I. General Protocol Information

Download 76.55 Kb.
Size76.55 Kb.
New/Initial Submission of Human Subjects Application.
I. General Protocol Information
A. Protocol Title

B. Research Personnel

Who are the personnel who will be conducting the research? ( Add Certified Personnel

The protocol's PI must be a faculty member. Students may not be listed as the PI or Co‑PI of an IRB protocol.)

C. Protocol Department

(Please identify the home department of the project's PI.. If you are a MAPSS student, list "Master of Arts SS" as the protocol's department.)

D. Research Funding (How will the research be funded? If applicable, Add Funding Sources)

E. Research Locations (What are the specific locations at which the research will be conducted (e.g., individual research sites, campus laboratories, institutions, organizations, parks/public areas. etc.)?
II. New Protocol Description
A. Describe in lay terms the purpose of the research including the research question. Please limit the description to five sentences. (If a funding or similar proposal includes a relevant, extended overview of the project, please attach the proposal and reference it in the description.)

B. Describe prior, relevant research findings and the importance of the knowledge expected to be gained through this research. Please limit the description to five sentences. (If a funding or similar proposal includes an extended overview of relevant research findings, please attach the proposal and reference it in the description.)

C. Describe all geographic and/or institutional sites at which the research will be conducted. Multi‑sited research projects should provide a list of all research sites. (Please provide as much information as possible, including: country, state, and city or other geographic location, and type of site(s) (e.g., school, lab, office, private home, or public space); and street/mailing address , if applicable).

D. Describe what each subject will be asked to experience or do as part of the research. Please include descriptions of all methodologies to be utilized.

(Attach copies of any questionnaires, ethnographic observations protocols, measurements, interview guides, survey instruments, or similar materials to be utilized as part of the research).

E. What is the expected duration of subjects' participation in the research?

F. Describe the potential direct and indirect benefits to subjects and the importance of the knowledge that is expected to be gained. (Please note that financial compensation is not considered a benefit of the research.)

G. What is the type or amount of compensation for subjects, if any?

H. Describe possible risks to subjects and the procedures that are in place to minimize those risks.

I. Will the research include any of the following items?

(1) Induction of mental and/or physical stress

(2) Procedures that might be regarded as an invasion of privacy

(3) Possible disclosure of information that could be harmful to the subject
J. If YES to Question I, describe and assess the likelihood and seriousness of risk associated with these procedures. Where appropriate, discuss provisions for ensuring necessary professional intervention in the event of a distressed subject.

K. If you will be working with a population or in an area where there is the possibility that subjects might disclose the intention to harm themselves or others, describe the procedures you will follow should this occur.

L. Describe any training in the ethical conduct of human subjects research received by members of the research team; training procedures for research team members who will interact with human subjects through the collection or analysis of subject data; and steps that will be taken to ensure that research team members are aware of procedures in place to protect the rights of study participants.

III. Human Subject Information and Interaction:


A. Describe the procedures for subject recruitment.

B. Describe if advertisements be used for subject recruitment and, if so, attach any flyers, advertisements, announcements, postings, emails, letters and web-page scripts to be used to recruit subjects.

Human Subject Population
A. Will the research involve direct interaction with human subjects? if not, then, describe datasets or other information that will be collected without direct contact with individuals?

B. How many subjects does this study anticipate enrolling? (include proportion of gender)

C. What are the exclusion or inclusion criteria for subject population(s) enrollment?

D. Describe the subject population, including age-ranges, gender, race/ethnicity/nationality, foreign nationals. Be sure to specify specific age ranges for subjects who will be under 18years of age (note that if any subjects under 18 years of age will be enrolled, all application regulations for the inclusion of children apply under 45 CFR 46 subpart D.

E. Vulnerable Populations (check all that apply):

Children (State of IL identifies children or minor as persons under 18 year of age and who are not emancipated)
Individuals who are cognitively impaired

Individuals who are decisionally impaired

Individuals who live outside of the U.S. or non-native English speakers
Prisoners or legally detained individuals, including pre-trial persons (if yes, see below for additional questions)
Pregnant women
University of Chicago students

F. Specify Proposed Consent Procedures– Any forms or scripts used as parts of the consent process must be included with this application for review by the IRB. For consent form templates and resources, click here. http://sbsirb.uchicago.edu

