Individuals Who Can Obtain Informed Consent in Human Subject

1 | Page

Version: November 8, 2021

Individuals Who Can Obtain Informed Consent in Human Subject Research

Informed consent must be obtained from a research participant or the participant’s legally authorized

representative as described in an IRB-approved study protocol. Depending on the nature and details of

the study, the IRB may approve the Principal Investigator and/or other study staff to obtain informed

consent from participants. The tables below summarize the IRB’s policy on who can obtain informed

consent for different types of studies. In all circumstances, the PI is responsible for providing training

and oversight of research staff involved in the consent process according to the IRB-approved protocol

and institutional policies. Please refer to the Informed Consent of Research Subjects

policy for additional

information.

Who Can Obtain Informed Consent by Role:

Role on Study Staff

Can Consent for Which Types

of Research Study?

Backup Needed?

 Licensed Physician Principal

Investigators and co-

Investigators

 Licensed Doctoral-level Nursing

Principal Investigators and co-

investigators

 More than minimal risk

 IND/IDE

 Minimal risk

 None

 Principal Investigators who are:

 Licensed Clinical Pharmacists

 Licensed Psychologists

 Other clinically licensed faculty

members

 Other IND/IDE holders

 More than minimal risk

 IND/IDE

 Minimal risk

 Licensed physician investigator

listed on study staff

 Principal Investigators who are

non-licensed or non-clinical

faculty including:

 Non-licensed Physicians

 Statisticians

 Physicists

 Epidemiologist

 Other doctoral-level scientists

 More than minimal risk

 Limited Investigational

Device studies: Only Non-

significant risk or IDE

exempt

 Limited Investigational

Drug studies: IND exempt

 Minimal risk

 Licensed physician investigator

listed on study staff



Other licensed advanced

practice provider co-

investigators including:

 Licensed Nurse Practitioners

 Licensed Physician Assistants



More than minimal risk

 IND/IDE studies

 Minimal risk



Licensed physician investigator

listed on study staff



Other study staff including:

 Study Nurses

 Research Coordinators



Minimal risk*

*Consent for minimal risk studies

involving drugs or investigational devices

should be obtained by clinically licensed

staff, including study nurses, co-

investigators, and PIs.



Principal Investigator/Co-

Investigators listed on study

staff

2 | Page

Version: November 8, 2021

Who Can Obtain Informed Consent by Type of Study:

Type of Study

Who Can Obtain Consent?

Backup Needed?



Investigational drugs and

devices, including under IND/IDE

 More than minimal risk



Licensed Physician

Investigators (PI and co-

Investigators)

 Licensed Doctoral-level

Nursing Investigators (PI and

co-investigators)



None

 Investigational drugs and

devices, including under IND/IDE

 More than minimal risk

 Principal Investigators who

are:

 Licensed Clinical Pharmacists

 Licensed Psychologists

 Other clinically licensed

faculty members

 Other IND/IDE holders

 Other licensed advanced

practice provider co-

investigators including:

 Licensed Nurse Practitioners

 Licensed Physician Assistants

 Licensed physician

investigator listed on study

staff

 Limited Investigational Device

studies: Only Non-significant risk

or IDE exempt

 Limited Investigational Drug

studies: IND exempt

 More than minimal risk

 Principal Investigators who are

non-licensed or non-clinical

faculty including:

 Non-licensed Physicians

 Statisticians

 Physicists

 Epidemiologist

 Other doctoral-level scientists

 Licensed physician

investigator listed on study

staff

 Minimal risk studies involving

drugs or investigational devices

 Clinically licensed study staff

including study nurses, co-

investigators, and PIs.

 Principal Investigator/Co-

Investigators listed on study

staff



Other minimal risk studies,

including those involving non-

invasive approved medical

devices (e.g., standard MRI, EEG,

EKG, etc)



Study staff including research

coordinators/assistants



Principal Investigator/Co-

Investigators listed on study

staff