IS MY PROJECT CONSIDERED RESEARCH BY THE IRB?

“Research” is a systematic investigation designed to develop or contribute to generalizable knowledge.  This is the definition of research given by the Common Rule (the federal regulations that guide us at Lourdes University).

So what does “generalizable knowledge” mean?
In order to contribute to generalizable knowledge, the activity’s conclusions are intended to be extended beyond the sample  or internal program.

If you plan to share your findings with a scientific or professional audience it is probably fits the criterion of “generalizable knowledge.”  Results may also be shared via the internet, professional conferences, peer-reviewed journals, etc.

Generalizable Knowledge includes one or more of the following:

• The data is geared for scholars, practitioners, and/or researchers within a specified field of study
• Results of the study are presented either by presentation and/or publication in order to illuminate some topic/issue within one’s field of study
• Results from the study are applied to some population in addition to the sample
• The study’s results can be replicated by others
• The study provides input into some field of study

Generally, research does NOT include:

• Classroom activities that teach research methodologies or simulate research activities
• Activities conducted to improve the quality of teaching in a particular classroom
• Activities required for quality assessment (QA) or quality improvement (QI)
• Institutional research studies that are not intended to be generalized beyond Lourdes University.
• Interviews of individuals where questions focus on things not on people(e.g. questions about policies, general facts about an organization or a business)
• Evaluation of speakers or other presentations conducted for the purposes of improving the presentation the next time
• Searches of existing literature or analysis of aggregate or public data that cannot be linked to a living individual (e.g. data sets available on the web that do not require any sort of privacy/confidentiality agreement or special request procedure, newspaper accounts, census data held in public libraries, published school test scores).  However if access to data is limited to researches and not publicly available, then IRB review is needed.

If you are not sure if the research you are proposing is covered by these rules and regulations, check with the Office of the IRB.

DOES MY PROJECT INVOLVE HUMAN SUBJECTS?

The IRB only reviews research that involves human subjects.

So what is a human subject?
According to the federal regulations, a human subject is a living individual about whom a research investigator (whether a professional or a student) obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.

The definition continues:
“Intervention includes both physical procedures by which data are gathered (for example, drawing blood) and manipulations of the subject or the subject’s environment that are performed for research purposes.”
“Interaction includes communication or interpersonal contact between investigator and subject.”

“Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects”

So what is Human Subject Research?
Putting these definitions together, human subjects research covers a wide variety of activities, including studies of:

• Data from surveys/questionnaires, interviews, focus groups (only if focus group information is generalized outside the group to the general population) and observation
• School or correction records
• Employment information or records of earnings
• Bodily materials, such as cells, blood, urine, tissues, organs, hair, nail clippings, or DNA, when these are linked to specific individuals
• Analysis of existing data (e.g., medical records, school records)
• Cognitive and perceptual experiments
• Case Studies

WHAT IS “EXEMPT” RESEARCH AND COULD MY PROJECT BE EXEMPT?

Exemption Doesn’t Mean You Don’t Apply
The IRB must determine whether your research is exempt by seeing if it fits into one of the covered categories.  If you think your research falls into one of the categories below you need to fill out a brief form describing your research.  We ask you to identify which category you think applies to your research that makes it exempt.

What Are The Exemption Categories, and Can You Give Me Some Examples?
The regulations are not easy to understand but examples help.

Exemption #1
Research conducted in established or commonly accepted educational settings, involving normal educational practices such as

• research on regular and special education instructional strategies, or
• research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

An established educational setting is any place where instruction would take place.  Typically this would be a school setting, but it might also include libraries, training centers, or workplaces such as hospitals.

Normal educational practices are activities that typically occur in a classroom or other educational setting. Examples of normal educational practices include:

• Test development
• Innovative instructional methods
• Assessment of attitudes about learning or curriculum
• Evaluation of classroom or school activities
• Use of educational tools such as computers or smart phones

When assessing a “normal educational practice”, the IRB will consider whether the proposed research involves an educational “best practice” that should benefit students and support the curriculum already required in that setting.  Even when research is exempt, researchers using student education records must meet the requirements of FERPA.

