consent letter for phd guide

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• Human Subjects
• IRB Health Sciences and Behavioral Sciences (HSBS)

Informed Consent Guidelines & Templates

U-m hrpp informed consent information.

See the HRPP Operations Manual, Part 3, Section III, 6 e .

The human subjects in your project must participate willingly , having been adequately informed about the research.  

• If the human subjects are part of a vulnerable population (e.g., prisoners, cognitively impaired individuals, or children), special protections are required.
• If the human subjects are children , in most cases you must first obtain the permission of parents in addition to the consent of the children.

Contact the IRB Office for more information .

See the Waiver Guidelines  for information about, and policies regarding, waivers for informed consent or informed consent documentation. 

See the updated  Basic Informed Consent Elements document  for a list of 2018 Common Rule basic and additional elements. 

Informed Consent Process

Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve.  The informed consent process is one of the central components of the ethical conduct of research with human subjects.  The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants.  

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement .

• Projects which collect biospecimens for genetic analysis must obtain documented (signed) informed consent.
• It is an ethical best practice to include an informed consent process for most exempt research .   IRB-HSBS reviews, as applicable, the IRB application for exempt research, but not the informed consent document itself.  A suggested consent template for exempt research can be found below under the References and Resources section.  A companion protocol template for exempt research may be found in the feature box, Related Information (top right).

Informed consent documents

An  informed consent document  is typically used to provide subjects with the information they need to make a decision to volunteer for a research study.  Federal regulations ( 45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.  New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information  that will help potential participants understand why they might or might not want to be a part of a research study.  

Key Information Elements

The image below displays the  five elements identified in the preamble to the revised Final Rule  as suggested key information.  

Note: Element number 5 (alternative procedures) applies primarily to clinical research.

General Information & Tips for Preparing a Consent Document

Reading level.

Informed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level .  A best practice is to have a colleague or friend read  the  informed consent document for comprehension before submission with the IRB application.  Always:

For guidance on using plain language, examples, and more, visit: http://www.plainlanguage.gov/

• Tailor the document to the subject population.
• Avoid technical jargon or overly complex terms.
• Use  straightforward  language that is understandable.

Writing tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

• Use the second (you) or third person (he/she) to present the study details.  Avoid use of the first person (I).  
• Include a statement of agreement at the conclusion of the informed consent document. 
• The consent doucment must be consistent with what is described in the IRB application.

Document Formating for Uploading into eResearch

• Remove "track changes" or inserted comments from the consent documentation prior to uploading the document into the IRB application (Section 10-1) for review.
• Use a consistent, clearly identified file naming convention for multiple consent/assent documents.

Informed Consent Templates

IRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements (per  45 CFR 46.116 ), as well as other required regulatory and institutional language.  The templates listed below include the new consent elements outlined in the 2018 Common Rule.

References and Resources

PDF.  Lists the basic and additional elements required for inclusion or to be included, as appropriate to the research, in the informed consent documentation, along with the citiation number [e.g., _0116(b)(1)] within the revised Common Rule.  New elements associated with the 2018 Common Rule are indicated in bold text.

Strongly recommended for studies that involve the collection of biospecimens and/or genetic or genomic analysis, particularly  federally sponsored clinical trials that are required to post a consent document on a public website.  Last updated:  04/10/2024.

Informed Consent documents are not reviewed by the IRB for Exempt projects.  However, researchers are ethically bound to conduct a consent process with subjects.  This template is suggested for use with Exempt projects. Last updated 4/17/24

(Word) Blank template with 2018 revised Common Rule key information and other required informed consent elements represented as section headers; includes instructions and recommended language.  It is strongly advised that you modify this template to draft a project-specific informed consent document for your study for IRB review and approval.  Last updated: 04/10/2024

(Word) General outline to create and post a flyer seeking participation in a human subjects study.  Includes instructions.

(Word) Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc.  Letters of cooperation must be on U-M letterhead and signed by an appropriate official.  These letters are uploaded into the Performance Site section of the eResearch IRB application.

For use by U-M Dearborn faculty, staff, and students conducting non-exempt human subjects research using subject pools. Last updated 4/10/24

For use by U-M Dearborn faculty, staff, and students conducting exempt human subjects research using subject pools

Researchers who will conduct data collection that is subject to the General Data Protection Regulation (GDPR) must use this template in tandem with a general consent for participation template/document.