Check all that apply for type of consent(s) below:
Signed Written Consent will be sought from the subject or the subject’s legally authorized representative.
Verbal Consent/Waiver of Signed Consent (Confidentiality). The requirement to obtain a signed consent form will be waived because the only record linking the subject and the research would be the signed consent document, and the principal risk would be potential harm resulting from a breach of confidentiality.(Each subject will be given the choice of signing or not signing a consent document that links the subjects the research data.
Verbal Consent/Waiver of Signed Consent (Minimal Risk). The requirement to obtain a signed consent form will be waived because the research presents no more than minimal risk of harm to subjects, and involved no procedures for which written consent is normally required outside of the research context.
Waiver or Alteration of Informed Consent. All of the following conditions much be met in order for the research to be eligible for the waiver or alteration of informed consent:

  1. The research presents no more than minimal risk of harm to subjects; (2) The waiver or alteration will not adversely affect the rights and welfare of the subject; (3) The research could not practicably be carried out without the waiver or alteration; (4) Whenever appropriate, the research subjects will be provided with additional pertinent information after participation.

F1. Provide a detailed description of the process that will be used to obtain subjects’ informed consent. Be sure to mention who will be responsible for obtaining consent, when consent will be obtained, how it will be sought (written/verbal/waiver), whether or not there is an ongoing consent process, and how subjects’ understanding of the terms of the consent will be verified.

F2. If a waiver or alteration of informed or of written consent is requested, please indicate the reasons for the waiver request.

F3. If subjects are unable to give consent (e.g., children or mentally incompetent), describe how and by whom permission will be granted.

F4. For research involving children, provide information about how assent will be sought from subjects and, if applicable, attach an assent form/script.

F5. If a waiver of parental consent and/or children assent are requested, provide the rationale and indicate whether the research meets the four conditions as listed above in “Waiver or Alteration of Informed Consent.”

G. If applicable, specify PRISONER RESEARCH
G1. Any there possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison? If so, are the advantages of such a magnitude that it would impair a prisoner’s ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison?

G2. Do the risk(s) involved in the research commensurate with risks that would be accepted by non-prisoner volunteers?

G3. Will the procedures for the selection of subjects within the prison be fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners? Unless the principal investigator provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project. Unless the principal investigator provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.

G4. Will researchers present to the subjects in a language that is understandable to the subject population? If not, why.

G5. Does adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research and that it will have no effect on his or her parole?

G6. Where there may be a need for follow-up examination or care of participants after the end of their participation, have adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners’ sentences, and for informing participants of this fact?

G7. In your opinion, does the research fall into one of the permissible categories below? The research in categories (A) and (B) must present no more than minimal risk and no more than inconvenience to the subjects. Note that for research with prisoners, minimal risk means the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
(a) study of the possible causes, effects, and processes of incarceration , and of criminal behavior.

(b) study of prisons as institutional structures or of prisoners as incarcerated persons.

(c) research on conditions particularly affecting prisoners as a class (for example, research on hepatitis which is much more prevalent in prisons that elsewhere, and research on social and psychological problems such as alcoholism, drug addiction and sexual assaults).

(d) research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well being of the subject.

IV. Subjects Data Questions:
A. Outline the steps that will be taken to ensure the confidentiality of data.

B. Will subjects be video or audiotaped?

Ba. If Yes, provide a rationale for taping, describe confidentiality procedures and what will become of tapes after use (e.g., destruction, archiving) and a reasonable timeline by which this disposition will occur. Also, be sure to include a speate signture ine for permission to tape in the informed consent documentation. Where written consent is waived by the IRB, subjects should be asked to confirm their consent at the start of the tape.

C. Will any information that directly or indirectly identifies individual research participants be retained (e.g., names, social security numbers, physical descriptions, addresses, etc.)? Please note that this includes contact information for initial and follow‑up interview scheduling and signatures on informed consent documents and payment/course credit tracking forms.

Ca. If Yes, provide a rationale for collecting or retaining these identifiers.

D. Will these identifiers be included in data files or a master list linked to data files (e.g., a master subject code list)?

Da. If Yes, explain why this is necessary, how the master list or data files will be secured, and how long it/they will be retained.

E. Will information that could identify the subject be shared or disseminated in any way?

F. Specify the approximate length of time research records will be kept.

G. Describe your plan for presentation and/or publication, data retention, and future use of records.

H. If a bilingual interpreter will be used, specify the procedures that are in place to ensure that the interpreter maintains confidentiality. Indicate as well the individual or organization for whom the interpreter works and the recruitment process for the interpreter.