Examples EXEMPT research under this criterion:

• Development and testing of a project-based science curriculum that meets state standards but presented in an innovative manner.  Data are collected via tests, student attitude surveys, and classroom observations.
• Use of electronic “clickers” in the classroom to elicit immediate feedback from students on the understanding of lesson concepts.  Data are collected via survey and evaluation of student grades.
• Comparing a new and a standard math curriculum both currently being implemented in the school.  Researchers will observe classrooms as well as interview instructors about their experience implementing the instructional methods (but not about specific students).
• Assessment of classroom management strategies used in Special Education classrooms.
• A study comparing driver’s education curricula offered by area driving schools.  The researchers will observe classes and compare driving test scores at the end of the courses.
• Evaluating the use of accepted or revised standardized tests.
• Testing or comparing a curriculum or lesson
• A program evaluation of pharmacy continuing education.

Examples of school based research that would NOT be exempt:

• Projects involving instructional or classroom management techniques that would not be considered educational best practice (e.g. implementation of an untested curriculum).
• Interviews or surveys that collect information focused on characteristics of the children rather than on the educational activity being evaluated.

Exemption #2

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:

• Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
• 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.

Exemption 2 is limited to adults except for educational tests of public observation where the researcher does not interact with the child subjects.

Many survey/interview projects fall into this exemption, particularly where the data are collected anonymously.

Projects that collect identifying information but do not collect data that could pose a reputational risk to respondents also qualify for this exemption.  Examples of information that might put the subject at risk of harm include disclosure of illegal activities, sexual behaviors, sensitive genetic or medical information or embarrassing behaviors in the workplace.

Examples EXEMPT research under this criterion:

• Minimal risk surveys of consumer attitudes and opinions collected monthly.
• Anonymous survey of sexual behavior.  In this case, the IRB must be careful to ensure that the data cannot be linked back to the respondent in any way.
• Observation of behavior in a public park.  Note that a school or place of business is not considered to be “public”.
• Surveying teachers, nurses or doctors about a technique or an outcome.
• Interviewing managers about a management style or best practice
• Conducting a focus group about an experience or an opinion of a community program
• A study involving a focus group with expectant mothers regarding their perceptions of parenting education.
• A study involving an anonymous survey regarding workplace satisfaction at area firms.
• An observational study of pedestrians crossing a street; the research takes notes of what occurs, recording sex, race, and type of clothing of pedestrians, but does not interact with subjects.
• A study involving interviews with college seniors about their plans after graduation.  The answers to questions asked would present no risk to subjects if divulged outside the research and all subjects are over 18.
• A survey of college students on their use of the internet.
• Observing adult and child interactions at a soccer game (as long as the researchers do not interact with the subjects).

Exemption #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.

This exemption is primarily used for surveys or interviews of public officials that would not meet the criteria for Exemption #2.

A public official is considered to be an elected or appointed official (or candidate for office). Public employees are not considered to be “public officials.” The superintendent of schools would be a public official; a teacher would not. A senator would be a public official; a member of their staff would not. There is clear guidance regarding the federal statutes referred to in the second part of Exemption #3.

An example EXEMPT research under this criterion:

• Interviews with public officials that solicit response to questions about politically sensitive issues that might have an impact on their reputation

Exemption #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.

The key element of this exemption is that the data/specimens to be used for research must be in existence (“on the shelf”) at the time the IRB application is submitted. Also, in order for a project to be exempt, the research must first be considered to be research with human subjects, meaning that investigators must have access to identifiable private information. Projects involving the analyses of de-identified or coded data where the investigator does not have access to the key would not be considered to be research with human subjects and do not meet the criteria for this exemption.

Examples EXEMPT research under this criterion:

• Retrospective chart review where the researcher has access to identifiable data but does not record it for research purposes.
• Projects that use personally-identifiable public data such as drivers license information.
• Analyzing de-identified national test scores
• Analyzing census data about aging or housing

Exemption #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

This is Federal Government Research. Projects qualifying for Exemption #5 must be conducted pursuant to specific federal statutory authority. Researchers should consult with their funding agencies for guidance as to whether a project might qualify for this exemption.

