45 CFR 46 Common Rule

What does "engaged in research" mean? Criteria for being engaged?

When agents of an instit for purposes of NON-EXEMPT research, do any of the following: 1) interact/intervene with indie 2) collect private ident info for research purposes 3) analyze identifiable data

Should an UP that is NOT an AE be reported to IRB?,

YES, since meets UP definition doesn't matter if AE or not.

Does OHRP have authority to investigate non-federally funded research?,

Yes but ONLY if instit has FWA.

Per 46.109 what are reg requirements in DISAPPROVING research?,

"1) IRB to notify in writing PI and instit of disapproval and give PI opportunity to respond 2) IRB can disapprove research via convened review procedure only ( Expedited NOT allowed)"

When can Expedited Review procedures be used?,

"1) If some/all research falls into Exp Cat list + reviewer det invl no more than MIN RISK 2) minor changes to approved research during approval period"

What is the criteria for UP that require reporting to IRB?,

"1) UNEXPECTED (in nature, severity, and frequency) based on info in protocol, CF and characteristics of pop 2) RELATED/POSSIBLY RELATED TO RESEARCH 3) POSES SUBJECTS OR OTHERS AT GREATER RISK than previously known

HIPAA definitions of "De-IDENTIFIED",

"2 definitions: 1) expert determines risk is very small that info could be used alone or in combo w/ other avail info to identify subj and 2) 18 identifiers of individual or relatives/employers/household members of indiv must be removed

What is the CFR and criteria for IRB approval (7)?,

"46.111 - criteria (RREDIPS) 1) risks minimized 2) risk/benefit ratio 3) equitable sel of pts 4) informed consent - obtain and document 5) privacy and confid protections in place 6) data safety monitoring 7) Special reg req for Vul Pop, Emergency Research, Education Research

When can an IRB suspend/terminate IRB approval of research?,

"46.113 1) If not being conducted in accordance with IRBs requirements 2) Associated with UNEXPECTED SERIOUS HARM TO SUBJ

What must an IRB do after they suspend/terminate IRB approval of research?,

"46.113 1) include statement of reasons for IRB action 2) report suspension/term to PI, Insistution Officials, and dept agency/head (3)

ABCs of the Common Rule: What 4 things does every institution engaged in DHHS supp/conducted HSR need to have?,

"ABCDs of45 CFR 46 ASSURANCE of Compliance by OHRP BOARD Approval (IRB, REB, ethics committee) CONSENT obtained from ea subject unless waived DISCLOSURE: Reporting of UP/NC

Expedited Cat 2,

"Blood collection where: a) healthy subj mini 110 lbs: blood collected < 550mL/ 8 weeks period/ 2 draws per week b) unhealthy: blood < 50mL/ 8 week period/ 2draws per week

Expedited Cat 1,

"Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs where IND not required = approved, marked drugs used per approved labeling (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) IDE not required OR (ii) APPROVED medical device used per cleared/approved labeling.

What is COOPERATIVE RESEARCH and what are the fed requirements?,

"Coop -HSR that involve more than 1 institution Requirements: 1) each instit responsible for HSR protections and complying with policy 2) with Dept Head approval, COOP research can enter joint review, reliance agreement, or other sim arrangement to reduce duplicative review

The federal government has the authority to regulate ALL non-federally-funded research. True or False,

"FALSE - Only for FDA-regulated research, OHRP oversight only covers federally funded research, *only strongly recommend that instit apply for FWA

46.108 What is quorum for convened meeting? To approve research?

*convened meeting: 1 NS + majority (half total members + 1) *approve: approval by majority vote: # members present to vote is more than half

46.107 What is required IRB Membership composition?

1) 1 NS 2) 1 Non-Affiliated 3) at least 5 members 4) Cant be all same gender or profession

Per 46.115, what records should an instit/IRB prepare and maintain as adequate documentation of IRB activities?

1) Copies of all RESEARCH PROPOSALS REVIEWED 2) Minutes (attendance, actions, vote, basis of changing, discussion/resolution of controverted issues) 3) CR activities 4) All correspondence between IRB and investigatiors 5) IRB member rosters 6) SOP 7) statements of significant new findings provided to subj;

What must be assessed during Continuing Review?,

1) IRB review criteria, 2)Sub B-D requirements, 3) any new info that warrant CF update, 4) progress of research

The Dept/Agency head may restrict/susped or choose not to authorize instit/IRB to use expedited review procedure. True or False?,

TRUE

Exempt Cat 6

Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

What's criteria to determine if activity is HUMAN SUBJ RESEARCH subject to 45 CFR 46?

1. Does activity meet research def? 2. HSR def? intervention/interaction or collects PRIVATE INDIV IDENTIF INFO 3. 45 CFR 46: SUPP/COND by HHS or FWA

46.101 When do 45 CFR 46 regs apply?

1. HSR CONDUCTED/SUPPORTED or otherwise subject to regulation by any federal dept/agency. 2. HSR ..conducted/supported by fed government OUTSIDE US 3. HSR conducted by FEDERAL CIVILIAN EMPLOYEE OR MILITARY PERSONNEL. 4. If not HHS supported, has FWA to apply regs to all HSR regardless of funding source 5. No impact on other fed/state/local laws if applic or provide stronger protections ; use whichever is stronger protection

How long do IRB records required by 46.115 regs need to be retained?,

3 years

Federal Code and purpose of FERPA

34 CFR 99: Protect confidentiality/disclosure of ed records from release

When do regulations require reporting of unanticipated problems involving risks to subjects to the IRB?,

ALWAYS - if event (regardless if AE or not) meets criteria of unanticipated problem UP, then must be reported

Interviews and focus groups are always exempt from IRB Review.

