human subjects and teaching scholarship

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CONSIDERATIONS IN HUMAN SUBJECTS RESEARCH FOR TEACHING SCHOLARSHIP Betsy Ripley April 7, 2014

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CONSIDERATIONS IN HUMAN SUBJECTS RESEARCH FOR TEACHING SCHOLARSHIP

Betsy Ripley April 7, 2014

Federal Regulations and Policy stemming from Belmont Principles

45 CFR 46 – DHHS Policy for Protection of Human Research Subjects

21CFR50, 56, etc. – drugs, devices, biologics Common Rule, DOD, DOE ……

Activities requiring IRB approval 45 CFR 46.102(f)

RESEARCH A systematic investigation designed to develop or

contribute to generalizable knowledge. 45 CFR 46.102(d) AND HUMAN SUBJECT A living individual about whom an investigator conducting

research obtains 1) data through intervention or interaction with the

individual, or 2) identifiable private information

Quality Improvement

• OHRP FAQ’s http://answers.hhs.gov/ohrp/categories/1569

• To determine whether these regulations apply to a particular quality improvement activity, the following questions should be addressed in order:

• (1) does the activity involve research(45 CFR 46.102(d)); • (2) does the research activity involve human subjects (45 CFR 46.102(f)); • (3) does the human subjects research qualify for an exemption (45 CFR

46.101(b)); and • (4) is the non-exempt human subjects research conducted or supported by

HHS or otherwise covered by an applicable FWA approved by OHRP.

QI as HSR Goals Purpose Methods Publication is not the main determinant Is it Research?? A systematic investigation designed to develop or contribute to generalizable knowledge.

Is this HSR? • A weekly survey to determine work hours by all housestaff. • A survey of housestaff regarding concentration, motor skill and sleep

patterns to be tied to work hours. • Using “clickers” for a pre and post test as part of a TBL and obtaining

ward scores to correlate with knowledge as determined by pre and post scores.

• Implementation of a discharge summary template to improve adequacy of summary. Training half of the housestaff on the template and providing it to the other half. Did the template and/or the training improve the adequacy.

• Receiving a dataset with MCAT scores and board pass rates and comparing by age, gender, and year of enrollment for past 5 years. Data set contains age, gender, year of MCAT, MCAT score, year of board exam and board score.

• Beginning a pilot project to train third year residents to teach fourth year medical students how to convey bad news to a patient. The program will involve role play, video, and writing. A survey will be conducted with the residents, students and with the students again at the end of their internship.

Document your decision! • If you determine that it is not HSR then make a note to your

study file with an explanation of how you determined that. • If you determine it is HSR then you will need to submit to the

IRB.

IRB Review Continuum

Exempt Expedited Full Low Risk High

Level of potential risk determines route of review

Minimal risk

The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.

45 CFR 46.102(i) and 21 CFR 56.102(i)

“Risk Assessment” Not just physical risks! Consider: - Emotional distress - Embarrassment/ stigma - Risk to financial status - Risk to social status - Risk to employment - Risk to criminal/ civil liability - Invasion of privacy - Etc.

Vulnerable Populations • Children (less than 18 in VA) • Pregnant women and neonates • Prisoners

• Students • Employees • Trainees • Adults with decisional challenges

Mechanisms for Initial IRB Review

•Exemption*

•Expedited Review

•Full Review (Convened)

*FDA requirements differ from the 45 CFR 46 and Common Rule

Exemption Categories: 45 CFR 46 101 (b)

1. *Typical educational practices 2. *Anonymous surveys, interviews, or

observation of public behavior (generally not applicable to children)

3. Research with elected public officials, appointed public officials, candidate for public office)

4. *Existing data, documents, pathological specimens, if publicly available or unidentifiable (no identifiers retained)

5. Evaluation of public benefit service programs

6. Taste and food quality evaluation and consumer acceptance studies

Exempt [46.101(b)]

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices

Exempt [46.101(b)] 2. Survey, interviews or observations of public behavior,

unless - information obtained is recorded in such a manner that

human subjects can be identified, directly or through identifiers linked to the subjects; and

- 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

Exempt [46.101(b)]

4. Research involving the collection or study of existing data, if the data are publicly available or 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

Categories for Expedited Review: No greater than minimal risk!