An example EXEMPT research under this criterion:

• Research sponsored by the Department of Housing and Urban Development to assess the effectiveness of a housing subsidy program

Exemption #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.

The key element of this exemption is that the research can only involve foods that are known to be safe.

Examples of EXEMPT studies under this criterion:

• Taste testing whole grain food products
• Comparing taste or smell of molasses, cheese or milk
• Sampling texture of ice cream
• A taste test of different varieties of a fruit to determine consumer preference, when the fruits do not have any additives and subjects are asked to indicate the fruit they prefer

NONE OF THIS APPLIES TO MY RESEARCH, SO WHAT NOW?

Don’t worry.  Although your research will need to be reviewed by the IRB, we are here to help you.  You will need to fill out the IRB application that describes your research, the risks and benefits of your research including the risks to the patients privacy, how you will protect and recruit the subjects.

Your research may fit into one of the categories for expedited review if it is of minimal risk and fits into one of the 9 specific categories.  Expedited reviews, as the name suggests, are reviewed more quickly than a full board review.  We will do our part to move this along but will require you to respond promptly to questions and suggestions.

• • Determine if your application falls under the Exempt or Expedited review process as outlined in the “Getting Started” section.
  • Required CITI Training.
    • CITI Education
    • Learner Group Modules (PDF)
  • Fill out the appropriate application in its entirety. The Verification of Exempt Application and the Application for Research Using Human Subjects Application can be found in the Forms section of this page. Please work closely with your advisor during this process.
  • Submit the electronic version of your application and all supporting documents (i.e. informed consent form) to irb@lourdes.edu.
  • The IRB Office will check the application for completeness. If items are missing, the investigator will be informed and asked to submit them.
  • The results of the review will be communicated to the investigator (and faculty advisor, if applicable.) The investigator may respond in writing to any IRB stipulations.
  • Exempt and Expedited reviews generally take 7-10 business from the time the submission of the application and all supporting documents are deemed complete.
  • If an application must be reviewed by the Full IRB Committee, reviews typically take place on the first Thursday of each month during the academic year. Follow up communications will be sent to the Investigator within 7 business days of the IRB meeting. The IRB will decide whether to approve the research without modification, require modifications prior to approval, table or disapprove the research.

  When the IRB has approved the research, the researcher will receive an approval letter and may begin the research. Under no circumstances may research begin until the IRB approval letter is received.

  HELPFUL TIPS AND EXAMPLES

  Top 10 Tips for a Successful IRB Application

  IRB Sample Application

Lourdes University requires all Lourdes students, faculty, and staff involved with human subject research to complete the training mandated by our Federal Wide Assurance. All individuals need to complete the Collaborative Institutional Training Initiative (CITI)  training before being approved as a member of the research team. The steps for Initial Human Subject CITI training are as follows:

1. Go to CITI Training Website.
2. New Users select Register Here.
3. Select Lourdes University as the institution.
4. Enter any personal information requested.
5. On the Select Curriculum page, choose “Yes, I conduct research with live human beings, human samples or with data derived from human beings.”
6. On the next page, select either Social Behavioral Researchers & Students OR Biomedical Researchers & Students.
7. Select Enter under Status and begin your training.

*Please print or save an electronic version of your competition certificate as the IRB Office will ask for verification with the application. For any questions regarding CITI, please email the IRB.

Note: These definitions are guidelines. Before engaging in any human subjects research, please contact the IRB for a determination of review requirements. Source: United States Department of Health and Human Services Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects

Anonymous Data: refers to research information that is collected without any personal identifiers. An example would be survey research that does not ask for the participants’ names or any other form of personal identification.

Benefit: is a research outcome that may be valuable or desired by participants, for example learning about ways to increase academic success. Note: a payment or reward for research participation is not a benefit.

Children: are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.402(a)]

Confidentiality: means the protection of private information that an individual has disclosed in a relationship of trust. Research participants are frequently asked to provide personal or private information for the purposes of the research. In some research, the private information could be linked to the individual participant. For example, a research study on improvement in student achievement might include work products with individual children’s names. In the informed consent process the researcher explains exactly what will be done with the private information and what he or she will do to keep the information confidential–safe from any other type of disclosure. [see Privacy]

Engaged in Research: In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. For a detailed discussion, see http://www.hhs.gov/ohrp/policy/engage08.html.

