久草国产福利

Except as provided elsewhere in this policy, investigators may not involve a human being as a participant in research covered by this policy unless the investigator has obtained the legally effective informed consent of the participant or the participant's legally authorized representative. Investigators may seek such consent only under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. 

The information that is given to the participant or the representative shall be in language understandable to the participant or the representative. Thus, participants should be presented with consent documents and other research-related documents (such as questionnaires or cover letters) written in a language understandable to them. Any verbal explanation of the consent or research procedures should be presented in a language understandable to the participant. The IRB must receive all translated versions of the written documents as a prior to approval. 

PIs assure the IRB by submission of the application that any translated documents are accurate. The IRB, at their discretion, may request additional information regarding translated documents. Translators involved only in translation of written documents are not required to fulfill the training requirement. 

The consent process may not involve the use of exculpatory language through which the participant or representative is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the investigator, sponsor, institution, or agents from liability for negligence.

Basic Elements of Informed Consent

When seeking informed consent, the informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of informed consent must be organized and presented in a way that facilitates comprehension. 

This presentation should then be followed by the required elements below: 

• A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
• A description of any reasonably foreseeable risks or discomforts to the subject;
• A description of any benefits to the participant or to others which may reasonably be expected from the research;
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
• A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
• For research collecting identifiable private information and/or identifiable biospecimens one of the following must be included: 1) a statement that collected samples/data may be de-identified and used for future research or be given to another investigator for future research without additional informed consent; 2) a statement that collected samples/data will not be used or distributed for future research, even if de-identified.
• For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
• Contact information for answers to pertinent questions about the research and research participants' rights, and contact information in the event of a research-related injury to the participant; and
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled. 

When appropriate, any of the following additional elements of informed consent may be required by the IRB: 

• A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable;
• Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
• Any additional costs to the subject that may result from participation in the research;
• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
• A statement that biospecimens, even if de-identified, may be used for commercial profit and whether/if that profit will be shared;
• For research involving biospecimens, whether the research will or might include (specifically) whole genome or exome sequencing;
• A statement regarding whether clinically relevant research results will be given to the subject and under what conditions;
• A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
• The approximate number of participants involved in the study.

Documentation of Informed Consent 

Informed consent must be documented by the use of an IRB approved written consent form that contains all of the required elements of informed consent and has been signed by the participant or the participant鈥檚 legally authorized representative. Participants must be provided with a copy of the consent forms. Investigators are prohibited from using any other form without the prior approval of the IRB.

The IRB may waive the requirement for investigators to obtain signed, written informed consent from participants, if the IRB makes one of the following determinations: 

• The only record linking participants to the research would be the consent document and the primary risk would be potential harm resulting from a breach of confidentiality.
• The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of a research context.

Current Contact Information for Informed Consent:

Chair of IRB: 
Sara Buster, DNP, APRN, CNP 
Clinical Assistant Professor 
Kramer School of Nursing 
久草国产福利 
2501 N. Blackwelder 
Oklahoma City, OK 73106 
[email protected]

Recruitment Materials 

All materials aimed at recruiting participants into a research study (including the final copy of printed advertisements, scripts, audio or video tapes, emails, or web sites) must be reviewed and approved by the IRB prior to use. 

Required elements: 

• The PI鈥檚 name and contact information
• A statement that the project is research
• A statement that participation is voluntary
• If using email or electronic means to recruit participants, the following statement is required, 鈥淭here is a potential risk of loss of confidentiality in all email, downloading, electronic meetings, and internet transactions.鈥� 

Recommended elements: 

• A brief summary of the basic eligibility criteria
• Statement about whether or not participants will be compensated for their participation. The amount of payment may be included but should not be the most prominent element on the page
• Purpose of the study
• A brief summary of the study
• The time commitment 

Elements That Are Not Allowed: 

• Claims that state or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent document and protocol
• Use of the term 鈥渇ree鈥� in reference to treatment or procedures although participants can be told that there is no charge
• Use of bold or enlarged print or other means to emphasize payment or the amount to be paid

All individuals (including but not limited to PIs, Co-PIs, research assistants, faculty, students, and staff) engaged in research with human subjects are required to successfully complete approved training in the protection of human research participants.  A current training certificate (no more than 3 years old) must be on file for all research team members before an exemption, approval, or renewal can be granted. This required training applies to OCU personnel on all studies regardless of the level of review. Training through HHS or CITI are accepted.

• For students at OCU: only Modules 1-3 are required.
• For faculty supervising or conducting research: all five modules are required.

A link to online training options is available at .

Use of Watermark CES for Human Subjects Research

This policy establishes requirements and clarifies roles related to the use of Watermark Course Evaluation & Survey (CES) in research involving human subjects reviewed by the Institutional Review Board (IRB). Its purpose is to ensure appropriate use of the platform, data integrity, and researcher preparedness. This policy applies to all faculty, staff, and students who propose to use Watermark CES as a tool for collecting data from human subjects as part of an IRB-reviewed research project.

Required Training and Initial Consultation

• All researchers who intend to use Watermark CES for data collection are required to complete an initial consultation with the Watermark CES Administrator prior to survey deployment.
• This consultation will provide training on the technical functionality of Watermark CES, including survey distribution, permissions, reporting, and data access.
• The purpose of the meeting is to ensure that researchers understand the capabilities and limitations of the Watermark CES system and can use the platform appropriately for their approved research protocol.

Role of the Watermark CES Administrator

The Watermark CES Administrator serves solely in the capacity of a system trainer and technical advisor.

• The CES Administrator does not design, develop, administer, distribute, or manage research surveys.
• The CES Administrator does not assume responsibility for IRB compliance, research methodology, question design, informed consent language, or data analysis.
• Responsibility for survey content, ethical conduct, human subjects protections, and adherence to the approved IRB protocol remains entirely with the researcher(s).

Researcher Responsibilities

Researchers using Watermark CES are responsible for:

• Ensuring all survey instruments, consent materials, recruitment language, and procedures receive IRB approval prior to distribution.
• Scheduling and completing the required CES training consultation before launching the survey.
• Using Watermark CES only in ways consistent with the IRB鈥慳pproved protocol.
• Complying with institutional data security, confidentiality, and record鈥憆etention requirements.

IRB Review Considerations

• The IRB may require confirmation that the required CES training consultation has occurred prior to survey deployment.