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CPRA > Awards & Pre-Award Compliance (15%) > Flashcards

Awards & Pre-Award Compliance (15%) Flashcards

1
Q

3 tenets of the Belmont Report

A
  1. Respect for persons
  2. Beneficence
  3. Justice
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2
Q

Respects for Persons means:
(Belmont Report)

A
  • individuals should be treated as autonomous agents
  • persons with diminished autonomy are entitled to protection
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3
Q

Beneficence means:
(Belmont Report)

A
  • do no harm
  • maximize possible benefits and minimize possible harms
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4
Q

Justice means:
(Belmont Report)

A

Certain individuals (eg those in marginalized or vulnerable groups) may not face greater risks in participation while others benefit. IRB or ethics committee should review all research studies

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5
Q

Where is the common rule found?

A

US Department of Health and Human Services (HHS) policy for the protection of human subjects (45 CFR 45, Subpart A)

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6
Q

What does the Common Rule do?

A

Provides additional protection for vulnerable groups:

  1. Pregnant women, fetuses, and neonates/ newborns (subpart B)
  2. Prisoners (subpart C)
  3. Children (subpart D)
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7
Q

Definition of “human subject” per IRB

A

A living individual about whom an investigator (whether professional or student) conducting research: (1) obtains Information or biospecimans through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimans; or (2) obtains, uses, studies, analyses, or generates identifiable private information or identifiable biospecimans.

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8
Q

How is “research” defined by the Common Rule and the Belmont Report?

A

Common Rule: research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge

Belmont Report: an activity designed to test a hypothesis and permit conclusions to be drawn

Through a formal study plan with a set of procedures to reach an objective

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9
Q

Is oral history considered research?

A

Not accordingly to federal regulations, but some institutions will review these activities to ensure protection of subjects are providing personal data

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10
Q

According to 45 CFR 46, IRB must include:

A
  • 5 members from relevant academic disciplines or experiences
  • at least one member not affiliated with the institution
  • at least one member with scientific expertise (conducts and is knowledgeable about research and human subjects research)
  • at least one member who is a “non-scientist” to provide a layperson perspective
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11
Q

What is Review for Exemption?

A

Studies with no more than minimal risk. Determined by experienced staff member, chair, or IRB member.

  • educational research (eG curriculum evaluation where info is non-identifiable and participation is voluntary)
  • interview/survey on non-sensitive subjects
    Public officials or professional/program evaluation
  • existing (“extant”) data that is de-identified / anonymous
    -taste testing, food quality, or marketing research
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12
Q

What is Expedited Review?

A

Typically involve some degree of risk but still to a minimal degree. An IRB member may review the study. For studies of slightly higher risk, multiple revisits may conduct the review.) Some categories:

  • collection of direct identifiers (voice or image) linked to responses of a more personal or sensitive nature
  • work with potentially vulnerable populations (children, homeless, undocumented)
  • potential for distress to participants beyond what normal in everyday life
  • possibility of undue influence ( eg supervisor recruiting office staff or professor recruiting students)
  • direct contact interviews, surveys, focus groups to collect sensitive or personal information
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13
Q

What is convened review?

A

When research activities pose significantly higher risks to subjects than those that might occur in daily life. Select IRB members may serve as “primary reviewers” and present their assessment as a convened meeting where all members will review the study and engage in a discussion. Examples include:

  • minors if the data are sensitive
  • pregnant women, fetuses, newborns
  • prisoners or parolees
  • individuals with decisional impairment
  • abuse, drug use, or sexuality
  • certain biomedical and/or experimental procedures
  • heightened physical discomfort, risk of injury, or invasion of privacy
  • use of a regulated drug/device, dietary manipulation, or medical/clinical assessment of identifiable patients/ volunteers
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14
Q

What documents are required as part of a complete IRB study plan?

A
  1. an application with plan for recruitment, study plan, managing data, managing potential risks of harm, list of who is involved
  2. Recruitment materials such as fliers, email scripts, social media announcements
  3. Informed consent form or script for oral project
  4. “Instruments” such as Interview our focus group questions, surveys (some require specific questions - others allow themes)
  5. Human subjects training for all researchers

(IRB may ask for additional items such as site permission, FDA approval, copyright permission)

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15
Q

Best practices in research studies

A

Recruitment: be careful when talking to friends and family, snowball sampling, and sliding social media that personal information may not inadvertently be disclosed.