Exempt from Further IRB Review: When the IRB Office receives an Application, the IRB Chair and IRB Coordinator will determine whether it may be considered exempt from further IRB review. To be considered exempt, the research may only involve human subjects in one of 6 categories. Briefly described, these are:

1. Research conducted in normal educational settings, using normal educational practices.
2. Anonymous educational tests, surveys, interviews or observations
3. Types of educational tests or surveys when the research subjects are public officials
4. Collection or study of existing data if individuals cannot be identified
5. Investigation of public benefit or service programs
6. Taste and food evaluations and acceptance studies.

Please see the Research Application form and 5 CFR 46.101(b) for full details. See Research Involving Children

Expedited Review: Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through an expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review—expedited or convened—utilized by the IRB. Categories one (1) through seven (7) pertain to both initial and continuing IRB review. Briefly described, the categories of research that may be reviewed using an expedited procedure are:

1. Clinical studies of drugs and medical devices only when an investigational new drug application is not required, or an investigational device exemption is not required.
2. Collection of limited amounts and frequency of blood samples by finger stick, heel stick, ear stick, or venipuncture from certain categories of adults and children.
3. Prospective collection of biological specimens for research purposes by noninvasive means and in a nondisfiguring manner, such as hair and nail clippings, saliva, or mucosal and skin cells collected by swab.
4. 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.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. 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.
8. Continuing review of research previously approved by the convened IRB as follows:
   (a) 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
   (b) where no subjects have been enrolled and no additional risks have been identified; or
   (c) where the remaining research activities are limited to data analysis.
9. 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.
10. For further details, please see the Research Application form, 45 CFR 46.100 and Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure. Office for Human Research Protections (OHRP).

Full IRB Committee Review: is required for research that is neither exempt from further IRB review nor expeditable.

Human Subject: A human subject is a living individual with whom an investigator interacts in order to gather private information. Gathering information about deceased individuals is not an activity subject to IRB review. However, caution is needed because the health privacy law (HIPAA) does mandate review of research that gathers information about deceased individuals. [45 CFR 46.102(f)]

Intervention and Interaction: Interventions include physical procedures such as drawing blood as well as manipulation of the subject or the subject’s environment for research purposes, as might occur in a classroom setting. Interactions are conversations and interpersonal contact between the investigator and the subject. Examples are interviews, telephone conversations, focus groups, classroom observations and email interchanges [45 CFR 46.102(f)(2)].

Individually Identifiable Information: Some information gathered by researchers contains data points that allow the researcher or others to determine who has provided the information. Identifiers include, but are not limited to names, social security numbers, student ID numbers, date of birth, addresses, videos and photos. Researchers should be aware that with very small sample sizes, especially in qualitative research, it can be relatively easy to piece together a subject’s identify from anecdotal information. Assigning pseudonyms in this type of research will usually not prevent identification.

Informed Consent: A person’s voluntary agreement to participate in research. Informed consent is a process, not only a document. The researcher must ensure that the person receives enough information to clearly understand what the person will be asked to do in the research project. IRB’s devote a great deal of attention to informed consent documents and processes. Federal regulations require that certain pieces of information are included in informed consent documents. For a checklist of informed consent requirements, see http://www.hhs.gov/ohrp/policy/consentckls.html.

Institutional Review Board (IRB): is a committee that is established in accordance with federal policy for the protection of human subjects. [45 CFR 46.102(g)]

IRB approval: means the determination of the IRB that the research reviewed may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. [45 CFR 46.102(h)]

Minimal Risk Research: is research that will most likely be safe for participants and not expose them to any type of harm. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. [45 CFR 46.102(i)]

Principal Investigator: The principal investigator is the researcher who is responsible for the ethical conduct of the research protocol. Responsibilities include safeguarding the rights and welfare of human subjects, conducting the research according to the IRB-approved protocol, promptly reporting any adverse effects or subject complaints, submitting an amendment request if any changes are being considered, and submitting a Continuing Review form for any research expected to continue beyond the initial approval period.

