Use of Human Subjects

Researchers must follow the use and care requirements for using human subjects in research to comply with University policies and federal law. The Institutional Review Board (IRB) is designated by Northwestern to review, approve the initiation of, and conduct periodic review of research involving human subjects or materials obtained from human subjects. The below links provide access to University procedures and federal policies for utilizing human subjects for research.

Resource/Topic	Description
Use of Human Subjects Policy	Institutional Review Board (IRB) policies and guidelines regarding the use of human subjects in research projects at Northwestern
IRB Submission Forms	Institutional Review Board (IRB) forms regarding the use of human subjects in research projects at Northwestern
Health Insurance Portability and Accountability Act (HIPAA) NU HIPAA Guidelines	Federal policy that addresses the HIPAA privacy obligations of provider entities relating to the disclosure of health information concerning subjects participating in research The role of NU and the NU IRB with respect to HIPAA obligations
Office for Human Research Protections (OHRP)	Federal policy for the protection of human subjects
United Stated Food and Drug Administration (FDA)	Food and Drug Administration (FDA) regulations governing clinical trials

Federal regulations regarding use of human subjects: Applies to all research involving human subjects

• Code of Federal Regulations, Title 45, Part 46: Protection of Human Subjects

FDA regulations regarding use of human subjects: Applies to FDA sponsored research

• Code of Federal Regulations, Title 21, Part 50: Protection of Human Subjects
• Code of Federal Regulations, Title 21, Part 54: Financial Disclosure by Clinical Investigators
• Code of Federal Regulations, Title 21, Part 56: Institutional Review Boards
• Code of Federal Regulations, Title 21, Part 312:Investigational and New Drug Application
• Code of Federal Regulations, Title 21, Part 314: Applications For FDA Approval To Market A New Drug

Institutional Biosafety Committees: NIH Guidelines for Research Involving Recombinant DNA Molocules

Code of Federal Regulations, Title 45, Part 46: Protection of Human Subjects

Department of Health and Human Services

National Institutes of Health

Office for Protection from Research Risks

Resource/Topic	Description
Subpart A: Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects)	Applicability Definitions Assuring compliance with this policy - research conducted or supported by any federal department or agency IRB membership IRB functions and operations IRB review of research Expedited review procedures Criteria of IRB approval for research Review by institution Suspension or termination of IRB approval of research Cooperative research IRB records General requirements for informed consent Documentation of informed consent Applications and proposals lacking definite plans for involvement of human subjects Research undertaken without the intention of involving human subjects Evaluation and disposition of applications and proposals for research to be conducted or supported by a federal department or agency Use of federal funds Early termination of research support: Evaluation of applications and proposals Conditions
Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research	Applicably Definitions Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates Research involving pregnant women or fetuses Research involving neonates Research involving, after delivery, the placenta, the dead fetus or fetal material Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates
Subpart C: Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects	Applicability Purpose Definitions Composition of Institutional Review Boards where prisoners are involved Additional duties of the Institutional Review Boards where prisoners are involved Permitted research involving prisoners
Subpart D: Additional DHHS Protections for Children Involved as Subjects in Research	Applicability Definitions IRB duties Research not involving greater than minimal risk Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children Requirements for permission by parents or guardians and for assent by children Wards

Code of Federal Regulations, Title 21, Part 50: Protection of Human Subjects

The Food and Drug Administration (FDA)

Resource/Topic	Description
Subpart A: General Provisions	Scope Definitions
Subpart B: Informed Consent of Human Subjects	General requirements for informed consent Exception from general requirements Exception from informed consent requirements for emergency research Elements of informed consent Documentation of informed consent
Subpart C: Reserved
Subpart D: Additional Safeguards for Children in Clinical	IRB duties Clinical investigations not involving greater than minimal risk Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children Requirements for permission by parents or guardians and for assent by children Wards

Code of Federal Regulations, Title 21, Part 54: Financial Disclosure by Clinical Investigators

The Food and Drug Administration (FDA)

