J-1 must be truly only observing—they cannot interact in any way. The activity is no longer observation the moment a doctor hands the J-1 a scalpel to hold, asks the J-1 to check someone's blood pressure, etc.

◦ A program involving observation will require a Five Point Letter

(https://terradotta.wisc.edu/index.cfm?FuseAction=PublicDocuments.View&

File_ID=84137) along with the other required materials for a DS-2019 application.

• A J-1 may do research involving data that has been collected from someone else's clinical

research. For example, if a host supervisor recently started a study involving checking heart rates during and after exercise, a J-1 may use the data from that study to help draw conclusions. However, the J-1 cannot be the one collecting the heart rates from the patients. That would be a clinical activity.

 

• J-1 Alien Physicians are the only J-1 category allowed to participate in any clinical activities. The Educational Commission for Foreign Medical Graduates (ECFMG) is the only entity authorized by the DOS to sponsor these physicians. The J-1 Alien Physician category is used for participation in accredited clinical programs or directly associated fellowship programs of

graduate medical education or training. There are usually J-1 Alien Physicians at Temple University Hospital and clinics, but none of them have been sponsored by Temple University. This means that ISSSdid not create their DS-2019s--ECFMG did.

 

No patient care attestation   22 CFR 62.27(c)(1)(i)

If no patient care is involved in the alien physician's duties, the RO/ARO must sign a certification and append it to Form DS-2019. The certification must state verbatim:

"This certifies that the program in which [name of physician] is to be engaged is solely for the purpose of observation, consultation, teaching, or research and that no element of patient care services is involved."

Incidental patient contact attestation    22 CFR 62.27(c)(1)(ii)

If incidental patient contact is involved in the alien physician's duties, the RO must append to Form DS-2019 a statement signed by the dean of the medical school or the dean's designee, certifying the following 5 points, verbatim:

 "(A) The program in which [name of physician] will participate is predominantly involved with observation, consultation, teaching, or research.

(B) Any incidental patient contact involving the alien physician will be under the direct supervision of a physician who is a U.S. citizen or resident alien and who is licensed to practice medicine in the state of Pennsylvania

(C) The alien physician will not be given final responsibility for the diagnosis and treatment of patients.

(D) Any activities of the alien physician will conform fully with state licensing requirements and regulations for medical and health care professionals in the state in which the alien physician is pursuing the program.

(E) Any experience gained in this program will not be creditable toward any clinical requirements for medical specialty board certification."

“No Patient Contact” or “Incidental Patient Contact” must be placed in the Subject/Field Remarks of the exchange visitor's SEVIS record.