Privacy: The OHRP online guidebook defines privacy as “control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.” Loss of privacy is considered to be a risk factor.

Privacy includes both personal behavior and information that a person has provided for other purposes. In most daily situations, individuals can reasonably expect that their behavior is not being observed or recorded; for example in a public park, store fitting room, or restroom. Unless persons have been told that there are security cameras in operation, they can assume that no one is watching them. Researchers must inform participants about any method involving observation or recording of personal behavior 45 CFR 46.102(f).

Individuals often provide private information for purposes such as education, social or psychological services, or medical care. Individuals expect and trust that this information will not be made public. Researchers who wish to access this private information must obtain informed consent from research participants [See Confidentiality]

Private Information: includes both personal behavior and information that a person has provided for other purposes. In most daily situations, individuals can reasonably expect that their behavior is not being observed or recorded; for example in a public park, store fitting room, or restroom. Unless persons have been told that there are security cameras in operation, they can assume that no one is watching them. Researchers must inform participants about any method involving observation or recording of personal behavior.

Also, individuals often provide private information for purposes such as education, social or psychological services, or medical care. Individuals expect and trust that this information will not be made public. Again, researchers who wish to access this private information must obtain informed consent from research participants [45 CFR 46.102(f)(2)].

Research: in general is any form of investigation that seeks to contribute to generalizable knowledge [45CFR 46.102(d)]. Research includes many different styles of inquiry, including scholarly investigation, survey research, and experimental research. What these styles have in common is the process of posing a question, gathering data, analyzing information, drawing conclusions and publishing results for the wider scholarly community. Research subject to IRB review and approval involves interacting with human subjects to gather private information that is individually identifiable. [45 CFR 46.102(d)]

Vulnerable Adult: is any person older than age 18, or emancipated by marriage who has a substantial mental or functional impairment.

Additional Resources

• Office of Human Research Protections (OHRP)
• Expedited Review
  • Procedures
  • Categories
• Human Subject Research Regulations, OHRP
  • Decision Charts on Human Subjects Regulations
  • Guidance
  • Frequently Asked Questions
• Informed Consent
  • Checklist
  • Frequently asked questions
• Institutional Guidance
  • Institutional Engagement in Research
  • Institutional Review Boards Membership and Functions

The Belmont Report
The Belmont Report summarizes the basic ethical principles in human subject research.  It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution’s Belmont Conference Center supplemented by the monthly deliberations that were held over a period of nearly four years. It is a statement of basic ethical principles that should guide the resolution of ethical problems that may arise during research with human subjects.

The Nuremberg Code
The Nuremberg Code is a set of research ethics principles for research using human subjects.  This code is a result of the Subsequent Nuremberg Trials that took place at the end of the Second World War.  The Nuremberg Code consists of ten points. The Nuremberg Code and the related Declaration of Helsinki are the basis for the Code of Federal Regulations Title 45 Volume 46 which are the regulations issued by the United States Department of Health and Human Services governing federally-funded human subjects research in the United States.  The Nuremberg code includes such principles as informed consent, absence of coercion  and beneficence towards experiment participants.

World Medical Association Declaration of Helsinki (PDF)
The World Medical Association developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.  The fundamental principle is respect for the individual and the right to make informed decisions  regarding participation in research.  The investigator’s duty is solely to the patient or volunteer.  In addition, the subject’s welfare must always take precedence over the interests of science and ethical considerations must always take precedence over laws and regulations.

APPLICATIONS

Reminder: Before you begin filling out the application, be sure to save it to either your desktop or an easily accessible location on your device.

• Application for Research Using Human Subjects
• Verification of Exempt Research

SAMPLE INFORMED CONSENT FORMS

• Adult Informed Consent w Signatures
• Adult Informed Consent w/o Signatures
• Child Written Consent
• Child-Verbal Informed Consent
• ProMedica Adult Informed Consent
  This informed consent form is to be used for projects that are conducted at any ProMedica facility.
• Parent/Guardian Permission

WAIVERS – INFORMED CONSENT

• Request to Waive Documentation of Informed Consent
• Request to Waive Informed Consent Requirements

PERMISSION FORMS

The following forms require a hard signature. This means that the forms must be signed, scanned and submitted along with the IRB Application:

• Agency Permission Form
  This form shows that permission has been granted to the investigator for access to the necessary data/resources/employees to complete the study.

