Human Research Protection Training for COVID-19 Researchers - PowerPoint Presentation

Slide1

Human Research Protection Training for COVID-19 Researchers

Office of Research Administration

Important to Note

These slides are not intended to replace the required CITI training on a long-term basis. Rather, they are being provided to researchers focused on COVID-19 research

and treatment efforts

and are being used to expedite the process of initiating

research or investigational treatment options

for that purpose alone.

Researchers are required to complete CITI training within 60 days of completing this abridged training

.

CITI training can be accessed at citiprogram.org. Register or log in (if you already have an account) and affiliate with Hackensack Meridian Health.

Basic Requirements for Initiating Research

This abridged training

(and later CITI training)

eResearch

registration

: Register at irb.humed.com.

Completion of Conflict of Interest form

: A link with the form will be sent upon registration in

eResearch

.

Human Subjects Research

Throughout the following slides, “human subjects research” is referenced. This term is defined below:

“

Human

subject

”-“…a

living individual about whom an investigator…conducting research:

(

i

)Obtains information or

biospecimens

through intervention or interaction with the individual, and uses, studies, or analyzes the information or

biospecimens

; or

(ii)Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable

biospecimens

.”

“

Research

”- “…a

systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge

.”

(45 CFR 46)

Introduction

Most research-related regulations are borne

from historic events involving mistreatment

of research subjects. The purpose of the regulations is to prevent those types of incidents from happening again.

Below are a few examples of such tragic events :

Tuskegee Syphilis Study (1932-1972)

Nazi Experimentation (1939-1945)

Willowbrook

Experiments (1956-1970)

The Belmont Report

T

he National Research Act (1974) established a commission charged with identifying

the basic ethical principles

that

should underlie

human subjects research

conduct.

The Commission drafted the 

Belmont Report

Belmont Report (1979)

Principle

Application

Respect for Persons

1.

Individuals should be treated as a

utonomous agents

2. Persons with diminished autonomy are entitled to protection

Demands

that subjects enter into the research voluntarily and with adequate information

=

Informed Consent

Beneficence

Do no harm

Maximize possible

benefits and minimize possible harms

Research should maximize possible benefits

and minimize the possible risks

= Risk/Benefit Assessment

Justice

Distribution of burdens and benefits to each person:

An equal share

According to individual need

According to individual effort

According to societal contribution

According to merit

Must be fair procedures and outcomes

= Selection of Subjects of Research

Research Guidelines and Regulations

Good Clinical Practice (GCP):

Established

by the International Conference on Harmonization (ICH

), GCP is “an

international

ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.”

It is a

standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or

studies

Code of Federal Regulations (CFR):

The CFR is comprised of the

general and permanent rules published in the Federal Register by

the

Federal Government

. Several sections of it relate to research activities.

Institutional Review Board (IRB)

“[A]

n IRB is an appropriately constituted group that has been formally designated to

review and monitor…research involving human subjects

….[A]n IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.”

(https://

www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm)

All human subjects research must be IRB approved before the study may begin.

After IRB Approval

Amendments

:

ANY

changes to an IRB approved protocol requires the submission of an amendment for IRB review and approval

PRIOR

to initiating those changes

.

Continuing Reviews

: Reports

the progress of approved research to the

IRB. The IRB

determines the approval period (based on risk to subjects

).

Reportable Events

:

Regulations require an organization to have written procedures for ensuring prompt reporting of

changes

in research activity;

unanticipated

problems involving risk to subjects or others;

and

any instances of serious or continuing non-compliance

to

the IRB, organizational officials, and applicable federal agencies.

Subject to Monitoring and Audits

: Audits could be internal (Corporate Compliance) or external (FDA, OHRP, NIH, Sponsor, etc.)

The FDA “…is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices…” (https://www.fda.gov/about-fda/what-we-do)Research that falls under the FDA’s auspices may not commence until approved by the FDA.

Food and Drug Administration (FDA)

Investigator Responsibilities

Ensuring

that a clinical investigation is conducted according to the approved investigational plan by personally conducting or supervising it

.

The investigator is

accountable for regulatory violations resulting from failure to adequately supervise

the conduct of the clinical study

.

Informed Consent

Informed consent must be obtained from all human subjects involved in research, unless an IRB has approved a waiver. Informed consent includes two components:

Informed Consent Form (ICF)

: A

form that informs the participant of the research and explains the subjects rights in

research.

Informed

Consent

Process

: The

process by which study personnel

disclose

appropriate

information about the study

to a competent

participant.

Required Elements of the ICF

Statement

of what the study involves (research)

Reasonably

foreseeable risks or discomforts

Benefits

Disclosure

of Alternatives

Confidentiality

of records

Compensation

and treatment for injury

Contact

Information

Voluntary

Participation

When Appropriate, Additional Elements of the ICF

Risks Currently Unforeseeable

Investigators may terminate participation

Additional Cost

Consequences of participation withdrawal

Significant new findings

Number of participants planning to participate

Non-English Speakers/Vulnerable Populations

There are certain populations for whom additional safeguards must be implemented when obtaining consent. These include:

Non-English Speakers

Illiterate

Subjects

Prisoners

Children

Pregnant women and fetuses

Employees/Students of the institution conducting the research

Elderly

Cognitively Impaired

Minorities

Before obtaining consent from individuals from any of the above groups, it is necessary to seek guidance from the Office of Research Integrity regarding the procedures.

Reportable Events

Regulations

require an organization to have written procedures for ensuring prompt reporting of

changes in research activity;

unanticipated problems involving risk to subjects or others;

and any instances of serious or continuing non-compliance

to the IRB, organizational officials, and applicable federal agencies.

Reporting

requirements vary, and it is important to be knowledgeable about what should be reported

(and how quickly) prior

to initiating a study.

Data Privacy and Confidentiality: Protected Health Information (PHI)

Health information that is associated with any of the 18 HIPAA identifiers is considered PHI. Utilizing this type of information in research imparts some level of risk to the subject, given the potential for confidentiality breach.

Investigators must indicate in their protocols how they intend to plan for the protection of PHI. This may include coding the data, storing the data on a password-protected computer, and redacting identifiers when providing documents to external agencies.

Contact Information

You are encouraged to contact us with any questions

:

Daniel Alderson, MS, CIP

Manager, Office of Research Integrity

Daniel.Alderson@hackensackmeridian.org

201-880-3652

Tamara Friedman, PhD

Clinical Research Education Specialist, Office of Research Administration

Tamara.friedman@hackensackmeridian.org

551-996-2193