MAGI's Clinical Research Conference

“But according to the Regulations…”

Session C293Tuesday, October 13, 2015

Ernest D. Prentice, PhD

Parker Nolen, MBA, CRCC, CIP

(C293) Regulatory Myths

MAGI's Clinical Research Conference 2

WELL, THINK AGAIN!

How often do we say, “According to the regulations …”

Assent document are never required

• TRUE

• 21 CFR §50.55(g) When the IRB determines that assent is required, it must also determine whether and how assent must be documented.

The IRB gets to decide whether an activity is research

• FALSE

• 45 CFR§46.101(c) Department or Agency heads retain final judgment as to whether a particular activity is covered by this policy.

It is OK to enroll an ineligible subject if the sponsor grants a waiver

• FALSE

• 21 CFR§56.108

Each IRB shall follow written procedures for ensuring that changes in approved research … may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.

If you do not check the box and there is no HHS funding, HHS regulations do not apply

• FALSE

• 45 CFR§46.101(a) … this policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any Federal Department or Agency which takes appropriate administrative action to make the policy applicable to such research.

IRB members can be told about expedited approvals by listing them on a Web site

• TRUE

• 21 CFR§56.110(c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure

Activities that are not human research are exempt from regulation

• FALSE

• 45 CFR§46.101(b) … research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy: (Exempt Categories)

A subject who becomes incarcerated must be dropped from the research if the research is not reviewed under Subpart C

• True

• However, OHRP guidance allows for exceptions (of course they do!)

You can review research involving prisoners without a prisoner rep on your IRB

• TRUE

• 45 CFR§46.304 (b) At least one member of the Board shall be a prisoner, or a prisoner representative …, except that where a particular research project is reviewed by more than one Board only one Board need satisfy this requirement.

All unanticipated problems involving risk to subjects or others in HHS-supported research must be reported to OHRP

• FALSE

• OHRP does not hold institutions accountable for not reporting UPIRTSOs unrelated to the local research context

When FDA conducts human research it must follow FDA regulations

• FALSE

• When FDA does human research it must follow HHS regulations

• FDA regulations apply only if the research is also a clinical investigation of a drug or device

Research with an approved drug with no intent to make label changes is IND exempt

• FALSE

• 21 CFR§312.2 (b)(iii) The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks … associated with the use of the drug product

Changes in IRB membership must be updated within 90 days

• FALSE

• 21 CFR§56.106 If an IRB’s contact or chair person information changes, the IRB must revise its registration … within 90 days of the change.

Documentation must be written using black ink

• FALSE

• The regulations are silent

If a retrospective chart review that records identifiers may be Exempt #4

• TRUE

• 45 CFR§46.101 (b)(4) Research involving the collection or study of existing data, … if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Quality Improvement studies intended to develop generalizable knowledge require prior IRB approval

• FALSE AND TRUE

• 45 CFR§46.102 45 CFR§46.101 (b) (d)

• However, the definitions of “Research” and “Human Subject” can trigger an IRB review in certain circumstances even if it is a QI project.

Just like in medicine, if it wasn’t documented it didn’t happen.

• FALSE

• When documentation is not required by regulations, having SOPs and following them is adequate (also true in medicine)

Documents provided to subjects as part of the consent process must be in language understandable to the subject or representative

• FALSE

• 45 CFR§46.116– The information that is

given to the subject or the representative shall be in language understandable to the subject or the representative.

– OHRP allows short form• 45 CFR§46.117

– … embodies the elements of informed consent required by §46.116

The IRB can vote on whether an IND or IDE is required

• FALSE

• 21 CFR §312– Sponsor responsibility– No role for the IRB

• 21 CFR §812– Sponsor responsibility– No role for the IRB

If a subject takes aspirin as part of a research study and fractures their arm, that is an Adverse Event

• TRUE

• 21 CFR§312.32(a) Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

Protocol deviations need to be reported to the IRB

• FALSE

• The term “protocol deviation” does not appear in– 21 CFR §50, 56– 45 CFR §46– 21 CFR §312– 21 CFR §812

Adverse events need to be reported to the IRB

• FALSE

• The term “adverse event” does not appear in– 21 CFR §50, 56– 45 CFR §46

• There is requirement to report adverse events to the IRB in:– 21 CFR §312– 21 CFR §812

Consent forms must disclose the procedures being used to maintain confidentiality

• FALSE

• 21 CFR§50.25 (a)(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained

For minimal risk research, the consent must disclose whom to contact in the event of research-related injury

• TRUE

• 21 CFR§50.25 (a)(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject.

Prisoner research can be reviewed using the expedited procedure

• TRUE

• OHRP prefers that you do not but the regulations do not prohibit it and OHRP does not cite people for expediting such research

All privacy board actions can be done by the Expedited procedure

• TRUE

Waiver criteria: – The use or disclosure of

protected health information involves no more than a minimal risk to the privacy of individuals

Expedited criteria: – The research involves

no more than minimal risk to the privacy of the individuals

HIPAA authorizations can be used prior to IRB/Privacy Board review

• FALSE

• 45 CFR§ 164.508 (b)(1)(i) A valid authorization is a document that meets the requirements in paragraphs (a)(3)(ii), (c)(1), and (c)(2) of this section, as applicable.

Expedited does not mean fast

• FALSE

• ex·pe·dited ekspə dī təd

1.made (an action or process) happen sooner or be accomplished more quickly.

synonyms: sped up, accelerated, hurried, hastened, stepped up, quickened, precipitated, dispatched