Subchapter A: General

Resource/Topic	Description
Subchapter A: General	Purpose Definitions Scope Certification and disclosure requirements Agency evaluation of financial interests Record keeping and record retention

Code of Federal Regulations, Title 21, Part 56: Institutional Review Boards

The Food and Drug Administration (FDA)

Subchapter A: General

Resource/Topic	Description
Subpart A: General Provisions	Scope Definitions Circumstances in which IRB review is required Exemptions from IRB requirement Waiver from IRB requirement
Subpart B: Organization and Personnel	IRB membership
Subpart C: IRB Functions and Operations	IRB functions and operations IRB review of research Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research Criteria for IRB approval of research Review by institution Suspension or termination of IRB approval of research Cooperative research
Subpart D: Records and Reports	IRB Records
Subpart E: Administrative Actions for Noncompliance	Lesser administrative actions Disqualification of an IRB or an institution Public disclosure of information regarding revocation Reinstatement of an IRB or an institution Actions alternative or additional to disqualification

Code of Federal Regulations, Title 21, Part 312: Investigational and New Drug Application

The Food and Drug Administration (FDA)

Subchapter D: Drugs for Human Use

Resource/Topic	Description
Subpart A: General Provisions	Scope Applicability Definitions and interpretations Labeling of an investigational new drug Promotion and charging for investigational drugs Waivers
Subpart B: Investigational New Drug Application (IND)	Requirement for an IND Phases of an investigation General principles of the IND submission IND content and format Protocol amendments Information amendments IND safety reports Annual reports Treatment use of an IND Submissions for treatment use Emergency use of an IND Withdrawal of an IND

Code of Federal Regulations, Title 21, Part 314: Applications for FDA Approval to Market a New Drug

The Food and Drug Administration (FDA)

Subchapter D: Drugs for Human Use

Resource/Topic	Description
Subpart A: General Provisions	Scope Purpose Definitions
Subpart B: Applications	Content and format of an application Notice of certification of invalidity or noninfringement of a patent Submission of patent information Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug Pediatric use information Amendments to an unapproved application Withdrawal by the applicant of an unapproved application Supplements and other charges to an approved application Procedures for submission of a supplement to an approved application Changes in ownership of an application Postmarketing reporting of adverse drug experiences Other postmarketing reports Waivers
Subpart C: Abbreviated Applications	Drug products for which abbreviated applications may be submitted Petition to request a change from a listed drug Content and format of an abbreviated application Notice of certification of invalidity or noninfringement of a patent Amendments to an unapproved abbreviated application Supplements and other changes to an approved abbreviated application Postmarketing reports Other responsibilities of an applicant of an abbreviated application
Subpart D: FDA Action on Applications and Abbreviated Applications	Timeframes for reviewing applications and abbreviated applications Filing an application and receiving an abbreviated new drug application Communications between FDA and applicants Dispute resolution Drugs with potential for abuse Approval of an application and an abbreviated application Foreign data Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(j) of the act Approvable letter to the applicant Not approvable letter to the applicant Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed Refusal to approve an application Adequate and well-controlled studies Refusal to approve an abbreviated new drug application Withdrawal of approval of an application or abbreviated application Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act Notice of withdrawal of approval of an application or abbreviated application for a new drug Suspension of approval of an abbreviated new drug application Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn Determination of reasons for voluntary withdrawal of a listed drug Removal of a drug product from the list Adulteration and misbranding of an approved drug
Subpart E: Hearing Procedures for New Drugs	Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing Procedure for hearings Judicial review
Subpart F: Reserved
Subpart G: Miscellaneous Provisions	Imports and exports of new drugs Drug master files Availability for public disclosure of data and information in an application or abbreviated application Addresses for applications and abbreviated applications Guidance documents
Subpart H: Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses	Scope Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity Approval with restrictions to assure safe use Withdrawal procedures Postmarketing safety reporting Promotional materials Termination of requirements
Subpart I: Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible	Scope Approval based on evidence of effectiveness from studies in animals Withdrawal procedures Postmarketing safety reporting Promotional materials Termination of requirements