HRPP Policy - Informed Consent

About This Policy

Effective date:
07/19/2018
Last updated:
01/21/2019
Policy Contact:

IU Human Subjects Office
(317) 274-8289
irb@iu.edu

IU HRPP Documents

Related IRB Questionnaires

  • Questionnaire H - Informed Consent Process
  • Questionnaire J - Child Assent and Parental Consent Process

View KC Crosswalk

Related Forms and Templates

  • IC Template - Biomedical
  • IC Template - Future Research
  • IC Template - Informational Risks Only
  • IC Template - Social Behavioral Educational (SBE)
  • IC Template - VA
  • IC Short Forms - Arabic, Burmese, Chinese, English, French, Italian, Russian, Spanish, Vietnamese, Italian
  • Study Information Sheet – Expedited Template

Browse IU HRPP Forms

Regulatory References

7.0 - Definitions

authorization Per the Privacy Rule, an individual's permission to allow a covered entity to use or disclose the individual's protected health information (PHI) described in the authorization for the purpose(s) and to the recipient(s) stated in the authorization.

biospecimen A quantity of tissue, blood, urine, or other human-derived material. A single biopsy may generate several biospecimens, including multiple paraffin blocks or frozen biological material. The molecular makeup of such specimens reflects the physiologic or pathologic condition of the person from whom they derive; therefore, they provide sensitive and specific insight into the biologic state of the donor. Examples of biospecimens include: subcellular structures (e.g., DNA), cells, tissue (e.g., bone, muscle, connective tissue, and skin), organs (e.g., liver, bladder, heart, and kidney), blood, buccal swabs, gametes, embryos, fetal tissue, saliva or other body fluids, and waste (e.g., urine and stool). Portions or aliquots of a biospecimen are referred to as samples.

clinical investigation (FDA) (see also research) For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).

clinical trial A research study in which one or more human subjects are prospectively assigned to one more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

confidentiality The assurance that certain information about individuals, which may include a subject's identity, health, behavior, or lifestyle information, or a sponsor's proprietary information, will not be disclosed without permission from the subject or sponsor.

federally-funded Supported, either directly or indirectly, by funds provided by the federal government. This includes federal pass-through funding (i.e., received as a subrecipient through subcontracts). Use of administrative services funded by a federal grant, alone, is not sufficient to consider research federally-funded.

fetus The product of conception from implantation until delivery.

HIPAA The Health Insurance Portability and Accountability Act of 1996. See also Privacy Rule.

identifiable biospecimen Biospecimen for which the identity of the subject is or may readily be ascertained by the research personnel or associated with the biospecimen.

identifiable private information Private information for which the identity of the subject is or may readily be ascertained by the research personnel or associated with the information.

identifier Information that can be used to link a sample or scientific result with a specific person or group of people, including any of eighteen (18) identifiers defined by the Privacy Rule and defined in the IU HRPP Policy on Use of PHI in Research, section 2.3, Safe Harbor Method.

informed consent An ongoing process by which a subject (or his/her legal representative) voluntarily confirms his or her willingness to participate in a particular research project in accordance with the IU HRPP Policy on Informed Consent.

interaction Includes communication or interpersonal contact between research personnel and the subject.

intervention Includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

investigator (FDA, see also research personnel, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), student, fellow, resident PI, site-specific PI) In research subject to FDA regulations, an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.

legally authorized representative (LAR) An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective participant to the participant's participation in the procedure(s) involved in the research. For definition of LAR in Indiana, see the IU HRPP Policy on Adult Individuals Lacking Consent Capacity.

life threatening Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the endpoint of the clinical trial analysis is survival. Also includes severely debilitating, meaning diseases or conditions that cause major irreversible morbidity (e.g., blindness, loss of arm, leg, hand, or foot).

minimal risk 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.

principal investigator (see also research personnel, Investigator, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, student, fellow, resident PI, site-specific PI) Responsible leader of a team of research personnel who has the ultimate responsibility for the conduct of the research.

prisoner Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute; individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution; and individuals detained pending arraignment, trial, or sentencing. Examples of individuals considered prisoners are available in the OHRP Prisoner Research FAQs.

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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., medical records).

research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).) The following activities are deemed not to be research under this definition: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

research involving a human being as an experimental subject Per DoD Directive 3216.02, an activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction (32 CFR 219.102(f), reference (c)). Examples of interventions or interactions include but are not limited to a physical procedure, a drug, a manipulation of the subject or subject's environment, and the withholding of an intervention that would have been undertaken if not for the research purpose.

research personnel (See also investigator, IU-affiliated research personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), Student, Fellow, Resident PI, site-specific PI) Individuals engaged in human subjects research; specifically, individuals who interact or intervene with human subjects or access identifiable information for research purposes. May also be called investigators.

sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of research.

test article Any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Food, Drug, and Cosmetic Act or under §351 or §§354-360F of the Public Health Service Act.

written/in writing Writing on a tangible medium (e.g. paper) or in an electronic format.

Back to top