For this assignment, write a one-page, single-sided reflection, summarizing the IRB application process. Be sure that you read all the resources before you write this summary

For this assignment, write a one-page, single-sided reflection, summarizing the IRB application process. Be sure that you read all the resources before you write this summary

For this assignment, write a one-page, single-sided reflection, summarizing the IRB application process. Be sure that you read all the resources before you write this summary. Submit your summary to the assignment area.

Preparing for the IRB Process

On the Institutional Review Board iGuide site, you will find all of the information you need regarding the IRB process. In particular, please review the following:

You cannot log into the IRB Manager to access a real form in action. You can still peruse the required documents:

• Field Tests, Pilot Studies, Test Run.
• Recruitment.
• Informed Consent.
• Site Permission.
• Instrument Permission.
• Conflict of Interest.
• Data Security & Destruction.
• Field Test, Pilot Studies, Test RunsField Test

  Field tests help establish the credibility of the research instrument. They are typically used to review qualitative instruments such as interview guides, open-ended questionnaires, and observation checklists. Credible instruments are those that have been reviewed by experts in the field and determined to be appropriate, clear, coherent, and representative of perspectives of the field. Field tests also help ensure that instruments are appropriate for the population and will not put participants through distress or discomfort. A field test helps determine if there are better ways to ask questions, questions that are not needed, and questions that might be stressful or inappropriate for the participant.

  How do I conduct a field test:

  1. Select three to five experts who have experience with the topic and the appropriate professional credentials. Field tests should be conducted by experts in the field including faculty, practitioners, or researchers. A field test should never include people who meet the criteria for inclusion in the study. Dissertation committee members should not be included as field test participants. Field tests must include experts who are not affiliated with Capella University.
  2. Send a cover-letter (see template ) by email or mail to request participation from the experts. Include the instrument to be reviewed. Field test experts should not provide personal data; rather they should provide feedback on the research instrument itself.
  3. Once the experts complete and submit the field-test results, review feedback and make necessary changes to the research instrument.
  4. In submitting your materials to the IRB you will be asked to provide detailed information on the identity and qualifications of experts, their feedback on the interview questions, and any revisions.

  Note that Counseling PhD learners should refer to the school specific Field Test Instructions. All learners should double-check their school resources for any school specific field test requirements.

  Pilot Studies

  A pilot study is most often used to assess the validity and reliability of a research instrument, but may also be used to test whether adequate protections for research participants have been implemented prior to conducting the larger study. Pilot studies are recommended when you create a new instrument or modify an existing instrument to the point that new validity and reliability information is necessary.

  How do I conduct a pilot study:

  1. Obtain IRB approval for your pilot study. All activities involving interaction with participants must be approved by the IRB.
  2. Recruit a small sample of participants who meet the inclusion criteria for the study.
  3. Administer the research instrument.
  4. Depending on results, revise the instrument prior to implementing the full-scale study.
  5. Seek approval from the IRB for any modifications to the research instrument.

  Pilot study data is generally not included as part of the larger study.

  Test Runs

  Your study may benefit from a test run. You may recruit colleagues, friends and family members in order to practice implementing research activities. You might practice introducing yourself, engaging in face-to-face recruitment, administering informed consent, interviewing participants, conducting focus groups, or responding to an individual who is experiencing distress. You might also practice using technology such as digital recorders or research equipment.

  You must ensure that those who offer their assistance understand that they are not actual participants in the study; test runs should use mock data, and information collected may not be used in the dissertation. Those taking part in practice sessions should not sign a consent form, which is reserved for actual research participants. Test runs should never be conducted with those who meet the inclusion criteria for the study.

  Recruitment

  Recruitment refers to the process of contacting potential participants in order to invite them to take part in the research study. In recruiting participants, you must:

  • Protect the privacy of potential participants.
  • Provide accurate information about the study to allow potential participants to consider whether they are interested in participating.
  • Avoid exerting undue pressure or influence on potential participants

  Recruitment Materials

  Participants are often recruited using materials such as newspaper or search engine advertisements, handouts, fliers, posters, online message board posts, emails, or mailings. Recruitment materials should provide the information that prospective subjects need to determine their eligibility and interest, using a reading level appropriate for the target audience.

  Recruitment materials must include:

  • Name of the researcher
  • Nature of the researcher’s affiliation with Capella University
  • The word research
  • Purpose of the research
  • Inclusion/exclusion criteria used to determine eligibility for the study
  • Contact (phone/email) for additional information
  • Details on how to enroll

  Recruitment materials might include:

  • Brief explanation of study procedures
  • Time or other commitment required of the participants
  • Location where research will be conducted
  • Sponsorship information if applicable

  Recruitment materials should not include:

  • Misleading statements
  • Over-emphasis of the participant incentive (bold and large print should be avoided)
  • Phrases such as “limited enrollment” “study ends soon” “don’t miss your chance” “enroll today!”
  • Coercive or enticing statements such as “Join this study and take charge of your life,” or “Help us find the cause of PTSD” or “Don’t our kids deserve a chance?” or similar phrases or logos
  • An understatement of the time commitment necessary for the study
  • Claim that a subject will receive free services or therapeutic benefits as a result of participation
  • Inappropriate images (be conservative when using images, graphics, etc).

