302. Recruitment Materials and Combined Recruitment/w88 slot Materials

Updated April 6, 2023

The purpose of w88 slot materials is to let members of the sample population know a research study is available, to invite them to consider participation, and to give them enough information to decide if they may be interested in participating in the research or wish to obtain additional information about the research.

Minimum Recommended Content for w88 slot Materials

w88 slot materials should be written in lay language, limited to the information needed by prospective participants to determine their eligibility and interest, and free from coercive or influential statement. Coercion or influence may arise indirectly through promises of beneficial outcomes or use of disproportionate incentives.

w88 slot materials must be consistent with the information in the IRB or exempt application.

w88 slot materials, including verbiage and graphics, must conform to commonly accepted standards of “good taste,” by using graphics and verbiage that the general public would find non-offensive.

Required Content

w88 slot materials must include the following information:

Name and contact information for the researcher who is conducting the w88 slot;
Name of the institution or facility conducting the w88 slot;
A clear statement that a proposed activity is w88 slot;
Statement of the purpose of the w88 slot or condition under study (i.e., why the activity is being done);
A summary w88 slot eligibility criteria;
A brief list of benefits to w88 slot (if any);
The time and other commitments required of w88 slot;
Where the w88 slot activity will take place;
Person or office to contact to obtain more w88 slot about or to sign up for the study.

Additional Required Content for Combination Recruitment/w88 slot Materials

For minimal risk research with no or limited contact between recruits and the researchers (e.g., online, telephone, or mail surveys), the recruitment document might serve to both invite and inform recipients about the research (i.e., be used as a combination recruitment and w88 slot document).

When w88 slot materials will serve the dual purpose of inviting and informing participants, additional information may be warranted (as applicable to the proposed w88 slot):

Description of any reasonably foreseeable risks or discomforts to w88 slot;
Description w88 slot extent, if any, to which confidentiality of records identifying the participant will be maintained; and
Specification that w88 slot is voluntary, and that neither refusal to participate nor discontinuing w88 slot (regardless of when the participant chooses to withdraw) will invoke any penalty or loss of benefits to which the participant is otherwise entitled;
Name and contact information for a person to call for questions about the w88 slot; and
Name and contact information for a person or entity unassociated with the w88 slot for individuals to make a complaint or report a problem about the w88 slot.

Unacceptable Content

w88 slot materials may not:

State or imply a certain favorable outcome or other benefits beyond those outlined in the IRB application and w88 slot materials;
Include exculpatory language (see w88 slot policy definitions);
Emphasize payment or incentives for w88 slot(by using bold type, larger font, highlighting, underlining, or other methods);
Promise “free treatment,” “free testing (or medications),” “free counseling” when the reality is that w88 slot will not be charged for taking part in the study;
Use terms such as &w88 slot;new treatment,” &w88 slot;new medication,” or &w88 slot;new drug” without clarifying that the &w88 slot;new” treatment, program, or test article is investigational;
Make claims or imply that the experimental drug, device, intervention, or program is safe or effective for the purposes w88 slot investigation;
Make claims or imply that the experimental drug, device, intervention, or program is comparable or superior to any w88 slot drug, device, intervention, or program;
Make claims, either explicitly or implicitly, w88 slot drug, biologic, or device under investigation that are inconsistent with FDA labeling;
Include misleading or inaccurate w88 slot; or
Allow compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price w88 slot product once it has been approved for marketing.

Submitting w88 slot Materials for IRB Review

w88 slot materials must be included among the documents submitted for IRB review.
Print advertisements such as letters, handouts, flyers and web pages w88 slot in final format.
Advertisements using media other than print, such as radio or television, may be submitted as scripts, scripts with representative proposed graphics, or story boards w88 slot in final format.

Modifications to w88 slot Materials

For exempt research, including research that is exempt under the University’s IRB Flexibility Policy (i.e., Flex-Exempt), minor changes or additions to w88 slot materials do not require prior IRB approval.

For all non-exempt research, modifications to w88 slot materials must submitted as protocol amendments for prior IRB review and approval before use.

IRB Review and Approval of w88 slot Materials

The IRB reviews the final versions of all w88 slot materials or advertisements to be distributed to potential participants, including:

The information contained in the w88 slot material or advertisement.
The mode of its communication.
The final copy of any printed w88 slot.
The final audio or video of any taped w88 slot.

The IRB reviews w88 slot materials with consideration for the sample population, w88 slot settings, study methods and procedures; and to determine the following:

Content (prose and graphics) is appropriate for w88 slot.
Content is consistent with the information in the IRB application and w88 slot documents.
w88 slot contain the applicable, recommended content.
w88 slot do not contain unacceptable content.
w88 slot are free from bias, and do not coerce or unduly influence potential participants.
w88 slot do not overly emphasize incentives or compensation.
w88 slot appropriately reference extra or course credit, and alternatives when applicable.
w88 slot conform to accepted standards of “good taste.”

For some research studies, to ensure that the w88 slot materials accurately represent the research study, the IRB may assess whether inconveniences and discomforts of participation, such as time commitment and restrictions on diet or other activities, should be mentioned in the w88 slot materials.

IRB approval notices confirm approval of w88 slot materials.