AMENDMENTS AND CONTINUING REVIEWS

• Amendment Request
• Continuing Review

COMPLETION OF PROJECT

• Project Closure Form

United States Department of Health and Human Services Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects 45 CFR §46.101- §46.504

Decision charts – Is it research? Must it be reviewed? Is Informed consent needed?: The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comment on these decision charts. The charts address decisions on the following:

• whether an activity is research that must be reviewed by an IRB
• whether the review may be performed by expedited procedures
• whether informed consent or its documentation may be waived

Important Considerations

The charts are intended to assist IRBs, institutions, and investigators in their decision-making process and should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.

Decision Charts

Institutional Review Boards

U. S. Food and Drug Association (FDA) Title 21 Part 56: Institutional Review Boards

RESEARCH INVOLVING CHILDREN

Federal regulations require special protections for children (45 CFR 46 Subpart D, Additional Protections for Children Involved as Subjects in Research.) The majority of studies involving children require full IRB review. If your research involves children, include in your Application a completed Research on Children (Persons under the age of 18) form.

OFFICE FOR HUMAN RESEARCH PROTECTIONS (OHRP) SPECIAL PROTECTIONS FOR CHILDREN AS RESEARCH SUBJECTS

General Regulatory Background:
HHS regulations at 45 CFR part 46 include subpart D, Additional Protections for Children Involved as Subjects in Research. All studies involving children, conducted or supported by HHS, which are not otherwise exempt, require IRB review in accordance with the provisions of subpart D. If an institution’s IRB does not believe the proposed research meets the requirements of 45 CFR 46.404, 46.405, or 46.406 of subpart D (described below), but finds and documents that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children (in accordance with HHS regulations at 45 CFR 46.407(a)), the IRB or other appropriate institutional official may submit the protocol and supporting materials to OHRP for HHS consideration under the provisions of 45 CFR 46.407(b). Before submitting a protocol to OHRP, the IRB must determine that, in addition to meeting the requirements of 45 CFR 46.407(a) and other applicable sections of subpart D, the proposed research also meets all of the requirements of 45 CFR part 46, subpart A.

HHS will consult with a panel of experts under 46.407 only when the proposed research is conducted or supported by HHS. Note that if an institution has elected in its assurance to apply all of the subparts of 45 CFR part 46 to all of its human subjects research regardless of the source of support, and the IRB finds that the proposed research meets the conditions for review under 46.407, the IRB is not required to submit the protocol to OHRP for review if the research under consideration is not supported by HHS. In such cases, OHRP recommends that the institution consult with appropriate officials at the relevant federal agency or department supporting the research. When such research is supported by a non-federal sponsor, OHRP recommends that the institution consider convening an independent panel of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law) and provide an opportunity for review and comment by the local community where the research is to be conducted before deciding whether to proceed with the research. Subpart D permits IRBs to approve three categories of research involving children as research subjects:

45 CFR 46.404 – Research not involving greater than minimal risk to the children. To approve this category of research, the IRB must make the following determinations:

• the research presents no greater than minimal risk to the children
• adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408

45 CFR 46.405 – Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child subjects involved in the research. To approve research in this category, the IRB must make the following determinations:

• the risk is justified by the anticipated benefits to the subjects
• the relation of the anticipated benefit to the risk presented by the study is at least as favorable to the subjects as that provided by available alternative approaches
• adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408

45 CFR 46.406 – Research involving greater than minimal risk and no prospect of direct benefit to the individual child subjects involved in the research, but likely to yield generalizable knowledge about the subject’s disorder or condition. In order to approve research in this category, the IRB must make the following determinations:

• the risk of the research represents a minor increase over minimal risk
• the intervention or procedure presents experiences to the child subjects that are reasonably commensurate with those inherent in their actual, or expected medical, dental, psychological, social, or educational situations
• the intervention or procedure is likely to yield generalizable knowledge about the subject’s disorder or condition which is of vital importance for the understanding or amelioration of the disorder or condition
• adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408