  Face to Face

  • You may recruit participants in a face-to-face setting. This can be an effective recruitment strategy because it allows you the opportunity to present information about the study directly to potential participants and address questions or concerns.
  • You may engage in face to face recruitment at staff or community meetings, in classroom settings, or with support or special interest groups. Recruitment in a public setting can be considered an invasion of privacy that could present an uncomfortable situation for the potential participant. Therefore, you must provide a way for potential participants to express their interest in your study outside of the public setting. It is important to secure permission before presenting at meetings or arranging for information tables in public settings. You must also prepare a script to guide face to face recruitment dialogues. This script must be reviewed and approved by the IRB. While engaged in recruitment, you should attempt to stay within the parameters established by the script, but a more natural delivery is usually acceptable.
  • In face-to-face recruitment, care should be taken to respect the privacy of the targeted participant. If you plan to present in a forum where not everyone meets the inclusion criteria, you should consider whether the venue is appropriate and whether a potential participant might be subject to embarrassment or distress

   

  Third party

   

  • It may help to involve a third party who agrees to act as a liaison between the participants and you. Their responsibility is to describe the study to potential participants and to provide your contact information to those who may be interested in participating. It’s important to consider what kind of relationship the third party recruiter has with potential participants. Might he or she have undue influence over a participant’s decision? Generally speaking those who are family members, employers, close friends, or in positions of authority over the participants should not engage in recruitment.

   

  Phone Calls

  • Scripts should be prepared for individuals who are engaged in recruitment on behalf of you.
  • Cold calling potential participants is not a good strategy. A particular concern is that the individual being targeted by phone may not be the one who picks up the call. Potential participants should be given a phone number to call if they are interested in learning more about the study.
  • Researchers recruiting by phone calls should be cautious when leaving messages in order to protect the confidentiality and privacy of potential participants. Phone scripts must be reviewed and approved by the IRB when the telephone is used in recruitment.

  Post Cards

  If you decide to recruit through the mail, you should prepare a cover letter and any other inserts to be included with the mailing; instructions and contact information should be included, as well. The IRB will review this material. It is important to protect the privacy of potential participants by omitting sensitive information from the mailing, since anyone in a household may access the mail.

   

  Emails

  Email is an effective way to recruit participants; it’s less invasive than a phone call and more efficient that postal mail. You should consider the appropriateness of this strategy based on the estimated technical proficiency of the targeted population and whether they have access to email. You should prepare the text of the email¿which must be reviewed and approved by the IRB. Researchers who recruite through email should always use blind copy (bcc) when sending emails to multiple individuals to protect the privacy and confidentiality of participants.

  Membership

  You must have written authorization if you use an organization’s membership directory (email, phone or mailing list) for the purpose of recruiting potential participants. Like all approval letters, the authorization must be printed on the organization’s letterhead and signed by the person authorized to grant access.

  Social Media

  Social media sites, online communities, and email list serves can be great resources for recruiting potential research participants, allowing you to access a specific population or target a broad range of potential participants. You must seek permission from the moderator of the online community or site (i.e. the person who administers, manages, or monitors the online community or group) in order to post information on online message boards or engage in chat room/discussion board dialogue with potential participants

  Informed Consent

  Informed consent is the process by which research participants decide if they will participant in a research study. As a researcher, you must ensure that:

  • participants voluntarily agree to take part in the study.
  • participants are provided with clear and accurate information concerning the study.
  • participants understand the information and have opportunities to ask questions.

  The consent form is a document used to convey information concerning the study. The consent form must be thorough, readable and easy to follow. Consent Form Templates are available to assist you in preparing your consent form.

  Obtaining Informed Consent

  The following practices should guide the consent process:

  • When research is being conducted face-to-face, you should go over each aspect of the consent form with the participant and allow adequate time for questions.
  • If the consent process is conducted via mail or email or as part of an online survey, potential participants should be encouraged to contact you with questions or concerns.
  • Use the IRB-approved (stamped) version of the consent form.
  • The consent form should be signed and dated by each participant in accordance with the procedures outlined in the IRB-approved protocol.
  • You must give a copy of their signed consent to participants once they have signed and keep a copy of the signed consent form for your records. Signed consent forms may be audited by the IRB.

  Child/Minor Assent & Parental Permission

  Research with children or minors requires permission from a parent or guardian followed by assent from the child or minor. Older children may be required to sign a statement of assent, while assent by younger children may be given verbally and witnessed.