• Child assent ages 3-6
• Child assent 7-11
• Parent permission
• Brief protocol for exempt research including data management and security questionnaire
• Child assent 12-14
• Introductory psychology subject pool general consent template
• Introductory psychology subject pool exempt consent template

IRB-Health Sciences and Behavioral Sciences (IRB-HSBS)

Phone: (734) 936-0933 Fax: (734) 936-1852 [email protected]

• Human Subjects Protections

UCL Research Ethics

• Advice on writing an information sheet and consent form

Writing a Participant Information Sheet and Consent Form

Recruitment documents help people make informed choices about whether to participate in a research study. Find out how to write a Participant Information Sheet, example forms and further guidance.

Writing a Participant Information Sheet

Participant Information Sheets must be designed to assist participants to make informed choices. Potential recruits must be given sufficient information to allow them to decide whether or not they want to take part. The process of obtaining consent and the accompanying documentation must be approved by a research ethics committee and, where only verbal consent to research is contemplated include consideration of an appropriate process for witnessing the consent.

Researchers must take the steps necessary to ensure that all participants in the research understand the process in which they are to be engaged, including why their participation is necessary, how it will be used, and how and to whom it will be reported so that the prospective participant can make an informed decision about whether they really do want to take part.

It is highly recommended that the information provided is presented on headed paper and is accurate, clear and simple so that someone with a reading age of 8 would understand the contents (use short words, sentences and paragraphs). The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon and abbreviations, bias, coercion or any inappropriate inducements.

What should the Participant Information Sheet include?

• A friendly invitation to participate.
• A brief and simple explanation of the purposes of the research and a statement explaining how the participant was chosen and how many other participants will be involved in the study.
• 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.
• A thorough explanation of the expected duration of participation in the research and the procedures to be followed.
• A description of any reasonably foreseeable risks or discomforts and any benefits to the participant. For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
• A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
• It is considered good practice for researchers to debrief participants at the conclusion of the research and to provide them with copies of any reports or other publications arising from their participation.
• If appropriate, a statement indicating that the data might be used for additional or subsequent research.
• An explanation of who to contact for answers to pertinent questions about the research and the rights of the participant and who to contact in the event of a research-related injury to the participant.
• If applicable, a statement declaring that each researcher who may have access to children (aged under 18) or vulnerable adults has undergone a satisfactory criminal records check.
• Remember to thank your participant for considering taking part in the study and include a statement indicating that the research study has been approved by the UCL Research Ethics Committee.

Language and layout

It is highly recommended that the information provided is presented on headed paper and is accurate, clear, and simple. The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon, and abbreviations, bias, coercion, or any inappropriate inducements.

The following points should be considered when writing an information sheet:

• Use clear, non-technical language. We recommend that you refer to the  Plain English Campaign
• Use appropriate language for the target audience. For example, consider the different ways needed to communicate with primary school children as opposed to their teachers, or people with expertise in the area of study as opposed to people with no such knowledge
• Divide the text into paragraphs for ease of reading
• Consider using sub-headings for clarity, such as questions and answers
• Make sure the font and font size are legible.

Ask someone else to review your information sheet before it is circulated.

Further guidance

• Guidance on obtaining consent from research participants online (for online and in-person study designs) , Authors: Dr Pippa Lally, Behavioural Science and Health, and Jack Hindley, Information Services Division, UCL
• Recording & Obtaining Consent , UCL Research Ethics Committee Guidance Note 2: Extract from Nuffield Council on Bioethics website

Example forms (annotated)

• Template Participant Information Sheet  (Word)
• Template Consent Form  (Word)

Page last updated: June 2024

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Consent Letter from PhD Co-guide

The DeanFaculty of Doctoral Studies & ResearchAnnamalai University,Annamalai NagarIndia - 608002

Sub: Consent Letter to be a Co-Guide for – Mr. M.Francis Luther King.

With reference to the above mentioned subject, I wish to inform you that I am

Dr.L.John Baruch, Ph.D., Dean, Priest University - Puducherry Campus, willing to be a

Co-guide till his completion of the PhD Course, and I will guide him for the entire duration of

his research work.

Thanking you

Yours Sincerely

(Dr.L.John Baruch, Ph.D.,)

Dean, Priest University.

Date: 18/07/2013Place

: Puducherry.

