Researchers: Harry Potter, Professor: Defense Against the Dark Arts, Hogwarts School of Witchcraft and Wizardry

We are asking you to be in a research study.  This form gives you information to help you decide whether or not to be in the study. Being in the study is voluntary. Please read this carefully.  You may ask any questions about the study. Then you can decide whether or not you want to be in the study.

The six chapters in this section of the book examine the Potter series as literature, as the subject matter of college classes, and in relation to other literary works. With the exception of the first chapter in the section, they do not lend themselves naturally to student assignments. Rather, they are directed towards scholarly readers and college-level teachers.

Six part procedure including the following chapters: 

• "Reading J. K. Rowling Magically: Creating C.S. Lewis’s ‘Good Reader"
• "The Problem of Identity in Harry Potter and the Sorcerer’s Stone"
• "Of Young Magicians and Growing Up: J.K. Rowling, Her Critics, and the ‘Cultural Infantilism’ Debate"
• "High-Brow Harry Potter: J. K. Rowling’s Series as College-Level Literature"
• "Hogwarts vs. ‘The “Values” Wasteland’: Harry Potter and the Formation of Character"
• "Metaphor and MetaFantasy: Questing for Literary Inheritance in J. K. Rowling’s Harry Potter and the Sorcerer’s Stone"

RISKS, STRESS, OR DISCOMFORT

Could include Pottermaniaand picking up sticks to be used as wands. 

ALTERNATIVES TO TAKING PART IN THIS STUDY

For studies involving interventions (educational, social, medical, or other) include descriptions of alternative procedures or standard care that are available if a subject chooses not to be in the study.

BENEFITS OF THE STUDY

Describe the expected benefits to individual subjects and/or society. State if subjects will not benefit from being in this study.

SOURCE OF FUNDING

This section is required only if there is external funding for the research.

For device clinical trials, state the following:  The researcher for this study [insert PI’s name] is receiving payment from the study sponsor [insert sponsor’s name] for the time spent [brief description of PI responsibilities, such as “completing study-related duties outside of the surgical procedure”].

For all other research receiving external funding or other type of external support, state:  The study team and/or the University of Washington is receiving [financial support, OR describe other type of support such as “the study drug”] from [insert sponsor’s name].

FINANCIAL INTEREST

This section is required when any investigator (as defined by UW policy GIM 10) has a Financial Conflict of Interest as defined by UW policy GIM 10.  If no one has a Financial Conflict of Interest, this section should be omitted.

[Investigator name] has a financial or other relationship with [company name]. The University of Washington (UW) developed a Conflict Management Plan to reduce the possible effects of this relationship on your safety or welfare.

CONFIDENTIALITY OF RESEARCH INFORMATION

State whether data will be confidential (linked to identifiers) or anonymous (no links). If you think it is important for your specific study to eventually destroy identifiers (or links to identifiers), state something like, "The link between your identifiers and the research data will be destroyed after the records retention period required by state and/or federal law." State who or what other agencies (sponsors, other researchers, etc.) will have access to identifiable data. Do not state that research data will not be released to subjects, unless you have a contractual obligation with a sponsor or other group to prevent release of data. However, it is acceptable to state that there are no plans to release the data to subjects, or to not mention this issue at all. Do not make statements to the effect that only the research team will have access to the data.

Describe any limits to confidentiality (for example if study procedures may elicit information about child abuse, elder abuse, or harm to self or others). You might state:
All of the information you provide will be confidential. However, if we learn that you intend to harm yourself or others, we must report that to the authorities.

For all studies in which links between subjects' identities and the data will be kept, add: Government or university staff sometimes review studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, your records may be examined. The reviewers will protect your privacy. The study records will not be used to put you at legal risk of harm.

For drug and medical device studies regulated by the U.S. Food and Drug Administration, add: The U.S. Food and Drug Administration (FDA) reserves the right to review study data that may contain identifying information.

For studies that are required to be listed in the federal clinical trials registry at www.clinicaltrials.gov, federal law requires that the following statement be included, without any revision: A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

If your research involves the use of clinical services, items, or tests through UW Medicine, UW Physicians (UWP), or the Seattle Cancer Care Alliance (SCCA), (this includes most uses of the UW Clinical Research Center (CRC)) state: Your participation in this study will be noted in your UW medical record.

If applicable, state that a copy of the consent form will be placed in the subject's medical, educational, personnel, or other record.

If you are obtaining a federal Certificate of Confidentiality, insert the following language:
We have a Certificate of Confidentiality from the federal [insert the name of the institution that issued the Certificate, such as the National Institutes of Health]. This helps us protect your privacy. The Certificate means that we do not have to give out identifying information about you even if we are asked to by a court of law. We will use the Certificate to resist any demands for identifying information.

We can't use the Certificate to withhold your research information if you give your written consent to give it to an insurer, employer, or other person. Also, you or a member of your family can share information about yourself or your part in this research if you wish.

There are some limits to this protection. We will voluntarily provide the information to:

• • a member of the federal government who needs it in order to audit or evaluate the research;

• individuals at the University of Washington, the funding agency, and other groups involved in the research, if they need the information to make sure the research is being done correctly;

• the federal Food and Drug Administration (FDA), if required by the FDA;

You may refuse to participate and you are free to withdraw from this study at any time without penalty or loss of benefits to which you are otherwise entitled.