  IRBs generally stipulate that children ages seven and older are capable of assenting to participate in a research study. State laws vary regarding the age at which a person is no longer considered a minor. In all cases, it is the researcher’s responsibility to review and understand relevant state laws.

  Waiving Documentation of Informed Consent

  You may decide not to document the consent process via a signed consent form. You will obtain informed consent, but will not obtain the participant’s signature on the form. You must request a waiver of documentation of consent in such cases. Waivers must be obtained when data will be conducted via an online survey, since there is no way to obtain a signed consent form electronically.

  Readability

  Consent forms intended for the general adult public should be written at the 8th grade reading level. Assent forms intended for children and minors should be written a maximum of one reading grade level below the lowest grade recruited. For example, if you are recruiting 7th and 8th graders, consent forms should be written at the 6th grade level. Generally speaking, children under the age of 7 are considered too young to take part in an assent process.

  Reading levels can be checked using free applications such as Blue Centauri’s Writing Sample Analyzer . In addition, Microsoft Word has a reading-level application for those using PCs

  Site Permission

  Capella University requires researchers to secure site permission for research conducted at institutions and organizations such as universities, schools, hospitals, clinics, businesses, non-profit organizations, and military organizations. Permission is also required if you obtain data or participant contact information from a site.

  Researchers may submit their IRB materials to the IRB without the letter of permission, but will not obtain full IRB approval until site permission has been obtained. To be considered sufficient, site permission letters must be:

  • Written on the organization’s official letterhead.
  • Signed by an authorized official within the organization.
  • Dated within six months of IRB submission.

  Keep in mind the following when obtaining site permission:

  • Veterans Administration (VA) facilities, military sites, and other complex organizations such as hospital systems and school districts may have arduous permissions processes or may require multiple levels of permission. For additional information on the DoD Permission requirements, consult the IRB’s Military Permissions Guide.
  • If the site has an IRB or formal research review process, you may be required to obtain IRB approval from the site. Contact irb@capella.edu for assistance in negotiating this process. You must determine who has the authority to grant permission to conduct research at the site. Failing to obtain appropriate permission can be considered a form of misconduct and could put your study at risk.
  • It is important to adhere to all policies and procedures relating to obtaining permission to conduct research at the site. Capella’s IRB may require you to submit additional documentation (such as organizational charts or policies and procedures) or may consult with the site directly to verify that the appropriate permissions have been obtained.
  • Consider feasibility when exploring potential research sites. Be familiar with how to obtain site permission, network with key stakeholders at the site, and have several sites in mind for your research. Though the signed permission letter must be dated within 6 months of IRB submission, you need to explore site permission early in the milestone process to avoid delays at scientific merit review and IRB review.

  Documents Requiring Capella University Signature

  If your research involves a data use agreement or contract, or you are required to submit documentation signed by your mentor or Capella University in order to obtain site permission, your documentation must be reviewed prior to signature. Documents requiring review and signature must be sent to the IRB Office. The IRB Office will coordinate this review process on your behalf. The IRB will also review the agreement to ensure it does not pose risks to participants. It is imperative that you have these documents reviewed as early as possible in your dissertation process (ideally at the time of topic approval) in the event that revisions to the documents are required or in case Capella University is unable to sign the agreement.

  There are a few data sets, such as restricted ICPSR data, restricted data from the Institute of Education Sciences (IES), that Capella University learners are unable to use  due to the required security measures for handling of this data. If you are seeking access to limited or restricted data sets, contact the IRB Office, for further information.

  Capella University Site Permission

  Depending on your research topic and design, it may be possible to recruit Capella faculty, learners, or alumni as part of your research.

  Requests to post recruitment information on Capella University’s social media sites are often granted provided that the study does not seek to collect sensitive or proprietary information from potential participants.

  Studies that seek to use Capella University data, draw on Capella University resources for recruitment, or involve an action research intervention are approved only in limited circumstances. Researchers should be aware of the following requirements for such approvals:

  • The researcher has obtained sponsorship from  the academic or business owner of all involved areas, including coverage of any costs associated with the research
  • The study does not pose significant risk to Capella University or participants in the study
  • The topic of the research and target population is directly related to Capella University. In other words, Capella University is not being used as a site of convenience

  Additionally researchers should note the following:

  • CU rarely approves studies that are intended to measure learner/faculty/staff satisfaction
  • CU rarely approves studies in which Capella University is the only research site.
  • If the researcher is external to CU, the study must be approved by an appropriate IRB
  • Learners who wish to use CU as a research site must explore feasibility early in the milestone process
  • The CU site permission request is separate from the IRB process (the IRB does not grant approval to use CU as a research site)

  Contact the Dissertation Support Center as you develop your

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