IRB Guidance

Informed Consent Information

Informed consent is a process that ensures potential participants receive enough information to make an informed, voluntary decision about participating in a research study.

Key features of informed consent:

1. Disclosure of relevant information.
2. Facilitation of participant understanding.
3. Promotion of voluntariness.

Consent must be obtained before participation and must be legally effective.

Basic elements of an informed consent form include:

• A statement that the study involves research, with its purpose, duration, and procedures.
• A description of risks, discomforts, and benefits.
• Any appropriate alternatives to participation.
• Information on confidentiality protections.
• Compensation and medical treatment details (for studies with more than minimal risk).
• Contact information for questions and concerns.
• A clear statement of voluntary participation.

Waiver or Alteration of Consent
Under specific conditions, the IRB may approve:

• A waiver of consent, such as for studies where informing participants would bias results.
• An alteration of consent, where certain elements are modified or omitted (e.g., not revealing the full purpose of the study).

All such cases must meet federal OHRP Human Research Protection Program (HRPP) criteria.

Privacy and Confidentiality Information

The Department of Health and Human Services oversees the protection of human subjects for biomedical, behavioral, clinical, and other research as cited in Public Health Service Act §301(d), 42 U.S.C. §241(d). To meet federal requirements, the IRB committee must consider both privacy and confidentiality in reviewing a study in its entirety. Below, we identify terms and strategies for researchers related to private information, privacy, and confidentiality. 

Private Information

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) [45 CFR 46.102(e)(4)]. Private information must be considered in addressing the privacy of human subjects.

Privacy

Privacy is the state or condition of being free from being observed or disturbed by other people. The term privacy in research refers to the individual’s right to control personal information and their identity. To maintain a subject’s privacy, the researcher must consider how to store and disseminate research findings to maintain confidentiality. 

Confidentiality

Confidentiality is the protection of research participants’ privacy from disclosure of their personal, sensitive, or private information to unauthorized persons. This includes methods used to ensure that information obtained by researchers about their research participants is not improperly divulged.

Strategies to Maintain Privacy and Confidentiality

Per the U.S. Department of Health & Human Services guidelines, the researcher should explain the following in the IRB submission:

• Where data will be stored,
• Who will have access to the data collected, and
• How the identity of participants will be kept private, for example, using a coding system on data records, limiting access to records, or storing identifiers separately from data. 

For further information related to acceptable IRB language and practices, please visit the U.S. Department of Health & Human Services.

Compensation Information

24.1 Compensation can include remuneration that is monetary (cash, gift cards, vouchers, etc.) and/or non- monetary (gifts/promotional items, course credit, extra credit, etc.).  Rewards such as course credit or goods with local monetary value should be forms of payment to study participants. Usually, researcher level the payment amount on the average wage in the location where the research is conducted. For monetary or gift, recommended value starts $10 to $50 depends on the degree of participation.  The appropriate level of payment is contingent upon a variety of factors. However, it should be a reasonable amount of value that cannot affect to subject’s decision to participate in the research.  Payment should not depend on the degree of risk with participation. 

24.2 A&M-Texarkana prohibited finder’s fees or referral fees to colleagues.  University employees may not accept gifts, payments, or in-kind support including financial payments, gift certificates, books, conference attendance and payment of travel expenses.

24.3 Investigators with only $200 to compensate 100 subjects need to propose a drawing for two $100 prizes rather than paying each subject $2. University research projects cannot distribute of prizes to the research subjects via chances purchased by the human subjects or obtained by them in exchange for something of value (e.g., money, human tissues, or blood samples).  Use of incentives such as “door prizes” may be considered by the IRB on a case-by-case basis for research studies of minimal risk if the proposed incentives do not have potential for coercion or undue influence.  While the incentive should avoid terms like “lottery” or “raffle,” acceptable terminology might include a reference to a “drawing based on chance in which each subject has equal odds of receiving [the incentive].”

24.4 Social security number (SSN) might be used when the SSN is collected as required by law, to comply with Internal Revenue Service (IRS) reporting requirements or may be collected as a unique identifier to help match research datasets. SSN should not be collected until the need for the SSN has been clearly documented and approved by the IRB.

24.4.1 Per university policy, investigators are required to collect and report SSN and related information when total payment(s) to an individual research subject will exceed $200 per calendar year.  Use as a unique identifier for a national registry or database where there is a potential for duplicate registration and no other means of unique identification exist.

24.4.2 For amounts that will total less than $200 per calendar year, investigators are not required to collect SSN if payments are made using a cash advance approach (e.g., gift cards or “petty cash” accounts).  However, SSN must be collected for checks of any amount issued through the Accounts Payable system.  SSN collection forms are explained in the SOP (pg. 86).

Reporting Adverse Events or Unanticipated Problems

Unanticipated Problems (any incident, experience, or outcome that meets all of the following criteria: 

1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; (b) the characteristics of the subject population being studied; and
2. is related or possibly related to the research (this means that it is more likely than not that the incident, experience, or outcome was caused by the procedures involved in the research); and
3. suggests that the research places subjects or others at a greater risk of harm(including physical, psychological, economic, or social harm) than was previously known or recognized.

Unanticipated problems that are serious adverse events should be reported to the IRB within one (1) week of the investigator becoming aware of the event. Any other Unanticipated Problem should be reported to the IRB within two (2) weeks of the investigator becoming aware of the problem.

Please see A&M-Texarkana SOP Section 19 for more information.

Policy Links

• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• Code of Federal Regulations
• Office of Human Research Protections (OHRP) Engagement Document
• Food and Drug Administration (FDA): 21 CFR 56.102
• OHRP: 45 CFR 46.102
• IRB Guidance on Data Storage using Platforms 

IRB Reliance Agreements

• S. Department of Health and Human Services (HHS): Registration of an Institutional Review Board (IRB)
• Federal-wide Assurance (FWA) for the Protection of Human Subjects

Guidance for Class Research