Clinical studies: IND/IDE

NOT required Blood sample collection

(routine methods –small amounts)

Prospective collection of biological samples—noninvasive means

Data collected though noninvasive means (routinely practiced in clinical settings)

Materials (data, documents, specimens etc.) have been collected or will be collected for non-research purposes

Collection of voice, video or digital data for research purposes

Individual or group behavior, surveys, interviews, oral histories

Exempt <<< Review >>>Expedited

(1)

Minimal risk

One IRB or Qualified Exempt reviewer

Fits one of 6 categories of

research Usually no recorded

identifiers, with some exception

Topic generally not sensitive

Minimal risk research

One IRB reviewer outside of convened meeting

Fits one of 7 expedited

categories (for initial review) May include identifiers (direct

or indirect)

Topics not sensitive OR may

include some sensitive topics, but confidentiality securely protected

Exempt <<< Review >>>Expedited (2)

• Non-vulnerable

populations, with some exception

• Exempt from formal

informed consent requirement (but subjects deserve to know about the research if possible)

• Exempt from continuing IRB review

• Populations may include regulated vulnerable & others with adequate protections

• Required formal informed consent process OR justify a waiver of consent

• Requires IRB continuing review at least annually

Full IRB Review

Does not qualify for exempt or expedited review based on risk assessment by PI and/or IRB…….

Greater than minimal risk!

(some non-HSR requires IRB approval per regs)

2 reviewers present the study at a convened meeting

IRB majority finds all Criteria for Approval are satisfied

Additional Review Requirements

• Type of Review Categories for Exempt and Expedited • Documents: Surveys, Questionnaires, Ads • Engagement of outside investigators or institutions • GWAS criteria • HIPAA • COI as relates to human subjects • Congruence of grants • IRB office: CITI training, COI resolution, other review groups

(ex. investigational drug plan, biohazards)

8 Criteria for IRB Approval 45 CFR 46.111(a)

Select One or More IRB_Approval_Conditions

Filter by Number

Total Selected: 8 1-8 of 8

Number Long Name

1 Risks to subjects are minimized (i) by using procedures consistent with sound research

design and do not unnecessarily expose subjects to risk and (ii) if appropriate, by using procedures already being performed for diagnostic or treatment purposes

2 Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,

and the importance of the knowledge that may reasonably result

3 Selection of subjects is equitable

4 Informed consent will be sought from each prospective subject or the subject's LAR to

the extent required by 45 CFR 46.116 / 21 CFR 50.20

5 Informed consent will be appropriately documented in accordance with 45 CFR 46.117

/ 21 CFR 50.27

6 When appropriate, the research plan makes adequate provision for monitoring the data

collected to ensure the safety of subjects

7 The research plan includes adequate provisions to protect the privacy of subjects and

to maintain the confidentiality of data

8 When some or all of the subjects are likely to be vulnerable to coercion or undue

influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects.(46.111 (b))

Total Selected: 8 1-8 of 8

Duty to Report • VCU Policy goes beyond traditional mandatory reporters • Should be in your consent if appropriate

Consent • Not formally required for Exempt • Required for Full board or Expedited unless waived with required and if applicable

information

• Waiver of Consent: Waiver of some or all elements of informed consent/permission may be appropriate: - research is no greater than minimal risk - no impact on rights or dignity of participants - not practicable to obtain informed consent - provide debrief after the research, as appropriate

• Waiver of Documentation of Consent

• Research presents no more than minimal risk* • AND • Research involves procedures that do not require written consent when performed

outside of a research setting

• Consent Templates on VCU IRB website • RAMSIRB Consent Groups: This is the types of folks you will be consenting. For

instance if you are consenting medical residents for one survey, nursing staff for another then that would be two groups.

Once Approved the Fun Starts • Regulatory Binder • Data Security • Continuing Review • Amendments • Study Closure • Prompt reports: Unanticipated Problems and SAEs • Non prompt reports

RAMSIRB • Main VCU IRB website http://www.research.vcu.edu/human_research/conducting.htm

• RAMSIRB • Must have VPN on computer if not at VCU/VCUHS • Sign in with eid • What you need to get started: CITI, FIR, PI CV, Consents,

Surveys, your plan. • Student Trainee research • Determine what type of research it is

Helpful hints to RAMSIRB • Add editors • Conversion Amendments • Have to answer questions with * • Help text • You have to upload one document when you get to the personnel

screen. PI CV is usually it. This will then appear anytime a document is requested. This is a running list of documents. Do not delete a document unless you really want it gone from the system.

• Create a dummy study if want to see what happens with different choices or know what you will be asked.

• Once submitted reviewer makes comments to you in the review section on each page. If changes required before approval or need clarifications they will send it back to you (electronically). You need to respond to every reviewer comment even if to say OK or done or changes made. Then submit again. Only those on the side with current access can work on it. You can however look to see progress on the first screen

• If you have a question about a submitted study you can send a public comment in the system.

HELP! • Email or talk to me • Send public comment in an already submitted protocol • Other reviewers, IRB panel coordinators • Michelle Stickler, Christine Davison, Susan Kimbrough • [email protected] for questions about the content of the study

forms • [email protected] for technical issues