Completing a first-rate w88 casino

Essentials of a Good Reviewer

• Knowledgeable of the regulations, w88 casino, and the IRB process
• Thorough
• Thoughtful
• Collaborative with investigators, the w88 casino staff, and colleagues on the panel
• Reasonable

The IRB Mission: To protect the rights and welfare of w88 casino participants

The IRB is charged with the responsibility of reviewing and overseeing human subject research. The IRB w88 casino process is designed to protect the rights and welfare of human subjects by ensuring equitable selection of participants, assuring adequate informed consent, assessing and minimizing risks and maintaining privacy and confidentiality.

How IRBs Got Started

• Tuskegee Syphilis w88 casino came to light in the early 1970’s
• National Commission created by Congress to develop principles and policy for w88 casino oversight (the Belmont Report)
• Peer w88 casino (i.e. the IRB) is established as an essential component of research ethics
  • Informed w88 casino
  • Investigator integrity

The Office for Human w88 casino Protections

OHRP is an office within the Dept. of Health & Human Services (DHHS) that deals with the ethical oversight of w88 casino.

Tip for interpreting the regs: “Know the lingo”

• “Must” = Required
• “Should” = Recommended or Suggested

Title 45 Code of Federal Regulations, Part 46

45 CFR 46 consists of Subparts A-D:

• Subpart A: “The Common Rule”
• Subpart B: Additional protections related to w88 casino involving fetuses, neonates, and pregnant women
• Subpart C: Additional protections related to w88 casino involving prisoners
• Subpart D: Additional protections related to w88 casino involving children

Key Points to Consider

w88 casino

Is the risk to the participant minimized? Have the investigators done everything they can to ensure the participants are only exposed to risk absolutely necessary to conduct the w88 casino?

Validity

Will the w88 casino yield results that matter?

w88 casino

Is the w88 casino document clear & easy to understand? Is the w88 casino document written appropriately for the population being studied?

Assessing w88 casino

Minimal w88 casino

The probability and magnitude of harm and discomfort anticipated in w88 casino are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological tests

Greater than Minimal w88 casino

Not minimal, or “less than” minimal w88 casino.

Minimizing w88 casino (45 CFR 46.111)

How do we ensure the risks to w88 casino are minimized?

• Use procedures consistent with sound w88 casino design and which do not unnecessarily expose subjects to risk
• Whenever appropriate, use procedures already being performed on the subjects for diagnostic or treatment purposes

The w88 casino/Benefit Ratio

The risk/benefit ratio is the comparison of the risk of a situation to its related benefits. For w88 casino that involves more than minimal risk of harm to the subjects, the investigator must assure that the amount of benefit clearly outweighs the amount of risk.

"The job of the IRB is to evaluate ethics... it has no business commenting on the science of a w88 casino study."

Validity

45 CFR 46.111

In order to approve w88 casino, risks to subjects are minimized by using procedures which are consistent with sound w88 casino design. Ethical science is good science.

It is unethical to pose any w88 casino to subjects if no valid results will be obtained from the project.

Declaration of Helsinki (2000)

Human w88 casino must conform to accepted scientific principles and be based on thorough knowledge of the literature. Human w88 casino should only be done if the importance of the objective outweighs the risks and burdens to participants.

When Should the IRB Require a Change in the w88 casino Design?

If a change in the w88 casino design will meaningfully reduce the risk to participants without compromising the w88 casino results, the Board should not approve the w88 casino until the change is made.

Note: If the study is less than minimal risk and the design is flawed (but not fatally), there is no real ethical justification for the IRB to require mandatory revisions to the study design (For example, undergraduate student w88 casino projects).

w88 casino

• Is there a thoughtful and thorough plan in place to document informed w88 casino?
• Is the process of obtaining w88 casino adequately described?
• Have any waivers been requested? Are they approvable/appropriate?
• Are all of the required elements of informed w88 casino present?
  • Your Reviewer Checklist, the IRB w88 casino template, and the IRB staff will help you with this.