Include a description of inducements (money, service, course credit) subjects may receive for participation. When the inducement will include money being paid to a subject, consider the following:

• Social Security number. When a onetime payment of $50 or less is being made to a research subject, the University's institutional requirement to obtain a Social Security number is waived. However, the University strongly encourages researchers to request Social Security numbers for all research subject payments made in the United State regardless of the amount. When Social Security numbers will be collected, the researcher and the IRB should consider whether it is appropriate to include this information in the consent form.

• If it is possible or likely that a subject will earn $600 or more in subject payments during the calendar year, the researcher and the IRB should consider whether it is appropriate to include in the consent form a statement that the University is required to report subject payments of $600 or more as miscellaneous income to the IRS.

Indicate what costs subjects may immediately or ultimately have to bear.

FOR ALL STUDIES
Add one of the following statements, or combine the language of both, as appropriate for the study:

If you think you have been harmed from being in this research, contact [INSERT NAMES AND CONTACT INFORMATION].

OR

If you think you have a medical problem or illness related to this research, contact [INSERT NAMES AND CONTACT INFORMATION] right away. He/She/They will treat you or refer you for treatment.

STUDIES INVOLVING MORE THAN MINIMAL RISK
Studies vary widely with regard to types of risks, and the magnitude and probability of risk. Therefore you are free to develop your own language except where specified below, as long as the federal requirements (the bullet points) are addressed. Regulations do not allow a waiver of this requirement or any parts of it, even when the only risks are non-physical risks that might arise (for example, from a breach of confidentiality).

• Inform subjects about whom to contact if they experience a research-related injury or adverse event. Specify the hours when the contact person(s) is available, and whether they will reach a person or will need to leave a voice mail message.
  Example: "It is important that you promptly tell the researchers if you believe that you have been injured because of taking part in this study. You can tell the researcher in person or call him/her at the number(s) listed at the top of this form. This number is monitored 24 hours a day."
  Example: For studies involving no physical risk, the statement above could be made more appropriate if you replace the word "injured" with "harmed".
  Example: For studies in the United States that might be associated with a life-threatening problem, this should generally include something like, "For a life-threatening problem, call 911 right away or seek help immediately. Contact [insert names and contact information] when the medical emergency is over or as soon as you can. For all other problems: contact [insert names and contact information] right away. He/she/they will treat you or refer you for treatment."

• Inform subjects about whether any medical treatment is available if an injury occurs and, if so, what it consists of, or where further information can be obtained.
  Example: For UW studies occurring in Seattle and that involve physical risks, you might state: "If you are injured as a result of being in this study, necessary medical treatment will be offered at a UW Medicine facility."
  Example: For studies in another country that involve physical risks, you might describe what treatment is available through the national health program, or at the research facility, such as, "If you are injured from being in this study, medical care is available to you at [insert name and location]."
  If you believe there is no chance for a medical research-related injury: State something like, "If you have questions, complaints or concerns about this study, you can contact [insert name] at [insert contact information such as phone number, location, or email address]."

• Inform subjects about whether any compensation is available.
  For UW studies involving medical risks, this language is REQUIRED: "The costs of the treatment may be billed to you or your health insurance [for international studies, refer to national health insurance or health service or program] just like other medical costs, or it may be covered by the UW's discretionary Human Subjects Assistance Program (HSAP), depending on a number of factors. The researcher may request HSAP coverage by following established procedures. If you wish to request HSAP coverage yourself, contact the researcher or the UW Human Subjects Division at hsdinfo@uw.edu or 206-543-0098. You may also call collect to the UW Human Subjects Division at 206-221-5940 if you do not otherwise have access to a telephone. Ask the researcher if you would like information about the limits and conditions of the HSAP. The UW does not normally provide any other form of compensation for injury. However, the law may allow you to seek payment for injury-related expenses if they are caused by malpractice or the fault of the researchers. You do not waive any right to seek payment by signing this consent form. [If appropriate, also add these two sentences] We will bill your health insurance for treating problems that result from your [insert name of disease or underlying condition] or from standard clinical care. If you have no health insurance or your insurance refuses to pay, we will bill you."
  For UW studies involving no medical risks, this language is REQUIRED: "The UW does not normally provide compensation for harm except through its discretionary program for medical injury. However, the law may allow you to seek other compensation if the harm is the fault of the researchers. You do not waive any right to seek payment by signing this consent form."
  For non-UW studies: Insert the compensation language required or recommended by your institution. HSD and the UW IRB will not review or modify the language for accuracy or completeness of this language. However, the language must include a statement like, "You do not waive any right to seek payment by signing this consent form."

Subject's statment

This study has been explained to me.  I volunteer to take part in this research.  I have had a chance to ask questions.  If I have questions later about the research, or if I have been harmed by participating in this study, I can contact one of the researchers listed on the first page of this consent form.  If I have questions about my rights as a research subject, I can call the Human Subjects Division at (206) 543-0098 or call collect at (206) 221-5940.  I give permission to the researchers to use my medical records as described in this consent form.  I will receive a copy of this consent form.