FALSE -Depending on the topic, an interview or focus group could carry greater than minimal risk. If disclosure of the subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability or reputation, the study is not exempt. See 45 CFR 46.101(b)(2).

Expedited Cat 6,

Collection of data from voice, video, digital, or image recordings made for research purposes

Expedited Cat 4,

Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

Expedited Cat 9,

Continuing review of research, with NO IND/IDE, where categories 2-8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

A disclosure of private subject data is a HIPAA violation that must be reported to the IRB.

DEPENDS. The investigator or institution must analyze the situation to determine if it constitutes an Unanticipated Problem Involving Risks to Subjects or Others. If so, it must be reported to the IRB.

Interviewing managers about a management style or best practice What level of IRB review is needed? Exempt/exp?

Exempt cat 2 - INTERVIEWING, non sensitive info

46.109 At what IRB review level do regulations apply?,

Exp and FB

A study that uses coded biosamples from an outside source is exempt from IRB review because the investigator does not have the codes to identify the donors. True or False,

FALSE - Does NOT qualify for Exemption bc a code still exists. Subjc cant be identiable directly OR indirectly.

If a subject withdraws from a study, he or she may require that his or her confidential study data be removed from the study records.

FALSE. FDA's "Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials" states: Data collected on study subjects up to the time of withdrawal must remain in the trial database in order for the study to be scientifically valid. If a subject withdraws from a study, removal of already collected data would undermine the scientific, and therefore the ethical, integrity of the research. Such removal of data could also put enrolled subjects, future subjects, and eventual users of marketed products at an unreasonable risk. Finally, removal of data would fundamentally compromise FDA's ability to perform its mission, to protect public health and safety by ensuring the safety and effectiveness of regulated products.

46.103 What must the FWA/ Assurance include?

FWA = IPMS/ IRB Designation Principles - Statement Members - List SOPs - Written IRB procedures

46.115 How long do records related to research need to be retained?,

Minimum 3 years after research completed

Do regulations require reporting of AE's to IRB?,

NO - Only when meet criteria of UNANTICIPATED PROBLEM, otherwise do not require AE's reporting otherwise do not require AE's reporting

Is expedited review mechanism always available to every institution?,

NO - ability may be taken away or unauthorized by Dept Agency head

Should an AE that is not a UP be reported to IRB?,

NO b/c does not meet UP definiition

What is 34 CFR 98?

PPRA: Parent, pupil rights from answering survey questions; and requires parental written permission.

Expedited Cat 3,

Prospective collection of biological specimens for research purposes by noninvasive means.

45 CFR 160/164 What is the HIPAA Rule?,

Requires AUTHORIZATION of pt for COLLECTION, USE, AND/OR DISCLOSURE/DISTRIBUTION of PHI, unless waived by privacy board.

Exempt Cat 5

Research about public benefit or service program Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Exempt Cat 1

Research conducted in ESTB or commonly accepted ED SETTINGS, involving SOC ED PRACTICES, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Expedited Cat 5,

Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

Exempt Cat 4,

Research involving the collection or study of EXISTING data, spp, if these sources are 1) PUBLICALLY AVAIL OR 2) if the information is recorded by the investigator in such a manner w/o NO IDENTIFIERS (direct/indirect)

Exempt Cat 3

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey, interview, or observation of public behavior that is not exempt under paragraph (2) of this section, if: (i) the human subjects are elected or appointed PUBLIC OFFICIALS or candidates for public office; or (ii) FEDERAL STATUE REQUIRING CONFIDENTIALITY require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Example: Interviewing public officials about a local or global issue.

Exempt Cat 2

Research involving use of educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews OR observation of PUBLIC behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. Note: The section of this category pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity. This section is not applicable to survey or interview research involving children. Examples: Surveying teachers, nurses, or doctors about a technique or an outcome Interviewing managers about a management style or best practice Conducting a focus group about an experience or an opinion of a community program

Expedited Cat 7,

Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

What is the regulatory (46.108) definition of CONVENED MEETING?

majority of IRB members are present + 1 NS (Regs don't define "majority")

What is the FWA checkbox for?,

presents institutions with the option of voluntarily applying either the Common Rule or the Common Rule and subparts B, C, and D to ALL RESEARCH, regardless of source of support

HHS and FDA Definition of "Human Subject"

• HHS: A living individual about whom an investigator doing research obtains 1) data through intervention/interaction with indiv or 2) identifiable private info. FDA: invid who is/becomes research participant via recipient of test article or control. and is either healthy or patient.

HHS and FDA Definition of "Research"

• HHS: A systematic investigation, including research dev, testing, and evalv, designed to develop/contribute to generalizable knowledge. (45 CFR 46.102) FDA: "Clinical investigation" - any experiment inv test article and >1 subject, where results to be used for research or marketing approval

"Minimal Risk"

• Probability & magnitude of harm/discomfort from research are not greater than encountered in daily life or from routine physical exam. (DHHS & FDA)