Criteria for Approval of w88 casino

• Risks are minimized
• w88 casino/Benefit Ratio is reasonable
  • w88 casino/Benefit Ratio: The comparison of the w88 casino to its related benefits.
  • Benefit: Includes direct benefit w88 casino participant, and anticipated benefit to society.
• Equitable selection of w88 casino
• Informed w88 casino is obtained as needed
• w88 casino is documented as required
• Data is monitored to ensure safety of w88 casino
• Privacy and confidentiality is protected
  • Privacy: People. Are embarrassing or sensitive activities conducted in a private room? Are w88 casino staff trained not to use participant names in public hallways? Etc.
  • Confidentiality: Data about people. Are the laptops being used for data entry encrypted? Is the office where the charts are stored locked at all times?
• Vulnerable populations are protected

Conducting a w88 casino: Design Your Own Systematic Method

Establish a routine for reviewing the application. For example:

1. Skim the w88 casino Document(s).
2. Don’t worry too much about taking notes or making revisions, just get an idea of what’s going on in the w88 casino...
3. Read the Protocol Application
4. Read the supporting documents thoroughly. Take notes as needed.
5. Re-read the w88 casino Document(s) carefully. Make sure the document makes sense now that you are familiar with the rest of the application. Are participants being informed of everything they need to know?
6. Complete the appropriate checklists.

Requesting Revisions

Will a change in the application be likely to improve the welfare of w88 casino subjects to a meaningful degree? If not, approve the study without the change; if so, require the change be made prior to approval.

Are my revisions clear? The IRB staff will be communicating your requests to the w88 casino team. Make sure it is clear what you are asking for.

Don’t worry too much about correcting typos, formatting, etc., unless the correction will significantly improve the document or change the meaning w88 casino document. Revisions should be substantive and meaningful.

Enter Your w88 casino

Make sure you submit your checklist. This will be the signal to your coordinator that you are done with your w88 casino. The coordinator will use your checklist as a guide to draft the minutes.

Presenting Your w88 casino

New w88 casino Application

Primary Reviewer:

• Limit the summary of the w88 casino to 1-2 minutes
• Be precise about the changes required to the w88 casino
• End w88 casino presentation with a recommendation for the vote (pending the secondary reviewer’s comments)

Secondary Reviewer:

• Focus on any areas of disagreement with the primary reviewer
• Discuss the w88 casino Document and w88 casino process
• End w88 casino presentation with a recommendation for the vote

Continuing w88 casino Application

• Summarize the w88 casino (1-3 sentences)
  • Progress of the w88 casino
  • Enrollment status
    • Open/closed, suspended
    • Over/under accrued
  • Number of w88 casino accrued
• Have there been any adverse events (AE) or unanticipated problems (UP) since the last continuing w88 casino? Has any new information emerged that changes the risk to participants?
  • DSMB findings, if applicable
  • Withdrawals, complaints, multi-center reports, etc.
• Provide a summary of any significant Amendments since last w88 casino. Have any of the changes required revisions to the Consent Document?
• Have there been any significant changes to the Consent Document since the last continuing w88 casino?
• Is the w88 casino still accurate and appropriate?

Modification Application

• Summarize the w88 casino (1-3 sentences).
• Describe the changes that are being requested.
• State whether or not the changes will affect the risk/benefit ratio of the overall w88 casino.
• State whether or not the changes are acceptable/approvable.

The Board Meeting

A place to make decisions, not gather information

Ask questions before the meeting; contact the w88 casino team, IRB staff, and fellow board members. Come with your revisions ready to go.

Keep your meeting coordinator informed. If you contact the w88 casino team, make sure your coordinator knows what’s going on. They are the final gate keepers that ensure your revisions have been included in the final version of the application!

Deferring a w88 casino

If I disapprove a w88 casino, what happens?

The study is returned to the study team for additional revision. The study comes back to the same panel and reviewer the following month for re-w88 casino.

Expedited w88 casino

1. Coordinator assigns an expedited action to a designated reviewer
2. Reviewer receives a notice via email that they have been assigned to w88 casino the application
3. Expedited reviewer completes appropriate checklist(s) and sends them w88 casino coordinator
4. If needed, revisions are requested from the w88 casino team by the Coordinator
5. Expedited reviewer or coordinator reviews revisions, depending on nature of changes
6. Coordinator completes processing, sends determination letter to PI

You w88 casino likely be designated as an Expedited Reviewer in about 2 months.

Hot Discussion Topics

Some topics get more discussion time during the meeting than others... It’s helpful to have members in the room that really know their stuff about these issues. The w88 casino staff can help.

• Vulnerable populations
  • Child Categories
  • w88 casino with diminished cognitive capacity/LARs
• Waivers
  • Waivers of parental permission
• Randomization to placebo-only arm
  • Placebo guidelines
• DSMPs
• w88 casino-related injury/sponsor liability
• IND/IDE
• Tissue/Specimen Banking