Manufacturing Consent and Intellectual Cloning at Leicester University - Letter to Dr. Rofe

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Strategies to Make Informed Consent Truly Informed Terry Davis, PhD Connie Arnold, PhD

Competence to Take Consent Procedurenssg.oxford-haematology.org.uk/oxford/haem-spr-sho-info…  · Web viewThe trainee must undertake a draft writing of the ‘consent letter’

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KMJ 2011.pdf · 2019. 4. 3. · a scanned copy of the signed consent letter of the author(s). The consent letter could otherwise be faxed to the journal officeat(00965)25317972or25333276

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COUNCIL CONSENT AGENDA - GovOffice6F77EE0A-5147... · COUNCIL CONSENT AGENDA July 20, 2017 ... Fishing Picnic /7: Ltr from PennDOT, ... /1 Letter from Special Olympics,

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LETTER OF ACCEPTANCE, WAIVER, AND CONSENT …...LETTER OF ACCEPTANCE, WAIVER, AND CONSENT Nos. 2018-07-00036; 2018-11-00038; 2019-09-00122 TO: NYSE Arca, Inc. RE: X-Change Financial

Deferred consent - Erasmus Critical Care · Deferred consent Prof. Jan Bakker MD, PhD Chair dept Intensive Care Adults [email protected] Thursday, March 22, 12

Maryville University Student Service Center Attn: Student ... · Letter 2 _____ Letter 3 _____ I understand that my consent is not required for the writer to disclose in a letter

CTU Lecture 08. Mai 2018 : General Consent · General Consent Danielle Krebs, PhD Leiterin Weiterentwicklung, Direktion Lehre und Forschung. Inhalt Consent Arten und Definitionen

ACT, Willingness and the Ethics of Informed Consent Rich Niolon, PhD Sandra Georgescu, PsyD

NYSEMKTLLC LETTER OF ACCEPTANCE, WAIVER AND CONSENT … · 2016. 10. 19. · LETTER OF ACCEPTANCE, WAIVER AND CONSENT NO. 20150441008 TO: NYSE MKT LLC c/o Department of Market Regulation

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Beyond HIPAA Health Information Exchange and Granular Consent · Beyond HIPAA—National Trends in Health Information Exchange and Granular Consent Marilyn Prosch, PhD, CIPP/US Associate

Security Alert May 17, 2024

Worldwide caution, update may 10, 2024, information for u.s. citizens in the middle east.

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Use our Form Filler tool  to fill out your child's form on a desktop or laptop computer and then print it. If you are experiencing technical issues with the Form Filler, download a PDF . 

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• You can apply for a passport book , a passport card , or both documents.
• You may ask for a larger passport book with more visa pages, at no extra cost, by checking the 'large book' box at the top of the DS-11.

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Your evidence must be an original or replacement copy. The document must have the official seal or stamp of the office which issued it. You must submit one of the following documents for your child:

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• Please note you must also provide a document, such as a birth certificate, that lists the parent(s) or legal guardian(s) of the child. Full validity means the document is or was valid for 10 years for adults and 5 years for children under 16. 

If you cannot submit one of these documents, go to our  Citizenship Evidence page  for more information.

Paper only : You cannot submit digital evidence of U.S. citizenship such as a mobile or electronic birth certificate. You must submit physical evidence of U.S. citizenship and a photocopy of the document. 

Returning your child's document : We will return your child's document in a separate mailing up to 8 weeks after you receive the new passport.

Tips for making a photocopy :

• Black and white (no color)
• Use 8.5 inch by 11 inch paper
• Use a single side of the paper

If you do not submit a photocopy, you must submit a second copy of your citizenship evidence. We will keep this copy for our records.

3. Show Your Relationship to Your Child

You must submit a document that lists the parent(s) or legal guardian(s) of the child. Examples include:

• U.S. birth certificate (also evidence of U.S. citizenship)
• Foreign birth certificate
• Adoption decree
• Divorce or custody decree
• A court order

Some documents, like a U.S. birth certificate, show  both  U.S. citizenship and parental relationship. These documents must be originals or certified copies (not photocopies).

You and your child may have different last names, as long as the document showing your relationship to your child lists your full name.

If your name is different than the one on the document showing your relationship to your child, submit proof of your legal name change.

4. Get a Photo ID (and a photocopy)

Both parents or guardians must bring a physical, photo ID and a photocopy of it. If your photo ID is from a different state than the state in which you are applying, bring a second photo ID. 

You must show at least  one  of these photo IDs:

• Valid or expired, undamaged U.S. passport book or passport card 
• In-state, fully valid driver's license or enhanced driver's license with photo
• Certificate of Naturalization 
• Certificate of Citizenship 
• Government employee ID (city, county, state, or federal)
• U.S. military or military dependent ID
• Current (valid) foreign passport
• Matricula Consular (Mexican Consular ID) used by a parent of a U.S. citizen child applicant
• U.S. Permanent Resident Card (Green Card) used by a parent of a U.S. citizen child applicant
• Trusted Traveler IDs (including valid Global Entry, FAST, SENTRI, and NEXUS cards)
• Enhanced Tribal Cards and Native American tribal photo IDs
• In-state, fully-valid learner's permit with photo
• In-state, fully-valid non-driver ID with photo
• Temporary driver's license with photo

If you do not have one of these photo IDs, go to our  Identification page  for more information.