Always consider hierarchies and influences. Eg school emails are not really private

Incentives are usually discouraged for minimal risk studies - but if necessary, consider what is appropriate in the context. (EG international situation might create discord, or a poor person might feel pressured to do it for the money)

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16
Q

Informed consent is an ongoing process

A

True - participants should feel free to ask further questions, reconsider participation, retract certain data, or withdraw their data at any time

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17
Q

What is HIPAA?

A

The Health Insurance Portability and Accountability Act of 1996 - federal law that generally prohibits health care providers from disclosing protected health information (PHI) without written consent from the patient

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18
Q

What are indirect identifiers?

A

Data that, in combination with other data, might reveal an individual’s identity, especially with a small sample size. Eg:
- Age, sex gender, race
- Size of town, general location, community characteristics (industrial, education, etc)
- characteristics of family structure
- details of personal characteristics or expressions of individuality

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19
Q

Anonymity vs confidentiality vs privacy

A

Anonymity - days are completely de-identified meaning you do not know the identity of the respondent in connection with the data. (Interviews and focus groups can never be anonymous)

Confidentiality - agreement that the respondent’s identity will not be disclosed beyond the research team without explicit permission. You can rarely guarantee absolute confidentiality. Also impacted by mandatory reporting laws and the possibility of a breach via email or videoconferencing

Privacy - the degree to which an individual has control over sharing personal information (physical, behavioral, and intellectual) - must be protected.

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20
Q

General Data Protection Regulation (GDPR)

A

EU rules over individual privacy and agency. Stricter than US. Could apply if you put out a survey over social media - for example.

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21
Q

Name 5 data storage considerations

A
  1. How will I collect the data?
  2. Where will I store the data?
  3. Who will have access to the raw data?
  4. Am i storing the data in the safest manner? Could they be lost?
  5. What will I do with the raw data at the end of the study?
22
Q

What makes data non-identified or deidentified?

A
  • no direct identifiers were collected or not enough indirect identifiers to reveal an individual’s identity
  • not maintain a code to link an individual to responses
23
Q

When is deception considered in IRB?

A
  • when necessary for research goal and data collection
  • when it will not increase risk (financial, physical, psychological, or social) to subjects
  • when there is an appropriate debriefing session following the data collection to inform subjects about the nature and purpose of the deception
24
Q

What IRB requirements exist for international work?

A
  1. You must provide the same or equivalent protections to individuals participating in other countries
  2. You must know and comply with local laws, regulations, political and socio-economic factors, and cultural contexts for all locations where you wish to conduct research
  3. For higher risk studies the IRB might request consultation with experts in that particular setting
25
Q

What should NOT be considered benefits in an IRB plan?

A
  1. Including marginalized voices is unlikely to “fill gaps” in larger societal conversations
  2. It make take years for information dissemination to create any measurable impact
  3. Incentives, and food are never benefits
  4. Pleasure or enjoyment from participating
26
Q

What are the 3 guidelines of informed consent?

A
  • disclosing to potential research subjects information needed to make an informed decision
  • facilitating the understanding of what has been disclosed
  • printing the voluntariness of the decision about whether or not to participate in the research
27
Q

What essential points of information must researchers provide to potential research subjects?

A
  • purpose of the research
  • description of what the subject will be expected to do
  • any foreseeable risks of harm
  • participation is voluntary and subjects are free to withdraw at any time
28
Q

Do public health surveillance activities require IRB?

A

No

29
Q

Is it necessary for precise, replicable measurements to be collected in order for research to be considered system?

A

No

30
Q

What type of interactions and interventions are used in research?

