New Jersey Forms Voluntary Termination of Parental Rights

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					IRB Tutorial
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Institutional Review Board
      Tutorial for
     Faculty & Staff
The College of New Jersey
Institutional Review Board


 • What is the IRB?
 • What is its purview?
 • How do I receive IRB approval for
   conducting human subjects
   research?
The College of New Jersey
Institutional Review Board


 • What is the IRB?
 • What is its purview? (or, what is
   human subjects research?)
 • How do I receive IRB approval for
   conducting human subjects
   research?
The College of New Jersey
Institutional Review Board
1. Established to protect rights and welfare of
   human subjects in research in accordance with
   Federalwide Assurance (FWA00004576)
2. Must meet federal guidelines as specified in
   Title 45 Code of Federal Regulations Part 46.
3. Charged with responsibility and authority to
   approve, require modifications in, halt
   unapproved or non-compliant research.
The College of New Jersey
Institutional Review Board


 • What is the IRB?
 • What is its purview? (or, what is
   human subjects research?)
 • How do I receive IRB approval for
   conducting human subjects
   research?
As a rule of thumb, IF . . .

1. Is the activity a systematic investigation
   designed to develop or contribute to
   generalizable knowledge? [45 CFR 46.102(d)]
2. Does the research involve obtaining
   information about living individuals? [45 CFR
   46.102(f)]
3. Does the research involve intervention or
   interaction with the individuals? [45 CFR
   46.102(f)(1),(2)]

. . .THEN your scholarly activity falls under the
    purview of 45 CFR part 46
Additional
guidelines and
regulations can
be found in IRB
policy manual.




source: http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm
The College of New Jersey
Institutional Review Board


 • What is the IRB?
 • What is its purview? (or, what is
   human subjects research?)
 • How do I receive IRB approval for
   conducting human subjects
   research?
Workflow Overview


     PI Receives Training              PI Submits Proposal

                                         Notification sent to PI & IRB




     IRB Reviews Proposal              PI Reviews Feedback

       Notification sent to PI if         Notification sent to IRB if
       revisions are required             revisions are made




     IRB Approval                      PI Submits Report

       Notification sent to PI & IRB      Notification sent to PI & IRB
Workflow Process
 STEP 1: PI Receives Training Online & Retains Certificate
 Principal investigators and student investigators are required to undergo
 online training and obtain NIH certification in conducting research involving
 human subjects. This certification must be renewed every three years.

 STEP 2: PI Generates Consent Document
 Effective August 2010, principal investigators are required to generate and
 upload consent documents using the eConsent form available on the eIRB
 system.

 STEP 3: PI Submits Proposal
 PI will login into the eIRB System and submit proposal (e.g. includes online
 application, eConsent, and supporting materials). Once the chair assigns
 the proposal to IRB reviewers, the PI will receive an e-mail notification that
 the proposal is in review.

 STEP 4: IRB Evaluates Proposal and Responds to PI
 IRB reviewers will read your proposal and provide feedback within the
 system. The PI will receive an e-mail notification if revisions are required.
Workflow Process
 STEP 4: PI Reviews Feedback and Addresses Concerns (if any)
 The PI will login into the eIRB System and respond to feedback by updating
 supporting materials or the application. The IRB reviewers will receive e-
 mail notifications when the proposal has been updated. Once the PI has
 addressed all of the concerns, IRB reviewers will recommend the proposal
 for approval.

 STEP 5: IRB Approves Proposal and PI Begins Research
 The IRB Chair approves the proposal and sets the expiration date for the
 protocol. The PI will receive an e-mail notification that the proposal is
 approved. Approval is granted on the condition that any deviation from the
 protocol will be submitted for separate approval in the eIRB System.

 STEP 6: PI Submits Annual Report and Renews Proposal to
 Continue Research
 Approval is valid until the expiration date of your protocol. You are required
 to apply for a renewal at least 45 days before the expiration date for as long
 as the study is active.
AGAIN, first decide: Is your
scholarly activity research
involving human subjects,
as codified under 45 CFR
46.101?
THEN decide: What TYPE
of research is it?
As a rule of thumb, IF . . .
1. conducted in established or commonly accepted
    educational settings, involving normal education
    practices
2. use of educational tests, survey procedures, interview
    procedures, or observation of public behavior
3. collection or study of existing data, documents,
    records, or pathological or diagnostic specimens
4. studying, evaluation, or examining public benefit or
    service programs
5. taste and food quality evaluation or consumer
    acceptance studies
. . .THEN your human subjects research falls under
    exempt category. [45 CFR part 46.101(i), 45 CFR part
    46.401(b)]
          Additional
          guidelines and
          regulations
          regarding
          exemptions can
          be found in IRB
          policy manual.



http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm
As a general rule of thumb, EXPEDITED research
  categories may include

1. Collecting data from subjects 18 or older using non-
   invasive procedures routinely employed in clinical
   practice.
2. Moderate exercise by healthy volunteers.
3. Study of existing data, documents, records,
   pathological specimens, or diagnostic specimens.
4. Research on individual or group behavior or
   characteristics of individuals, such as studies of
   perception, cognition, game theory or test
   development.
REFER TO THE POLICY MANUAL FOR DETAILED LIST OF RESEARCH
                 CATEGORIES and EXCEPTIONS
As a general rule of thumb, following categories fall
  under FULL BOARD review

Research characteristic:
1.Procedure may result in greater than minimal risk

Participant characteristics:
1. Children under the age of 18
2. Pregnant women
3. Prisoners
4. Individuals with cognitive impairments
5. Senior citizens.

REFER TO THE POLICY MANUAL FOR DETAILS
Step 3: Submit the IRB
proposal, following the
step-by-step instructions.
Helpful Hint:

Complete all forms and
documentation prior to
submitting the IRB
proposal.
Helpful Hint:

Use the sample forms that
have been provided for
you as you gather
documentation.
IRB Protocol Review Standards [45 CFR 46.111]

1. Proposed research design is scientifically sound and
   will not unnecessarily expose subjects to risk.
2. Risks to subjects are reasonable in relations to
   anticipated benefits to subjects and the importance
   of knowledge that may reasonably be expected to
   result.
3. Subjects selection is equitable.
4. Additional safeguards required for subjects likely to
   be vulnerable to coercion or undue influence.
5. Informed consent is obtained from research subjects.
6. Risks to subjects are minimized.
7. Subjects privacy and confidentiality are maximized.
Informed Consent [45 CFR 46.116 (a) through (f)]
Some common mistakes and missing elements:
1. A statement that the study involves research and
   explanation of the purpose of the research.
2. Description of: duration, procedures , risks , benefits.
3. Statement describing confidentiality of records.
4. Contact info about the research and participant rights,
   including contact info for IRB chair for additional
   questions and concerns.
5. Statement that participation is voluntary and that
   refusal or termination of participation will not result in
   penalty or harm.
6. Parental permission and child assent for Ss under 18.
REFER TO THE POLICY MANUAL FOR DETAILS
The College of New Jersey
Institutional Review Board

 Thank you!



              www.tcnj.edu/~irb

				
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