5. Show More Documents (if both parents or guardians cannot apply)

• Both parents or guardians must approve that we can issue a passport to a child, and go with the child to apply in person.
• If one or both parents or guardians cannot apply in person with their child, you will need to show more documents.

Important : Submit  Form DS-3053  and other notarized statements within three months of signing them.

6. Provide a Photo

You must provide one photo with your child's application. Go to our  Passport Photo page  for photo requirements and to see examples of photos. 

• Do not attach or staple your child's photo to the form. The acceptance agent or passport employee will review the photo and staple it to your form.
• Some  passport acceptance facilities
• A company which offers photo services
• Home. Ask your friend or family member to take your child's photo. Print it on glossy or matte photo quality paper. 

7. Calculate Fees

When applying using Form DS-11, you will pay two separate fees - an application fee and an execution (acceptance) fee. You will pay the application fee to the U.S. Department of State, and the execution (acceptance) fee to the facility which takes your application. 

• Add $60 to your application fee if you want  expedited service .
• Add $19.53 to your application fee if you want us to ship your completed passport in 1-2 days after we issue it.  

Child Applicants :

For more information on how to pay and a full list of fees, go to our  Passport Fees  page.

*How to fill out your check and pay the application fee to the U.S. Department of State. Please note you must pay a separate execution (acceptance) fee. 

Families may write one check or money order to the U.S. Department of State if they are applying at the same time. The check or money order must include the name and date of birth of each applicant.

8. Find Location to Apply

In the United States:

• Traveling in more than 3 weeks?  Go to a  passport acceptance facility  such as a post office, library, or local government office. Check with the facility to see if you need to make an appointment. 
• Traveling in less than 3 weeks?   Make an appointment  to apply at a passport agency or center.

In another country:

• Contact your  U.S. embassy or consulate .

9. Track Your Application Status

You can  subscribe to email updates  about your application status, and  learn more about each status update .

It may take 2 weeks from the day you apply until your child's application status is “In Process.” 

Frequently Asked Questions

How will you send my child's passport and supporting documents.

You will get multiple mailings. The number of mailings depends on what document(s) you asked for.

Passport Book : You may get your new passport and citizenship documents in two mailings. You may wait 8 weeks after getting your passport before you get a second mailing with your citizenship documents. We will return the passport book using a trackable delivery service.

Passport Card : You may get your new passport card and your citizenship documents in two mailings. You may wait 8 weeks after getting your passport before you get a second mailing with your citizenship documents. We only send the passport card via First Class Mail. We do not send cards using 1-2 day delivery services.

Both a Passport Book and Card : You may get three separate mailings:

• New passport book
• New passport card
• Citizenship documents

Contacting Us : If you have been waiting more than 8 weeks for your documents, call us at  1-877-487-2778  to report that you have not received your documents. 

If you want us to reimburse you for a lost supporting document, you must contact us within 90 days of the date which we mailed your passport. You will also need to provide a receipt to show the cost of replacing the document. 

Can I pay for faster delivery and return shipping?

Yes. You may choose one or both of the following shipment options:

• Delivering application to us : Pay for Priority Mail Express for faster shipping. The price for this service varies depending on the area of the country.
• Returning the passport to you : Pay $19.53 for 1-2 day delivery. This means you will receive your passport   1-2 days after we send it. Include this fee with your check or money order payable to the U.S. Department of State. Do not submit a return envelope to us with postage pre-paid. 

You may receive your passport and supporting documents in separate mailings. If you are renewing a passport card, we will send it to you via First Class Mail. We do not use 1-2 day delivery services if you only applied for a passport card.

What countries require Form DS-3053 "Statement of Consent" to be notarized at an embassy or consulate?

In certain countries, a DS-3053 must be notarized at a  U.S. embassy or consulate  and cannot be notarized by a local notary public. Currently, these countries include:

Special Passport Fairs

Find a Special Passport Fair  near you!

We're holding special passport fairs all across the United States to help you get your passport more easily. New events are added to our site every week.

Most events are for first-time applicants and children, (who use Form DS-11). If you can use Form DS-82, you can renew by mail at your convenience!

Processing Times

Routine:  6-8 weeks*

Expedited: 2-3 weeks and an extra $60*

*Consider the total time it will take to get a passport when you are booking travel.  Processing times only include the time your application is at a passport agency or center.

• It may take up to 2 weeks for applications to arrive at a passport agency or center. It may take up to 2 weeks for you to receive a completed passport after we print it. 
• Processing times + mailing times = total time to get a passport

Urgent Travel:  See our Get my Passport Fast page. 

How to Apply for your Child's Passport

Watch this video to learn how to apply in person for your child's U.S. passport!

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