A

Interventions include:
- physical procedures through which data are collected (eg measuring brain function)
- behavioral interventions (eg experimental education programs or unproven psychosocial therapies)
- may also include manipulation of the subject or their environment (eg effect of music on memory)

Interactions:
Communication or interpersonal contact between the subject and researcher. Communication does not have to be in person and could be entirely on paper. Online surveys that do not ask for any identifying information are considered interactions. Participants observation is a variant of interaction

31
Q

Name the 3 possible sets of IRB reviewers

A
  1. Individuals identified by the organization to screen research for exempt status
  2. One or more experienced IRB members designated by the IRB chair to conduct expedited reviews
  3. A convened meeting of the IRB. A convened meeting is generally understood as a majority of the members of the IRB present either in person or via telephone conference call
32
Q

What other names might an institution use for IRB?

A

Research ethics board
Independent ethics committee

33
Q

What are two examples of additional regulatory requirements for clinical trials?

A
  1. Common rule governed clinical trials must post informed consent forms on a publicly available website
  2. NIG-supported clinical trials have additional training requirements such as “good clinical practice”
34
Q

What are the main considerations in addressing level of risk for IRB?

A
  • probability and magnitude of harm
  • time, situation, and culture
  • subject population (eg smoking is harmful for adults, but illegal for teens)
35
Q

Who issues certificates of confidentiality and what do they do?

A

NIH - and they prohibit PI or others with access from disclosing identifying information on research participants in: civil, criminal, administrative, legislative, or other proceedings- whether at federal, state, or local level

36
Q

Key points about Certificate of confidentiality

A
  • permanent and do not expire
  • do not override requirements to report child abuse or neglect - or other legal mandated reporting
37
Q

Do federal regulations require documentation of minors’ consent?

A

No

38
Q

Which subpart is related to children?

A

Subpart D of the HHS regulations

39
Q

Are the provisions is subpart D applicable to all federal agencies?

A

No - only HHS (including NIH), and now also the FDA and the department of education

40
Q

What is FERPA?

A

The family educational rights and privacy act (aka the Buckley Amendment). Gives parents certain rights over their children’s educational records

41
Q

What is the threshold at which NIH applications must include a plan for sharing final research data for research purposes or state why data sharing is not possible?

A

$500,000 or more

42
Q

What sections are required in an NIH data management plan?

A
  1. Data type
  2. Related tools, software, and/or codes
  3. Standards
  4. Data preservation, access, and associated timelines
  5. Access, Distribution, orReuse Considerations
  6. oversight of data management and sharing
43
Q

Sections os an NSF data management plan

A
  1. Data and materials produced
  2. Standards, formats, and metadata
  3. Roles & responsibilities
  4. Dissemination methods
  5. Policies for data sharing and public access
  6. Archiving, storage, and preservation
44
Q

Which 8 agencies are part of the department of health and human services, Public Health Service (PHS)?

A

Comprised of: Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA).

45
Q

What do the numbers on NIH grants mean?

A

Not all research grants are R grants, and not all R grants are research.

Research Project grants Include R1, R15, R21, DP1, P01

Small business (STTR and SBIR) grants include R41 - R44

Center grants include most P awards

Other research grants include conference grants (R13), resource grants (R24, R25), and the alphabet blur

Research career development awards (K)

Research training and fellowship (T & F)

Cooperative agreements (U) research, small buddies, centers and others with lots of NIH involvement

46
Q

What’s an R01?

A

Research project
No specific dollar amount
Advanced permission required for more than $500k per year (direct cost) spending
Generally 3-5 years but can be renewed
Oldest and most common

47
Q

NIH grants require pre-approval if they are over what amount?

A

$500,000 in any year (excluding F&A). Must be in writing and included in application

48
Q

When must an NIH grant be requested in modules of $25,000

A

When:
- is for R01, R03, R15, R21, R34 or cooperative equivalent
- requests no more than $250,000 direct costs in any budget period
- does not propose use of human fetal tissue from elective abortions
- is not from a foreign organization

OR when required by FOA

49
Q

What is the NIH salary cap?

A

$212,100

50
Q

How are modular budgets different?

A

Typically limited to a personnel justification, level of effort and role without individual salary info

Additional justification not necessary if each year is the same, or in response to an FOA that cannot be spread evenly across budget periods

Well justified Modular increments may be requested but require additional justification. Separate justifications still required for subaward/ consortium budgets

51
Q

Which is a better NIH score - 10 or 99?

A

99 is very poor, 10 is excellent

CPRA (5 decks)

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