V. Site Location Where Research will be Conducted, including International Sites:

  1. Where will the research be conducted (specify the geographic location as well as the performance site.

  1. For international sites, has the research undergone IRB or an ethics committee review from the host country or performance site?

  1. Specify your familiarity with and/or knowledge of the local research context.

  1. Specify whether there are any additional risks subjects might face as a result of the population being studies and/or the local research context.

  1. Please address each of the following questions in the space below:

  1. In what language(s) will the research be conducted?

  2. Are you fluent in this language, or will a translator be used?

  1. If a translator will be used, does this pose any additional risk to subjects to protect confidentiality?

VI. Type of Review Requested. (see last three pages of this application called Expedited Review, Exempt Studies or Full Committee Review, please indicate which type of review (exempt, expedited or full) the researchers are requesting. Click either exempt or expedited categories boxes or indicating full committee review).

VII. Review Questions

A. Have the following items been included with this submission, as appropriate?
Recruitment Scripts/Ads, Interview Guide(s), Survey samples, named Standardized Testing Instruments, Confidentiality Agreements or Data Use Agreement, Consent Script/Forms, Debriefing Statements, Grant Proposals, copies of IRB approvals and Permission Letters to conduct research at a particular site.

B. Conflict of Interest: Researchers involved in the design, conduct, or reporting of research involving human subjects have a special obligation to avoid bias or the appearance of bias in their research.
Does any participating faculty member, staff, students (or his/her spouse or dependant students and employees) have any personal financial outside interest such as royalty, equity or any other payments (e.g., consulting, salary, etc.) from the sponsor of the research or any commercial interest in any intellectual property, product, or service which is the subject of the proposed research?

C. Does the outside financial interest involve holding ownership interest in the (potentially) benefitting company?
D. Does the financial relationship involve in any way the proposed research involving human subjects?
D1. If yes to any of the above questions, indicate whether your potential conflict of interest has been disclosed to the Provost's Office as required by University of Chicago policy. (Reference: Click here )

Endorse Protocol
You must endorse the protocol before submitting it by signing below or having the principal investigator send us this application via an email from his/her email address.

I will obtain informed consent from all subjects unless a waiver or alteration of the informed consent process was approved by the IRB.

I will report to the IRB any harmful effects to the subjects.

I will renew my application if the research extends beyond one year.

I will gain IRB approval before altering the research protocol, recruitment materials, or consent forms.

I will protect the rights and welfare of human research subjects and comply with the provisions of the University of Chicago's Multiple Project Assurance.
By checking this box and providing your full name and password (below), you signify that you agree to abide by the statements above for this submission.
Your Full Name
Submit Protocol
Note: Only the PI of the project may submit the protocol directly to the IRB. If you are not the PI, you MUST forward the proposal to the PI for approval (UNLESS you are responding to a request from the IRB for modifications to the submission).

Expedited Review, Exempt Studies or Full Committee Review
Expedited Research Categories can be applied if the research is minimal risk. An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in §46.110. (boxes 3, 4, 5, 6 and 7 are common in Social and Behavioral Sciences)

Expedited Research Categories

Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) excreta and external secretions (including sweat); (c) saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; or (d) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;

Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment, diagnosis, school records, performance evaluations).


Collection of data from voice, video, digital, or image recordings made for research purposes.

Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. §46.101(b). This listing refers only to research that is not exempt.

Continuing review of research previously approved by the convened IRB as follows:

where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or

where no subjects have been enrolled and no additional risks have been identified; or

where the remaining research activities are limited to data analysis.

Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.


Exempt Studies Categories --§46.101(b). Exempt studies involve no risk, and must fit one or more of the following categories below. (NOTE: These exemption categories below do not apply to research involving prisoners (45 CFR Part 46 Subpart C), and Category 2 does not apply to research with children (45 CFR Part 46 Subpart D) except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observations of public behavior when the researcher(s) do not participate in the activities being observed.)

Exempt Studies Categories
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Full Committee Review is conducted on a monthly basis at a convened meeting by the IRB. Research that involves more than minimal risk, or research involving persons who are incarcerated or research involving cognitively-impaired people are required to be reviewed at full committee meetings.
Other research that may constitute full committee review can involve studies that involve experimental deception likely to result in emotional or psychological distress, non-exempt or non-expedited research involving minors - under the age of 18 that involves topics such as abuse, drug use, sexuality, illicit behavior and other sensitive, private activities, or studies that specifically target human fetuses and involving pregnant women.

Download 76.55 Kb.

Share with your friends:

The database is protected by copyright ©ininet.org 2024
send message

    Main page